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The HomMed Genesis Patient Monitor with Options is a system designed to monitor patient vital signs at home and/or in healthcare facilities. Vital signs include pulse oximetry (optional), noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products including glucose meter, spirometer, and prothrombin time can be exported via the Genesis communication module. Vital signs data is transmitted via modem to a central viewing station for display, analysis and monitoring by healthcare professionals. All patient data is collected, stored, forwarded and displayed in a retrospective manner, and is not intended to provide real-time critical care monitoring of patients, nor any local alarms or alerts of patient status.

The HomMed Genesis Patient Monitor System with Options (HomMed Genesis) is a portable patient vital signs monitoring system. The system measures pulse oximetry (optional), noninvasive blood pressure, pulse rate, and weight. HomMed Genesis will have four serial ports available for external options. The Genesis acquires the patient vital signs data and displays it. The data can also be transmitted via the communication system through the Skytel or PageNet Pager Network to a central station for storage with retrospective display and analysis.

The provided text is a 510(k) summary for the HomMed Genesis Patient Monitor System. It outlines the device description, intended use, and a comparison with a predicate device. However, it does not contain acceptance criteria for device performance or a detailed study proving the device meets specific performance criteria beyond general compliance with voluntary standards.

The summary states:

• "The HomMed Genesis employs the same technologies as the predicate Technology: device, HomMed Sentry III Patient Monitor System with Card Reader."
• "The Genesis monitor complies with the following voluntary standards: Medical Electrical Safety EN 60601-1, EMC Compliance IEC 601-1-2, Biocompatibility ISO 10993-5,10-11."
• "It is the HomMed position that the results of these measures demonstrate Conclusion: HomMed Genesis is as safe, as effective and performs as well as the leqally marketed predicate device, HomMed Sentry III Patient Monitor System with Card Reader."

This indicates that the device's acceptance is primarily based on substantial equivalence to a predicate device and compliance with general safety and EMC standards, rather than specific performance metrics (like accuracy, sensitivity, specificity, etc.) for its vital sign measurements as would be expected for a diagnostic AI/ML device.

Therefore, many of the requested details about acceptance criteria and a study proving device performance cannot be extracted directly from this document.

Here's an attempt to answer based on the available information, noting the missing details:

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

Comment: The document focuses on regulatory compliance and equivalence rather than specific performance metrics for the vital sign measurements themselves. For a device measuring vital signs like blood pressure, pulse oximetry, and pulse rate, one would typically expect to see performance criteria related to accuracy, bias, and precision against a reference standard. These are absent here, likely because the 510(k) process in this instance relies heavily on the predicate device's established performance.

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

• Sample Size (Test Set): Not specified. The document does not describe a clinical performance study with a test set.
• Data Provenance: Not applicable, as no specific performance study with a test set is detailed.

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

• Not applicable, as no specific performance study with a ground truth-established test set is detailed.

4. Adjudication method for the test set

• Not applicable, as no specific performance study with a test set requiring adjudication is detailed.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a vital signs monitor, not an AI-assisted diagnostic imaging tool with human-in-the-loop performance.

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

• The device itself is a standalone vital signs monitor. Its performance is compared to a predicate device, and it complies with voluntary standards. However, the document does not detail specific standalone performance studies for accuracy of the vital sign measurements against a gold standard as one might see for an AI algorithm. Its function is to acquire and transmit data, not to perform complex algorithmic interpretations that require "human-in-the-loop" interaction in the typical AI/ML sense.

7. The type of ground truth used

• Not applicable, as no specific performance study with a ground truth is detailed. Performance is asserted based on technological equivalence to a predicate device and compliance with general safety standards.

8. The sample size for the training set

• Not applicable, as this device does not appear to involve AI/ML that would require a "training set" in the conventional sense (e.g., for image recognition or predictive modeling). It is a hardware system for measuring physiological parameters.

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

• Not applicable.

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