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The STA® - Coag Control (N + ABN) PLUS is a kit containing a normal plasma and an abnormal plasma intended for the quality control of the following tests on STA-R® and STA Compact analyzers: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, thrombin time (TT), and antithrombin (AT).

The STA® - Coag Control (N + ABN) PLUS kit is a set of two control levels. Each kit provides: 12 x 2-ml vials of Reagent 1 (STA® - Coag Control N PLUS), citrated normal human plasma, lyophilized. 12 x 2-ml vials of Reagent 2 (STA® - Coag Control ABN PLUS), citrated abnormal human plasma, lyophilized. STA® - Coag Control (N+ ABN) PLUS Reagents are used as controls for clotting assays (PT, APTT, fibrinogen, and TT) and chromogenic assays (AT) performed on analyzers of the STA® line. Analyzers of the STA® line utilize the chronometric principle (viscosity based detection system) for clotting tests while the chromogenic assays are based on the photometric method (measurement of absorbance of monochromatic light).

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided document:

Device Name: STA® - Coag Control (N + ABN) PLUS

Device Intended Use: For the quality control of prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, thrombin time (TT), and antithrombin (AT) tests on STA-R® and STA Compact analyzers.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes "Precision" as the primary performance characteristic evaluated for this quality control device. The acceptance criteria are implicitly defined by the reported performance, as the study aims to demonstrate that the device performs equivalently to the predicate device and within acceptable analytical limits for precision in a clinical laboratory setting. While explicit numerical acceptance limits are not stated as "acceptance criteria," the study's results (CV%) are presented as demonstrating acceptable precision for a quality control material.

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

• The precision studies were performed according to CLSI guideline EP5-A2.
• Sample Size: The STA® - Coag Control N PLUS and ABN PLUS were tested for 20 days, 2 runs per day, in duplicate. This means for each analyte and control level, there were 20 (days) * 2 (runs/day) * 2 (duplicates/run) = 80 measurements.
• Data Provenance: The document does not specify the country of origin of the data. It is a prospective study, as it describes a specific testing protocol conducted to evaluate the device's performance.

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

This is a study evaluating the performance of a clinical laboratory quality control material, not a diagnostic device requiring expert interpretation of results. Therefore, the concept of "experts" establishing a "ground truth" for interpretation of test results is not applicable in the traditional sense. The "ground truth" for precision is the actual variability observed across repeated measurements, assessed using statistical methods.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation of data (e.g., medical images) to resolve discrepancies among experts. This study evaluates the quantitative precision of a laboratory control material, which does not involve subjective interpretation or adjudication among multiple reviewers.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This study evaluates the analytical performance (precision) of a quality control material used in in-vitro diagnostic assays, not the performance of an AI system, nor does it involve human readers or cases in the context of interpretation.

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

This is not an AI device or algorithm. The study evaluates the analytical performance of a quality control reagent on an automated analyzer. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.

7. The Type of Ground Truth Used

For this precision study, the "ground truth" is the statistical measure of variability (Coefficient of Variation, CV%) observed from repeated measurements of the control materials. There is no external "gold standard" or "definitive diagnosis" in the way one would refer to pathology for an imaging device. The performance is compared to generally accepted analytical performance standards for laboratory control materials and, implicitly, to the predicate device's expected precision.

8. The Sample Size for the Training Set

This study evaluates the analytical performance of a quality control material; it does not involve machine learning or a "training set" in the context of AI model development. The study is a direct performance evaluation.

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

As noted above, this study does not involve a training set as it is not an AI device.

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