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The above device family is intended for use as simulators, testers/analyzers for Pulse Oximeters, and their probes. The Oximeter tests can be conducted through a simulated human "finger" (F and EF models) or electronically (E and EF models) as if the tester is a probe. Oximeter probes can be tested, using E and EF models, for shorts, continuity, opens and LED functionality.

Basically the devices allow accurate monitoring and verification of the operation of commercially available Pulse Oximeters without use of arterial blood. They can quickly establish the state of any given pulse oximeter and determine its performance qualities. Index 2/CardioSat 100 can test and evaluate virtually any pulse oximeter on the market today. Ear and toe type oximeters and their probes can be tested electronically as components and the probe/oximeter system can be tested fully if the probe fits on the simulated "finger".

The testers can also be used as a transfer standard for Pulse Oximeters. That is, a Pulse Oximeter's performance may be compared to another of the same type or a different type. The devices are not intended to be used as Pulse Oximeter calibrators, but can be used for Quality Control purposes.

The primarily use for these types of devices is: by Biomedical Engineers and technicians in Hospitals; by third party repair and calibration facilities; and by Original Equipment Manufacturers (OEMs). Other personnel could also learn how to use the devices. The Hospital or third party repair environment varies from, use of the device in a controlled calibration lab, to portable ward use by the Biomed staff. The OEMs use of the device would primarily involve final QC of pulse oximeters in their manufacturing or repair facilities, but could also involve the use of these simulators in the development of new oximeters.

The device family is intended for use as simulators, testers/analyzers for Pulse Oximeters, and their probes. The Oximeter tests can be conducted through a simulated human "finger" (F and EF models) or electronically (E and EF models) as if the tester is a probe. Oximeter probes can be tested, using E and EF models, for shorts, continuity, opens and LED functionality.

Basically the devices allow accurate monitoring and verification of the operation of commercially available Pulse Oximeters without use of arterial blood. They can quickly establish the state of any given pulse oximeter and determine its performance qualities. Index 2/CardioSat 100 can test and evaluate virtually any pulse oximeter on the market today. Ear and toe type oximeters and their probes can be tested electronically as components and the probe/oximeter system can be tested fully if the probe fits on the simulated "finger".

The testers can also be used as a transfer standard for Pulse Oximeters. That is, a Pulse Oximeter's performance may be compared to another of the same type or a different type.

The devices are not intended to be used as Pulse Oximeter calibrators, but can be used for Quality Control purposes.

The primarily use for these types of devices is: by Biomedical Engineers and technicians in Hospitals; by third party repair and calibration facilities; and by Original Equipment Manufacturers (OEMs). Other personnel could also learn how to use the devices. The Hospital or third party repair environment varies from, use of the device in a controlled calibration lab, to portable ward use by the Biomed staff. The OEMs use of the device would primarily involve final QC of pulse oximeters in their manufacturing or repair facilities, but could also involve the use of these simulators in the development of new oximeters.

Index 2/CardioSat 100 simulates a human "finger" (toe/ear).utilize technology similar to that which the Pulse Oximeters utilize to measure SpO2 and pulse rate. This aspect of the technology used in Index 2/CardioSat 100 is protected by US Patent No. 5,348,005. Oximeters use the ratio of Red to InfraRed light to simulate readings related to the partial pressure and thus arterial oxygenation level of blood, which is expressed as SpO2 for this method of measurement. In Index 2/CardioSat 100 the pulsation of the signal serves to simulate the heart rate pulsation. This feature is identical to the predicate Index, K933519, SpO2 Simulator with the addition of a near simultaneous pulsing of the Red and InfraRed LEDs to test a wider range of Pulse Oximeter manufacturers models. Most Pulse Oximeters alternate the Red and InfraRed signals.

The simulators can also send this same types of signals electronically to the Oximeter under test simulating the Oximeter Probe's signal. Additionally, they can operate as intelligent volt/ohmmeters to analyze Oximeter Probes for continuity, shorts, opens, LED operation and Photodiode Operation.

This document describes the Bio-Tek Index 2 E, F, EF & CardioSat 100 E, F, EF, which are pulse oximeter simulators, testers, and analyzers. The information provided focuses on the device's performance testing and regulatory submission, rather than a clinical study evaluating the device's diagnostic accuracy or effectiveness in a patient setting.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or specific quantitative performance metrics. It generally states that the device is designed to "allow accurate monitoring and verification of the operation of commercially available Pulse Oximeters" and "determine its performance qualities."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document refers to testing "over a wide range of Oximeter types" but does not give a number of oximeters or probes tested.
• Data Provenance: The testing is internal to Bio-Tek Instruments, Inc., and is described as "verification and validation" of the device itself rather than a study on clinical data. The text doesn't mention specific countries of origin for test data or whether it was retrospective or prospective. It's an internal product development and regulatory submission document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The document describes the testing of a medical device simulator/tester, not a device that makes clinical diagnoses. The "ground truth" for this device would be its own electrical and simulated physiological outputs, verified against known engineering standards and the expected behavior of pulse oximeters, rather than expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring expert adjudication of clinical findings. Verification and validation would involve engineering and quality assurance practices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not describe a MRMC comparative effectiveness study. The device is a simulator/tester for pulse oximeters, not a diagnostic tool for human readers.

6. Standalone Performance Study

Yes, in a sense. The described "Performance Testing: (Verification and Validation)" is essentially a standalone evaluation of the algorithm/device's functionality. The document states:

• "The predicate INDEX design was extensively verified and validated to be working per the design and published specifications."
• "The Index 2 and CardioSat 100 is being and will be fully verified and validated per a written plan prior to release. This plan includes verification/ validation that the device features work as intended over a wide range of Oximeter types and in some cases involves external confirmation of the features integrity (e.g. use a volt/ohm meter to determine appropriate outputs etc.)."

This indicates testing of the device's ability to accurately simulate and analyze, without human interpretation as part of its primary function.

7. Type of Ground Truth Used

The ground truth for this device is based on:

• Engineering specifications and known electrical/physiological parameters: The device simulates pulse oximeter readings using ratios of Red to InfraRed light and pulsation for heart rate. Its ability to create these signals accurately is the ground truth.
• External confirmation: "...involves external confirmation of the features integrity (e.g. use a volt/ohm meter to determine appropriate outputs etc.)." This implies calibration against known electrical standards and measurements.
• Reference to predicate devices: The device's technological characteristics are compared to legally marketed predicate devices, implying that their established performance serves as a benchmark for what the new device should achieve.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning algorithm requiring a "training set" in the typical sense. Its functionality is based on direct simulation and measurement according to designed electronic and optical parameters.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

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