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The H100B Pulse oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate of single adult, pediatric or neonate patient in hospitals, intra-hospital transport and hospital type facilities.

H100B Pulse Oximeter is intended for continuous monitoring or spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate of single adult, pediatric or neonate patient in hospitals, intra-hospital transport and hospital type facilities. The sampled signal from finger sensor is processed in the main unit and transferred into electronic signal to display the SpO2 value, pulse rate value on the LCD at the form of numeral, plethysmogram, bar graph and waveform. Data management software (Oximeter Viewer) can transferred stored data into PC for storage, review and printing. The subject device is powered by 4 pieces 1.5V AA batteries or 4 pieces 1.2V Ni-H rechargeable AA batteries. Alarm capability including audio alarm and indicator is provided when the SpO2 value is lower than the limit setup or some technical reason.

The provided text is a 510(k) summary for the H100B Pulse Oximeter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of acceptance criteria and device performance based on a new clinical trial.

Therefore, this document does not contain the detailed information required to fill out the requested table and answer many of the specific questions. The submission primarily discusses the intended use, device description, comparison with a predicate device (PM 60 Pulse Oximeter K072581), and a general statement about "Verification and validation testing." It explicitly states that "This premarket notification submission demonstrates that H100B Pulse Oximeter is substantially equivalent to the predicate device."

Here's what can be extracted based on the limited information provided:

1. Table of acceptance criteria and the reported device performance

This information is not present in the provided 510(k) summary. The document does not specify quantitative acceptance criteria or report performance data.

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

This information is not present in the provided 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not present in the provided 510(k) summary.

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

This information is not present in the provided 510(k) summary.

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

This information is not present and likely not applicable. The H100B Pulse Oximeter is not an "AI" device that assists human "readers" in a diagnostic context; it's a physiological monitoring device.

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

This information is not explicitly stated in the provided 510(k) summary. As it's a pulse oximeter, its primary function is standalone measurement and display. Performance would typically involve comparing its readings to a gold standard, not necessarily evaluating an "algorithm only" in the context of diagnostic AI.

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

This information is not present in the provided 510(k) summary. For pulse oximeters, ground truth for SpO2 measurements typically involves a co-oximeter or blood gas analyzer. The document does not specify how "verification and validation testing" was conducted.

8. The sample size for the training set

This information is not present in the provided 510(k) summary. This type of submission does not typically detail training sets for algorithms in the way an AI/ML device would.

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

This information is not present in the provided 510(k) summary.

In summary, the provided 510(k) document is a regulatory submission focused on substantial equivalence rather than a detailed scientific study report detailing acceptance criteria and performance data from a specific clinical or technical study. It lacks the granularity of information needed to answer most of your questions.

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