Preliminary Verified (2024)

Zacurate 500DL

by CMS

About this oximeter:

Zacurate made numerous models of pulse oximeters. Many models look similar to those made by other manufacturers.

Click here to see more information.

Fingertip

Type

2.9%

Arms

YES

Signal quality indicator

OpenOx Performance

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

Arms 2.9%

Purchase Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

23

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

820.00

Lifetime Cost

Beta

CMS

Zacurate 500DL

See details

Estimated Lifetime Cost:

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

820.00

Estimated Lifetime Cost:

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

820.00

Purchase Cost

US$

Time to processor replacement

Years

Monthly power cost (e.g batteries)

US$

Lifetime is assumed to be 10 years. Salvage cost at the end of 10 years is assumed to be zero for all devices. Cost of device maintenance or repair is not assumed to be zero. We assume probe and device replacement intervals based on evolving input from clinician collaborators around the world based on device type alone (i.e. fingertip, handheld, etc.), though note these vary widely by setting and manufacturer. These intervals attempt to grossly account for wear and tear, damage or misplacement and theft.

Specification Overview

Manufacturer

Model

Zacurate 500DL

Type

We categorize devices as fingertip, handheld, tabletop, multiparameter, phone-based or wearable.

Fingertip

Reflectance or Transmittance

Some devices may have the capability to function with transmission or reflectance probes. Read more about the difference between reflectance and transmission devices in our FAQ.

Transmittance

Patient population

This indicates the intended patient populations for the device (adult, pediatrics, neonates), as specified by our review of the manufacturers' published specifications. Use in certain patient populations may require procurement of a separate probe.

Adult, Pediatrics

Where made

This indicates the location where the device is manufactured as stated by the manufacturer (or the stated location of the manufacturer). Please note, devices may contain components manufactured in different location.

USA

Ingress Protection (IP)

"Ingress Protection" ratings define levels of sealing effectiveness of devices from foreign bodies (e.g. dust) and moisture. Read more at our FAQ.

IP22

Cost

Here we report retail purchase costs (USD) for buying the pulse oximeter, including one adult finger probe. Costs are obtained from one or multiple sources including manufacturers or online retail stores. Of note, some devices have special discount pricing for low and middle-income countries. The special prices are not accounted for in this report.

$23

Lifetime Cost

Here we estimate the 10-year lifetime cost of ownership for this type of pulse oximeter (Caution: We make many assumptions!). Click the settings button next to the cost to see the formula and adjust these assumptions to your local data.

820.00

Features

Here we report device features such as signal quality indicator, waveform, carboxy-Hb, perfusion index and ability to measure Hb. These are based on review of manufacturers' manuals and may be incomplete.

Extended skin pigmentation performance testing, Extended low perfusion performance testing

Standard Performance info

Manufacturer claimed Arms (root mean square error) for SpO2 70-100%

Here we report the root mean square error (ARMS) as provided in the manufacturer’s product manual or other literature, which may include data from the 510(k) submission.

No data

Independent Arms (root mean square error) for SpO2 70-100%

Root mean square error (ARMS) is a common measure of pulse oximeter device performance that combines bias and precision. Here we report Arms based on Open Oximetry device testing using 2013 FDA Guidelines for 510k submissions and 2017 ISO 80601, while also trying to account for expanded criteria to improve diversity of skin pigment in study cohorts (US FDA "Approach for Improving the Performance Evaluation of Pulse Oximeter Devices Taking Into Consideration Skin Pigmentation, Race and Ethnicity"). Read more about quantification of oximeter performance on our FAQ.

*NOTE: performance is only reported here once we have tested the device in ≥10 study subjects (i.e. as required by 2013 FDA and 2017 ISO requirements). Performance may change significantly as we continue to perform testing in additional subjects and conditions. Please continue to check back as we update frequently. Click the device to see details on how many subjects have been tested as well as details of skin color testing.

2.9%

Independent Arms Study Cohort Size

Currently, there is lack of consensus on optimal study cohort sizes for pulse oximeter validation studies. The 2017 ISO 80601 and 2013 FDA regulatory frameworks stipulate at least 10 subjects, 15% of whom should be darkly pigmented.

We report device results as preliminary once at least 10 subjects have been tested, though continue testing devices in as many diverse participants as we can. We are awaiting updated regulatory guidance for optimal cohort sizes.

44.0

% of study cohort with dark skin pigmentation

Currently, there is lack of consensus on optimal methods for characterizing skin pigment and optimal sample sizes for validation study cohorts. 2017 ISO and 2013 FDA documents stipulate at least 10 subjects, 15% of whom should be darkly pigmented. Here we define ‘dark skin pigmentation’ as Monk Skin Tone Scale HIJ and Individual Typology Angle <-30. For the purpose of data analysis and to avoid operator bias from assigning MST, we use ITA >30 for light, ITA 30 to -30 for medium, ITA < -30 for dark, and ITA < -50 for very dark.

