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510(k) Data Aggregation
(35 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Super Sani-Cloth wipes are effective for cleaning and disinfection of the device. | The corresponding test results on the device components demonstrate that the Super Sani-Cloth wipes are effective for the cleaning and disinfection of the device. |
| The device must meet performance requirements for its intended use after being subjected to cleaning and disinfection with Super Sani-Cloth. | Robustness and effectiveness cleaning and disinfecting testing on the CoaguChek XS Plus System for Super Sani-Cloths demonstrated that the device meets the performance requirements for its intended use. Overall, the data demonstrate that the CoaguChek XS Plus System operates in the same manner when cleaning and disinfecting occurs with the Super Sani-Cloth wipes. |
| Neither meter accuracy nor meter functionality should be impacted by the cleaning and disinfection procedure over the device's lifetime. (Implicit: the device should continue to accurately measure prothrombin time and function correctly.) | Acceptance criteria were met when testing with venous blood the CoaguChek XS Plus meters that had been subjected to 10,950 Cleaning and Disinfection (C&D) cycles representing three-years lifetime of the meter based on a testing frequency of 10 tests per day. Neither meter accuracy nor meter functionality were impacted by the cleaning and disinfection procedure. |
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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