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The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Blood Glucose Test Strip and the FOR A GTel Blood Glucose meter.

The FORA GTel Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. It is intended for in vitro diagnostic use by 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. It is intended to be used by a single person and should not be shared.

The FORA GTel Blood Glucose Monitoring System consists of FORA GTel blood glucose meter and FORA GTel blood glucose test strip which have been designed, tested, and proven to produce accurate blood glucose test result only when used in combination.

Here's a breakdown of the acceptance criteria and study information for the FORA GTel Blood Glucose Monitoring System, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The document specifies the acceptance criteria as "95% within ± 15%; 99% within ± 20%" under the 'Proposed Device' column for Accuracy in Table 2, but it also lists this as the reported performance, implying the device met these criteria.

Study Information

The provided document summarizes testing, but details regarding certain aspects are limited.

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated for either the non-clinical or clinical studies.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be part of the submission to the FDA (U.S.). The submission is for a device from "ForaCare Inc." with an address in Moorpark, CA, USA, and a contact person with phone/fax numbers in both the US and possibly Taiwan (indicated by +886 country code). The studies are summarized to meet FDA guidance.
• Retrospective/Prospective: Not explicitly stated. Clinical testing usually implies a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Not specified. The ground truth is established by the YSI-2300 Glucose Analyzer.

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 MRMC study was not done. This device is a blood glucose monitoring system, not an AI-assisted diagnostic tool for human readers.

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

• Yes, a standalone study was done. The "System Accuracy" (95% within ± 15%; 99% within ± 20%) is a measure of the device's performance in comparison to a reference method (YSI-2300 Glucose Analyzer). While a "user evaluation" confirmed system accuracy, the numerical accuracy presented reflects the device's inherent measurement capability.

7. The type of ground truth used

• Reference method comparison: The ground truth was established by comparing the FORA GTel Blood Glucose Monitoring System results to those from a YSI-2300 Glucose Analyzer.

8. The sample size for the training set

• Training Set Sample Size: Not explicitly mentioned. Blood glucose monitoring systems typically do not have a "training set" in the sense of machine learning algorithms. The performance is validated through non-clinical and clinical studies.

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

• Not applicable as there isn't a "training set" in the conventional machine learning sense. The YSI-2300 Glucose Analyzer, calibrated with NIST (SRM) 917A reference material, serves as the reference standard for establishing the accuracy of the device.

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