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The Nexsystem ambulatory patient monitoring system is intended for use in the home or alternate care settings. It consists of a patient-worn sensor (Nexisensor), signal transfer unit (Nexender), communications module (Nextation), and a telemonitoring station computer based display and storage system (TMS) located at the health care professional's facility. The device stores and transmits ECG data, respiratory data, skin temperature, systolic and diastolic blood pressure (Non-invasive), and PEF and FEV1.

The Nexsystem is not for use as a critical care monitoring system. The Nexsystem is not an apnea monitor.

The Nexystem is a non-invasive ambulatory patient monitoring system for recording multiple physiological parameters from patients who may be located at home or in an alternate care setting. The Nexystem continuously gathers physiological data from a sensor band attached to the patient and transmits the data wirelessly via a Signal Transfer Unit (Nexender) to a Base Station Unit (Nextation) where the data are recorded and stored. Additionally, the Base Station Unit has interfaces for auxiliary sensors - spirometer and blood pressure monitor - for recording point in time lung function and blood pressure measurements. A Call Discriminator Unit enables incoming telephone calls to be correctly routed to either the Nextation or a telephone handset.

The data are transmitted for display, monitoring and storage on a computer (Telemonitoring Station TMS running the Nexoft application software) at a distant location (Telemonitoring Centre). This data transfer is under the control of the Health Care Professional (HCP) at the TMS. Data may be transferred in real time to enable the HCP to check on the quality of the physiological data being recorded and/or the status of the patient. Normally data is transferred at a scheduled time after the end of a patient data recording session. Once transferred to the TMS the data can subsequently be displayed for analysis by the HCP. The Nexystem enables the HCP to print reports of raw or summary data.

The Nexystem comprises a number of system components identified below.

Here's a summary of the acceptance criteria and study information for the Nexystem based on the provided K993643 Premarket Notification:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define acceptance criteria in terms of numerical thresholds for all evaluated parameters. Instead, it relies heavily on compliance with recognized standards (ANSI/AAMI EC12 and EC38) and direct comparison to predicate devices, highlighting where the Nexystem meets or exceeds predicate performance.

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

The submission explicitly states: "14.7 Clinical performance data for equivalence: Not applicable". This indicates that no separate clinical test set of patient data was used to demonstrate the performance of the Nexystem in a clinical setting compared to a ground truth established from patient data. The primary method of demonstrating equivalence was through non-clinical testing against standards and direct comparison of specifications with predicate devices.

Therefore, for a clinical test set:

• Sample size: Not applicable.
• Data Provenance: Not applicable.

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

Since no clinical test set was utilized for demonstrating performance against a "ground truth" derived from patient data, this information is not applicable. The "ground truth" for the non-clinical tests was defined by the requirements of the standards (ANSI/AAMI EC12 and EC38) and the specifications of the predicate devices.

4. Adjudication Method for the Test Set

As no clinical test set with human-established ground truth was used, an adjudication method is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The submission explicitly states "Clinical performance data for equivalence: Not applicable". Therefore, no MRMC study was conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, in a way. The performance evaluation primarily involved standalone testing of the device's technical specifications and compliance with recognized standards. This is akin to standalone performance for the various physiological data acquisition and transmission functions. For example:

• Compliance testing of the Nexisensor to ANSI/AAMI EC12 for disposable ECG electrodes.
• Compliance testing of the Nexystem to ANSI/AAMI EC38 for ambulatory electrocardiographs.
• Verification of heart rate range and accuracy, respiration range and accuracy, and temperature range and accuracy based on the device's internal functionality.
• The use of legally marketed and separately cleared devices for blood pressure (Omron IC) and spirometry (Micromedical MicroPlus) implies their standalone performance was relied upon.

However, it's important to note this is not a standalone performance of an AI algorithm, as this device does not appear to incorporate AI for diagnostic purposes. It's a standalone performance demonstration of monitoring hardware and software capabilities.

7. The Type of Ground Truth Used

The ground truth used in this submission is multifaceted and based on:

• Industry Standards: The requirements and specifications outlined in ANSI/AAMI EC12 (Disposable ECG Electrodes) and ANSI/AAMI EC38 (Ambulatory Electrocardiographs).
• Predicate Device Specifications: The technical parameters and performance characteristics of the legally marketed predicate devices (Sabratek PHMS, Propaq Encore, Mortara Ambulatory X-12 Telemetry Module, Reynolds Tracker/Pathfinder, Instromedix Poseidon Cardiac Monitoring System). The Nexystem demonstrated "substantial equivalence" by meeting or exceeding these established benchmarks.
• Functional Testing: The inherent design specifications and measured performance of the Nexystem components (e.g., heart rate accuracy, temperature accuracy) as validated by engineers/testers against known input signals or reference devices.

8. The Sample Size for the Training Set

This information is not applicable. The Nexystem is an ambulatory patient monitoring system that primarily collects and transmits physiological data; it is not described as an AI-powered diagnostic or analysis device that would require a "training set" in the context of machine learning. The focus is on hardware and software functionality and compliance with performance standards for data acquisition and transmission.

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

As no training set (in the context of machine learning/AI) was used, this information is not applicable.

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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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