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Control Plasma N is an assayed control for use in monitoring performance of the following parameters in the normal range:

1. Prothrombin time (PT)
2. Activated partial thromboplastin time (APTT)
3. Thrombin time (TT)
4. Batroxobin time
5. Fibrinogen
6. Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII
7. Inhibitors: Antithrombin III, protein C, protein S, α2 –antiplasmin
8. Plasminogen
9. Lupus anticoagulants
10. Factor V Leiden

ProC® Control Plasma is an assayed control used to monitor the performance of Factor V Leiden assay in the pathological range.

Control Plasma N is a lyophilized control prepared from pooled human plasma, stabilized with HEPES buffer solution. ProC® Control Plasma is a lyophilized control prepared from pooled human plasma and rabbit plasma, and stabilized with HEPES buffer solution.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "pooled human plasma" for both Control Plasma N and ProC® Control Plasma, and "rabbit plasma" additionally for ProC® Control Plasma, but doesn't specify the number of samples or their origin. The study appears to be prospective, as it involves testing the stability of the new control plasmas.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not a study assessing diagnostic performance or requiring expert consensus for ground truth. The "ground truth" for this device would be its expected performance within established ranges for coagulation parameters.

3. Adjudication method for the test set: Not applicable. There's no subjective assessment requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a stability study for in vitro diagnostic (IVD) control plasmas, not a comparative effectiveness study involving human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, in the sense that the device's performance (stability) was evaluated directly without human interpretation of clinical cases. However, this isn't an "algorithm-only" study in the typical AI context; it's a performance study of a laboratory control.

6. The type of ground truth used: The "ground truth" here refers to the pre-established analytical values and expected stability of the control plasmas. The study assesses if the reconstituted plasmas remain within these assigned values over time under various storage conditions.

7. The sample size for the training set: Not applicable. This device is a control plasma, not an AI/ML algorithm that requires training data.

8. How the ground truth for the training set was established: Not applicable.

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