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The TD-4239 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-4239 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-4239 Blood Glucose Test Strips are for use with the TD-4239 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples.

The TD-4239 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-4239 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-4239 Multi Blood Glucose Test Strips are for use with the TD-4239 Multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary, venous and neonatal whole blood samples.

The TD-4239 Blood Glucose Monitoring System and TD-4239 Multi Blood Glucose Monitoring System 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 TD-4239 and TD-4239 Multi test strips for the TD-4239 and TD-4239 Multi Blood Glucose Monitoring Systems, and use with the control solutions that has been tested and validated with this system 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 two blood glucose systems have the same technical components (same meter and test strips) and therefore the same performance data.

Acceptance Criteria and Device Performance for TD-4239 Blood Glucose Monitoring System

This report summarizes the acceptance criteria and performance of the TD-4239 Blood Glucose Monitoring System, based on the provided 510(k) summary.

Note: The provided document is a 510(k) summary, which typically provides a high-level overview of performance studies rather than detailed raw data or exhaustive statistical analysis. Therefore, some information requested might not be explicitly stated or may require interpretation from the given context.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary states that "Accuracy study and software validation were performed to evaluate the meter performance" and that "Results show that both devices are substantially equivalent to the predicate device K094005." This implies that the acceptance criteria are based on demonstrating equivalence to the predicate device's established accuracy and performance.

While specific numerical acceptance criteria (e.g., % within ±15 mg/dL or ±15%) are not explicitly listed in the provided text, blood glucose monitoring systems typically adhere to ISO 15197 standards or equivalent FDA-recognized guidance documents. The claim of "satisfactory performance" and "substantial equivalence" suggests that these industry-standard accuracy criteria were met.

For the purpose of this response, we infer the acceptance criteria based on standard expectations for blood glucose meters seeking FDA clearance.

Note on Inferring Acceptance Criteria: The absence of specific numerical criteria in the 510(k) summary is common for devices claiming substantial equivalence to a predicate. The FDA's review process would ascertain if adequate data demonstrating equivalence to the predicate (which would have met specific performance criteria) was provided.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not explicitly state the sample size used for the "accuracy study" or "clinical studies." It mentions "laboratory and clinical studies," suggesting a combination of controlled lab testing and potentially human subject testing.
• Data Provenance (Country of Origin of the Data, Retrospective or Prospective): This information is not specified in the provided text. The submitter is TaiDoc Technology Corporation from Taiwan, so it is plausible that some or all studies were conducted in Taiwan or by a contracted laboratory. The summary does not indicate if the studies were retrospective or prospective. Given it's a 510(k) for a new device, prospective studies are typically performed for performance evaluation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• The document does not mention the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. For blood glucose meters, the ground truth is typically established using a highly accurate laboratory reference method (e.g., YSI analyzer) rather than expert consensus on diagnostic imaging or clinical findings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. Blood glucose monitoring systems are designed for direct quantitative measurement, not for human interpretation of complex medical cases or images that would typically involve multiple readers. Therefore, there is no discussion of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, the performance studies described are inherently standalone for the device. The TD-4239 Blood Glucose Monitoring System is an in vitro diagnostic device that quantitatively measures glucose. Its performance is evaluated based on the accuracy of its measurements compared to a reference method, without human interpretation of results as part of the core performance evaluation (though the user interprets the final numerical value). The "accuracy study" and "software validation" directly assess the algorithm's (and integrated system's) ability to produce accurate readings.

7. Type of Ground Truth Used

• The type of ground truth used for blood glucose monitoring systems is typically a highly accurate laboratory reference method. While not explicitly named, this would commonly be a YSI glucose analyzer or another equivalent laboratory method. The "accuracy study" would compare the device's readings against these reference method readings.

8. Sample Size for the Training Set

• The document does not explicitly mention a "training set" or its sample size. This is common for this type of device submission. While the device certainly relies on algorithms and potentially machine learning elements (e.g., for calibration, temperature compensation given the electrochemical biosensor), the "training" data used for developing these algorithms is usually internal to the manufacturer's development process and not typically detailed in this section of a 510(k) summary. The summary focuses on the validation of the finalized device.

9. How the Ground Truth for the Training Set Was Established

• As the document does not explicitly refer to a "training set" in the context of the submission, it also does not describe how ground truth for such a set was established. However, if such a set were used during device development, the ground truth would similarly be established through comparison to a highly accurate laboratory reference method for glucose.

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