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The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in the quantitative determination of thrombin time in citrated plasma. The thrombin time test is a one-stage quantitative test performed on diluted plasma samples in the general patient population. The thrombin time test is used to detect disorders of fibrinogen. The T-Tek, Thrombin Time Reagent should only be used in an appropriate clinical laboratory by qualified laboratory professionals.

The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in the quantitative determination of thrombin time in citrated human plasma. The thrombin time test is a one-stage quantitative clotting test performed on citrated plasma samples in the general patient population. The thrombin time test is used to detect disorders of fibrinogen. The T-Tek, Thrombin Time Reagent should only be used in an appropriate clinical laboratory by qualified laboratory professionals. The test may be performed manually, or using semi-automated and automated coagulation analyzers.

Here's an analysis of the acceptance criteria and study proving device performance for the R2 Diagnostics T-Tek, based on the provided 510(k) premarket notification:

Note: This submission is for a medical reagent (thrombin time test) which typically focuses on chemical and functional equivalence to a predicate device, rather than the complex clinical performance metrics often seen with imaging AI devices. Therefore, some of the requested categories (e.g., MRMC studies, ground truth for training) are not directly applicable or explicitly detailed in this type of submission.

Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document implies these values (especially the correlation coefficients and precision benchmarks) were considered acceptable for establishing substantial equivalence to the predicate device. The comparison device, STA Thrombin 10, is reported to have CV's of less than 3% in its Instructions for Use, serving as a benchmark for the T-Tek's precision.

Study Details Proving Device Performance

1. Sample Size and Data Provenance:

   • Test Set Sample Size: The exact number of plasma samples (normal, abnormal, and heparin therapy patients) tested for correlation studies is not explicitly stated in the provided document.
   • Data Provenance: Not explicitly stated, but the "correlation studies at two sites" suggests clinical laboratory settings. It's likely retrospective in nature, using banked or collected patient samples. The country of origin is not specified but implicitly assumed to be the USA, given the applicant and regulatory body.

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

   • Not applicable / Not specified. For diagnostic reagents like the T-Tek, the "ground truth" is typically the quantitative measurement obtained from a reference method (the predicate device, STA Thrombin 10). The study focuses on comparing the output of the new device to the predicate, demonstrating analytical performance equivalence. There is no subjective interpretation by experts in the determination of a thrombin time value, unlike in imaging studies.

3. Adjudication Method for the Test Set:

   • Not applicable. As the "ground truth" is a quantitative measurement from a comparative device, no adjudication is required or performed by human experts in the context of this study.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. This type of study is typically performed for imaging devices where human readers interpret images. The T-Tek is a laboratory reagent for a quantitative blood test, so MRMC studies are not relevant.

5. Standalone Performance (Algorithm only without human-in-the-loop performance):

   • Yes, implicitly. The device (reagent) performance is assessed independently of user influence, although qualified laboratory professionals perform the test. The "performance" refers to the reagent's analytical output. The study evaluated the reagent's performance when used "manually, or using semi-automated and automated coagulation analyzers" (described in the device description), which covers its standalone analytical capability.

6. Type of Ground Truth Used:

   • Comparative Measurement to a Predicate Device. The "ground truth" for the performance study was the thrombin time values obtained using the STA Thrombin 10 predicate device. The study sought to demonstrate analytical equivalence, meaning the T-Tek should yield similar results to a legally marketed, established product.

7. Sample Size for the Training Set:

   • Not applicable / Not specified. This device is a chemical reagent, not an AI or machine learning model that requires a "training set." Its formulation and performance are based on chemical properties and manufacturing, not iterative learning from data.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. As noted above, there is no "training set" in the context of this reagent. The "ground truth" concept is applied to the performance evaluation against the predicate device.

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