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Dried Rabbit Brain Thromboplastin with Calcium. For use in prothrombin time (PT) determinations and prothrombin time based assays.

Dade® Thromboplastin C Plus is a lyophilized preparation of dried rabbit brain with calcium and stabilizers. The reagent initiates clotting via the extrinsic common pathway in a global screening test, the prothrombin time (PT). The obtained clotting time detects single or combined deficiencies of the extrinsic coagulation system indicative of hereditary and acquired coagulation disorders, is a sensitive monitoring test for oral anticoagulation therapy and an assay for specific coagulation factors.

Here's a summary of the acceptance criteria and study details for the Dade® Thromboplastin C Plus, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Max. Error Criteria %CV" column in the precision study. The device performance (Total %CV) is compared against these maximum allowable values. For the method comparison studies, the "Coefficient of Correlation (r)" values suggest that a strong positive correlation (closer to 1) is desired, though a specific threshold for acceptance isn't explicitly stated. However, given the context of demonstrating substantial equivalence, values close to 1.0 are indicative of good performance.

• BCTTM/BCTTM: r = 0.951
• BCSTM/BCTTM: r = 0.935
• Sysmex® CA-1500/BCT: r = 0.965
• Sysmex® CA-6000/BCT: r = 0.943
• Sysmex® CA-500/BCT: r = 0.975 |
  | Precision Study (Derived Fibrinogen) | %CV should be ≤ Max. Error Criteria %CV (10%) | Control Plasma N (CPN): Total %CV = 5.4% (vs. 10% criteria)
  Control Plasma P (CPP): Total %CV = 1.1% (no criteria specified for this low-level control, but low is good)
  Normal Plasma Pool (NPP): Total %CV = 4.6% (vs. 10% criteria)
  Pathological Plasma Pool (PPP): Total %CV = 4.5% (vs. 10% criteria) |

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

• Test Set Sample Size: For the method comparison studies, the sample sizes ranged from 103 to 176 specimens, depending on the analyzer used. For the precision study, each control/plasma pool had 40 replicates (n=40).
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

• This information is not applicable as the device is an in vitro diagnostic (IVD) for laboratory testing, not an imaging or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for these studies would be the actual fibrinogen concentration or prothrombin time as measured by an established reference method (the predicate device, Multifibren™ U, in the comparison study).

4. Adjudication Method for the Test Set

• Not applicable. As an IVD, an adjudication method by human experts is not typically used for establishing ground truth for chemical/coagulation assays. Ground truth is based on the reference method's results.

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

• Not applicable. This device is an IVD for prothrombin time and fibrinogen determination, not an AI-assisted diagnostic tool for human readers.

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

• Yes, a standalone performance study was done. The studies presented (method comparison and precision studies) demonstrate the performance of the Dade® Thromboplastin C Plus reagent in conjunction with automated coagulation analyzers. These are essentially standalone performance evaluations of the reagent and analyzer system.

7. The Type of Ground Truth Used

• For Method Comparison Studies: The ground truth was essentially the measurements obtained using the predicate device, Multifibren™ U. The goal was to show strong correlation and agreement between the new device and the predicate.
• For Precision Studies: The ground truth for calculating variability (%CV) would be the true/reference value of the control plasmas, which are characterized for their expected fibrinogen levels.

8. The Sample Size for the Training Set

• Not applicable. The provided text describes performance validation studies for an IVD reagent. There is no indication of a machine learning model or "training set" in the context of this device's development or regulatory submission.

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

• Not applicable. (See point 8.)

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