36.4%

Date independent Arms data collected

This is the most recent date that the Open Oximetry Project collected data in the UCSF Hypoxia Lab to assess this device's performance. If ARMS data were obtained from a source other than the Hypoxia Lab, please review the date for that source. Of note, device performance may be specific to a model year (even if the model name has not changed).

05/31/2024

Source of independent Arms data

Root mean square error (ARMS) is a common measure of pulse oximeter device performance. 'ARMS' may be ascertained from manufacturers' published data, 510k reports, package inserts or primary data from testing conducted by the UCSF Hypoxia Lab. Devices independently tested by the Open Oximetry Project will be marked 'verified' or 'failed' depending on study findings.

UCSF Hypoxia Lab

CE-XXXX

Open Oximetry attempts to request CE certificates from manufacturers and distributors though this is not always possible. CE numbers shown here are largely obtained from manufacturer's literature and are unverified by our team. Read more about CE marking in our FAQ..

CE -

Extended Performance info

Peer reviewed Manuscripts

Here are select manuscripts published in the peer-reviewed literature.

This device was tested by the UCSF Hypoxia Lab and found to have an ARMS of approximately 2.5% in the subjects with skin colors represented below

According to the manufacturer, all regular Zacurate pulse oximeters are FDA cleared but do not have FDA certification since they are marketed for sports and aviation use.

Extended skin color data

This figure shows the forehead skin color for healthy volunteer participants in the study cohort tested with this pulse oximeter. Each square represents one subject, with the square’s color corresponding to the Monk Skin Tone Scale category observed by UCSF Hypoxia Lab clinical research coordinators. More info on skin color quantification.

Here we show data on the forehead color for healthy volunteer subjects on which the device was tested. Each square represents a single study subject. The square's color is derived from the Monk skin tone color observed by the UCSF Hypoxia Lab clinical research coordinators.

Skin pigment bias for SpO2 70-85%

This number (i.e. 'differential bias’ or 'disparate bias') describes how much pulse oximeter performance is impacted by skin pigment. This is done by using real data to model what happens if we compare how accurate SpO2 is (i.e. how SpO2 compares to gold standard blood SaO2 co-oximetry) for a healthy volunteer with very light skin pigment and SpO2 accuracy for a healthy volunteer with very dark skin pigment (i.e., an ITA difference of 100), by subtracting the difference. Read more about differential bias here in our FAQ.

0.45%

Skin pigment bias for SpO2 85-100%

This number (i.e. 'differential bias’ or 'disparate bias') describes how much pulse oximeter performance is impacted by skin pigment. This is done by using real data to model what happens if we compare how accurate SpO2 is (i.e. how SpO2 compares to gold standard blood SaO2 co-oximetry) for a healthy volunteer with very light skin pigment and SpO2 accuracy for a healthy volunteer with very dark skin pigment (i.e., an ITA difference of 100), by subtracting the difference. Read more about differential bias here in our FAQ.

1.29%

Bias by skin pigment

Here we illustrate the skin pigment bias in SpO2 readings across different saturation ranges (70-85% and 85-100%) for Monk skin tone groups ABCD, EFG, and HIJ. Each dot represents a single healthy volunteer subject tested with the device. The dot’s color is derived from the Monk skin tone color observed by the UCSF Hypoxia Lab clinical research coordinators.

Perfusion performance data

We collected the percent modulation of the infrared (IR) signal—often termed pulsatility amplitude or perfusion index (PI)—from our reference devices, Nellcor PM1000N and Masimo Rad-97. This measure serves as an indirect, albeit imperfect, surrogate for perfusion and signal strength.

This column provides insights into the PI distribution of the cohort by reporting the median PI and interquartile range (Q1–Q3). The median PI represents the typical blood flow strength of the collected samples, while the interquartile range (Q1-Q3) shows the middle 50% of PI values, giving an idea of how much variation exists around this typical flow level.

We report PI from the Nellcor PM1000N for all devices, except for the Masimo Rad-97, which provides its own PI measurement. For consistency across devices, we applied a correction factor to the PM1000N pulsatility amplitude by dividing the values by 10, making them comparable to the PI reported by other devices, such as Masimo.

Not Available

Raw PPG data

We are working to gather raw data for device performance to share for independent analysis. We expect to launch this feature soon.

Not Available

In vitro (simulator) performance data

We are working on novel in vitro testing protocols for both commercially available devices (e.g. Fluke ProSim8) and novel in vitro devices. We expect to report data for this testing soon.

Not Available

Real world clinical data

Here we link to studies conducted in the clinical settings.

Not Available

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