(74 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Wireless Transmission Functionality | "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." (Implies successful transmission and adherence to specifications.) |
| Adherence to Polymap Procedures & Specifications | "results were acceptable" |
| Performance under actual use conditions | "results were acceptable" |
| Adherence to performance standards | "results were acceptable" |
| Substantial Equivalence | Achieved based on fundamental scientific technology and intended use, and technological characteristics (Bluetooth, battery-powered, frequency band). |
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.
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.