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The Sabratek Patient Home Monitoring System (PHMS), is a physiological data monitoring and communications system intended for use predominately in alternate care settings.

The system consists of three major components as shown in Fig.1. The Ambulatory Patient Monitor (APM-2000) is an ambulatory device that monitors physiological data of the ambulatory patients. The Virtual Hospital Room Communicator (VHRC) is a data storage and transfer device that resides in a patient's home or at an alternate care center. The VHRC has the capability to detect and monitor the APM-2000. A number of peripheral devices such as a Scale, Non Invasive Blood Pressure device (NIBP), Oral Temperature probe and other devices can also be connected to the VHRC. Sabratek has selected peripheral devices with current agency rulings of substantial equivalence for use with the VHRC is accessible by a standard telephone line (POT). The Remote Device Access Software (RDAS) is a Microsoft Windows 95/NT applications program. The program interacts with the Virtual Hospital Room Communicator (VHRC) via modem and standard telephone line. The program collects the data stored in the VHRC and presents the information for review by the caregivers. The program can also control the functions of the APM-2000 and monitor the functions of other devices connected to the VHRC.

The Sabratek Patient Home Monitoring System (PHMS) is a physiological data monitoring and communications system. The device itself is not a diagnostic tool but gathers various physiological data. Therefore, the "acceptance criteria" discussed here relate to the device's technical specifications and engineering performance rather than diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The document states: "NON-CLINICAL TESTING CONCLUSIONS: Engineering bench testing Verification and Validation testing. The Sabratek Patient Home Monitoring System (PHMS) is equivalent in safety and efficacy to its predicate devices."

This indicates that the Sabratek PHMS underwent Engineering bench testing Verification and Validation testing to demonstrate its equivalence in safety and efficacy to predicate devices. The details of these tests are not provided in the summary.

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

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be found in detailed verification and validation reports, which are not included in this summary.

3. Number of Experts and Qualifications for Ground Truth:

The document does not mention the use of experts to establish ground truth for a test set. This is consistent with the nature of the device, which is for physiological data monitoring rather than diagnostic interpretation. The acceptance criteria focus on technical performance metrics (e.g., accuracy of respiration rate, ECG recording capability).

4. Adjudication Method for the Test Set:

No adjudication method is mentioned, as the reported testing appears to be non-clinical engineering bench testing focusing on technical specifications rather than human interpretation or diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The device is a monitoring system and does not involve human readers interpreting data from the device in a comparative effectiveness study scenario to improve diagnostic accuracy.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

The evaluation described as "Engineering bench testing Verification and Validation testing" implies a standalone performance assessment of the device's ability to accurately measure and record physiological data according to its specifications, without human intervention in the primary data acquisition and processing steps that define these metrics. However, the document does not explicitly state "standalone performance."

7. Type of Ground Truth Used:

The ground truth for the device's performance, such as respiration rate accuracy or ECG recording capability, would have been established through calibrated instruments and reference standards during the engineering bench testing. For example, a known, precisely controlled respiration rate would be used to test the device's respiration rate measurement, or a calibrated signal generator for ECG. The document implicitly relies on the technical specifications and performance of the listed component sensors (e.g., Pro-Tech 1246 for respiration, Nonin OEM II for pulse oximetry, AND Medical for NIBP) which themselves would have been validated against their respective ground truths.

8. Sample Size for the Training Set:

The document does not refer to a "training set" as the device is a hardware system for physiological monitoring, not an AI/machine learning algorithm requiring a separate training set.

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

Not applicable, as there is no mention of a training set for an AI/machine learning algorithm.

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