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Sigma Diagnostics ACCUCLOT™ LA Control is a human plasma control that is suitable for use as a positive control for lupus anticoagulant testing such as activated partial prothrombin time (APTT) and dilute Russell's viper venom time (dRVVT). Plasma controls are routinely used in the coagulation laboratory as a means of quality control.

Sigma Diagnostics ACCUTROL™ LA Control is a lyophilized human plasma based product. After reconstitution with water, ACCUTROL™ LA Control is stable for 48 hours when stored at 2-8°C and 4 weeks when stored at -20°C.

This submission focuses on a control material used for in-vitro diagnostic tests, rather than an AI/ML device that would typically generate performance metrics like sensitivity, specificity, or AUC. Therefore, many of the requested categories (e.g., sample size for test sets, number of experts, MRMC studies) are not applicable in this context.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for specific test sets. The submission relies on demonstrating substantial equivalence to a predicate device, which implies that the performance characteristics were compared against established parameters of the predicate, rather than an independent "test set" in the context of an AI/ML diagnostic.
• Data Provenance: Not specified. As a human plasma control, the source of the plasma itself (e.g., country of origin) is not detailed in the provided summary. The data presented is for the characterization of the control material (stability, intended use) to demonstrate equivalence.

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

• This is not applicable as this is a control material for in-vitro diagnostic tests, not a device requiring expert interpretation for ground truth establishment. The effectiveness is determined by its behavior as a control in laboratory assays, which have their own established validation procedures.

4. Adjudication method for the test set

• Not applicable for the reasons stated above.

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 an in-vitro diagnostic control material, not an AI/ML diagnostic tool.

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

• Not applicable. This is an in-vitro diagnostic control material.

7. The type of ground truth used

• The "ground truth" for this device is its performance characteristics as a control material, primarily its ability to mimic a positive sample for lupus anticoagulant testing and its stability. This is established through laboratory experiments and comparison to a legally marketed predicate device with established performance. The "ground truth" here refers to the expected behavior and stability of the control plasma itself, not a diagnosis for a patient.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, and therefore does not have a "training set" in that conventional sense. The product development would involve manufacturing and quality control batches, but these are not analogous to training data for an algorithm.

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

• Not applicable for the reasons stated above.

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