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The Fisher Diagnostics ThromboScreen® 1000 is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma specimens in the clinical laboratory. Coagulation testing capabilities of the device include routine clotting tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and Fibrinogen.

The Pacific Hemostasis® Fibrinogen Reagent plus Kaolin is intended to be used on the Fisher Diagnostics ThromboScreen® 1000 Coagulation Instrument for the quantitative determination of fibrinogen in plasma.

The ThromboScreen® 1000 (TS1000) is a photo-optical instrument used for the performance of in-vitro diagnostic clotting procedures in the clinical laboratory. The instrument utilizes photo-optical principles to measure and record the time required for subject plasma specimens to clot. The TS1000 light source is provided by a 660 nm LED. The incubator block is temperature regulated to 36.5 - 37.5°C and contains six measuring positions and six reagent positions.

The Pacific Hemostasis® Fibrinogen Reagent plus Kaolin is identical to the Pacific Hemostasis® Thrombin for Fibrinogen Kit, except that the thrombin is reconstituted with water containing kaolin rather than water. Kaolin is added to increase the visibility of the clot in the stirred reaction cell.

Here's a breakdown of the acceptance criteria and the study details for the Fisher Diagnostics ThromboScreen® 1000 and Pacific Hemostasis® Fibrinogen Reagent plus Kaolin, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative manner (e.g., "The correlation coefficient must be >0.95"). Instead, it presents comparative performance data against predicate devices to demonstrate substantial equivalence. The implication is that the performance must be comparable to the legally marketed predicate devices.

Important Note: The acceptance criteria are implicitly met by demonstrating "substantial equivalence" to the predicate devices. The correlation coefficients are all very high (close to 1.0), and the precision data (CV%) also appears comparable between the ThromboScreen 1000 and the predicate MLA instruments.

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

• Test Set Sample Sizes:

  • Method Comparison (Correlation Studies):
    • Prothrombin Time (General Clinical Samples): 60 samples per site (across 3 sites = 180 total)
    • Prothrombin Time (Coumadin Samples): 100 samples per site (Site 1 & 2), 92 samples (Site 3) = 292 total
    • Activated Partial Thromboplastin Time (General Clinical Samples): 58 (Site 1), 60 (Site 2), 60 (Site 3) = 178 total
    • Activated Partial Thromboplastin Time (Heparin Samples): 60 samples per site (across 3 sites = 180 total)
    • Fibrinogen Concentration (General Clinical Samples): 28 (Site 1), 30 (Site 2), 30 (Site 3) = 88 total
  • Precision Studies: The specific number of samples for precision studies is not explicitly stated, but it involves "Coag 1, Coag 2, Coag 3" which likely represent different control levels or concentrations, and were performed "within-run," "run-to-run," and "day-to-day" at three sites.

• Data Provenance: The studies were conducted "in-house and at two external testing laboratories." While specific countries are not mentioned, the context of the FDA submission (U.S. Department of Health & Human Services) strongly suggests the data was generated within the United States or from sites compliant with U.S. regulatory standards. The data is prospective as it involves comparison testing and precision measurements on collected specimens. The document indicates specimens were collected from "apparently healthy individuals and from subjects with different pathological conditions which are expected to affect the results for a particular assay."

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

The description does not mention the use of "experts" in the sense of human readers adjudicating results or establishing ground truth for the test results. This is an in-vitro diagnostic device (IVD) where the "ground truth" is typically established by comparing the device's quantitative measurements against a legally marketed predicate device (MLA 900C/1600C) using the same patient samples and/or established reference methods for precision. The performance is assessed by correlation coefficients and precision metrics against these established methods, not by expert consensus on interpretations.

4. Adjudication Method for the Test Set:

Not applicable. As described above, this is an IVD device measuring quantitative coagulation parameters. The "ground truth" is based on the results from predicate devices and internal validation, not human adjudication of subjective interpretations.

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

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for imaging or diagnostic interpretation devices where multiple human readers interpret cases. The ThromboScreen® 1000 is an automated instrument for quantitative laboratory tests (Prothrombin Time, APTT, Fibrinogen), not an interpretation aid for human readers.

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

Yes, a standalone performance evaluation was done. The entire study focuses on the performance of the ThromboScreen® 1000 instrument and the Pacific Hemostasis® Fibrinogen Reagent plus Kaolin. Its measurements are compared directly to those of established predicate instruments (MLA 900C/1600C). There is no "human-in-the-loop" aspect to its measurement process; it's an automated photo-optical instrument.

7. The Type of Ground Truth Used:

The ground truth for the device's performance was established by:

• Predicate Device Comparison: The results obtained from the ThromboScreen® 1000 were compared against results from legally marketed predicate devices, the MLA 900C and MLA 1600C, using the same "citrated plasma specimens."
• Internal Validation/Reference Methods: For precision studies, it implies that control materials or repeated measurements on samples were used to establish the variability (CV%) of the device itself and in comparison to the predicate devices.

Therefore, the ground truth is based on comparative measurements to predicate devices and established laboratory standards for precision and accuracy, rather than pathology, expert consensus, or outcomes data in the typical sense for imaging or pathology devices.

8. The Sample Size for the Training Set:

The document does not contain information about a "training set" or "training data." This type of terminology is usually associated with machine learning or artificial intelligence models. The ThromboScreen® 1000 is a photo-optical instrument. Its design and operational parameters would be developed through engineering and calibration processes, not a "training set" in the AI sense.

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

Not applicable, as there is no mention of a "training set" in the context of this device's development or evaluation.

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