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The OxiMax™ NPB-40 handheld pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital type facilities, transport and mobile environments as well as in the home care environment.

The OxiMax NPB-40 is a handheld, battery powered pulse oximeter used for monitoring of pulse rate and saturated oxygen in arterial blood. The OxiMax NPB 40 include the addition of audible alarms, addition of keys and display icons in the user interface board to access the alarm settings and the OxiMax in-sensor data features. The OxiMax NPB-40 also has menu features to allow the user to set the time, date and measurement alarm limits

The provided document is a 510(k) premarket notification summary for the OxiMax™ NPB-40 Pulse Oximeter. It states that the device is substantially equivalent to legally marketed predicate devices and demonstrates this through performance data. However, it does not contain specific acceptance criteria with numerical targets or detailed results of a study that directly proves the device meets those criteria, as typically presented in a table with performance metrics.

The document broadly mentions "performance data includes results from environmental testing, in-house clinical studies and laboratory testing" to evaluate "oxygen saturation and pulse rate accuracy... during non-motion and motion conditions as well as low perfusion levels." It concludes that this data "demonstrates substantial equivalence" to predicate devices.

Therefore, many of the requested details cannot be extracted directly from this document.

Here's an attempt to answer based on the available information, with clear indications where information is not present.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not specified in the document.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are referred to as "in-house clinical studies and laboratory testing."

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

• Not specified. The document does not describe the methodology for establishing ground truth within the context of expert review.

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

• 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:

• No. This device is a pulse oximeter, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable and was not performed.

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

• Yes, in essence. The performance data mentioned (clinical and non-clinical laboratory testing for oxygen saturation and pulse rate accuracy) refers to the performance of the device itself (the "algorithm only" in this context) under various conditions. The document states this testing "was conducted to evaluate oxygen saturation and pulse rate accuracy of the OxiMax NPB-40." This implies a standalone evaluation of the device's measurement capabilities.

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

• For oxygen saturation and pulse rate accuracy, the ground truth in such studies typically comes from arterial blood gas analysis (ABG) for oxygen saturation and a simultaneous ECG or direct measurement for pulse rate, often used in conjunction with a controlled desaturation study in human subjects (for SpO2). While the document doesn't explicitly state "ABG," it is the standard reference method for validating pulse oximeter accuracy.

8. The sample size for the training set:

• Not applicable. This device is a pulse oximeter, which relies on established physiological principles and sensor technology, not a machine learning algorithm that requires a separate "training set" in the conventional sense of AI/ML devices.

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

• Not applicable (see point 8).

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