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IL Test™ Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma based on a synthetic chromogenic substrate. Protein C deficiency is associated with recurrent venous thrombosis, especially in young adults. Acquired deficiencies of Protein C are associated with hepatic disorders, oral anticoagulant therapy and disseminated intravascular coagulation.

IL Test™ Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma based on a synthetic chromogenic substrate.

The provided text describes the IL Test™ Protein C, an in vitro diagnostic device, and its performance in comparison to a predicate device.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly state quantitative acceptance criteria in a dedicated section. However, based on the Statement of How the Technological Characteristics of the Device Compare to the Predicate device, the implied acceptance criterion is that the new device is "substantially equivalent in performance, intended use and safety and effectiveness" to the predicate device. The performance data provided supports this claim of substantial equivalence.

• At 52.4% activity: 1.6% CV
• At 104.6% activity: 1.4% CV
  ACL Futura:
• At 51.4% activity: 2.1% CV
• At 105.6% activity: 1.4% CV |

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

• Sample Size: 52 plasma samples were used in the method comparison studies.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It just states "method comparison studies evaluating 52 plasma samples."

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 to this device. The IL Test™ Protein C is an in vitro diagnostic test for quantitative determination of a biomarker (Protein C). The "ground truth" for evaluating its performance is another established quantitative method (the predicate device) or reference methods, not subjective expert assessment of images or clinical cases.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation is based on quantitative measurements against a predicate device, not subjective interpretation requiring adjudication.

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

This is not applicable. The device is an in vitro diagnostic quantitative test, not an AI-assisted diagnostic tool that involves human readers interpreting cases.

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

Yes, the studies presented are standalone performance evaluations of the IL Test™ Protein C device. The method comparison and precision studies assess the device's inherent analytical performance without human interpretation or intervention beyond performing the test according to its instructions.

7. The Type of Ground Truth Used

The "ground truth" for evaluating the IL Test™ Protein C was the results obtained from the legally marketed predicate device, Coamatic® Protein C. This is a form of comparative ground truth where the new device's performance is measured against an already accepted and established method.

8. The Sample Size for the Training Set

This information is not provided in the submission. For an in vitro diagnostic test, there isn't typically a "training set" in the machine learning sense. Performance validation usually involves analytical studies (like precision, accuracy, linearity) using characterized samples and method comparison studies against a predicate or reference method.

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

As mentioned above, the concept of a "training set" with established ground truth in the context of machine learning is not applicable here. For an IVD device, analytical performance characteristics are established through various lab studies. The "ground truth" for comparison was the predicate device's results.

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