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The FORA V30 Blood Glucose Monitoring System/TD-4242 Blood Glucose Monitoring System are 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 V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

This meter has some speaking functions but is not intended for use by the visually impaired.

The kit of FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring Systems consist of Glucose Meter, Test Strips, Control solution, A commercially available lancing device and sterile Lancets, User Manual, and Storage Pack.

The provided text does not contain detailed acceptance criteria for the FORA V30 Blood Glucose Monitoring System/TD-4242 Blood Glucose Monitoring System, nor does it describe a specific study proving the device meets those criteria with the requested level of detail.

The document is a 510(k) summary for a medical device, primarily focusing on demonstrating substantial equivalence to a predicate device (FORA G30/TD-4241 Blood Glucose Monitoring System).

Here's what can be inferred from the text regarding performance and testing, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "A comparison of system accuracy performance demonstrated that the FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring System and the currently marketed FORA G30/TD-4241 Blood Glucose Monitoring System are substantially equivalent."

It also mentions: "Software verification and validation testing confirmed that the performance, safety and effectiveness of the FORA V30 Blood Glucose Monitoring System /TD-4242 Blood Glucose Monitoring Systems are equivalent to the predicate device."

• Acceptance Criteria: Not explicitly stated in terms of specific thresholds for accuracy, precision, or other metrics. The implied acceptance criterion is "substantial equivalence" to the predicate device in terms of performance.
• Reported Device Performance: No specific numerical performance metrics (e.g., mean absolute relative difference, percentage within specific error zones) are provided for either the new device or the predicate. The performance is reported as being "substantially equivalent."

Missing Information for a comprehensive table: Specific numerical targets for accuracy, precision, linearity, or other relevant performance characteristics as defined in recognized standards (e.g., ISO 15197) or internal specifications.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

This information is not provided. The study is described as a "system accuracy performance" comparison, implying a comparison against a reference method (often a laboratory analyzer), not necessarily ground truth established by experts in a diagnostic imaging or pathology context.

4. Adjudication method for the test set:

Not applicable or not specified, as the study appears to be a direct comparison of glucose measurements, not an interpretation task requiring adjudication.

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:

Not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that involves human readers.

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

The device itself is a standalone system for measuring blood glucose. The "performance characteristics" mentioned refer to the device's accuracy in measuring glucose. This would inherently be a standalone evaluation of the device's measurement capabilities.

7. The type of ground truth used:

The text refers to "system accuracy performance." For blood glucose monitoring systems, ground truth is typically established by comparing the device's readings to those obtained from a laboratory reference method (e.g., hexokinase method on a central laboratory analyzer) known for its high accuracy and precision. The document does not explicitly state the reference method used.

8. The sample size for the training set:

Not applicable. This device is an electrochemical biosensor system, not a machine learning model that requires a training set in the conventional sense. The "software modification" mentioned would have undergone software verification and validation, not model training.

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

Not applicable, as there is no "training set" for an electrochemical biosensor.

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