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The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (nonanticoagulated venous whole blood). It is indicated for use by healthcare professionals. The system is ideally suited to monitor coagulation values in people who are taking oral anticoagulation medication (vitamin K antagonists, VKAs).

No technological, material, performance, or design changes to the CoaguChek XS Pro System have been implemented since its clearance on K093460. Thus, the device description for the CoaguChek XS Pro System remains the same as that presented and cleared in K093460. This submission deals only with the performance of Super Sani-Cloth wipes for the effective cleaning and disinfection of the CoaguChek XS Pro System housing and components.

This document (K180693) describes a Special 510(k) Premarket Notification for the CoaguChek XS Pro System. The purpose of this submission is not to introduce a new device or change the core functionality of the existing CoaguChek XS Pro System (cleared under K093460). Instead, it's to add Super Sani-Cloth wipes to the approved cleaning and disinfection procedures for the device, replacing 10% sodium hypochlorite solution. Therefore, the acceptance criteria and study described focus on the device's robustness and continued performance after repeated exposure to the new cleaning agent.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for the Test Set: "CoaguChek XS Pro meters that had been subjected to 10,950 C&D cycles". This refers to the number of cleaning and disinfection cycles applied to the meters, not individual patient samples. The number of actual meters tested is not explicitly stated in this excerpt, but it implies a sufficient number were used to confirm the robustness over the simulated lifetime.
• Data Provenance: Not explicitly stated, but given this is a robustness study for cleaning chemicals, it would likely be laboratory-based testing conducted by the manufacturer (Roche Diagnostics). It is implicitly prospective testing as the devices were subjected to a defined number of cleaning cycles.

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

• Not applicable. This study is not a diagnostic performance study requiring expert interpretation of results to establish ground truth (e.g., radiologists reviewing images). Instead, it focuses on the physical and functional integrity of the device after exposure to cleaning agents. The "ground truth" here is the original, un-degraded performance of the CoaguChek XS Pro System, against which the post-cleaning performance is compared.

4. Adjudication Method for the Test Set

• Not applicable. This study does not involve expert adjudication of results. The assessment is based on objective measurements of meter accuracy and functionality compared to established performance specifications.

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

• No. This is not an MRMC study. An MRMC study assesses the impact of a device (often AI) on human reader performance, which is not relevant to a study validating a cleaning agent's compatibility with a medical device.

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

• Yes, effectively. The study implicitly evaluates the "standalone" performance of the CoaguChek XS Pro System itself after undergoing the cleaning process. The CoaguChek XS Pro System is a quantitative measurement device, and its accuracy and functionality are assessed intrinsically, not in conjunction with human interpretation in the way an AI diagnostic algorithm would be.

7. The Type of Ground Truth Used

• Established Performance Specifications / Reference Method. The "ground truth" is the expected accurate and functional performance of the CoaguChek XS Pro System when measuring prothrombin time using venous blood, against which the performance of the repeatedly cleaned meters is compared. The original clearance (K093460) would have established the accuracy of the device against a reference method.

8. The Sample Size for the Training Set

• Not applicable. This is a validation study for cleaning procedures, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not applicable. As there is no training set, this question is not relevant.

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The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (nonanticoagulated venous whole blood). It is indicated for use by healthcare professionals. The system is ideally suited to monitor coagulation values in people who are taking oral anticoagulation medication (vitamin K antagonists, VKAs).

The CoaguChek XS Pro System represents a modification of the CoaguChek XS Plus System to incorporate an embedded barcode scanner. The unmodified device was cleared for use under premarket notification K071041. The intended use of the modified device, as described in its labeling, has not changed as a result of the modification(s) described in this 510(k). The fundamental scientific technology of this device has not changed as a result of the modification(s) described in this 510(k).

The provided text is a 510(k) summary for the CoaguChek XS Pro System. It indicates that the device is a modification of a previously cleared device (CoaguChek XS Plus System) and that the intended use and fundamental scientific technology have not changed.

The document does not describe an acceptance criteria study for the CoaguChek XS Pro System because it is presented as a modification of an already cleared device, the CoaguChek XS Plus System (K071041). The core performance characteristics (accuracy, precision, measuring range, hematocrit range, bilirubin, triglyceride, hemolysis, heparin, LMWH effects) are stated to be "Same" as the predicate device.

Therefore, the study to "prove the device meets the acceptance criteria" refers to the studies that established the performance of the predicate CoaguChek XS Plus System, as indicated by the "Same" designation.

Here's an analysis based on the information provided, focusing on the predicate device's performance as accepted for the modified device:

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission is a modification of an existing device, the "acceptance criteria" are implied to be that the performance of the CoaguChek XS Pro System is "Same" as the previously cleared CoaguChek XS Plus System. The performance characteristics reported for the predicate device are listed as the acceptable performance for the modified device.

2. Sample Sizes and Data Provenance for the Test Set

The provided summary does not explicitly state the country of origin or whether the data was retrospective or prospective. However, the sample sizes for the performance characteristics which are attributed to the predicate device are:

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

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information about the number of experts used or their qualifications for establishing ground truth for the test set. For in vitro diagnostic devices like this, the "ground truth" (or reference method) is typically established by laboratory reference instruments or validated manual methods, not human expert interpretation in the same way it would be for imaging devices.

4. Adjudication Method

The document does not describe any adjudication method as it relates to expert review of results. For in vitro diagnostic assays, the comparison is typically against a reference laboratory method rather than an adjudicated human interpretation.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. This type of study is usually conducted for imaging or interpretation-based diagnostic devices to evaluate the impact of AI on human reader performance. This device is an in-vitro diagnostic (IVD) test, where the instrument directly provides a quantitative result.

6. Standalone Performance

Yes, standalone performance was done for the predicate device, and the modified device's performance is stated to be the "Same." The reported accuracy and precision values are measures of the algorithm's (or system's) performance in determining prothrombin time against a reference. The device provides a quantitative result without human intervention for interpretation beyond reading the displayed value.

7. Type of Ground Truth Used

The ground truth used for the predicate device's performance evaluation would have been a reference laboratory method for prothrombin time (PT) or International Normalized Ratio (INR). This is implied by the terms "Accuracy compared to the reference" and the quantitative nature of the results (INR values).

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. For an in-vitro diagnostic device based on electrochemical technology, the "training set" might not be relevant in the same way it is for machine learning algorithms. Instead, the device's operational parameters would be established through extensive analytical validation using samples with known values.

9. How Ground Truth for the Training Set was Established

Similar to the test set, the ground truth for any calibration or validation of the device during its development (analogous to a "training set") would have been established using reference laboratory methods for PT/INR.

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