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510(k) Data Aggregation
(162 days)
COAGUCHEK XS PLUS PST SYSTEM
The CoaguChek XS Plus System measures blood-clotting time for people who are taking warfarin anticoagulation medications. The CoaguChek XS Plus System uses blood from a fingerstick. The system is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.
The CoaguChek XS Plus System was previously cleared for professional use under premarket notification K071041. This premarket notification is being submitted to obtain clearance for patient self-testing.
Here's a breakdown of the acceptance criteria and the study details for the CoaguChek® XS Plus System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states "Acceptance Criteria" under each performance characteristic evaluated in the study.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (N=307) | Device Meets Criteria? |
|---|---|---|---|
| Accuracy | High correlation between self-tester and healthcare professional results. Specifically, a correlation coefficient (r) indicating a strong linear relationship and a regression line close to ideal (slope = 1, intercept = 0). | N = 307, Slope = 1.000, Intercept = 0.0, Correlation Coefficient (r) = 0.963. The regression equation is Y = 0.000 + 1.000 * X. | Yes (Correlation Coefficient = 0.963 is very high, and regression parameters are ideal). |
| Precision | Self-tester results should be as precise as healthcare professional results. (Evaluated by comparing SD and CV values for duplicate capillary blood results). | Self-Tester: N=296, Mean=2.47, SD=0.135, CV=5.47. Professional: N=308, Mean=2.45, SD=0.101, CV=4.12. | Yes (The CV for self-testers (5.47) is comparable to or slightly higher than, but still close to, professionals (4.12), indicating acceptable precision for self-testing). |
| Consistency Over Time | Self-tester results should be consistent over time. | "This study also demonstrated that self-tester results are consistent over time." (No specific quantitative criteria or data provided in the excerpt for this. It's a general statement about the study's finding.) | Yes (Based on the general statement in the summary, implied by the overall success of the study. No specific data provided within this document portion to quantify this.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Accuracy Test Set: 307 patients (for the comparison between self-tester and healthcare professional results).
- Sample Size for Precision Test Set: 296 for self-testers, 308 for professionals.
- Data Provenance: The study was conducted by Roche Diagnostics. It was a prospective clinical study involving four visits to a clinical site, with subjects self-testing in a home setting for up to 8 weeks, and also having 3 scheduled visits to their study site to collect user vs. technician data. The demographic information for the trained users who completed all visits (103 patients) lists "Age range (years) 34-86", with educational levels ranging from "Some high school through advanced college degree." The specific country of origin is not explicitly stated, but Roche Diagnostics is based in Indianapolis, IN, USA, and the 510(k) submission is to the FDA, suggesting a US-based study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for comparison was established by "healthcare professionals trained in the use of the CoaguChek XS Plus System" (referred to as "technician" in the regression analysis). The exact number of individual healthcare professionals is not specified, nor are their specific qualifications (e.g., number of years of experience, specific medical degrees). However, the study involved a comparison against "healthcare professionals," implying a standard of reference for accurate PT/INR measurement.
4. Adjudication Method
The document does not explicitly describe an adjudication method for conflicting results. The study compares results from "trained users" (self-testers) against "healthcare professionals." It's implied that the healthcare professional's measurement serves as the reference or "ground truth" against which the self-tester's performance is compared, rather than a conciliation process between discrepant readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is focused on the performance of a device used by patients (self-testers) compared to its use by healthcare professionals, not on how an AI system changes human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this study is inherently a standalone performance evaluation of the device. The "algorithm" here is the entire CoaguChek XS Plus System. The study evaluated its performance when used by two distinct "classes" of users: self-testers and healthcare professionals. The objective was to demonstrate the device's accuracy and precision in the hands of self-testers, without a human-in-the-loop AI component being assessed. It compares the device's performance under different user conditions.
7. The Type of Ground Truth Used
The ground truth for the test set was established by measurements obtained by trained healthcare professionals using the same CoaguChek XS Plus System. This serves as the reference standard for evaluating the accuracy of results obtained by self-testers.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" in the context of machine learning. The study describes training for the users of the device (self-testers) rather than training for an algorithm. The patient demographics section describes the characteristics of the study subjects who were trained and whose data was collected.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an algorithm in the machine learning sense, this question is not applicable. The "training" described in the document refers to the face-to-face training provided to the study subjects (self-testers) on how to use the CoaguChek XS Plus System, not the training of an AI model with ground truth data.
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