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Pacific Hemostasis Coagulation Control Level 3 is intended for use as a control to monitor the performance of Prothrombin Time (PT) and Activated Partial Time (APTT) testing. It will yield PT and APTT values in the markedly abnormal range.

Pacific Hemostasis Coagulation Control Level 3 (Abnormal) is a lyophilized preparation of citrated plasma obtained from healthy donors, which has been adjusted to yield prolonged Prothrombin Time and Activated Partial Thromboplastin Time values. Stabilizers and buffers have been added to the plasma prior to lyophilization. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found non-reactive 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 Coagulation Control Level 3 (Abnormal) device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it compares the performance of the new device (Pacific Hemostasis Coagulation Control Level 3) directly against a legally marketed predicate device (Dade Ci-Trol Coagulation Control Level III) to establish substantial equivalence. The implication is that if the new device performs similarly to the predicate device within reasonable bounds, it meets the "acceptance criteria" for substantial equivalence.

Based on the "Summary of Performance Data for Substantial Equivalence Comparisons," the implicit acceptance criteria are that the new device should demonstrate comparable precision (CV%) to the predicate device for both Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) measurements.

Conclusion: The reported device performance meets the implicit acceptance criteria, as the CV% values for Pacific Hemostasis are either comparable to or lower than the predicate device, and all are within the stated thresholds (less than 6% for between-run, less than 4% for within-run PT, and less than or equal to 2% for within-run APTT).

2. Sample Sizes Used for the Test Set and Data Provenance:

• Test Set Sample Size:
  • Between-run Precision: 20 duplicate measurements over a 10-day period. This means 20 individual samples were tested in duplicate (40 total measurements) over 10 days for each control (new and predicate).
  • Within-run Precision: 3 runs of 20 duplicate measurements. This means 3 runs, each consisting of 20 individual samples tested in duplicate (40 total measurements per run), for each control (new and predicate).
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) summary for a new product, it is most likely a prospective study conducted by the manufacturer, Pacific Hemostasis, but this is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable to this type of device. The ground truth for a coagulation control is established by its performance characteristics (precision, accuracy, etc.) when measured against standard laboratory tests, not by expert interpretation. The performance itself is the "truth" being assessed in comparison to a predicate device.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple experts interpret data (e.g., medical images) and their disagreements need to be resolved to establish ground truth. For a laboratory control device like this, the measurements are quantitative, and there's no subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for devices that involve human interpretation of results, such as diagnostic imaging aids. This device is a quality control material for automated laboratory assays, not a device interpreted by human readers.

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

This concept is not applicable in the traditional sense of an "algorithm only" study. The device itself is a material – a lyophilized plasma preparation. Its "performance" is its behavior when used in conjunction with a coagulation analyzer. The study presented is the standalone performance of the control material when measured by laboratory instruments. There is no "human-in-the-loop" interaction in the sense of a user interpreting the control's output that needs to be quantified or assisted. The human interaction is in the laboratory technician performing the test.

7. The Type of Ground Truth Used:

The "ground truth" for this study is the measured performance characteristics (mean, standard deviation, and CV%) of an established, legally marketed predicate device (Dade Ci-Trol Coagulation Control Level III). The new device's performance is compared against the predicate's performance to establish substantial equivalence.

8. The Sample Size for the Training Set:

This document describes a performance validation study for a medical device substance (coagulation control), not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI. The product itself is the "device," and its performance is being evaluated, not an algorithm being trained.

9. How the Ground Truth for the Training Set was Established:

As there is no "training set" for an AI algorithm in this context, this question is not applicable.

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