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To verify the performance of the HMS Plus and Heparin Assay Cartridges. For In Vitro Diagnostic use.

The modification to the current control is to replace old USP heparin with revised USP heparin from the new heparin monograph that became effective October 1, 2009. The source of the heparin remains porcine.

The provided 510(k) summary (K103313) for the Medtronic Heparin Assay Controls describes a device modification and claims substantial equivalence to its predicate devices. However, it does not contain the kind of detailed information typically found in studies that establish acceptance criteria and prove device performance in the context of medical AI or complex diagnostic systems.

This document describes a change in the source of heparin used in the control substance, from "old USP heparin" to "revised USP heparin from the new heparin monograph." The purpose of the submission is to demonstrate that this change does not alter the fundamental scientific technology or intended use, and that the modified device remains substantially equivalent to the previously cleared predicate.

Here's an analysis based only on the provided text, highlighting what is missing or not applicable within the context of your request:

Analysis based on the provided K103313 document:

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

   • Not provided. The document states "verification testing indicated that the fundamental scientific technology and the intended use are unchanged," but it does not detail specific acceptance criteria (e.g., accuracy, sensitivity, specificity, or specific range of values) nor does it report quantitative performance results from this verification testing.

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

   • Not provided. The document mentions "verification testing" but does not specify the sample size of the test set or the provenance of any data used. Given the nature of a heparin assay control, the "test set" would likely refer to batches of the control material tested against an assay, not patient data.

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

   • Not applicable/Not provided. For a heparin assay control, the "ground truth" would be established by the known concentration and characteristics of the heparin within the control, likely determined by chemical and analytical methods, not by expert human interpretation of medical images or other diagnostic data. Experts might be involved in formulating the control or validating the analytical methods, but the document does not specify this.

4. Adjudication method for the test set:

   • Not applicable/Not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where multiple human readers interpret ambiguous cases. This concept is not relevant to the verification testing of a chemical control product.

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 document describes a modification to a chemical control product, not an AI-powered diagnostic device or an imaging system involving human reader interpretation. No MRMC study was performed or is relevant here.

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

   • Not applicable. This is not an algorithm or an AI device.

7. The type of ground truth used:

   • Not explicitly stated, but inferred to be analytical/chemical validation. For a heparin assay control, the ground truth would be the known concentration and properties of the heparin within the control, established through rigorous analytical chemistry and adherence to pharmacopeial standards (like the USP heparin monograph). The document only states the source of heparin changed to "revised USP heparin."

8. The sample size for the training set:

   • Not applicable. This is not an AI or machine learning device that requires a training set.

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

   • Not applicable. (See point 8)

In summary, the provided K103313 document is a 510(k) submission for a minor modification to an in vitro diagnostic control product (Heparin Assay Controls). It focuses on demonstrating substantial equivalence due to a change in a chemical component, not on proving the performance of a new diagnostic algorithm or system using clinical data against defined acceptance criteria in the manner your request describes.

The document's "Conclusion" states: "The modifications to the Medtronic Heparin Assay Controls described in this submission result in a substantially equivalent device because verification testing indicated that the fundamental scientific technology and the intended use are unchanged." This implies that the 'acceptance criteria' were met by demonstrating that the performance of the modified control was equivalent to the predicate, likely through internal analytical testing consistent with existing standards for such controls. However, the specifics of this testing are not detailed in this public summary.

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