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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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Sigma Diagnostics ACCUCLOT™ Thrombin Time Reagent (A8713/A4589) is a device intended to measure fibrinogen concentration and to detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.

Sigma Diagnostics' ACCUCLOT™ Thrombin Time Reagent is intended for use as a screening procedure to detect functional fibrinogen and thrombin inhibitors such as heparin, in citrated plasma. The ACCUCLOT™ Thrombin Time Reagent provides thrombin for fibrinogen hydrolysis and is able to detect normal fibrinogen function even in the presence of severe coagulation abnormalities such as hemophilia (Factor VIII or Factor IX deficiency) or a decrease in factor levels associated with vitamin K deficiency.

The provided text describes the safety and effectiveness of the Sigma Diagnostics' ACCUCLOT™ Thrombin Time Reagent, primarily by demonstrating its substantial equivalence to a legally marketed predicate device, Organon's Thromboquik™ Thrombin Time Reagent.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a substantial equivalence study comparing the Sigma Diagnostics' ACCUCLOT™ Thrombin Time Reagent to Organon's Thromboquik™ Thrombin Time Reagent (the predicate device).

2. Sample Sizes Used for the Test Set and Data Provenance:

• Correlation Study:
  • AMAX Optical & AMAX Mechanical: N = 101 plasma samples (normal and abnormal)
  • KC4a: N = 49 plasma samples (normal and abnormal)
• Precision Study: Normal and abnormal control plasmas were used, but the specific number of samples or replicates is not explicitly stated, only that the "within run CV" and "total precision" were measured.
• Heparin/Fibrinogen Sensitivity: The text states the reagent's sensitivity but does not provide specific sample sizes for these evaluations.
• Data Provenance: The document does not specify the country of origin of the data. The study appears to be retrospective in the sense that existing plasma samples (normal and abnormal) were used to compare the new device against the predicate.

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

Not applicable. This study does not involve expert interpretation of results to establish ground truth in the way medical imaging or clinical diagnostics typically would. The "ground truth" for the correlation study is the result obtained from the legally marketed predicate device (Organon's Thromboquik™). For precision, it's the expected value of the control plasmas.

4. Adjudication Method for the Test Set:

Not applicable. This is a quantitative comparison against a predicate device, not an interpretation task requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of the new reagent compared to a predicate, not on human reader performance with or without AI assistance.

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

Yes, the studies described are essentially "standalone" in nature, comparing the performance of the ACCUCLOT™ reagent (the "algorithm" or test method) directly against the predicate Thromboquik™ reagent. There is no human-in-the-loop component described for interpreting the results beyond standard laboratory technician procedures.

7. The Type of Ground Truth Used:

The primary "ground truth" used for substantial equivalence is the results obtained from the legally marketed predicate device (Organon's Thromboquik™ Thrombin Time Reagent). For the precision studies, the ground truth would be the known values of the normal and abnormal control plasmas.

8. The Sample Size for the Training Set:

Not applicable. This study does not describe a machine learning model with a separate training set. The "training" in this context refers to the development and optimization of the reagent itself, not an algorithm.

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

Not applicable, as there's no machine learning training set described. The "ground truth" for the development of the reagent would stem from established scientific principles of coagulation testing and chemical reactions.

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The BC Thrombin Reagent is intended for the determination of the thrombin time in human plasma. The determination of thrombin time is important in:

• The monitoring of heparin therapy.
• The monitoring of fibrinolysis therapy.
• The screening of disorders of fibrin formation.
• The differentiating between a heparin-induced prolongation of the thrombin time and fibrin formation disorders.

The BC Thrombin Reagent consists of lyophilized bovine thrombin and bovine albumin, and buffer solution (HEPES).

The provided document is a 510(k) summary for the BC Thrombin Reagent. This document focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive acceptance criteria and a standalone study for novel device performance. However, I can extract the relevant information from the "Comparative Analysis" and "Precision" sections to address your request as much as possible within the context of this submission.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

Note: The document does not explicitly state numerical acceptance criteria for correlation, slope, or Y-intercept. The criteria are implicitly derived from the goal of demonstrating substantial equivalence to the predicate device. For precision, the reported values are within typically acceptable ranges for IVD assays.

2. Sample size used for the test set and the data provenance

• Sample size for comparative analysis: 67 patients.
• Data provenance: The document does not specify the country of origin of the data. It states the samples were from "normal blood donors, patients undergoing heparin therapy, patients with increased fibrin degradation products," which implies they were collected for the purpose of this comparative study, thus being prospective data for this specific comparison, although the samples themselves might have been collected over time.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For a comparative study comparing a new device to a predicate, the "ground truth" is typically established by the predicate device's measurement. The document does not describe any independent adjudication or expert panel to establish a separate ground truth.

4. Adjudication method for the test set

This information is not provided and is not applicable in this context. The study compares the new device's results directly against the predicate device'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

• A MRMC study was not done.
• This is an in vitro diagnostic (IVD) reagent, not an AI-assisted diagnostic imaging or interpretation device. Therefore, the concept of "human readers improving with AI vs without AI assistance" does not apply.

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

• A standalone performance study was not explicitly detailed as a separate "algorithm only" study. The comparative analysis with the predicate device served as the primary performance demonstration. The precision study can be considered a standalone performance assessment of the reagent's inherent variability.

7. The type of ground truth used

The "ground truth" for the comparative analysis was the results obtained from the predicate device (Behring Test Thrombin Reagent). The study's purpose was to show that the new reagent performs similarly to the established legal predicate.

8. The sample size for the training set

The document does not mention a training set. This is likely because the BC Thrombin Reagent is an IVD reagent, not a machine learning or AI-based device that typically requires a training set. Its performance is evaluated through direct chemical and analytical comparison.

9. How the ground truth for the training set was established

As there is no mention of a training set, this information is not applicable.

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