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The ALLY™ Platform System is a multi-platform medical device that is an accessory to approved 510k devices and is intended to be used as a means of receiving, storing, and transmitting patient biometric data including vital signs measurements. The ALLY™ Platform System is to be used upon prescription and under the supervision of an authorized healthcare provider.

The ALLY " Platform System will send information to a remote database to be accessed by authorized clients, such as healthcare professionals or patient family members. Electronic data consisting of patient vital sign information, educational material, reminders, questionnaires, and patient responses are exchanged over a secure network connection. Information may be communicated via standard telephone lines, high speed internet connections, serial port interfaces, or Bluetooth® radio transceivers.

The ALLY™ Platform is a multi-platform application that is not intended to provide automated treatment decisions or perform data manipulation, diagnostics, or real-time alerts. The ALLY™ Platform is not intended to act as an emergency response system. All patient medical diagnosis and treatment are to be performed by an appropriate health care professional.

ALLY™ is comprised of a home unit, legally marketed diagnostic peripherals, and a server. The home unit is a communications device that collects data from the diagnostic peripherals and. The patient in the home and transmits the data to the server over the home's existing telephone line or other identified method (existing high-speed connection in patients' home). The diagnostic peripherals comprise a wide range of legally marketed medical electronic devices capable of measuring patient parameters such as blood pressure, pulse rate, weight, etc. The server application responds to calls from the home units, collects the data, and then compares the data to preset thresholds. The healthcare practitioners and privileged users access the server through a secure website.

ALLYTM Care Portal: The ALLY TM Care Portal is intended to be used as an accessory to communication tools, such as the ALLYTM Home Appliance (RTX 337X). The ALLY TM Care Portal enables healthcare providers to request, receive, and review historical patient information. It is intended to be used in combination with a variety of external devices.

ALLYTM Home Appliance (RTX 337X): The ALLYTM Home Appliance (RTX 337X) is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable healthcare providers to receive historical patient information. It is intended to be used in combination with a variety of external devices.

The ALLY™ Home Appliance (RTX 337X) serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center or with the healthcare/wellness provider or other out of hospital caregivers.

This 510(k) summary is for the ALLY™ Platform System, a telehealth system. Based on the provided document, here's an analysis of the acceptance criteria and study information:

The document does not contain specific details about acceptance criteria or a dedicated study proving the device meets them in the way modern AI/ML device submissions typically do (e.g., performance metrics, ground truth, expert review). This is largely because the ALLY™ Platform System is a data transmission and storage platform, not a diagnostic or AI-powered analytical device. Its primary function is to securely transmit biometric data.

Here's an attempt to answer your questions based on the available information, noting where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the ALLY™ Platform System, acceptance criteria would likely revolve around technical functionalities like successful data transmission, data integrity, security, and compatibility with peripherals, rather than diagnostic accuracy metrics. The document does not provide a table of performance metrics.

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

The document does not describe a test set or data provenance in the context of evaluating a diagnostic algorithm's performance. The ALLY™ Platform System is a communication and data management system, not one that generates diagnostic insights. Therefore, there wouldn't typically be a "test set" of patient data for performance evaluation in the same way an AI-powered image analysis tool would have.

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

N/A. Ground truth establishment with experts is not relevant for this type of device, as it does not perform diagnostic tasks.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies, which is not applicable here.

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

N/A. This device is not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

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

N/A. The ALLY™ Platform System is a data transmission platform, not a standalone diagnostic algorithm. It explicitly states it is "not intended to provide automated treatment decisions or perform data manipulation, diagnostics, or real-time alerts."

7. The Type of Ground Truth Used

N/A. Ground truth (e.g., expert consensus, pathology, outcomes data) is used for validating diagnostic devices. For the ALLY™ Platform System, validation would likely involve demonstrating technical functionality, data integrity, security, and compliance with communication standards.

8. The Sample Size for the Training Set

N/A. This device does not use machine learning or AI models that require a training set of data.

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

N/A. Not applicable, as there is no training set or ground truth in the context of an AI/ML model for this device.

Summary:

The 510(k) submission for the ALLY™ Platform System focuses on its function as a secure communication and data storage platform for biometric data, acting as an accessory to other approved medical devices. It explicitly states that it does not provide automated treatment decisions, perform data manipulation, diagnostics, or real-time alerts.

Therefore, the typical acceptance criteria and study designs for AI/ML-powered diagnostic devices (involving test sets, ground truth, expert adjudication, MRMC studies, and training sets) are not relevant to this submission. Instead, the "study" demonstrating the device meets its acceptance criteria likely involved testing its technical capabilities, interoperability, security features, and compliance with electrical safety and communication standards to ensure it performs its intended function of reliably receiving, storing, and transmitting patient biometric data. The provided document heavily emphasizes substantial equivalence to predicate devices based on similar intended use and technological characteristics, suggesting that the primary "proof" of meeting criteria was demonstrating these similarities and outlining safety considerations for a "Moderate" level of concern device.

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