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The Coag-Sense® Prothrombin Time (PT) / INR Monitoring System (Self-Test) is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in seconds and 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 physician to monitor patients who are on anticoagulation therapy. Patients should be stabilized on warfarin-type (coumarin) anticoagulation therapy prior to self-testing.

The device is not intended to be used for screening purposes.

For professional users, the Coag-Sense® Prothrombin Time (PT) / INR Monitoring System is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in seconds and INR units. It uses fresh capillary whole blood. It is intended for use by health care professional at the point of care to monitor patients who are on warfarin-type (coumarin) anticoagulation therapy.

The device is not intended to be used for screening purposes.

For self-test users, the Coag-Sense® Prothrombin Time (PT) / INR Monitoring System is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in seconds and INR units. It uses fresh capillary whole blood.

The device is intended for use by properly selected and suitably trained patients or their caregivers on the order of the treating physician to monitor patients who are on anticoagulation therapy. Patients should be stabilized on warfarin-type (coumarin) anticoagulation therapy prior to self- testing.

The device is not intended to be used for screening purposes.

The Coaq-Sense Prothrombin Time (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 stick. The Coag-Sense Prothrombin Time (PT)/INR Monitoring System is a hand held device and directly detects clot formation. The System measures the PT of fresh capillary whole blood using micro-mechanical end point detection. The test is performed by inserting a test strip into the meter and applying a drop of blood to the sample receptacle of the disposable test strip. The test 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.

The PT test and the result is displayed as International Normalized Ratio (INR) and seconds (PT). The result is date/time stamped and stored in the memory of the meter.

The device is powered by batteries and/or AC adapter. This PT/INR System uses the exact same test and control strip as the predicate devices.

This document describes the Coag-Sense Prothrombin Time (PT)/INR Monitoring System, a medical device for measuring PT/INR using fresh capillary whole blood. The submission aims to establish substantial equivalence to previously cleared predicate devices (K050243 and K093243) for both professional and self-testing use.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a specific table of numerical acceptance criteria with corresponding performance metrics for clinical accuracy or diagnostic performance (like sensitivity, specificity, or agreement with a gold standard). Instead, it discusses the successful completion of various tests against pre-determined acceptance criteria and design specifications.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the "test set" in the context of clinical performance or accuracy. The tests mentioned (bench, electrical safety, software V&V, usability) are primarily engineering and human factors validations, not clinical trials with patient samples.

• Data Provenance: The document does not specify the country of origin for any data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for an in vitro diagnostic device, it's highly likely that the "comparison of strip lots" and "comparison to predicate device" studies involved prospective testing of patient or quality control samples.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. For an in vitro diagnostic device like a PT/INR monitor, "ground truth" would typically be established by:

• For strip lot comparisons: Reference laboratory methods (e.g., automated coagulometers, specific plasma-based PT assays).
• For predicate device comparisons: The results from the predicate device itself, or potentially a gold-standard laboratory method the predicate device correlates with.

4. Adjudication Method for the Test Set

This information is not mentioned. Given that this is an IVD device measuring a quantitative value (PT/INR), "adjudication" in the traditional sense (multiple readers reviewing images) would not be directly applicable to the device's output. The "ground truth" would be the reference measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

An MRMC study is not applicable here because the device is an in vitro diagnostic (IVD) measurement device, not an image interpretation AI tool. There's no "human reader" component in using the device that requires assistance from AI; it provides a direct quantitative measurement. Therefore, no effect size of human improvement with AI assistance is reported.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself is a standalone measurement system. The "algorithm" is inherent in its electromechanical design to detect clot formation and calculate PT/INR. The performance studies described (comparison of strip lots, comparison to predicate) are effectively standalone performance evaluations. The device provides a direct result without human interpretation of raw data.

7. The Type of Ground Truth Used

The document implicitly refers to the following as ground truth/reference for comparative testing:

• Standard laboratory tests: Used for calibrating Coag-Sense strip lots and confirming correlation. This implies a highly accurate and established method for measuring PT/INR.
• The predicate device: Used as the comparator for the modified Coag-Sense PT/INR meter to demonstrate equivalent or better performance.

This is best characterized as Reference Method Comparison / Comparative Performance Study rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not specified. The document describes verification and validation studies but does not detail the development process of the device's internal algorithms or any machine learning components that would necessitate a "training set" in the modern AI sense. It's a bio-mechanical and electromechanical system.

9. How the Ground Truth for the Training Set Was Established

As no "training set" (in the context of AI/ML) is explicitly mentioned, the method for establishing its ground truth is also not described. The device's operation is based on physical principles of clot detection rather than learning from a vast dataset.

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