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CoaguChek XS PT Controls are intended for system checks and quality control of Prothrombin Time Testing with the CoaguChek XS monitor and CoaguChek XS PT test strips.

The control consists of lyophilized non-human plasma with varying levels of coagulation factors, which is reconstituted for use with diluent from a plastic bulb pipette.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study for the CoaguChek XS PT Controls:

Acceptance Criteria and Device Performance

The acceptance criteria for the CoaguChek XS PT Controls are implicitly demonstrated through a comparison with a legally marketed predicate device (CoaguChek PT S System Controls, K0208631). The key performance characteristic highlighted and compared is precision (CV%).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only explicitly states the Level 1 precision for both the predicate and the new device. The predicate's Level 1 CV is presented as an acceptance benchmark for the new device, which the new device outperforms.

Study Details Proving Device Meets Acceptance Criteria

The provided text focuses on establishing substantial equivalence to a predicate device, primarily through direct comparison of characteristics and some performance data. It does not detail a separate, dedicated clinical or performance study with specific design and methodology as would be expected for a complex medical device. Instead, the "study" is an internal comparison to the predicate's known performance.

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

The document does not explicitly state the sample size used for the precision testing of either the new device or the predicate device. It provides overall CV values, which are typically derived from multiple measurements, but the exact number of replicates, runs, or operators is not specified.

The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective). Given that the submission is to the FDA, it's highly probable the testing was conducted in the USA or under protocols acceptable for FDA submissions.

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

This information is not applicable to this type of device and submission. CoaguChek XS PT Controls are quality control materials for an in vitro diagnostic (IVD) device (Prothrombin Time testing). The "ground truth" for such controls is typically established by:

• Manufacturing specifications: The controls are manufactured to contain specific, known concentrations or activity levels of coagulation factors.
• Reference methods/calibrators: The target values and acceptable ranges for the controls are determined using highly accurate reference methods or clinical laboratory calibrators, not by expert interpretation of patient data.

There would be no need for expert consensus on images or clinical outcomes, as this is not a diagnostic device that interprets patient-derived data directly.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used when expert interpretation is required to establish a ground truth for subjective data (e.g., medical images). Since the "ground truth" for a quality control material is based on objective, quantitative measurements and manufacturing specifications, expert adjudication is not relevant.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic devices where human readers interpret patient cases (e.g., radiologists reading medical images) and the impact of AI assistance on their performance is evaluated. This device is a quality control material, not a diagnostic tool that assists human readers.

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

This is also not applicable in the traditional sense. The "device" here is a control solution, not an algorithm. Its performance is measured intrinsically (e.g., precision of its stated value), not as a standalone algorithm interpreting data.

7. The Type of Ground Truth Used

The ground truth for this device (quality control material) is based on manufacturing specifications and quantitative validation of factor levels, tied to established reference methods for Prothrombin Time. It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic device would be. The "truth" is the known, manufactured value of the control material, and its performance is assessed by how consistently the CoaguChek XS system measures that known value.

8. The Sample Size for the Training Set

This information is not applicable. This device is a quality control material, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable as there is no training set for this type of device.

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