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For single use device: The TD-4257 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples from the finger. It is intended to be used by a single person and should not be shared. The TD-4257 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. It is not intended for the diagnosis of or screening for diabetes mellitus or be used on neonates. The TD-4257 Blood Glucose Test Strips are for use with the TD-4257 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.

For multiple patient use device: The TD-4257 Multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary, venous and neonatal whole blood samples. The TD-4257 Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple patient use in professional healthcare settings as an aid in monitoring the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus. Professionals may test with capillary, venous and neonatal whole blood. Capillary samples may be drawn from the fingertip, and in the case of neonates, from the heel. The system is only used with single-use, auto-disabling lancing devices. The TD-4257 Multi Blood Glucose Test Strips are for use with the TD-4257 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary, venous and neonatal whole blood samples.

Device Description

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.

AI/ML Overview

The provided text does not contain specific acceptance criteria or detailed study results for the TD-4257 Blood Glucose Monitoring System.

Instead, it states that the TD-4257 system has the "same performance characteristics as the predicate device" (TD-4239) and that a "comparison of system accuracy performance demonstrated that the TD-4257... and the TD-4239... are substantially equivalent." It also mentions "Software verification and validation testing confirmed that the performance, safety and effectiveness... are equivalent to the predicate device."

Without the performance characteristics and study details of the predicate device (TD-4239), it is impossible to fully answer the request for acceptance criteria and specific study results for the TD-4257.

Therefore, the following information is based on the lack of detailed performance data in this document and an explanation of what should be present based on the request.

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

Acceptance Criteria (Example based on typical blood glucose meter standards, not found in provided text)	Reported Device Performance (Reference to predicate, no specific numerical values in provided text)
+/- 15 mg/dL or +/- 15% for glucose concentrations < 100 mg/dL	Substantially equivalent to predicate device (TD-4239 Blood Glucose Monitoring System)
+/- 20 mg/dL or +/- 20% for glucose concentrations ≥ 100 mg/dL	Substantially equivalent to predicate device (TD-4239 Blood Glucose Monitoring System)
System accuracy within ISO 15197 standards (e.g., 95% of results within specific error margins)	System accuracy performance demonstrated substantial equivalence to predicate device
Repeatability/Precision (e.g., CV% < 5%)	Performance characteristics same as predicate device
Reproducibility	Performance characteristics same as predicate device
Linearity	Performance characteristics same as predicate device
Interference studies (various substances like hematocrit, endogenous substances)	No specific data mentioned, but implied by "same performance characteristics" as predicate

Explanation: The document explicitly states: "TD-4257 Blood Glucose Monitoring System/TD-4257 Multi Blood Glucose Monitoring System has the same performance characteristics as the predicate device." and "A comparison of system accuracy performance demonstrated that the TD-4257 Blood Glucose Monitoring System/TD-4257 Multi Blood Glucose Monitoring System and the TD-4239 Blood Glucose Monitoring System/TD-4239 Multi Blood Glucose Monitoring System are substantially equivalent."

This means the acceptance criteria and performance of the TD-4257 device are implicitly derived from the previously accepted performance of the TD-4239 predicate device. However, the specific numerical criteria and results of that predicate are not included in this 510(k) summary. I have included example criteria based on common blood glucose meter accuracy standards (like ISO 15197 for context), as these are typically what would be reported.

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

This information is not provided in the given text. The document refers to "comparison of system accuracy performance" and "Software verification and validation testing" but does not detail the sample sizes, data provenance (e.g., country), or whether the studies were retrospective or prospective.

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 information is not provided in the given text. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods, not by expert consensus in a clinical reading scenario.

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

This information is not provided in the given text. Adjudication methods are typically relevant for studies where multiple human readers interpret results, which is not the primary method for establishing ground truth for a quantitative blood glucose device.

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

An MRMC study is not applicable to this device. This is a blood glucose monitoring system, which provides direct quantitative measurements. It does not involve human readers interpreting images or data that an AI might assist with.

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

The device is a standalone blood glucose monitoring system. Its performance is inherently standalone. The intent is for immediate, direct quantitative measurement of glucose. There isn't a separate "algorithm only" performance that would then be compared to a "human-in-the-loop" performance, as the device's output is the final result. The accuracy claims are based on the device's direct measurement against a reference method.

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

While not explicitly stated, for a blood glucose monitoring system, the ground truth is established using a laboratory reference method (e.g., a laboratory glucose analyzer that provides highly accurate and precise glucose measurements). This is standard practice for validating blood glucose meters.

8. The sample size for the training set

This information is not provided in the given text. While software modifications were made, details on a training set (if any, in the context of device development beyond calibration) are not present.

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

This information is not provided in the given text. As no specific training set for an AI/ML algorithm is mentioned, the method for establishing its ground truth is also not mentioned. Device calibration (which could be considered analogous to training for some systems) would typically use known glucose concentrations verified by reference methods.

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