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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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The Polytel GMA (models PWR-08-06, PWR-08-07, and PWR-08-09) are remote communications link devices intended to be used to wirelessly transmit glucose meter readings from a compatible Blood Glucose Monitor to a compatible cellular phone, such as the Nokia N73 or access point, such as the Polytel® APT. The receiving device, in turn, sends the readings to the healthcare provider in another location. The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.

The Polytel® GMA is a telemedicine device that uses Bluetooth technology to transmit data from a glucose monitor to compatible access points such as a personal computer, standalone device or cellular phone with Bluetooth capability. It is connected to the glucose meter by a phono jack and uses short-range low power wireless transmission (Bluetooth v2.0) to send the data to Bluetooth compatible access point. The unit is battery powered.

The provided text describes a 510(k) summary for the Polytel® GMA (Glucose Meter Accessory). However, it does not contain the detailed information typically found in a study proving the device meets specific acceptance criteria with reported device performance metrics, sample sizes, expert qualifications, or ground truth establishment.

The document primarily focuses on:

• Device identification and contact information.
• Predicate device identification.
• Device description: It's a telemedicine device using Bluetooth to transmit glucose meter data.
• Intended use and indications for use: Wirelessly transmits glucose meter readings to a compatible cellular phone or access point, which then sends the readings to a healthcare provider. It does not send real-time alarms.
• Claim of substantial equivalence to predicate devices based on fundamental scientific technology and intended use.
• Technological characteristics: Bluetooth technology, battery-powered, same frequency band (2.402 to 2.480 GHz).
• Testing: It broadly states that "The testing consisted of three types: bench testing using Polymap procedures and specifications; field testing under actual use conditions; and, performance standards testing. The results were acceptable."
• Conclusions: Substantial Equivalence was demonstrated.

Based on the provided text, I can respond to your request as follows:

1. A table of acceptance criteria and the reported device performance

Note: The document provides general statements of acceptance rather than specific quantitative performance metrics against predefined criteria. The acceptance criteria are inferred from the types of testing mentioned.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It only mentions "bench testing," "field testing under actual use conditions," and "performance standards testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the use of experts to establish a ground truth for a test set. The device is a data transmission accessory, not a diagnostic tool that would typically require expert-adjudicated ground truth for its core function.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not mention any adjudication method for a test set, as it does not describe a study involving human interpretation of data for which ground truth would be established through adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI (Artificial Intelligence) or CAD (Computer-Aided Detection/Diagnosis) systems where the device assists human readers in interpretation. The Polytel® GMA is a communication link device, not an AI or interpretative system.

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

A "standalone" performance evaluation in the context of an algorithm's diagnostic accuracy was not performed because the Polytel® GMA is a data transmission device, not an algorithm that performs diagnostic analysis. Its "standalone" performance would refer to its ability to transmit data correctly, which is generally covered under the "bench testing" and "field testing" mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not describe the use of specific "ground truth" types like expert consensus, pathology, or outcomes data. For a device that merely transmits data, the "ground truth" would likely relate to the accuracy and integrity of the transmitted data compared to the input data, and the reliability of the wireless connection. These are assessed through technical performance standards rather than clinical ground truth establishment.

8. The sample size for the training set

The document does not mention a training set. This is because the Polytel® GMA is a hardware accessory for data transmission, not a learning algorithm or AI system that requires a training set.

9. How the ground truth for the training set was established

As there is no mention of a training set (see point 8), there is no ground truth established for it.

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The Polymap PWR-008-03 is a remote communications link intended to be used to wirelessly transmit glucose meter readings from a Blood Glucose Monitor to a compatible access point or cellular phone, such as the Nokia 6620. The device does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered.

The PWR-08-03 is a telemedicine device that uses Bluetooth technology to transmit data from a glucose monitor to compatible access points such as a personal computer or cellular phone with Bluetooth capability. It is connected to the glucose meter by a phono jack and uses short-range low power wireless transmission (Bluetooth VI .2) to send the data to a Bluetooth compatible access point. The unit is battery powered.

This 510(k) summary describes a remote communication link (Polymap PWR-08-03) that transmits glucose meter readings wirelessly. The submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance studies or specific acceptance criteria for the device's functional performance in terms of data transmission accuracy or reliability.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or detailed performance metrics in the way one would typically see for diagnostic accuracy or clinical effectiveness. Instead, the "performance" discussed relates to the device's functional operation and compliance with technical standards.

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

The document mentions "bench testing" and "field testing under actual use conditions" but does not specify any sample sizes for these tests. There's no information provided regarding the data provenance (e.g., country of origin, retrospective or prospective nature).

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

This type of information is not applicable to this submission. The device is a data transmission accessory, not a diagnostic tool requiring expert interpretation of results. The "ground truth" here would relate to the accurate transmission of data, which is typically verified through technical validation rather than expert consensus.

4. Adjudication Method for the Test Set:

Not applicable. As the device is for data transmission, there's no adjudication process relevant to clinical or diagnostic outcomes.

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:

Not applicable. This device is a communication link and does not involve AI or human interpretation of medical images or data in a way that an MRMC study would be relevant.

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

The device itself is a standalone communication module, meaning it functions without direct human interaction during data transmission. Its performance (e.g., successful data transfer, range, battery life) would have been assessed as part of the "bench testing" and "field testing" mentioned, but no specific details on these standalone tests or their metrics are provided beyond "results were acceptable."

7. The Type of Ground Truth Used:

The "ground truth" for this device would be the accurate and complete wireless transmission of glucose meter readings. This would be validated by comparing the data received at the access point/cellular phone with the original data recorded by the glucose meter. The document states "bench testing using Polymap procedures and specifications" and "field testing under actual use conditions," implying that such validation was performed, but it doesn't elaborate on the specific methodology or metrics.

8. The Sample Size for the Training Set:

Not applicable. This device is a hardware accessory for data transmission and does not utilize machine learning or AI models, therefore, there is no "training set."

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

Not applicable. (See point 8.)

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