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IL Test™ PT-Fibrinogen Recombinant permits the in vitro diagnostic determination of Prothrombin Time (PT) and Fibrinogen (Fib) in human citrated plasma using a high sensitivity recombinant rabbit tissue factor based thromboplastin. This product is intended for the evaluation of the extrinsic coagulation pathway, monitoring Oral Anticoagulant Therapy (OAT) and for quantitation of fibrinogen.

IL Test™ PT-Fibrinogen Recombinant permits the in vitro diagnostic determination of Prothrombin Time (PT) and Fibrinogen (Fib) in human citrated plasma using a high sensitivity recombinant rabbit tissue factor based thromboplastin.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance Study for IL Test™ PT-Fibrinogen Recombinant

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "slope must be between X and Y," or "r-value must be greater than Z"). Instead, it presents the results of method comparison and precision studies and implies that these results demonstrate substantial equivalence to the predicate device. Therefore, the "acceptance criteria" are inferred from the demonstrated performance that led to the 510(k) clearance by the FDA, signifying that the performance was deemed acceptable for market release.

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

• Sample Size for Method Comparison: n=79 (normal and abnormal plasma samples).
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective. Given the nature of laboratory method comparison and precision studies, they are typically conducted prospectively with specifically collected or procured samples for the purpose of the study.

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

This type of diagnostic device (in vitro diagnostic for PT and Fibrinogen) does not typically involve human experts establishing a "ground truth" in the same way an imaging or AI diagnostic algorithm might. In this context, the "ground truth" for the method comparison study is the measurement provided by the predicate device (IL Test™ PT-Fibrinogen HS Plus). The document does not mention the involvement of any human experts for this purpose.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" is the predicate device's measurement. There is no mention of human adjudication for discrepancies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is an in vitro diagnostic reagent and system for laboratory testing, not an AI or imaging diagnostic tool that would involve human readers interpreting cases.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, in a sense, a standalone performance study was done. The "device" in this context refers to the reagent and the analytical system (ACL 3000, ACL Futura). The provided data represents the performance of the system (reagent + analyzer) in measuring PT and Fibrinogen, without direct human intervention in the result generation itself, beyond performing the test according to standard lab procedures. The results (slopes, correlation coefficients, precision) are quantitative measures of the device's analytical performance.

7. Type of Ground Truth Used

For the method comparison studies, the "ground truth" was established by the predicate device (IL Test™ PT-Fibrinogen HS Plus). The performance of the new device was compared against the measurements obtained from the legally marketed predicate device.

For the precision studies, the "ground truth" is the statistically derived mean value of the repeated measurements for normal and abnormal samples, against which the variability (% CV) is assessed.

8. Sample Size for the Training Set

The document does not mention a "training set." This terminology is primarily relevant for machine learning or AI models. This submission is for an in vitro diagnostic reagent, which does not involve a machine learning model that requires a separate training set. The samples used are for performance validation (method comparison and precision).

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

Not applicable, as there is no training set for this type of medical device submission.

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