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The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin® or warfarin. The CoaguChek XS System uses blood from a finger stick. The system is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor. Users should be stabilized on anticoagulation medications such as Coumadin® or warfarin prior to self-testing with the CoaguChek XS System.

The CoaguChek XS is a 3rd generation Roche Diagnostic's CoaguChek meter which was cleared for professional use under premarket notification K060978.

This premarket notification is being submitted to obtain clearance for patient self-testing.

This document describes the CoaguChek® XS System for patient self-testing, a device intended to measure blood-clotting time (PT-INR) for individuals on anticoagulation medications like Coumadin® or warfarin. The 510(k) submission (K062925) aims to clear the professional-use CoaguChek XS System (cleared under K060978) for patient self-testing.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes studies validating the accuracy and precision of the CoaguChek XS System for self-testing by patients. The "acceptance criteria" are implied by the conclusions drawn from these studies (e.g., "correlation was very good," "able to obtain results that are as accurate as those obtained by healthcare professionals").

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

• Sample Size for Accuracy Study: N = 258 (patients who self-tested and were compared to healthcare professionals).
• Sample Size for Precision Study: N = 222 (patients for patient results) and N = 257 (professionals for professional results).
• Data Provenance: The study was an "external user study" conducted as the system is intended to be used. Subjects self-tested "in the home setting for up to 8 weeks." They also had "3 scheduled visits to their study site to collect user vs. technician data as well as user vs. reference method." This indicates a prospective study conducted in a real-world setting (home) and clinical sites. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by Roche Diagnostics Corporation in Indianapolis, IN, suggesting the study likely took place in the United States.

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

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. However, it indicates:

• For accuracy, self-trained patient results were compared to "those obtained by healthcare professionals using the CoaguChek XS meter." These professionals' results served as a comparator, representing an established standard.
• For precision, results from "healthcare professionals" were also used for comparison.
• Additionally, subjects had visits to "collect user vs. reference method (Dade Innovin on a Sysmex analyzer) data." The INR results from the Dade Innovin on a Sysmex analyzer would be considered a form of ground truth or reference standard.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1 consensus) for establishing the ground truth. It focuses on direct comparison between patient results, healthcare professional results, and a reference laboratory method.

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

No, an MRMC comparative effectiveness study was not explicitly described in the provided text. The study compared patient self-testing performance with healthcare professional performance and a reference method, but it was not structured as an MRMC study to determine the effect size of AI assistance on human readers. The device itself (CoaguChek XS System) is a point-of-care diagnostic device, not an AI-assisted diagnostic tool for interpretation by multiple readers in the typical MRMC sense.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The CoaguChek XS System is not an algorithm that operates in isolation. It's a device that requires a human user (either a patient or a healthcare professional) to perform the test. Therefore, a "standalone algorithm-only" study (without human involvement) is not applicable or described. The studies evaluate the performance of the system (device + user).

7. The Type of Ground Truth Used

The ground truth or reference standard used in the studies appears to be a combination of:

• Results obtained by healthcare professionals using the same CoaguChek XS meter.
• A "reference method": specifically, "Dade Innovin on a Sysmex analyzer." This is a laboratory-grade prothrombin time (PT) method, considered a highly reliable reference for INR measurements.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of device development or algorithm training. The studies described are performance validation studies, not studies related to machine learning model training. The "training" aspect mentioned refers to the human users (patients) undergoing "self-directed training" to use the device.

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

As there is no mention of a traditional "training set" for an algorithm or machine learning model, information on how its ground truth was established is not applicable. The device validation focused on the ability of trained users (patients) to operate the device accurately and precisely, and their results were compared against established clinical and laboratory standards.

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