(132 days)
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.
| Performance Characteristic | Acceptance Criteria (from predicate CoaguChek XS Plus System) | Reported Device Performance (CoaguChek XS Pro System) |
|---|---|---|
| Accuracy compared to the reference | Venous Blood: N=811, Slope= 1.090, Intercept = -0.2, Correlation = 0.974 | |
| Capillary Blood: N = 822, Slope = 1.075, Intercept = -0.1, Correlation = 0.972 | Same as predicate (implied to meet these criteria) | |
| Whole Blood Precision | Venous Blood: N = 399, Mean INR = 2.32, SD = 0.046, CV = 2.00 | |
| Capillary Blood: N = 399, Mean INR = 2.26, SD = 0.077, CV = 3.39 | Same as predicate (implied to meet these criteria) | |
| Control Precision | Level 1: N = 538, Mean INR = 1.18, SD = 0.04, CV = 3.37 | |
| Level 2: N = 535, Mean INR = 2.95, SD = 0.12, CV = 4.10 | Same as predicate (implied to meet these criteria) | |
| Measuring range | 0.8 – 8.0 INR | Same |
| Hematocrit range | Hematocrit ranges between 25 – 55% have no significant effect on test results | Same |
| Bilirubin | Bilirubin up to 30 mg/dL have no significant effect on test results | Same |
| Triglyceride | Lipemic samples containing up to 500 mg/dL of triglycerides have no significant effect on test results. | Same |
| Hemolysis | Hemolysis up to 1000 mg/dL have no significant effect on test results | Same |
| Heparin | Test results are unaffected by heparin concentrations up to 0.8 U/mL | Same |
| Low Molecular Weight Heparin (LMWH) | The CoaguChek XS PT Test is insensitive to low molecular weight heparins (LMWH) up to 2IU anti-factor Xa activity/mL | Same |
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.
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).