(85 days)
The FORA V10 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The alternative site testing in the FORA V10 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.
The FORA V10 Blood Glucose Monitoring System consists of Glucose meter, Test Strips, Two levels of Control Solution, commercially available Lancing Device and Sterile Lancets, User Manual, and Storage Pack.
The FORA V10 Blood Glucose Monitoring System (Model TD-4244) met the acceptance criteria by demonstrating substantial equivalence to its predicate device through performance characteristics, specifically by meeting the requirements of ISO 15197.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ISO 15197 Requirements | "the device met the requirements of ISO 15197." |
| Precision | Demonstrated to be "substantially equivalent" to the predicate device. |
| System Accuracy | Demonstrated to be "substantially equivalent" to the predicate device. |
2. Sample size used for the test set and the data provenance:
The document mentions "laboratory tests" and "software verification and validation testing," but does not specify the sample size used for the test set. It also does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth.
4. Adjudication method for the test set:
The document does not specify any adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it relevant for a glucose monitoring system. The study focused on the device's accuracy against a known standard (ISO 15197) and comparison to a predicate device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the performance evaluation of the FORA V10 Blood Glucose Monitoring System appears to be a standalone assessment of the device's accuracy and precision, without human interpretation in the loop. The "laboratory tests" and "software verification and validation testing" confirm the device's inherent performance.
7. The type of ground truth used:
The ground truth used for performance comparison was likely based on reference glucose measurements obtained from a laboratory standard method against which the device's readings were compared to assess compliance with ISO 15197. This would involve a highly accurate and precise laboratory instrument with an established accuracy profile.
8. The sample size for the training set:
The document does not provide information regarding a training set sample size. This type of device (blood glucose monitor) typically undergoes calibration during manufacturing rather than a machine learning "training" phase.
9. How the ground truth for the training set was established:
As above, the concept of a "training set" and its associated ground truth establishment is not applicable in the context of this device's reported evaluation. The device would be calibrated against known glucose concentrations.
§ 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.