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The Coag-Sense Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in INR units. It uses fresh capillary whole blood.

The Coag-Sense Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing is intended for use by properly selected and suitably trained patients or 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 Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is not intended to be used for screening purposes.

The Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is intended to be used by a single person and should not be shared.

The Coaq-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing 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 for Patient Self-Testing is a handheld device that directly detects clot formation. The System measures the PT of fresh capillary whole blood using micromechanical 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). The result is date/time stamped and stored in the memory of the meter.

The device is powered by 4 AA batteries. This Coag-Sense Prothrombin Time (PT)//NR Monitoring System for Patient Self-Testing uses the exact same test and control strip as the predicate devices.

The information provided describes a Special 510(k) submission for the Coag-Sense Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing (K212779). This submission focuses on modifications to the user interface (from touchscreen to button navigation) and power source, asserting substantial equivalence to its predicate device (K183255).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

Acceptance Criteria and Reported Device Performance

The document states that "All testing results met the pre-determined acceptance criteria that were established in the test protocols." However, the specific quantitative acceptance criteria for each test and the corresponding reported performance values are not explicitly listed in a detailed table format within the provided text. The text generally states that the device "demonstrated that it met the predetermined acceptance criteria and design specifications."

Based on the available text, a table can be constructed to show the types of tests performed and the general statement about meeting criteria, rather than specific numerical acceptance criteria and performance data.

Study Details:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify a numerical sample size for the test set used in the functional bench testing, electrical safety/EMC testing, or software V&V. For the usability study, it mentions "All users" and "100% of professional and self-test users," but does not provide the number of users involved. For the side-by-side performance comparison, it mentions "identical test samples" but does not specify the number of samples.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective in nature, as they were conducted specifically for this 510(k) submission to verify the modified device's performance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided. The testing described (functional, electrical, software V&V, usability, and side-by-side performance) does not typically involve "experts" establishing a "ground truth" in the same way clinical diagnostic studies might (e.g., radiologists interpreting images). Instead, performance is assessed against established engineering specifications, regulatory standards, or predicate device results. For the usability study, users evaluated the device, but they are not described as "experts" establishing a "ground truth."

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • This information is not provided and is generally not applicable to the types of engineering and performance verification tests described for this device. Adjudication methods are typically associated with clinical studies involving interpretation of results by multiple human readers.

4. 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:

   • No MRMC study was done. This device is a Prothrombin Time (PT) / INR Monitoring System, which measures a physiological parameter. It is an in vitro diagnostic device, not an AI-assisted diagnostic tool that would typically involve human readers interpreting results with or without AI assistance. The study described focuses on device performance and usability, not on improving human reader effectiveness.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • The core of the described studies focuses on the standalone performance of the modified device. The functional bench testing, electrical safety/EMC testing, and software verification/validation are all evaluations of the device itself (algorithm and hardware) without human interpretation affecting the primary measurement. The side-by-side comparison also assesses the device's measurement accuracy against a predicate. While there is a human user interface, the primary measurement output (PT/INR) is generated by the device's mechanism and algorithm. Therefore, yes, standalone performance was assessed in the sense that the device's ability to generate accurate PT/INR results was verified independently.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the various performance tests seems to be based on:
     • Predetermined acceptance criteria and design specifications: For functional, electrical safety, and software V&V.
     • Applicable electrical safety standards (e.g., IEC 61010-1): For electrical safety and EMC.
     • Predicate device results: For the side-by-side performance comparison, where the predicate device served as the established reference for "no difference" in results.
     • User feedback: For the usability study.

7. The sample size for the training set:

   • Not applicable / Not explicitly provided. This submission is for modifications to an existing device and focuses on verification and validation of those changes. There is no mention of a "training set" in the context of machine learning model development. The device's underlying algorithm for detecting clot formation (micromechanical end point detection) is established and not part of a machine learning paradigm that would typically involve training sets.

8. How the ground truth for the training set was established:

   • Not applicable. As a traditional in vitro diagnostic device, the concept of a "training set" and "ground truth establishment" for it as it relates to machine learning is not relevant to this submission.

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