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510(k) Data Aggregation
(174 days)
COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM
The CoaguSense Self-Test PT Monitoring System is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in seconds and international normalized ratio (INR) units. It uses fresh capillary whole blood. It is intended for use by properly selected and suitably trained patients or their caregivers on the order of the treating doctor. Patients should be stabilized on warfarin-type (coumarin) anticoagulation therapy prior to self-testing with the CoaguSense Self-Test PT Monitoring System. It is not intended to be used for screening purposes.
The CoaguSense Self-Test PT/INR Monitoring System is a portable medical device for the measurement of the Prothrombin Time (PT) using fresh capillary whole blood obtained from a finger prick. The test is performed by inserting a test strip into the meter and applying a drop of blood to the sample receptacle of the test strip. The meter automatically performs the PT test and the result is displayed as International Normalized Ratio (INR) and seconds (PT). The meter automatically stores all test results in memory. The device is powered by batteries or AC adapter. The disposable strip contains a rotating, spoked wheel that draws the sample into the reaction well after it is applied to the sample receptacle. The spokes rotate across the path of an infrared light beam and mix the liquid sample with the thromboplastin which is dried in the reaction well. When the sample clots, the clot is picked up by the spokes, interrupting the path of the infrared light beam that is detected by the meter. A bar code on each test strip conveys calibration and lot information. A control strip is also provided for quality control purposes.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a typical quantitative pass/fail format. Instead, it focuses on demonstrating comparable performance to professional healthcare provider (HCP) measurements and acceptable precision.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Strong correlation between patient self-test results and HCP results. | Correlation of 0.98 between trained users (patients) and HCPs. |
| Acceptable precision (low coefficient of variation). | Overall average CV% of 3.48% for subjects (patients) and 2.52% for HCPs. |
| Performs as designed and intended for lay users. | "The CoaguSense Self-Test PT/INR Monitoring System performs as designed and intended in the hands of lay users." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Over 100 patients.
- Data Provenance: The study was conducted at "clinical sites and in patient's homes," indicating a prospective, real-world setting. The country of origin is not explicitly stated, but the context of the 510(k) submission to the FDA suggests it's likely within the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The "ground truth" in this context was established by healthcare practitioners (HCPs) taking PT/INR measurements. The document does not specify the number of HCPs, nor does it detail their specific qualifications (e.g., "radiologist with 10 years of experience"). It implies that these were standard clinical professionals involved in patient care and PT/INR testing.
4. Adjudication Method for the Test Set
The document describes a comparative method where patient self-test results were compared to results obtained by a healthcare practitioner. It doesn't mention an explicit "adjudication method" in terms of multiple experts resolving discrepancies. It's a direct comparison of two measurements – one from the patient, one from the HCP.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a traditional MRMC study as typically understood in diagnostic imaging (comparing multiple readers' interpretations of cases) was not performed. This study compared patient self-testing to HCP testing, not different readers' interpretations of the same "cases" (blood samples) in an MRMC framework.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This device (CoaguSense Self-Test PT/INR Monitoring System) is a point-of-care testing device that the patient directly uses to measure their PT/INR. The "performance" being evaluated is the patient's ability to use the device accurately compared to a professional. Therefore, the concept of a "standalone" algorithm-only performance is not directly applicable in the same way it would be for an AI diagnostic imaging algorithm. The device is the "algorithm" and performs the measurement. The study assessed the overall system's performance in the hands of the end-user (patient).
7. The Type of Ground Truth Used
The ground truth for comparison was healthcare practitioner (HCP) obtained PT/INR test results. This represents a form of expert-derived reference standard.
8. The Sample Size for the Training Set
The document does not provide information regarding a separate "training set" or its sample size. The performance testing section describes a validation study. This suggests the device's measurement algorithm was likely developed and validated internally during product development, prior to this specific patient-use study, which served as a clinical validation.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, there's no information on how its ground truth might have been established.
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