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PlasmaCon N is a human lyophilized plasma control intended for use as a normal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.

PlasmaCon L-1 is a human lyophilized plasma control intended for use as a mid-level abnormal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.

PlasmaCon L-2 is a human lyophilized plasma control intended for use as a high level abnormal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.

The PlasmaCon Control Plasma devices contain lyophilized citrated human plasma, for use in the verification of system performance for PT and aPTT assays.

Here's a breakdown of the acceptance criteria and study information for the PlasmaCon N, PlasmaCon L-1, and PlasmaCon L-2 devices, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size:
  • Within-run: 10 vials of each sample (PlasmaCon N, PlasmaCon L-1, PlasmaCon L-2) were pooled, tested in duplicate or triplicate.
  • Between-run: 2 vials of each sample were pooled, tested in duplicate, and recorded daily for 5 days.
• Data Provenance: The text does not specify the country of origin for the data. The study was a prospective precision study, as it was performed to establish CVs for the new R2 Diagnostics PlasmaCon devices.

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

This type of information is not applicable (N/A) to this device and study. The PlasmaCon devices are control plasmas used to monitor the performance of PT and aPTT assays, not to diagnose conditions directly. Therefore, there is no "ground truth" in the sense of a medical diagnosis established by experts. The study focuses on the precision of the controls themselves when used in laboratory settings.

4. Adjudication Method for the Test Set

This is N/A for similar reasons as point 3. There was no expert adjudication involved, as the study's goal was to measure the statistical precision (CVs) of the control plasmas.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study investigates how human readers' performance changes with or without AI assistance, which is not relevant for a control plasma device. The study focused on the performance of the control plasmas compared to a predicate device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is N/A as the device is a control plasma, not an algorithm or AI system. The study evaluated the performance of the physical control plasma in laboratory settings, which can be performed manually, semi-automated, or fully automated, but the evaluation is of the control itself, not an algorithm's standalone performance.

7. The Type of Ground Truth Used

This is N/A as the study did not involve establishing a direct "ground truth" for a medical condition. Instead, the study aimed to demonstrate the precision and substantial equivalence of the control plasmas to predicate devices, using established laboratory protocols (NCCLS EP-15A) to measure Within-Run and Between-Run Coefficient of Variation (CV). The "truth" in this context refers to the expected performance characteristics of a high-quality control plasma.

8. The Sample Size for the Training Set

This information is N/A. The document describes a study to evaluate the performance of a medical device (control plasma), not the development or training of an algorithm or AI model. Therefore, there is no "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

This information is N/A as there was no training set for an algorithm.

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