(295 days)
For quantitative prothrombin time (PT) testing in fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients (or their care givers) on the prescription of the treating doctor.
• The CoaguChek test strip contains reagent and iron particles. Blood mixes with these reagents and particles on the test strip. At the same time, the meter starts a timer. The iron particles move in response to an oscillating magnetic field. When the blood clots, the particles stop moving. The meter stops the timer and displays the result.
The provided document is a 510(k) Premarket Notification for the CoaguChek® PST System. It mainly focuses on demonstrating substantial equivalence to a predicate device and studies related to the new user group (patients) rather than establishing specific quantitative acceptance criteria or a detailed clinical study for the device's accuracy against a ground truth.
Therefore, many of the requested sections (like explicit acceptance criteria values, multi-reader multi-case studies, effect size, standalone algorithm performance, number of experts for ground truth, adjudication methods, and sample sizes for training/test sets with ground truth methods for training) cannot be fully populated from this document. The document highlights a correlation study for the new user group.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in a quantitative, pass/fail manner. The document focuses on demonstrating substantial equivalence to a predicate device and showing that trained patients can achieve results comparable to healthcare professionals. | |
| Correlation between trained patients and healthcare professionals using CoaguChek PST System: | N = 315 observations |
| Slope = 0.973 | |
| Intercept = 0.05 | |
| Correlation Coefficient = 0.966 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (for the patient vs. professional comparison): 315 observations.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved a comparison between "trained patients" and "health care professionals," suggesting this was likely a prospective study conducted for the purpose of this submission. It is implicitly prospective as it compares results from different user groups using the "new" device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The study described compares measurements by "trained patients" with measurements by "health care professionals." The "health care professionals" are acting as a reference group or a proxy for a high-quality measurement.
- Number of Experts: Not specified. It refers to "health care professionals" in general, not a specific number of adjudicated experts providing a 'ground truth' in the traditional sense of a diagnostic interpretation.
- Qualifications of Experts: Assumed to be "health care professionals trained in the use of the CoaguChek System." Specific qualifications (e.g., medical degrees, years of experience) are not detailed.
4. Adjudication Method (for the test set)
- Not applicable. The study is a direct comparison of measurements between two user groups (patients vs. professionals) using the same device, not an adjudication process to establish a definitive ground truth from multiple expert interpretations.
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-based device, nor is it an MRMC study in the typical sense comparing human readers with and without AI assistance. The study compares patient performance with professional performance.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) study was done
- Not applicable, as this is a medical device that requires human interaction (patient or professional) for operation and specimen collection. The device itself (the meter and test strip system) is a standalone measurement tool, and its internal performance characteristics were previously established (under K930454) and are asserted as unchanged. The focus of this submission is on the new user group.
7. The type of ground truth used
- The "ground truth" in the comparative study described here is represented by the test results obtained by "health care professionals trained in the use of the CoaguChek PST System." This acts as the reference for evaluating whether trained patients can achieve comparable accuracy. It is a comparative ground truth rather than an independent gold standard like pathology or long-term outcomes.
8. The sample size for the training set
- Not explicitly mentioned in the context of algorithm training. The device does not appear to be an AI/machine learning device that would have a distinct training set for an algorithm. The "training" referred to in the document is the training of patients on how to use the device.
9. How the ground truth for the training set was established
- Not applicable, as there's no mention of an algorithm training set or associated ground truth establishment in this document. The document refers to the "training of patients" to use the device, not a machine learning model.
§ 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).