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The AutoSure HT Blood Glucose Monitoring System is intended for the quanitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is indicated for lay use by people with diabetes, as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

The AutoSure HT Blood Glucose Test Strips are to be used with the AutoSure HT Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

The Contrex Plus 4 glucose control solution is used with the AutoSure HT test strips to verify that the meter and test strips are working together properly and that the test is performing correctly.

The AutoSure HT blood glucose meter and AutoSure HT test strips are used for testing of blood glucose. Contrex Plus 4 Glucose Control Solutions are used for quality control testing of the systems.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list numeric acceptance criteria for the device's accuracy in the way a typical performance study's pre-defined thresholds would. Instead, it states that "Results demonstrate substantial equivalence to the predicate system" and that "Clinical and non-clinical testing demonstrated that the AutoSure HT system performs in a substantially equivalent manner to that of the predicate."

However, we can infer the type of performance being evaluated. For Blood Glucose Monitoring Systems (BGMS), the primary performance metric related to accuracy is typically the comparison of results against a laboratory reference method. The document mentions "accuracy study" and "precision testing." While specific numerical criteria are not provided for the AutoSure HT, for BGMS devices, the FDA typically references ISO 15197 standards for accuracy, which often involve criteria like:

• X% of results within Y mg/dL of the reference method for glucose concentrations < Z mg/dL
• W% of results within V% of the reference method for glucose concentrations ≥ Z mg/dL

Since the document emphasizes "substantial equivalence to the predicate system," the acceptance criteria for the AutoSure HT would implicitly be that its performance is comparable to or better than the predicate's, and that it meets relevant industry standards for BGMS.

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

• Sample Size: The document does not explicitly state the sample sizes for the "accuracy study" or "user performance study."
• Data Provenance: The studies were described as "An accuracy study was conducted with blood testing at finger, palm, and forearm sites by healthcare professionals. A User Performance study was conducted with self-testing at finger, palm, and forearm sites by home users..." The country of origin of the data is not specified, but the submitter is Apex Biotechnology Corp. in Hsinchu, CHINA (TAIWAN). It is typical for such studies to be prospective, but this is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: The accuracy study involved "blood testing... by healthcare professionals." The specific qualifications (e.g., medical technologists, nurses) or their years of experience are not mentioned.

4. Adjudication Method for the Test Set

• The document does not mention any adjudication method for establishing ground truth or resolving discrepancies. For an accuracy study, the "ground truth" is typically established by a laboratory reference method, not by expert consensus adjudication of device readings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done in the context of human readers interpreting results produced by AI. This device is a blood glucose monitoring system, which provides a numerical output, not an image or complex diagnostic interpretation requiring human expert analysis that could be augmented by AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, the primary clinical studies described (the "accuracy study" and "precision testing") represent standalone performance of the device's algorithm and hardware to measure blood glucose. The "user performance study" evaluates the human-device interaction but the core measurement is still standalone. The device outputs a numerical glucose value directly.

7. The Type of Ground Truth Used

• For the "accuracy study," the ground truth would have been established by a laboratory reference method for glucose measurement. Common reference methods include hexokinase or glucose oxidase methods performed on a clinical chemistry analyzer in a certified laboratory setting. This is implied by the nature of a blood glucose monitoring system accuracy study.
• For the "user performance study," the ground truth typically relates to the correctness of self-testing procedures and the readability/understandability of results and instructions, rather than a separate "truth" about the glucose level itself.

8. The Sample Size for the Training Set

• This information is not provided. Blood glucose monitoring systems like the AutoSure HT are typically based on electrochemical principles and algorithms that are developed and calibrated using internal data (training/development sets), but the size of these internal sets is not disclosed in the 510(k) summary.

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

• This information is not provided. Similar to the test set, the ground truth for any internal training or calibration performed during the development of the device's algorithm would be established using a laboratory reference method for glucose measurement.

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