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Nonin's Models 6500MA and 6500SA Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused, weighing greater than 60 pounds (30 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.

The 6500MA (wrap-around model) and 6500SA (interlocking model) are fingertip single-patient use disposable, transmittance sensors. They are comprised of a lamination of two foams (patient contact side and external side) with the optical components and a malleable wire within the lamination. The optical components are identical to the currently marketed Model 7000 single-patient use disposable sensor. The sensors are compatible with all Nonin-branded pulse oximeters.

This is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report for a new device's absolute performance. Therefore, many of the requested details about specific study methodologies (like sample size for training sets, adjudication, or MRMC studies) are not present in this type of document.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document states: "Nonin's Model 6500 sensor series have successfully undergone both bench and clinical testing in order to demonstrate that it meets the requirements of ISO 9919:2005 Clause 50 Accuracy of Operating Data, Clause 102 section 102.2 Labeling, and IEC 60601-1:1998 (ISO 10993-1:2003) Clause 48 Biocompatibility."

The table above demonstrates that the subject device (Model 6500 Sensor Series) meets or exceeds the performance criteria of the predicate device (Model 7000 Sensor Series) for SpO2 accuracy, and matches it for pulse rate accuracy. This forms the basis of the substantial equivalence claim.

Missing Information (Based on the Provided Text):

The following information is not detailed in the provided 510(k) summary:

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "clinical testing" but does not provide details on the sample size of the test set, its provenance, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. For pulse oximetry, the "ground truth" for SpO2 accuracy is typically established by comparing the oximeter readings to arterial blood gas measurements (co-oximetry) in induced hypoxia studies, often without "experts" in the traditional sense for reading images, but rather with clinical staff performing procedures and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not specified.
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: Not applicable. This is a pulse oximeter sensor, not an AI diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself is an algorithm (oximeter) and sensor, so its performance is standalone in the context of its function. However, the exact methodology for this standalone performance (e.g., how the clinical test dataset was used to derive the accuracy metrics) is not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For SpO2 accuracy, the ground truth is typically arterial blood gas analysis with co-oximetry, under controlled desaturation conditions, which is considered the gold standard for SpO2. This is implied by the standard ISO 9919:2005 for oximeters, but not explicitly stated as the method for this specific study.
8. The sample size for the training set: Not applicable or not specified. Pulse oximeters generally use established algorithms based on optical properties of blood, rather than machine learning training sets in the modern sense.
9. How the ground truth for the training set was established: Not applicable or not specified.

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