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The PressMate Advantage monitors non-invasive blood pressure (NIBP), Oxygen saturation (Sp02), ECG, Respiration Rate and Body Temperature of an Adult, Pediatric or Neonate in the clinical setting.

The PressMate Advantage Monitor measures, displays and (optionally) prints the following parameters:

1. NIBP (systolic, Diastolic, Mean and Pulse Rate)
2. ECG
3. Body Temperature
4. Sp02 ( Oxygen Saturation and Pulse Rate)

The provided 510(k) summary for the PressMate Advantage does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a detailed study report. The document is a premarket notification for substantial equivalence, focusing on comparisons to predicate devices and general regulatory compliance rather than in-depth performance study results.

However, based on the information provided, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document states: "The design of the PressMate Advantage has been thoroughly validated at the unit and system level. Non-clinical tests were conducted to determine the complete system and has been tested to the electrical safety requirements and the Electromagnetic Compatibility requirements of EN 60601."

And "The testing of the PressMate Advantage demonstrates that the performance is substantially equivalent to predicate devices cited above."

This indicates that acceptance criteria likely involved meeting relevant electrical safety and EMC standards (EN 60601) and demonstrating performance equivalent to the predicate devices (PressMate Model 8800 and Escort Model 102). However, specific numerical acceptance criteria (e.g., accuracy ranges for NIBP, SpO2) and the corresponding reported performance values for the PressMate Advantage are not provided in this summary.

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

The document does not provide any information on the sample size used for clinical performance testing, data provenance, or whether the study was retrospective or prospective. The focus is on non-clinical tests.

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 is not applicable or not provided. The document describes non-clinical engineering and comparison testing, not a study involving human expert ground truth for medical interpretations.

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

This is not applicable or not provided as there is no mention of clinical readings requiring adjudication.

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 is not applicable. The device is an automated vital signs monitor, not an AI-assisted diagnostic tool for human readers. There is no mention of any MRMC study or AI.

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

The document refers to "Non-clinical tests" and "testing of the PressMate Advantage" demonstrating its performance. This implies standalone testing of the device's measurement capabilities. However, specific details of this testing (e.g., number of subjects, accuracy metrics) are not provided. The phrase "algorithm only" is not directly applicable as it's a hardware device with embedded software for measurements.

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

For non-invasive blood pressure, SpO2, ECG, and temperature, the "ground truth" would typically involve validated reference devices (e.g., invasive arterial pressure lines for NIBP, CO-oximeters for SpO2, calibrated temperature probes). However, the document does not specify the type of ground truth used in its "Nonclinical Tests." It only states the device uses "the standard oscillometric technique for obtaining. NIBP Nellcor Sp02 technology for Oxygen saturation, standard ECG technology and YSI temperature probes," implying a comparison to these established gold standards.

8. The sample size for the training set

This is not applicable or not provided. The device in question is a vital signs monitor, not typically a machine learning model that requires a "training set" in the conventional sense. Its "training" would be through design, calibration, and engineering validation.

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

This is not applicable or not provided for the same reasons as point 8.

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