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The OX201 Pulse Oximeter is a non-invasive device intended for prescription use spot-check of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients (weight ≥ 40kg) in home, hospital and clinic environments. The device is not intended for continuous monitoring, use during motion or use with low perfusion.

The OX201 pulse oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rage (PR) of single adult and pediatric patient in home and hospital. The fingertip pulse oximeter features small size, low power consumption, convenient operation and portability. Power consumption of the product is low and two AAA batteries can be operated continuously for 24 hours. It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement, use it very easy. Principle of the fingertip pulse oximeter as follows: A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in glow and near-infrared zones. Operation principle of the instrument: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm glow and 905nm near infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant dada is shown on the Oximeter's display through electronic circuits and a microprocessor.

The document provided is a 510(k) summary for a Pulse Oximeter (Model: OX201). It primarily focuses on demonstrating substantial equivalence to a predicate device and includes information about non-clinical testing. However, it does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study proving the device meets these criteria for a typical AI/ML medical device.

The provided document describes a traditional medical device (pulse oximeter) that relies on established physical principles for measurement, not an AI/ML device that requires a test set, ground truth established by experts, or MRMC studies.

Therefore, I can only provide information based on what is available in the document, which pertains to the performance of a pulse oximeter and its validation against established standards for non-AI devices.

Here's an attempt to answer your questions based on the provided text, highlighting where the information is not applicable for a traditional medical device like a pulse oximeter or is missing from the document:

Acceptance Criteria and Device Performance Study (Pulse Oximeter OX201)

The device, a Pulse Oximeter (Model: OX201), is a non-invasive device intended for spot-check of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. Its performance is evaluated against recognized international standards for pulse oximeters, particularly ISO 80601-2-61.

1. Table of Acceptance Criteria and Reported Device Performance:

For a pulse oximeter, acceptance criteria typically relate to the accuracy of SpO2 and pulse rate measurements within specified ranges.

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

• Test set sample size: The document states "Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011". This guideline typically specifies minimum numbers of subjects across a range of SpO2 values. However, the specific number of subjects or data points used in the clinical test is not provided in this 510(k) summary.
• Data Provenance: The document does not specify the country of origin of the clinical data or whether it was retrospective or prospective. Clinical testing for pulse oximeters is typically prospective, involving human subjects purposefully desaturated under controlled conditions.

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

• For traditional pulse oximeters, the "ground truth" for SpO2 accuracy is typically established using a co-oximeter (a laboratory instrument that directly measures arterial oxygen saturation from blood samples) as the reference method, not by human experts adjudicating images. Therefore, the concept of "experts" to establish ground truth as would be relevant for an AI image analysis device does not apply in the context of this pulse oximeter's performance claims.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This is not applicable for a pulse oximeter. Adjudication methods are relevant for subjective interpretations, especially in image analysis, which is not how pulse oximeter accuracy is assessed.

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:

• An MRMC study is not applicable for a standalone device like a pulse oximeter. These studies are designed for AI devices that assist human readers in tasks like image interpretation. This device does not involve human readers for its primary function.

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

• Yes, the performance evaluation of the pulse oximeter is inherently a standalone (device-only) performance assessment. The device measures SpO2 and pulse rate, and its accuracy is directly compared against a reference standard (e.g., co-oximetry), without human intervention in the measurement or interpretation process.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):

• For pulse oximeters, the ground truth for oxygen saturation (SpO2) is typically established by arterial blood gas analysis with co-oximetry. This is the gold standard for measuring fractional oxyhemoglobin and other hemoglobin species, allowing for a precise determination of true arterial oxygen saturation. The document references "Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011," which outlines the methodology for such clinical studies.

8. The sample size for the training set:

• This device is a traditional medical device (pulse oximeter) that operates based on established physical principles (Lambert Beer Law, Photoelectric Oxyhemoglobin Inspection Technology) rather than a machine learning or AI algorithm that requires a "training set." Therefore, the concept of a "training set" does not apply to this device.

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

• Given that the device does not employ a machine learning algorithm with a "training set," this question is not applicable.

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