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Indicated use - Factor deficient plasma, Factor - VIII is a human plasma immunodepleted of the indication and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.

Factor deficient plasma to be free of antigen of Factor VIII utilized in in vitro diagnostic use.

This document is a Summary of Safety and Effectiveness for a medical device (Factor deficient coagulation plasma - VIII) from 1997. The provided text does not describe a study involving an AI/Machine Learning device, but rather a conventional in-vitro diagnostic (IVD) product.

Therefore, most of the requested information (sample sizes, experts, adjudication, MRMC studies, standalone performance, training sets, etc.) is not applicable to this document as it pertains to AI/ML device studies.

However, I can extract the acceptance criteria and reported device performance from the document based on the comparison to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The "Acceptance Criteria" here are inferred from the attributes of the predicate device (OTC Factor VIII - K823453) which the new device aims to match or improve upon. The "Reported Device Performance" for the "Intended product" is indicated by "Yes" for meeting these attributes.

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

• Not Applicable. This document pre-dates widespread AI/ML product development. The performance testing described is for a chemical reagent (Factor deficient plasma). Specific sample sizes for "test sets" in the context of AI validation are not mentioned. Clinical studies for IVDs typically involve testing against known samples or patient samples, but the method and sample size are not detailed here beyond "Compare assay to known sample". Data provenance (country, retrospective/prospective) is also not specified.

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

• Not Applicable. This document refers to an In Vitro Diagnostic (IVD) product. "Ground truth" for such a product would typically be established by laboratory methods, reference standards, and established assays, not by expert consensus in a clinical image/data review setting as would be the case for AI/ML.

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

• Not Applicable. Adjudication methods are relevant for human interpretation tasks, especially in AI studies involving multiple readers. This document describes the performance of a lab reagent.

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 not an AI-assisted device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

• Not Applicable. This device is an in-vitro diagnostic reagent, not an algorithm. Its performance is inherent to its biochemical properties.

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

• For the performance testing, the ground truth is implicitly based on reference standards or known samples (e.g., "Compare assay to known sample," "Deficiency of relevant factor less than 1%"), as well as FDA-approved tests for viral markers (HIV, HBSAG, HCV).

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of this traditional IVD product. This is not an AI/ML device.

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant to the provided document.

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