Search Results

The FORA G90 Perform 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 G90 Perform Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

The system consists of three main products: the meter, test strips, and control solutions. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only FORA G90 Perform test strips and control solutions with the FORA G90 Perform Blood Glucose Monitoring System.

This submission describes a 510(k) for the FORA G90 Perform Blood Glucose Monitoring System. The basis for substantial equivalence is the predicate FORA G90/TD-4234 Blood Glucose Monitoring System (K091898). The changes to the device compared to the predicate include software modifications for "no-coding" functionality and preset measurement in mg/dL.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria for the FORA G90 Perform Blood Glucose Monitoring System's accuracy. Instead, it states that "A comparison of system accuracy performance demonstrated that the FORA G90 Perform blood glucose monitoring system and the currently marketed FORA G90/TD-4234 Blood Glucose Monitoring System (cleared under K091898) are substantially equivalent."

Therefore, the reported device performance is that its accuracy is "substantially equivalent" to the predicate device. To determine the actual acceptance criteria, one would need to refer to the 510(k) summary for the predicate device, K091898.

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

The document states: "A comparison of system accuracy performance demonstrated that the FORA G90 Perform blood glucose monitoring system and the currently marketed FORA G90/TD-4234 Blood Glucose Monitoring System (cleared under K091898) arc substantially equivalent."

However, the document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for this device or its predicate. This information would typically be found in the detailed performance study sections of the 510(k) submission itself, not necessarily in the summary.

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. For blood glucose monitoring systems, "ground truth" is typically established by laboratory reference methods (e.g., YSI analyzer) rather than expert human interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. Adjudication methods are typically used when subjective expert review is involved in determining ground truth or evaluating performance. For a quantitative device like a blood glucose monitor, the comparison is against an objective reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic devices where human interpretation is involved. This device is a quantitative measurement system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance evaluation described, though not detailed, is inherently a standalone (algorithm only) comparison. The device measures glucose levels, and its accuracy is assessed against a reference method. The "substantial equivalence" claim is based on the device's technical performance.

7. The Type of Ground Truth Used

Based on the nature of a blood glucose monitoring system, the ground truth would be established using a laboratory reference method (e.g., a YSI STAT PLUS Glucose & Lactate Analyzer). While not explicitly stated in this summary, this is the standard practice for validating such devices.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for the training set. For a device like this, the "training" (algorithm development and calibration) would occur prior to the performance studies, and details on the data used for this are not typically in the 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

Similar to the ground truth for the test set, the ground truth for any training data would have been established using a laboratory reference method for glucose measurement. However, this is not explicitly stated in the document.

Ask a specific question about this device