(154 days)
The FORA GD43 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertip and alternative sites (palm, forearm and upper arm). This blood glucose monitoring system is intended to be used by a single person and should not be shared. Alternative site testing (AST) should only be done during steady-state times (when glucose is not changing rapidly).
The FORA GD43 Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.
The FORA GD43 Test Strips are for use with the FORA GD43 Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingertip and alternative sites (palm, forearm and upper arm).
The system consists of blood glucose meter and test strips. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA GD43 test strips with the FORA GD43 Blood Glucose Monitoring System.
The provided text describes the FORA GD43 Blood Glucose Monitoring System and its performance studies. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from ISO 15197:2003, for self-testing BGMS) | Reported Device Performance (FORA GD43) |
|---|---|
| >95% of individual glucose results fall within ±15 mg/dL for glucose concentrations 95% of individual glucose results fall within ±15 mg/dL for glucose concentrations 95% of individual glucose results fall within ±15% for glucose concentrations ≥ 75 mg/dL | >95% of individual glucose results fall within ±15% for glucose concentrations ≥ 75 mg/dL |
| CV (%) less than 5% for intermediate precision | CV (%) less than 5% |
| CV (%) less than 5% for repeatability | CV (%) less than 5% |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the exact sample size for the "test set" in terms of number of patients or samples. It only mentions that "Clinical and non-clinical studies were conducted".
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied to be prospective clinical and non-clinical studies for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
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:
This is a blood glucose monitoring system, not an AI-based diagnostic imaging or interpretive device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study with human readers and AI assistance is not applicable and was not done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone algorithm (meter) for measuring blood glucose. The performance described is the standalone performance of the FORA GD43 system compared to a reference method (YSI 2300 Glucose Analyzer). There isn't a "human-in-the-loop" component in the algorithm's performance measurement as described for this type of device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth for the clinical and non-clinical studies was established by comparison to the YSI 2300 Glucose Analyzer. The YSI is a laboratory reference instrument often used as a gold standard for glucose measurement.
8. The sample size for the training set:
The document does not mention a separate "training set" or its sample size. For blood glucose meters, the performance validation typically involves comprehensive testing against a reference method rather than a distinct training/testing split in the conventional machine learning sense.
9. How the ground truth for the training set was established:
As no separate training set is explicitly mentioned, this question is not directly applicable. However, the document states that the YSI 2300 Glucose Analyzer was calibrated with NIST (SRM) 917A reference material. This indicates the traceability and establishment of the reference standard for all measurements.
§ 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.