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This UASure II Blood Uric Acid Monitoring System measures blood uric acid levels in fresh capillary whole blood drawn from fingertips. It is intended for single-patient home use by prescription and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with gout as an aid to monitor the effectiveness of uric acid control.

The UASure II Blood Uric Acid Monitoring System helps track uric acid levels but does not diagnose Hyperuricemia or Gout. Do not change medications based on test results without talking to a doctor.

The UASure II Blood Uric Acid Monitoring System includes the UASure II Meter, UASure II Blood Uric Acid Test Strips and UASure II Uric Acid Control Solution.

The UASure II Blood Uric Acid Monitoring System consists of the UASure II Blood Uric Acid Meter, UASure II Blood Uric Acid Test Strip and UASure II Uric Acid control solution. It is used for testing of blood uric acid by self-testers at home use by prescription only. The UASure II Blood Uric Acid Test Strip and UASure II Uric Acid control solution are purchased separately.

The provided FDA 510(k) clearance letter for the UASure II Blood Uric Acid Monitoring System details its intended use and general regulatory information. However, it does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria in the comprehensive manner requested.

The document only broadly states:

• "Non-Clinical Testing: [...] results demonstrate substantial equivalence to the current methods for uric acid measurements."
• "Clinical Testing: An accuracy study was conducted with home users using finger capillary whole blood. Results demonstrate substantial equivalence to the predicate system."
• "Conclusion: Clinical and analytical testing demonstrated that the UASure II Blood Uric Acid Monitoring System perform in a substantially equivalent manner to that of the predicate."

To answer your request comprehensively, information typically found in the applicant's submission (e.g., the 510(k) summary with more detailed study results, or the actual study reports) would be necessary. This includes:

1. A table of acceptance criteria and reported device performance: This would typically involve specific statistical metrics (e.g., bias, precision, correlation coefficient, Bland-Altman agreement) and their acceptable ranges, and the actual results from the study. The document does not provide these specific numbers.
2. Sample size used for the test set and data provenance: The document indicates "home users using finger capillary whole blood" but does not specify the number of samples or whether the data was retrospective or prospective, or the country of origin.
3. Number of experts used to establish ground truth and qualifications: This is not applicable in this context as this is not an imaging AI device requiring expert reads, but rather a blood diagnostic device where ground truth is established by a reference method/laboratory.
4. Adjudication method: Not applicable for this type of device. Ground truth is typically a direct measurement from a reference method.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable for this type of in-vitro diagnostic device. MRMC studies are specific to imaging devices often involving human interpretation.
6. Standalone (algorithm only) performance: For this device, "standalone performance" is essentially the device's accuracy when measuring uric acid, which is compared to a reference method. The letter states "results demonstrate substantial equivalence to the predicate system" but lacks specifics.
7. Type of ground truth used: For a blood uric acid monitoring system, the ground truth would be established by a well-calibrated, high-precision laboratory reference method for uric acid measurement. The document doesn't explicitly state what reference method was used.
8. Sample size for the training set: This refers to the data used to develop the device/algorithm. This information is not present in the clearance letter.
9. How ground truth for the training set was established: Similar to point 8, this information is not provided.

In summary, based solely on the provided FDA 510(k) clearance letter, I cannot provide the detailed information requested regarding the acceptance criteria and the specific study results proving the device meets them. The letter serves as an official clearance notice, confirming substantial equivalence, but generally does not include the granular data from the performance studies.

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