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The MedApps /Alere Connect 2.0 Remote Patient Monitoring System is not intended for diagnosis or as a substitute for medical care, nor is it intended to provide real-time / time-critical data. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

The MedApps 2.0 - Remote Patient Monitoring System consists of:

• HealthPAL hardware: (1) The physical component of the HealthPAL is an electronic device contained in a plastic enclosure with an OLED screen, built-in M2M cellular chip, speaker, smart cable connection, smart cables, wireless module. LED lights to indicate activity, timer button to assist patients with their reading schedule (i.e. remind them to take their reading in X minutes), last reading button, volume up and down buttons. The HealthPAL Model 105 contains a GSM cellular module while the HealthPAL Model 106 contains a CDMA cellular module.
• HealthHUB hardware / software: (2) The HealthHUB hardware is an extension of the HealthPAL functionality. HealthHUB acts as a "docking" station for the HealthPAL in order to act as a conduit for the AC power adaptor connecting the electrical wall outlet to the HealthPAL providing power and battery charging capability. The Hubs also provide additional connections to off the shelf Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters, via smart cables (per validated in HealthPAL software). The HealthHUB model MA200 allows for multiple wired connections for accessory devices. HealthHUB Model 205 is specific for the HealthPAL MA105, and the HealthHUB 206 is specific for the HealthPAL MA 106 with both Hubs having one wired connector.
• HealthPAL firmware / software: (3) The firmware captures data from commercially available health monitors, and stores and transmits the information to the HealthCOM server, via the embedded communication chip / platform. The firmware allows HealthPAL to receive information via wire or via embedded wireless module from accessory medical devices that are compatibly wireless enabled, which have been paired to the MedApps HealthPAL. The firmware has many additional functions including: Download of user profiles from the server to configure HealthPAL remotely. HealthPAL has audio capability to deliver verbal announcement of readings and acknowledgment of data transmission from all connected accessory medical devices, time settings, volume control, educational content and reminders, in any language that is loaded to the device. Timer capability, activated by the user to provide assistance with adhering to a reading schedule (reminders to take readings within a set timeframe). OLED screen displays information regarding the HealthPAL's status including battery level, volume level, data transmission status, transmission pending indicator, activity icons / messages and other information to provide ease of use and promote patient adherence; as well as information received from accessory medical devices, such as the type of device, measurement, date and time of the last reading collected. Battery charging, isolation circuits, and interfaces to individual accessory medical devices / protocols via the smart cable.
• MobileLink hardware / software: (4) AC020 MobileLink is a modified MA105 HealthPAL device. The physical component of the MobileLink is an electronic device contained in a plastic enclosure with built-in M2M cellular chip, speaker, standard USB cable and USB Smart Cable connection, OLED screen to review the reading, and LED lights to indicate activity regarding the receiving and transmitting of collected data. Like the HealthPAL, MobileLink's firmware / software captures, data from commercially available retail health monitors, and transmits information. to the HealthCOM server, via the embedded communication chip / platform. The firmware allows MobileLink to receive information via wire, either standard USB or with a customized USB Smart Cable, from accessory medical devices. The firmware has many additional functions including: Download of user profiles from the server to configure MobileLink remotely. MobileLink's Audio feature uses audio tones to indicate acknowledgment of collected readings from all connected accessory medical devices as well as reading transmission via the cellular network. MobileLink's visual user interface utilizes an OLED display to display collected readings from attached accessory medical devices as well as reading transmission acknowledgements. MobileLink's visual interface also contains a LED light to show power and provide reading request indication capability.
• HomeLink hardware / software: (5) AC200 HomeLink is a modified MA105 HealthPAL device. The physical component of the HomeLink is an electronic device contained in a plastic enclosure with built-in M2M cellular chip, speaker, standard USB cable and USB Smart Cable connection, touch screen to review the reading and allow patients with ability to have "IVR" (questions and answers) functionality that was formally part of the HealthCOM IVR section, and wireless module. Like the HealthPAL or MobileLink, HomeLink's firmware / software captures biometric data from FDA cleared commercially available accessory devices, and stores and transmits information to the HealthCOM server, via the embedded communication chip / piatform. The firmware allows HomeLink to receive information via wire or via embedded wireless module from accessory medical devices that are compatibly wireless enabled, which have been paired to the HomeLink device. The firmware has many additional functions including: Download of user profiles from the server to configure HomeLink remotely. HomeLink's has audio capability to deliver verbal announcement of readings and acknowledgment of data transmission from all connected accessory medical devices, volume control, user feedback, in any language that is loaded to the device. HomeLink's visual user interface utilizes a touch screen display to display collected readings from attached accessory medical devices as well as other user interactions. One such patient HomeLink user interface includes the MedApps 2.0 System IVR functionality, which originally was executed from the HealthCOM webportal by professionals to patient's phones. The updated version allows end users (patients) to provide answers on the HomeLink device based on professional predefined questions that are reviewed in HealthCOM. This allows an improved user interaction of the previous IVR procedure. HomeLink screen also displays information regarding the device's status including volume level, data transmission status, preferred language, transmission pending indicator, activity icons / messages and other information to provide ease of use and promote patient adherence; as well as information received from accessory medical devices, such as the type of device, measurement, date and time of the last reading collected.
• MedApps HealthCOM software application: (6) The HealthCOM software application allows caregivers access to review patient data collected from accessory medical devices using MedApps hardware on the secure HealthCOM website. HealthCOM software allows professional caregivers to set patient readings. HealthCOM software also allows the patient to establish an account and to direct / authorize their data to be directed to an outside, validated Personal Health Record (PHR), Electronic Health Record or Medical Record (EHR or EMR),
• MedApps IVR software application from HealthCOM: (7) The IVR (Interactive Voice Response) software application provides the ability to contact the patient remotely, by phone (designated in the user profile), and executes an pre-approved ("canned") scripts to deliver pre-approved ("canned") reminder messages ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings"), educational content and gather survey information. In addition, the MedApps IVR application will send out Email, SMS / Text Messages, Paging, IM and other forms of communications in order to contact patients or caregivers. This will include reminders and alerts, based on clinically defined parameters / thresholds established in HealthCOM by the professional care provider. The original IVR system has moved to the HomeLink device for easier interaction with the patient compared to the need for the patient to receive an IVR phone call on their personal phone, which includes professionally defined questions that the patient can answer and both the questions and answers will be recorded in the HealthCOM system for professional review.
• Accessory Device Descriptions: (8)

