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The Polytel® APT receives data wirelessly from compatible devices to transmit over the Internet or common telephone lines. The APT is an optional accessory to other Polytel® devices, including the various GMA (glucose meter accessory) models, blood pressure meter, weight scale and spot-check SpO2. The APT is intended to aid people at home and health care professionals to review and evaluate historical blood glucose, weight and blood pressure test results, to support effective health care management.

The APT does not measure, interpret, or make any decisions with respect to any of the data it transports. All patient medical diagnosis and treatment are to be performed under the supervision and oversight of appropriate healthcare professional. This device is not intended as a substitute for medical care.

Any device certified by Polymap Wireless as compatible can use the Polytel® APT to forward its data.

The device is not intended for emergency calls, and may not be used to send any real-time alarms or time-critical data. The device is not intended for use in systems set up for patients who need direct medical supervision or who might need emergency intervention.

The APT and its compatible devices must be used in conjunction with a subscription to a compatible monitoring service. The monitoring service may distribute the APT to the patient; alternatively, the patient may acquire the APT and other compatible devices and subscribe to a compatible service.

A list of compatible devices and services will be available on the Polymap Wireless website.

The Polytel® APT device performs transmission of physiological patient information to and from wireless patient monitors and a remote data server healthcare facility over an encrypted dialup Internet connection. The APT, with its built-in telephone modem, transmits data over the public switched telephone network and the dial-up Internet.

The APT is contained in a small plastic unit, containing two standard telephone jacks for connection to standard phone outlets, a 5V power input jack for connection to an AC adapter, and four indicator lights. The indicator lights are used to show the reception of a measurement from a transmitting device, to show when the telephone line is in use, and to indicate if there has been an error (delay) in transmission.

Two server-side components are involved in the operation of the APT, the first providing a centralized configuration database, the second providing for data collection and translation to a standard protocol.

The APT device is not used directly on a patient, nor attached electrically to any device that is used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.

Here's a breakdown of the acceptance criteria and study information for the Polytel® APT device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria in terms of performance metrics (like accuracy, sensitivity, specificity, etc.) for the Polytel® APT. This is common for devices like data transmission gateways, where the focus is on functional verification rather than diagnostic performance. Instead, the "acceptance criteria" are implied by the nature of the testing performed, which aimed to demonstrate that the device functions as intended and is substantially equivalent to predicate devices.

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

The document does not specify a numerical "sample size" for the test set in terms of patients or data points. However, it mentions:

• Bench Testing: Conducted using "Polymap procedures and specifications."
• Field Testing: Conducted "under actual use conditions."

The data provenance is not explicitly stated in terms of country of origin, nor is it explicitly labeled as retrospective or prospective. Given the nature of "field testing under actual use conditions," it would inherently be prospective, simulating real-world usage.

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

The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., expert consensus on a medical image) is not applicable here. The Polytel® APT is a data transmission device, not a diagnostic tool. Therefore, there's no mention of experts establishing a ground truth for a test set in the traditional sense of medical diagnosis. The "truth" in this context is whether the data is transmitted correctly and reliably.

4. Adjudication Method for the Test Set

No adjudication method is described, as it's not relevant for a device whose primary function is data transmission. The evaluation would have been based on successful transmission, data integrity, and functional operation.

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

No. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance, typically in diagnostic tasks. The Polytel® APT is a data transmission gateway, not an AI diagnostic tool, so such a study would not apply.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence. The "testing" described (bench testing, field testing, and performance standards testing) evaluates the device's functional performance in a standalone capacity, without direct human intervention in its data transmission function. The device's role is to automate data transfer.

7. The Type of Ground Truth Used

As mentioned in point 3, the concept of "ground truth" (expert consensus, pathology, outcomes data) doesn't directly apply here for a data transmission device. Instead, the "ground truth" for the testing would have been:

• Expected Functional Behavior: The device should transmit data correctly and reliably according to its design specifications.
• Successful Data Reception: Data sent by the APT should be received accurately by the remote server/healthcare facility.
• Compliance with Standards: Meeting established performance standards for wireless communication and data transfer.

8. The Sample Size for the Training Set

The Polytel® APT is a hardware device for data transmission, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI or machine learning. The device's functionality is based on its hardware design and firmware programming, not on being trained on a dataset.

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

Not applicable, as there is no training set for this type of device.

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