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510(k) Data Aggregation
(116 days)
The FORA G30a 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 G30a 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 G30a test strips and control solutions with the FORA G30a Blood Glucose Monitoring System.
The provided text describes a 510(k) summary for the FORA G30a Blood Glucose Monitoring System. However, it does not contain specific acceptance criteria, comprehensive performance data, or detailed study methodology in the way requested by the user's template.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (FORA G30 Blood Glucose Monitoring System, K090187) due to minor modifications (software and labeling changes). It states that the FORA G30a has the "same performance characteristics" and that "A comparison of system accuracy performance demonstrated that the FORA G30a blood glucose monitoring system and the currently marketed FORA G30 Blood Glucose Monitoring System (cleared under K090187) are substantially equivalent."
Therefore, based on the provided text, it's impossible to fill in all the requested information. I can, however, extract the limited information present and point out what is missing.
Here's the breakdown based on the provided text:
Acceptance Criteria and Study Information (Based on provided text)
| Information Category | Details (from provided text) | Missing Information / Not Explicitly Stated |
|---|---|---|
| 1. Table of Acceptance Criteria & Reported Device Performance | The document states: - "FORA G30a blood glucose monitoring system has the same performance characteristics as the predicate device." - "A comparison of system accuracy performance demonstrated that the FORA G30a blood glucose monitoring system and the currently marketed FORA G30 Blood Glucose Monitoring System (cleared under K090187) are substantially equivalent." | No specific quantitative acceptance criteria for accuracy (e.g., % within +/- X mg/dL or % within +/- Y% compared to a reference method) are provided in this summary. |
| No specific reported device performance metrics for FORA G30a (e.g., accuracy percentages, bias, precision) are explicitly stated in a table format. The claim is based on equivalence to the predicate. | ||
| 2. Sample size used for the test set and data provenance | Not explicitly stated for performance testing. The provenance is likely global given "Taipei County, Taiwan" for the submitter and "China (Taiwan)" in the FDA letter. | Specific sample size for the test set is not provided. |
| Specific data provenance (country of origin of participants, retrospective/prospective nature) for the performance study is not detailed. | ||
| 3. Number of experts used to establish ground truth & qualifications | Not applicable/Not mentioned, as this is a blood glucose monitoring system for quantitative measurement, not an AI diagnostic imaging device requiring expert interpretation for ground truth. | Not applicable in the context of a blood glucose meter's performance study. Ground truth for blood glucose meters typically involves a laboratory reference method. |
| 4. Adjudication method | Not applicable, for the same reasons as above. | Not applicable. |
| 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done | No, this is not an MRMC study. It is a blood glucose meter performance study. | Not applicable. |
| 6. If a standalone (algorithm only) performance was done | Yes, the "system accuracy performance" mentioned would refer to the standalone performance of the blood glucose monitoring system (meter + strips). Human-in-the-loop is not a relevant concept for this type of device in the same way it is for AI-assisted image analysis. | The "standalone" nature would imply the system is tested on its own against a reference. No specific "algorithm only" performance would be separately evaluated as the algorithm is inherent to the device's function. |
| 7. The type of ground truth used | While not explicitly stated, for blood glucose monitoring systems, the ground truth is universally established by a laboratory reference method (e.g., YSI analyzer) which is considered highly accurate. | The specific laboratory reference method used is not mentioned in the summary, though it is implied by "system accuracy performance." |
| 8. The sample size for the training set | This device is not described as an AI/ML device that requires a "training set" in the traditional sense. It's an electrochemical biosensor with pre-programmed algorithms. The software modification mentioned implies updates to the existing algorithm, not a machine learning model requiring new training data. | Not applicable. The device is not presented as an AI/ML device requiring a training set. The "software verification and validation testing" refers to confirming the functionality and accuracy of the device's embedded software. |
| 9. How the ground truth for the training set was established | Not applicable, as no training set (in the AI/ML sense) is mentioned. | Not applicable. |
Summary of what the document does convey:
- Device Name: FORA G30a Blood Glucose Monitoring System
- Intended Use: Quantitative measurement of glucose in fresh capillary whole blood from the finger and alternative sites (palm, forearm, upper-arm, calf, thigh) for use by healthcare professionals and people with diabetes mellitus at home. Not for diagnosis, screening, or neonates.
- Predicate Device: FORA G30 Blood Glucose Monitoring System (K090187)
- Modifications: Software modification in the glucose meter and a corresponding labeling change.
- Performance Claim: Substantial equivalence to the predicate device in performance, with the FORA G30a having the "same performance characteristics." Software verification and validation confirmed this.
- Test Principle: Electrochemical biosensor technology using glucose oxidase.
The provided 510(k) summary is typical for a device demonstrating substantial equivalence based on minor changes to an already cleared predicate device. It relies heavily on the predicate's established performance without reiterating all specific performance criteria and detailed study results, as the expectation is that the minor changes did not alter these characteristics. To get the detailed acceptance criteria and performance data, one would typically need to review the original 510(k) submission for the predicate device (FORA G30, K090187).
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