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For single use:
The U-Right TD-4279A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of qlucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared. The U-Right TD-4279A Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. The U-Right TD-4279 A Test Strips are for use with the U-Right TD-4279A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The U-Right TD-4279B Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared. The U-Right TD-4279B Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. The U-Right TD-4279B Test Strips are for use with the U-Right TD-4279B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The FORA GD40a /TD-4272A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared. The FORA GD40a / TD-4272A Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. The FORA GD40a /TD-4272A Test Strips are for use with the FORA GD40a / TD-4272A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The FORA GD40b / TD-4272B Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the finqertips. This blood glucose monitoring system is intended to be used by a single person and should not be shared. The FORA GD40b / TD-4272B Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system should not be used for the diagnosis of or screening for diabetes, nor for neonatal use. The FORA GD40b / TD-4272B Test Strips are for use with the FORA GD40b / TD-4272B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

For multiple patient use:
The U-Right TD-4279A MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The U-Right TD-4279A MULTI Test Strips are for use with the U-Right TD-4279A MULTI Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips.
The U-Right TD-4279B MULTI Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The U-Right TD-4279B MULTI Test Strips are for use with the U-Right TD-4279B MULTI Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips.
The FORA Wisdom GD40a /TD-4272A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The FORA Wisdom GD40a / TD-4272A Test Strips are for use with the FORA Wisdom GD40a / TD-4272A Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips.
The FORA Wisdom GD40b / TD-42728 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in venous whole blood or fresh capillary whole blood from the fingertip. Testing is done outside the body (In Vitro diagnostic use). This system is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with single-use lancing devices. This system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. The FORA Wisdom GD40b / TD-4272B Test Strips are for use with the FORA Wisdom GD40b / TD-4272B Blood Glucose Meters to quantitatively measure glucose (sugar) in fresh capillary and venous whole blood samples drawn from the fingertips.

The U-RIGHT TD-4279 A/B Blood Glucose Monitoring Systems and FORA GD40a/b Blood Glucose Monitoring Systems consist 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 U-RIGHT TD-4279 A/B test strips and FORA GD40a/b test strips for the U-RIGHT TD-4279 A/B Blood Glucose Monitoring Systems and FORA GD40a/b Blood Glucose Monitoring Systems, and use with FORA control solutions to perform quality checks. The blood glucose detection method and measurement is by an electrochemical biosensor technology using FAD-dependent glucose dehydrogenase (FAD-GDH).

The provided document is a 510(k) summary for several blood glucose monitoring systems. It states that "The laboratory and clinical studies for the system performance of U-RIGHT TD-4279 A/B Blood Glucose Monitoring Systems and FORA GD40a/b Blood -Glucose Monitoring Systems demonstrated the meters and test strips works well as a system." However, it does not provide specific details about the acceptance criteria or the results of these performance studies.

Therefore, I cannot generate the requested table of acceptance criteria and reported device performance or other detailed information about the study. The document primarily focuses on establishing substantial equivalence to a predicate device and outlining the intended use of the devices.

Summary of what can be extracted and what is missing:

• 1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document states that performance studies were conducted and "demonstrated the meters and test strips works well as a system," but no specific criteria or results are given.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the document.
• 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): Not applicable/provided. For a blood glucose monitoring system, the "ground truth" would typically be established by a reference laboratory method, not by experts adjudicating cases like in imaging studies. However, details of the reference method or how accuracy was determined are not in the provided text.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/provided.
• 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 is a standalone diagnostic device, not an AI-assisted reading system.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the device itself is a standalone system for measuring blood glucose. The performance studies would assess its accuracy against a reference standard. However, the details of these studies are not provided.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a blood glucose meter, the ground truth would typically be established by a highly accurate laboratory reference method (e.g., hexokinase method). However, the specific method used is not mentioned in the document.
• 8. The sample size for the training set: Not applicable/provided. This device is a traditional electrochemical biosensor, not an AI/ML device that requires a training set in the conventional sense.
• 9. How the ground truth for the training set was established: Not applicable/provided.

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