The document describes the MedApps 2.0 - Remote Patient Monitoring System and states that its conformity to FDA's recognized consensus standards demonstrates its safety and efficacy. No specific acceptance criteria or a dedicated study proving device performance against such criteria are explicitly provided. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a sample size for a "test set" in the context of clinical performance evaluation. The testing described is primarily non-clinical performance data testing and review, focused on design control verification and validation. The data provenance is internal to MedApps' development process, likely involving various test environments and scenarios, rather than patient data from a specific country or collected retrospectively/prospectively from a clinical trial.

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

This information is not provided in the document. The testing described appears to be engineering and software verification/validation, not a study requiring expert-established ground truth on patient data.

4. Adjudication Method for the Test Set

This information is not provided as the described testing is not an adjudication process involving multiple reviewers for clinical outcomes.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The MedApps 2.0 Remote Patient Monitoring System does not rely on an assessment of clinical performance data."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is a "Remote Patient Monitoring System" that facilitates the collection and transmission of data from accessory medical devices for review by healthcare professionals. While the system operates without direct human intervention during data collection and transmission, its overall function is designed to support human monitoring. The described testing is primarily about the reliability and functionality of data collection and transmission, not a standalone diagnostic or interpretive algorithm's performance in a clinical sense. Therefore, a standalone study evaluating an "algorithm only" performance in the typical sense (e.g., diagnostic accuracy of an AI model) does not appear to have been done or is not relevant to the described device's function as a data transmission hub.

7. Type of Ground Truth Used

For the non-clinical performance testing described, the "ground truth" would be the expected functional behavior and compliance with design specifications and regulatory standards. This is established through the device's design requirements, engineering specifications, and validated test procedures, rather than expert consensus on clinical cases, pathology, or outcomes data.

8. Sample Size for the Training Set

This information is not applicable/not provided. The MedApps 2.0 System is a hardware and software system for data collection and transmission, not a machine learning or AI algorithm that requires a "training set" in the conventional sense for clinical interpretation or prediction.

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

This information is not applicable/not provided for the same reasons as #8.

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