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Coreray Reusable SPO2 Sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel. The Reusable SPO2 Sensor is intended for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40kg.

The Reusable SPO2 Sensor is comprised of a connector and a cable which terminates into sensor housing. The sensor contains two specific wavelength LEDs and a photo detector assembled into the sensor housing which separate by one housing half and the other half. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. One type of sensor housing is described in this submission: Reusable finger clip sensor. The sensor has a labeling and specifications designed for compatibility with a specific monitor.

The provided text is a 510(k) Premarket Notification for a Reusable SpO2 Sensor. It outlines the device's characteristics, intended use, and a comparison to predicate devices to demonstrate substantial equivalence. The document includes information on the non-clinical and clinical tests performed.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details:

1. Table of Acceptance Criteria and Reported Device Performance: See table above. The acceptance criteria for SpO2 and Pulse Rate accuracy are directly compared to the predicate device's performance, specifically K153184 for SpO2 accuracy. The document states "compliance with the ISO80601-2-61" standard, which the SpO2 accuracy of ±3% (70-100%) meets.

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

   • Sample Size for Test Set: The document states, "Clinical testing is conducted for validation of SoO2 the Coreray Reusable & Disposable SpO2 Sensor." However, the exact number of subjects or data points for the clinical test is NOT explicitly stated in the provided text.
   • Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It only mentions "Clinical testing is conducted for validation."

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

   • The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical testing.

4. Adjudication Method for the Test Set:

   • The document does not describe any adjudication method used for the clinical test set.

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?

   • No. The device in question is a SpO2 sensor, which provides direct physiological measurements, not an AI-based diagnostic tool requiring human reader interpretation or MRMC studies. Therefore, this type of study is not applicable and was not performed.

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

   • Yes, effectively. For a device like an SpO2 sensor, the "standalone performance" refers to its ability to accurately measure SpO2 and pulse rate. The clinical testing mentioned ("Clinical testing is conducted for validation of SoO2 the Coreray Reusable & Disposable SpO2 Sensor") serves as the standalone performance evaluation, confirming the device's accuracy without requiring human interpretation of its output beyond standard clinical use. The reported accuracies (±3% for SpO2) are the standalone performance metrics.

7. The Type of Ground Truth Used:

   • For SpO2 sensors, the gold standard (or "ground truth") for SaO2 (arterial oxygen saturation) measurement in clinical studies is typically arterial blood gas (ABG) analysis (Co-oximetry). While the document doesn't explicitly state "ABG," the mention of "Clinical testing is conducted for validation of SoO2" implies comparison against such a reference method as per ISO 80601-2-61, which requires induced hypoxia studies with arterial blood sampling.

8. The Sample Size for the Training Set:

   • This question applies to machine learning models. The device in question is a physiological sensor, not an AI/ML model that requires a "training set" in the computational sense. Therefore, N/A.

9. How the Ground Truth for the Training Set was Established:

   • As this is not an AI/ML device, the concept of "ground truth for the training set" does not apply. N/A.

In summary, the document primarily focuses on demonstrating substantial equivalence through comparison of technical characteristics and adherence to relevant standards for a medical device. While it mentions clinical testing for validation of SpO2, it lacks detailed specifics regarding sample size, expert involvement, or adjudication methods for this clinical study, which are more commonly detailed for AI/ML device submissions.

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