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Control Plasma N is assayed for use as an accuracy control of the following parameters in the normal range: Prothrombin time (PT); Activated partial thromboplastin time (aPTT); Thrombin time (TT); Batroxobin time; Fibrinogen; Coagulation factors II, V, VII, VIII, VWfF IX, X, XI, XII and XIII ; Inhibitors: Antithrombin III, Protein C, Protein S, as -antiplasmin, C, inhibitor: Plasminogen; Total complement activity**, Lupus anticoagulants. (* Not for BFT ™II analyzer, ** Not available in the U.S.)

Control Plasma N is a Iyophilized control prepared from pooled human plasma. stabilized with HEPES buffer solution. It is an assayed control intended to monitor and evaluate the precision and accuracy of coagulation and fibrinolysis tests in the normal range.

The provided text describes a 510(k) modification for "Dade Behring Inc. Control Plasma N." This product is a control plasma used to monitor the precision and accuracy of coagulation and fibrinolysis tests. The study described focuses on the stability of the control plasma.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states, "In duplicate determinations, reconstituted stability data met the acceptance criteria..." This indicates that the test for stability was performed in duplicate, meaning each stability condition was tested twice.

• Sample Size: "Duplicate determinations" (implies n=2 for each condition tested).
• Data Provenance: The document does not specify the country of origin of the data. Given the manufacturer is Dade Behring Marburg GmbH (Germany) and the contact is Dade Behring Inc. (USA), the testing could have occurred in either location or a combination. The study is prospective as it's testing the stability of the device under defined conditions.

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

This type of study (stability testing of a control plasma) does not typically involve human experts establishing a "ground truth" in the same way as, for example, a diagnostic imaging study. The "ground truth" here is the assigned values of the control plasma, which are determined through standardized assays and extensive validation by the manufacturer, likely involving laboratory scientists and statisticians. The document does not provide details on this process or the number/qualifications of individuals involved in establishing these assigned values.

4. Adjudication Method for the Test Set

Not applicable. As this is a quantitative analytical measurement (recovery within assigned values), there is no "adjudication method" in the sense of expert review or consensus. The results are compared directly against predefined acceptance limits.

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

No. This is a stability study for a laboratory control, not a diagnostic device involving human interpretation of cases. Therefore, an MRMC comparative effectiveness study is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The "device" (Control Plasma N) itself is a chemical reagent. Its performance is evaluated through laboratory assays. The "standalone" performance here refers to the Control Plasma N maintaining its intended characteristics (i.e., its concentrations/activity of various analytes) over time under specified storage conditions, as measured by standard laboratory tests. There is no "algorithm" in the context of image analysis or AI, but the performance is measured purely instrumentally/analytically without human intervention influencing the concentration results.

7. The Type of Ground Truth Used

The ground truth used here is the assigned values for each parameter (e.g., PT, aPTT, Fibrinogen, etc.) in the Control Plasma N. These assigned values are established by the manufacturer through rigorous testing using reference methods and/or calibrated instruments to determine the expected concentration or activity of each analyte within the control. The stability test then verifies if the values obtained after storage remain within acceptable limits of these assigned ground truth values.

8. The Sample Size for the Training Set

Not applicable. This is a stability study for a control plasma, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set. The "assigned values" for the control material (which serves as the "ground truth" for the stability study) are established by the manufacturer through extensive characterization and validation of the product, typically involving multiple lots and rigorous measurement protocols, prior to its use as a control in other assays. The document doesn't detail this process for the assigned values themselves, only their use in the stability test.

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