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The FORA D20/TD-3263 Blood Glucose plus Blood Pressure 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, or for testing on neonates.

The alternative site testing in this system can be used only during steady-state blood glucose conditions.

The system is also intended to be used to measure non-invasively the systolic and diastolic blood pressure and pulse rate of an adult individual at home. The blood pressure is measured by using a technique in which an inflatable cuff is wrapped around the arm. The cuff circumference is limited to 9.4" ~ 13.8".

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

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The provided document is a 510(k) premarket notification letter from the FDA to TaiDoc Technology Corporation regarding their FORA D20/TD-3263 Blood Glucose Plus Blood Pressure Monitoring System. It mainly discusses the substantial equivalence of the device to legally marketed predicate devices and outlines regulatory requirements.

While it mentions the intended use of the device and its functions (blood glucose measurement and blood pressure/pulse rate measurement), it does not contain the detailed study information or acceptance criteria requested in the prompt.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document only states the device's functions.
2. Sample sized used for the test set and the data provenance: No study details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No study details are provided.
4. Adjudication method for the test set: No study details are provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No study details are provided.
6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: No study details are provided.
7. The type of ground truth used: No study details are provided.
8. The sample size for the training set: No study details are provided.
9. How the ground truth for the training set was established: No study details are provided.

To answer your request, a different document, such as a summary of safety and effectiveness (SSE) or the full 510(k) submission, would be required. The provided text is a regulatory clearance letter, not a technical study report.

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