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The LifePath Remote Patient Monitoring Platform connects with compatible physiological measurement devices (blood pressure meters, pulse oximeters, thermometers, glucometers) to collect vital sign using a Patient App and securely transmit them, unaltered, to LifePath servers. The LifePath Platform is intended to be used at home or in healthcare-related environments such as long-term care facilities or clinics, nursing homes and hospitals. The LifePath Remote Patient Monitoring Platform serves as Software as a Medical Device and can be used only with specific FDA cleared third-party measurement devices.

The LifePath Remote Patient Monitoring Platform securely stores the collected information on LifePath servers and make it available for viewing by remotely located clinicians using a Clinician App installed on their smartphones. The clinician can analyze the data, prescribe medications or contact the patient if needed. Clinicians can set thresholds individually for each patient; notifications are sent to the clinician for threshold breaches.

The LifePath Platform does not interpret, make diagnoses or serve as a substitute for medical care. It is not intended to provide real time data.

The LifePath Platform is contraindicated for use in high-acuity environments, such as the ICU or operating rooms, and is not intended for use on acutely or critically ill patients or those requiring time-critical or emergency intervention.

It is intended for patients who are willing and capable of managing its use or where its operations can be performed by a caregiver. Clinical judgment and experience of a Clinician are required to check and interpret the information delivered.

The LifePath Remote Patient Monitoring Platform (the "LifePath RPM Platform") is a software application. It is used in conjunction only with FDA cleared Commercial, Off-The-Shelf (COTS) Third-Party Medical Devices (TPDs). These TPDs are with Bluetooth functionality to collect, aggregate, and present, without modification, vital signs and symptoms required by clinicians to assess a patient's health. The device is intended for patients who have non-critical conditions and are located either in their own homes or in professional healthcare facilities such as hospitals, skilled nursing facilities, nursing homes, or long-term care facilities. The LifePath RPM Platform constitutes a telemedicine system for remote monitoring of patients with the connected Clinician. Both the Patient App and Clinician App are accessed via authentication using a one-time security code by the respective users.

The LifePath Patient App connects through a short-range radio system using Bluetooth to FDA 510(k) cleared devices (listed in Table 1 below) to measure physiological parameters of adult patients and securely transmit unmodified data to the LifePath Processing Software residing on the LifePath Server (or central server) for storage, formatting, remote display, and download. The information is available for secure viewing by remotely-located healthcare professionals (eg. Clinicians). The data may be retrieved and viewed via the Clinician App and Patient App on smartphones through internet access using local Wi-Fi 802.11 or a 3G/4G/LTE cellular network. By using the Clinician App a Clinician can view the vital signs of the connected patient, analyze the data, and prescribe medications. Clinicians will also be able to set thresholds for each patient such that notifications will be sent to the Clinician in the event of any threshold breach. The LifePath RPM Platform will be prescribed by the Clinician to the patient as per the need to remotely monitor the patient. The patient, using the Patient App, can book appointments with the Clinician. The Patient App also has the provision for the patient to respond to the Clinician's questions on their prior health conditions, medical conditions, any allergic conditions, etc., that will enable Clinicians to get a clear medical status of the patient. The patient and the Clinician can interact through chats and video calls using their respective apps.

The LifePath RPM Platform is not intended for use in high-acuity environments, such as the ICU or operating rooms, and is not intended for use on acutely or critically ill patients or those requiring time-critical or emergency intervention.

The provided document does not contain details about specific acceptance criteria, a standalone study proving the device meets those criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, or MRMC comparative effectiveness studies.

The document states:

• No clinical performance data was collected because "Hazard Analysis performed on LifePath RMP Platform did not identify any features that will introduce hazards concerning safety and performance on the users." (Page 15)
• The determination of safety and performance is based on software verification and validation testing. (Page 15)
• "All non-clinical performance tests performed on the LifePath Remote Patient Monitoring Platform passed." (Page 14)

Instead of a clinical study, the submission relies on:

1. Software Verification and Validation (V&V):

   • The V&V was "robust and detailed" and based on FDA guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff." (Page 13, 15)
   • "All executable code and functionality were tested against design specifications, including accessibility, communication, and business components, data storage, processing, and multi-level security, to ensure that each component of the software performs as intended." (Page 13)
   • "Tests executed were documented as recommended by the FDA Guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Page 13)
   • Specifically, V&V included:
     • "Verification testing to demonstrate that the software meets the established product requirement specifications and identified risk mitigation measures work as intended." (Page 14)
     • "Verification that physiological parameters and vital sign readings collected from FDA 510k cleared third-party devices were captured, transmitted, stored, and displayed properly while maintaining data integrity (e.g. no loss of data or breaches)." (Page 14)

2. Risk Analysis:

   • Performed as recommended by ISO 14971:2007 (Medical devices - Application of Risk Management to Medical Devices). (Page 14)
   • Risk controls were implemented through "suitable modifications to software functionality, user interfaces, documentation, labeling, user instructions, and SOPs." (Page 14)
   • An "extensive Usability Risk Analysis was performed as recommended by ISO 14971:2007, IEC 62366-1:2015, and the FDA guidance 'Applying Human Factors and Usability Engineering to Medical Devices (2016)' to identify critical tasks and associated user errors." (Page 14)

3. Substantial Equivalence to a Predicate Device:

   • The LifePath RPM Platform's safety and effectiveness are supported by its substantial equivalence to the Comarch e-Care Platform (K181248). (Pages 9, 15)
   • Similarities include intended use, principle of operations, technological characteristics, and that "any technological differences... do not pose any additional risk and are supported by non-clinical performance data." (Page 15)

The table below summarizes the device performance claims based on the non-clinical tests mentioned, rather than specific quantitative acceptance criteria and proven performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Details from the Study:

2. Sample size used for the test set and the data provenance:
* Not applicable/Not provided. The document describes software verification and validation, not a study involving a patient test set or data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not provided. Ground truth in a clinical sense was not established for this type of software V&V.

4. Adjudication method for the test set:
* Not applicable/Not provided.

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 MRMC comparative effectiveness study was done. The device does not involve AI interpretation or diagnostic capabilities; it is a platform for collecting, transmitting, storing, and displaying data for clinicians to analyze. "The LifePath Platform does not interpret, make diagnoses or serve as a substitute for medical care." (Page 9)

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* A "standalone" performance evaluation in the sense of software verification and validation (algorithm only) was done. The document states: "Determination of the safety and performance of LifePath Remote Monitoring Platform is based on software verification and validation testing." (Page 15)

7. The type of ground truth used:
* Not applicable in the clinical sense. For software verification, the "ground truth" would be the design specifications and expected system behavior.

8. The sample size for the training set:
* Not applicable/Not provided. This is a software platform, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:
* Not applicable/Not provided.

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