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The CoaguChek XS Plus system is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood.

No technological, material, performance, or design changes to the CoaguChek XS Plus System have been implemented since its clearance on K071041. Thus, the device description for the CoaguChek XS Plus System remains the same as that presented and cleared in K071041. This submission deals only with the performance of Super Sani-Cloth wipes for the effective cleaning and disinfection of the CoaguChek XS Plus System housing and components.

The provided document describes a Special 510(k) submission for extending cleaning and disinfection claims for the CoaguChek XS Plus System to include "Super Sani-Cloth" wipes.

Here's an analysis of the acceptance criteria and study for the device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document mentions that the CoaguChek XS Plus meters were subjected to 10,950 Cleaning and Disinfection (C&D) cycles. This number represents the simulated lifetime (three years at 10 tests/day) of the cleaning/disinfection robustness. The number of actual meters tested (i.e., the sample size of the devices themselves) is not explicitly stated. However, it implies testing was performed on at least one or more devices to generate this data.
• Data Provenance: Not specified, but the context is an FDA submission from Roche Diagnostics, implying internal testing conducted by the manufacturer. The document does not mention the country of origin of the data or whether it was retrospective or prospective. It is implied to be prospective testing carried out for this submission.

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

• Not Applicable. This study is focused on the robustness of the device itself to a cleaning and disinfection process, not on diagnostic performance where expert interpretation of results would be required to establish ground truth. The 'ground truth' here is the continued accurate function and performance of the instrument.

4. Adjudication Method for the Test Set:

• None. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments. This study evaluates the objective performance (accuracy and functionality) of a medical device after a specific treatment (cleaning/disinfection).

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:

• Not Applicable. This is not an AI-assisted diagnostic device, nor is it a study involving human readers.

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

• Yes, in the sense that the device's performance was evaluated standalone. The study assessed the inherent accuracy and functionality of the CoaguChek XS Plus System after cleaning with Super Sani-Cloth wipes. There's no human-in-the-loop variable being tested here; it's about the device's physical and operational integrity.

7. The Type of Ground Truth Used:

• The ground truth used is the inherent accurate measurement capability and continued functionality of the CoaguChek XS Plus System before and after repeated cleaning and disinfection cycles. This is established by comparing the device's performance (specifically, meter accuracy) using venous blood measurements against established standards or baseline performance, and verifying that its functionality (e.g., ability to power on, display results, etc.) remains intact.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" for this type of robustness study. The study involves demonstrating that the already cleared device, K071041, maintains its performance after being subjected to a specific cleaning agent. It's not a machine learning or AI algorithm that requires training data.

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

• Not Applicable. As there is no training set, there is no ground truth established for one.

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The CoaguChek XS Plus System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood.

The CoaguChek XS Plus system is a portable coagulation monitoring system to monitor prothrombin time (PT) in patients receiving oral anticoagulant therapy. The system uses the amperometric detection of thrombin in the blood sample. A test strip is used to determine a PT value from 10 uL of whole blood. Onboard quality control is available on every test strip and the system also features an optional external quality control material (CoaguChek XS PT Control).

Here's a breakdown of the acceptance criteria and study information for the CoaguChek XS Plus System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" as a separate, quantified set of thresholds for each performance metric. Instead, it presents performance characteristics (e.g., accuracy, precision) of the new CoaguChek XS Plus System and compares them directly to the predicate device (CoaguChek XS System) to demonstrate substantial equivalence. The implication is that the performance of the new device is comparable to, or as good as, the predicate device.

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

• Accuracy (Venous Blood): N = 811
• Accuracy (Capillary Blood): N = 822
• Whole Blood Precision (Venous): N = 399
• Whole Blood Precision (Capillary): N = 399
• Control Precision (Level 1): N = 538
• Control Precision (Level 2): N = 535

Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given the nature of a 510(k) submission for a medical device that measures PT, these are typically prospective clinical studies conducted in a controlled environment to evaluate immediate device performance.

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

The document refers to "lab reference" for accuracy studies. This implies that standard laboratory methods for Prothrombin Time testing were used as the gold standard. However, it does not specify the number or qualifications of experts involved in performing these reference tests or establishing the ground truth. It's likely that certified medical laboratory technologists or similar professionals performed these reference tests.

4. Adjudication Method for the Test Set

Not applicable. This device measures a quantitative value (INR). Adjudication methods like 2+1 or 3+1 are typically used for qualitative or subjective assessments where multiple readers might interpret findings, for example, in image-based diagnostics. For quantitative measurements compared to a lab reference, such adjudication is not generally needed.

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

No, an MRMC comparative effectiveness study was not done. The CoaguChek XS Plus System is a device designed for quantitative measurement of prothrombin time, not for subjective interpretation by multiple readers like an imaging device. Therefore, the concept of human readers improving with or without AI assistance is not directly applicable in this context.

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

Yes, the studies reported are standalone performance studies of the device. The "System Performance Characteristics" section reports the accuracy and precision of the CoaguChek XS Plus System itself, comparing its measurements to a "lab reference" or evaluating its internal consistency. This is the device's inherent performance without human interpretation influencing the final reported value beyond the act of operating the device and performing the test.

7. The Type of Ground Truth Used

The ground truth used for accuracy studies was a "lab reference." This indicates that the device's PT/INR measurements were compared against results obtained from established, likely hospital- or clinical laboratory-based reference methods for Prothrombin Time determination. This would typically involve trained technicians using calibrated laboratory instruments.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" or its sample size. This is typical for a 510(k) submission for a device like the CoaguChek XS Plus, which is primarily an analytical measurement device. The device's underlying technology (electrochemical detection of thrombin activity) is well-established, and its "software" is focused on measurement processing and user interface features, rather than learning from a large dataset in the way a machine learning algorithm would. The "measurement software" is stated to be identical to the predicate, suggesting it's not a new algorithm "trained" on data.

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

As no training set is mentioned or applicable in the context of this device's development as described, there is no information on how its ground truth would have been established. If any internal development iterations involved data, it would likely be against reference lab methods to ensure the electrochemical principle and measurement algorithms were correctly implemented.

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