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The U-RIGHT TD-4249/ U-RIGHT TD-4250 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 U-RIGHT TD-4249/ U-RIGHT TD-4250 Blood Glucose Monitoring System can be used only during steady-state blood glucose conditions.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a blood glucose monitoring system. This type of document primarily confirms the substantial equivalence of a medical device to a legally marketed predicate device. It does not typically contain detailed descriptions of acceptance criteria, study methodologies, or specific performance data from clinical trials or standalone algorithm evaluations in the format requested.

Therefore, many of the requested items cannot be extracted from this document, as they are not present. However, I can provide information based on what is available in the letter and general knowledge of FDA submissions for such devices.

Here's an attempt to answer your questions based on the provided text and general context where information is missing:

1. A table of acceptance criteria and the reported device performance

This document does not contain a table of acceptance criteria or reported device performance for blood glucose accuracy. For blood glucose monitoring systems, acceptance criteria typically involve comparisons to a laboratory reference method (e.g., YSI analyzer) and are often expressed as percentages of readings within certain error margins (e.g., ISO 15197 standard criteria). These specific performance metrics are usually found in the detailed submission data, not in the FDA's decision letter.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document does not specify the sample size for the test set or the data provenance. These details would be part of the clinical study report submitted with the 510(k) application.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable to a blood glucose monitoring system. The "ground truth" for blood glucose measurements is established by a highly accurate laboratory reference method (e.g., a YSI STAT Plus Glucose & Lactate Analyzer), not by human experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable to a blood glucose monitoring system. Adjudication methods like 2+1 are typically used in imaging studies where multiple readers interpret images, and discrepancies are resolved by an adjudicator.

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

This is not applicable to a blood glucose monitoring system. MRMC studies are used for diagnostic imaging devices involving interpretation by multiple readers. Blood glucose monitors primarily provide quantitative measurements.

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

A blood glucose monitoring system itself is a "standalone" device in that it provides a direct measurement without human interpretation of complex visual data. The performance study would evaluate the accuracy of the device's measurement algorithm against a reference standard. The document confirms the FDA has reviewed the "premarket notification of intent to market the device," which would include such performance data. However, the specific results or methodology details are not in this letter.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for a blood glucose monitoring system's performance evaluation is almost always a highly accurate laboratory reference method for blood glucose measurement, such as a YSI STAT Plus Glucose & Lactate Analyzer. This is considered the accepted standard for comparison.

8. The sample size for the training set

This document does not specify the sample size for any training set. For blood glucose meters, "training set" is not a typical term in the way it is used for AI/ML algorithms. The device is calibrated and validated using a series of known glucose concentrations and patient samples, but these are generally referred to as calibration and validation samples rather than a "training set" in the machine learning sense.

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

As with the test set, the "ground truth" for calibration/validation samples would be established by a highly accurate laboratory reference method for blood glucose measurement. The device is designed to measure glucose, and its internal algorithms are developed to accurately translate electrochemical signals into glucose concentrations that correlate with these reference values.

Summary of what can be gleaned from the document regarding the device and its regulatory status:

• Device Name: U-RIGHT TD-4249/U-RIGHT TD-4250 Blood Glucose Monitoring System
• Manufacturer: TaiDoc Technology Corporation
• Regulatory Class: Class II
• Regulation Number/Name: 21 CFR 862.1345, Glucose Test System
• Indications for Use: Quantitative measurement of glucose in fresh capillary whole blood from the finger and alternative sites (palm, forearm, upper-arm, calf, thigh). Intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control. Not for diagnosis/screening for diabetes or use on neonates. Alternative site testing only during steady-state blood glucose conditions.
• Regulatory Outcome: Found substantially equivalent (SE) to a legally marketed predicate device, allowing it to proceed to market.

The FDA letter confirms the regulatory clearance for the device based on the substantial equivalence determination, which implicitly means the submitted data (including performance studies, which are not detailed here) met the criteria for this determination.

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