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Pacific Hemostasis Heparin Control Plasma Level 1, an unassayed control plasma, is intended for use in heparin assay procedures. In addition, it can be used for quality control in monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing. It will yield APTT values in the slightly abnormal range.

Pacific Hemostasis Heparin Control Level 1 is a lyophilized preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found nonreactive for HBsAG and negative for antibodies to HIV and HCV.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Heparin Control Plasma Level 1:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the precision studies (test set). It mentions "Between-run and within-run precision studies" were performed.

The document does not explicitly state the data provenance in terms of country of origin or whether it was retrospective or prospective. Given it's a premarket notification, it's highly likely to be prospective data generated specifically for this submission.

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

This information is not applicable as the device is a control plasma for an in vitro diagnostic test, not an AI or imaging device requiring expert interpretation for ground truth establishment. The "ground truth" for this product would be the actual concentration or activity level of heparin, determined by established laboratory methods, and its correlation with APTT values.

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

This information is not applicable for this type of device and study. Adjudication methods are typically relevant for studies involving human interpretation of medical images or diagnostic tests where there's subjectivity and a need to resolve discrepancies.

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

This information is not applicable. The device is a control plasma, not an AI-assisted diagnostic tool involving human readers.

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

This information is not applicable. The device is a physical reagent, not an algorithm.

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

The "ground truth" implicitly used for this device involves quantitative analytical measurements of Activated Partial Thromboplastin Time (APTT) and potentially the known concentration of heparin added to the control plasma. The comparison is against a legally marketed predicate device, implying that the predicate's established performance serves as a benchmark for equivalence.

8. The sample size for the training set

This information is not applicable. The product is a diagnostic control, not a machine learning model that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

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