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The Clever Choice Voice + 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 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 this system can be used only during steady-state blood glucose conditions.

The Clever Choice Voice+ Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

This system contains a speaking functionality which provides step by step instructions to aid visually impaired persons.

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 Clever Choice Voice+ Test Strips with the Clever Choice Voice + Blood Glucose Monitoring System.

The provided text is a 510(k) summary for the Clever Choice Voice + Blood Glucose Monitoring System. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain detailed information about acceptance criteria, a specific study proving device performance against those criteria, or the methodology typically associated with such studies (like sample sizes for test/training sets, expert qualifications, or adjudication methods).

The document states:

• "Clever Choice Voice + Blood Glucose Monitoring System has the same performance characteristics as the predicate device."
• "A comparison of system accuracy performance demonstrated that the Clever Choice Voice + Blood Glucose Monitoring System and the FORA V20 Blood Glucose Monitoring System are substantially equivalent."
• "Software verification and validation testing confirmed that the performance, safety and effectiveness of the Clever Choice + Blood Glucose Monitoring System are equivalent to the predicate device."

This indicates that the manufacturer relies on the performance of the predicate device (FORA V20 Blood Glucose Monitoring System) to establish the performance of the Clever Choice Voice + system, rather than presenting a new, detailed performance study with explicit acceptance criteria. The modifications listed are primarily cosmetic (meter casing), software language, and unit selection, suggesting that the core analytical performance is considered identical to the predicate.

Therefore, many of the requested details about acceptance criteria and the study proving conformance cannot be extracted from this specific document.

If this were a submission for a novel device or one with significant changes to the measurement principle, these details would be critical. In this case, the FDA's acceptance of the 510(k) suggests they agreed with the manufacturer's argument of substantial equivalence based on the predicate's established performance, and the minor nature of the changes.

Missing Information:

• A table of acceptance criteria and the reported device performance: Not provided. The document claims "same performance characteristics" as the predicate but doesn't list specific metrics or acceptance criteria for either device.
• Sample sized used for the test set and the data provenance: Not provided. No specific test set data is mentioned for this device.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. This type of detail is typical for imaging or diagnostic interpretation devices, not for a blood glucose meter where ground truth is established by a reference laboratory method.
• Adjudication method: Not applicable/provided.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is for devices requiring human interpretation.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a standalone algorithm, but no specific performance metrics are provided in this summary.
• The type of ground truth used: For blood glucose meters, ground truth is typically established by comparing the device's readings to a high-precision reference laboratory method (e.g., YSI analyzer). This is not explicitly stated but is standard for such devices.
• The sample size for the training set: Not provided.
• How the ground truth for the training set was established: Not provided.

In summary, this 510(k) submission leverages the substantial equivalence rule by asserting that the new device has the same performance characteristics as the predicate device due to minor, non-performance-affecting modifications. It does not present a de novo performance study against explicit acceptance criteria within this document.

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