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The NONIN® AVANT™ 9600 Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals. medical facilities. home care and subacute environments. It is also used in patient transport, sleep laboratories, and EMS environments. The Avant 9600 Pulse Oximeter is intended for continuous monitoring and/or spot-checking of patients.

The Model 9600 Pulse Oximeter determines arterial hemoglobin saturation (%SpO2) by measuring absorption of red and infrared (IR) light passed through the tissue. The Model 9600 also measures pulse rate and displays the rate in beats per minute.

The provided document is a 510(k) premarket notification for the Nonin Avant Model 9600 Pulse Oximeter. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results in the same way a PMA (Premarket Approval) submission would.

Therefore, much of the requested information (such as specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods for ground truth) is not explicitly available within this document. The document primarily describes the device, its intended use, and states that testing was performed to confirm performance and safety.

Here's an attempt to answer the questions based on the available information and highlighting what is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative manner or provide a table of performance figures against such criteria. It generally states: "Bench and safety testing have been done to verify the performance of the device."

2. Sample size used for the test set and the data provenance

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For a pulse oximeter, "ground truth" for SpO2 is often established through in-vivo studies involving induced hypoxia, with comparison to arterial blood gas measurements, rather than expert consensus on images or data. However, the details of such studies are not present here.

4. Adjudication method for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. Pulse oximeters are standalone diagnostic devices that provide direct measurements (SpO2 and pulse rate), not an AI-assisted interpretation for human readers. Therefore, the concept of "human readers improve with AI" does not apply in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a pulse oximeter is inherently a standalone device that performs its function (measuring SpO2 and pulse rate) without human interpretation as part of its core performance evaluation. Its accuracy is assessed as a standalone algorithm/device. The document states "Bench and safety testing have been done to verify the performance of the device." This implies standalone performance testing.

7. The type of ground truth used

While not explicitly stated, for pulse oximeters, the ground truth for arterial oxygen saturation (SpO2) is typically established through arterial blood gas analysis (SaO2), often verified in controlled clinical studies with induced hypoxemia. The document mentions following "Reviewer Guidance for Premarket Notification Submission of November of 1993, from the Anesthesiology and Respiratory Branch, Division of Cardiovascular, Respiratory and Neurological Devices," which would include guidelines for oximeter testing, likely referring to such methods.

8. The sample size for the training set

This information is not provided in the document. Pulse oximeters generally rely on physiological models and signal processing rather than machine learning "training sets" in the contemporary sense. If any form of algorithm optimization or calibration occurred, the details of the data used for that are not included here.

9. How the ground truth for the training set was established

As noted in point 8, the concept of a "training set" in the modern AI sense is likely not applicable to this device in the way it is asked. If any calibration data was used, the ground truth for that would similarly be established through comparison to a gold standard like arterial blood gas analysis. This information is not provided in the document.

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