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The Accu-Chek Active system is designed to quantitatively measure the concentration of glucose in capillary whole blood. The device is indicated for professional use and over-the-counter sale.

The Accu-Chek Active Test System includes a handheld meter, lancet device, lancets, and instructions for use. Test strips and liquid controls may be acquired separately.

The provided text (K012324 for the Accu-Chek Active Test System) is a 510(k) summary for a blood glucose test system. It focuses on establishing substantial equivalence to predicate devices for its intended use, particularly for an Alternate Site Testing (AST) claim.

However, the document does not contain the detailed information necessary to fully answer all aspects of your request. Specifically, it lacks a dedicated section outlining acceptance criteria, rigorous performance study results with specific sample sizes, expert ground truth establishment, or statistical methods.

Blood glucose meters are typically evaluated against ISO 15197 standards for accuracy, but this document does not explicitly state those standards as acceptance criteria or present data in that format.

Based on the available information, here's what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format. However, the overall implication of a 510(k) submission is to demonstrate that the device performs as well as or similarly to legally marketed predicate devices.

The "Comparison to Predicate Devices" table provides a qualitative comparison of features, including the AST claim, but no quantitative performance metrics.

Study Details (Based on available information)

1. A table of acceptance criteria and the reported device performance:
   • Acceptance Criteria: Not explicitly stated in quantitative terms within this document. For blood glucose meters, general acceptance is usually tied to meeting analytical accuracy performance standards (e.g., ISO 15197), but these are not listed.
   • Reported Device Performance: No specific quantitative performance data (e.g., accuracy percentages, bias, or precision studies) are provided in this summary. The summary focuses on comparing features and intended use to predicate devices.

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

   • Sample Size: Not mentioned.
   • Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not mentioned. For blood glucose meters, "ground truth" would typically come from a recognized laboratory reference method (e.g., YSI analyzer), rather than expert consensus on images.

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

   • Not applicable as the study type and performance data are not described.

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 blood glucose meter, not an AI-based imaging diagnostic device involving human readers.

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

   • Not applicable in the context of an AI algorithm. For a medical device like a blood glucose meter, "standalone performance" refers to the analytical accuracy of the device itself against a reference method. While such studies would have been performed, the details are not included in this 510(k) summary.

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

   • Not explicitly stated, but for blood glucose meters, the "ground truth" or reference method is invariably an established laboratory method (e.g., a YSI glucose analyzer) that is well-calibrated and highly accurate.

8. The sample size for the training set:

   • Not applicable. This is a blood glucose meter, not a device using machine learning with a distinct "training set."

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

   • Not applicable.

Summary of Missing Information:

This 510(k) summary primarily serves to establish "substantial equivalence" based on intended use and features, rather than providing a detailed report of clinical or analytical performance study results. Key details regarding sample sizes, specific performance metrics, the methodology of accuracy studies, and the reference methods used as "ground truth" are not included in this publicly available summary document. These details would typically be found in the full submission to the FDA, but not in the abbreviated 510(k) summary.

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