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The Disposable Pulse Oximeter Sensor is indicated for non-invasive spot checking and/or continuous monitoring of arterial oxygen saturation and pulse rate of the adult or neonatal patients with oximeter equipment in hospitals, hospital-type facilities, and home care environments.
The Reusable Pulse Oximeter Sensors are indicated for non-invasive spot checking and/or continuous monitoring of arterial oxygen saturation and pulse rate of the adult or pediatric patients with oximeter equipment in hospitals, hospital-type facilities, and home care environments.

The proposed devices of the Pulse Oximeter Sensors (Disposable and Reusable), are used in conjunction with oximeter equipment to measure and display the arterial oxygen saturation of blood.

The provided document is limited in detail regarding the acceptance criteria and study that proves the device meets them. It primarily focuses on substantiating equivalence to predicate devices based on safety and effectiveness, rather than providing specific performance metrics against defined acceptance criteria from a standalone study.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define quantitative acceptance criteria for device performance (e.g., accuracy ranges for SpO2 or pulse rate) nor does it present a table of reported device performance against such criteria. The "Test Conclusion" section mentions "Bench tests were conducted to verify that the proposed device met all design specifications," but these specifications are not detailed or quantified in the provided text.

The closest equivalent to "acceptance criteria" discussed are the standards the device complies with, which are safety and electrical performance standards, not clinical accuracy standards.

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

The document mentions "Bench tests were conducted" but does not provide any information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). Without details on a clinical accuracy study, this information is absent.

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

This information is not provided in the document as there is no mention of a clinical accuracy study that would involve expert assessment for establishing ground truth. The submission focuses on technical equivalence and compliance with general safety/performance standards.

4. Adjudication Method for the Test Set

This information is not provided as there is no mention of a human-involved study or test set requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not mentioned or conducted according to this document. The submission is for a pulse oximeter sensor, which is a diagnostic device that outputs numerical values (SpO2 and pulse rate), not an imaging or diagnostic aid that would typically involve human readers interpreting cases with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document describes "Bench tests" and compliance with standards, which can be considered standalone testing of the device's performance. However, specific details of these tests (e.g., specific accuracy values for SpO2 and pulse rate, details of controlled hypoxia studies) are not provided in this summary. For pulse oximeters, standalone performance typically involves testing against a reference oximeter during induced hypoxia studies, but the specifics of this particular device's results from such a study are not in this summary. The mention of ISO 9919:2005 implies such testing was likely performed.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance evaluation. For pulse oximeters, the ground truth for SpO2 measurements in clinical accuracy studies is typically established using co-oximetry of arterial blood samples. However, as a detailed clinical study is not summarized here, the method for establishing ground truth is not specified. For the bench tests, the ground truth would typically be established by calibrated reference equipment.

8. The Sample Size for the Training Set

This information is not applicable as the device is a pulse oximeter sensor, not an AI/ML-based algorithm that requires a "training set" in the conventional sense. The device's underlying technology and calibration would be based on physiological models and empirical data, but not referred to as an "AI training set."

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

This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set).

In summary: The provided document is a 510(k) summary that focuses on establishing substantial equivalence through regulatory compliance and bench testing without detailing specific clinical performance acceptance criteria or the results of a dedicated clinical accuracy study. It primarily asserts that the device meets safety and basic performance criteria common to pulse oximeters and is comparable to existing predicate devices.

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