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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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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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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.

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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