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The AccuChek® Instant Plus Dual Testing System is designed to quantitatively measure cholesterol and glucose in capillary whole blood. The AccuChek Instant Glucose Test Strips are for use in home and professional settings for testing glucose in whole blood. The AccuChek Instant Cholesterol Test Strips are for use by health care professionals and for home use by people with diabetes for cholesterol screening.

The AccuChek Instant Plus system had each parameter (cholesterol and glucose) cleared separately. Since the device can use either the glucose test strip or the cholesterol test strip, the agency considers this dual testing system a new device which requires data to prove that users can distinguish between the two test strips. The AccuChek Instant Plus Dual Testing System has not been modified. The performance data for the individual test strip type can be found in the following 510(k) submissions: AccuChek Instant Plus Cholesterol Test Strip: K944458 AccuChek Instant Plus Glucose Test Strip: K944459 In addition, the agency's request does not impact the performance data submitted in the previous 510(k) submissions; however, a new additional study was performed to answer the concerns expressed by the agency.

This document describes the AccuChek Instant Plus Dual Testing System, which measures both cholesterol and glucose. The key aspect of this submission is to demonstrate that users can distinguish between the two types of test strips.

1. Table of acceptance criteria and the reported device performance

Unfortunately, the provided text does not include specific acceptance criteria for distinguishing between the two test strips, nor does it explicitly report performance against such criteria. The document states that the agency requested a new additional study to answer concerns expressed by the agency regarding users distinguishing between the two test strips. However, the results of this study are not presented in the provided text.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given information. The document focuses on the regulatory submission and intent, rather than detailed study results.

2. Sample size used for the test set and the data provenance

The document mentions that a "new additional study was performed to answer the concerns expressed by the agency" regarding distinguishing between the two test strips. However, the sample size used for this test set and the data provenance (e.g., country of origin, retrospective/prospective) are not provided in the given text.

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

This information is not provided in the document. The study mentioned is related to user distinction of test strips, not expert interpretation of results.

4. Adjudication method for the test set

This information is not provided in the document.

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

The device described is a blood glucose and cholesterol meter, not an AI-powered diagnostic imaging tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with or without AI assistance is not applicable and not mentioned in the document.

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

This information is not provided in the document. Given the nature of a handheld testing system, a "standalone algorithm only" performance without a human in the loop for operating the device might not be directly relevant in the same way as for an AI diagnostic algorithm. The primary concern here is the user's ability to differentiate between the physical test strips.

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

For the specific "new additional study" concerning users distinguishing between test strips, the "ground truth" would likely involve direct observation of user behavior or a verified method of identifying which strip type was being used. For example, the ground truth could be the actual type of test strip (glucose or cholesterol) used in a simulated or real testing scenario. However, this information is not explicitly stated in the provided text.

For the performance of the glucose and cholesterol measurements themselves, the ground truth would have been established during the original 510(k) submissions (K944458 and K944459) for each individual parameter, likely through comparison with laboratory reference methods or established standards. This specific document, however, does not detail those ground truth methods.

8. The sample size for the training set

The document mentions a "new additional study" to address user distinction of test strips, but it does not refer to a "training set" in the context of an algorithm or machine learning model. Therefore, this information is not applicable or provided.

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

As there is no mention of a "training set" in the context of an algorithm, this information is not applicable or provided.

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