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The Propaq 200 Series monitors are intended to be used by skilled clinicians for multiparameter vital signs monitoring of neonatal, pediatric, and adult patients in health care facility bedside applications; as well as for intrafacility and interfacility transport.

The Propaq 200 Series monitors are small, light weight, portable, multi-parameter patient monitors equipped with either a monochrome or color display. The monitors provide real time monitoring and display of ECG, respiration, invasive blood pressure, noninvasive blood pressure, temperature, CO2 and SpO22. Rechargeable batteries power the monitors. The Propaq 200 Series monitors can communicate with Welch Allyn Protocol's Acuity® central station through a local area network. The communication link is bi-directional, ventral station and one a louity central station and remote control of the Propaq from the Acuity central station.

This 510(k) summary provides limited information regarding specific acceptance criteria and detailed study results. Based on the provided text, here’s a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantifiable acceptance criteria for the Propaq 200 Series Monitors' overall performance or for the improved SpO2 channel in a clear table format. The performance section states:

For the improved SpO2 channel, the device is considered "substantially equivalent to the SpO2 channel in the Nellcor model N-395 Pulse Oximeter," which was previously cleared. This implies that the performance of the improved SpO2 channel is expected to meet the same standards demonstrated by the predicate Nellcor N-395.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only generally states that testing was performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. The type of testing mentioned relates to compliance with standards, not performance against expert-established ground truth for diagnostic accuracy in a clinical setting.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No MRMC comparative effectiveness study is mentioned. This 510(k) relies on substantial equivalence to predicate devices and compliance with recognized standards, not a comparative study demonstrating improvement with AI assistance (as AI is not explicitly mentioned as a component here).

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

The Propaq 200 Series monitors are patient monitors intended for use by "skilled clinicians." The document does not describe standalone algorithm performance without human intervention. The testing described appears to be for the device's adherence to engineering and safety standards.

7. The Type of Ground Truth Used

For the overall device, the "ground truth" seems to be compliance with "recognized national and international, performance, safety, and electromagnetic compatibility standards for medical devices and product specifications listed in the Propaq labeling."

For the improved SpO2 channel, the "ground truth" for substantial equivalence is implied to be the performance characteristics of the predicate Nellcor N-395 Pulse Oximeter, which presumably met its own set of performance standards at the time of its clearance. No specific clinical ground truth data (e.g., pathology, outcomes data, or expert consensus on clinical readings) is mentioned as being used for the Propaq 200 Series in this summary.

8. The Sample Size for the Training Set

This information is not provided. The development of the Propaq 200 Series monitors and its SpO2 channel would have involved development and verification processes, but specific "training set" sample sizes, as might be relevant for machine learning algorithms, are not discussed.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. Given the nature of medical device standards compliance and substantial equivalence claims for patient monitors, the concept of a "training set" and "ground truth establishment" in the context of diagnostic accuracy (as would be typical for AI/CAD devices) is not explicitly applicable or discussed in this document. The "ground truth" for development and verification would be derived from engineering specifications, established physiological principles, and compliance with recognized standards.

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