(138 days)
The CoagCare Anticoagulation Management System (CoagCare®) is an interactive, internet-based (web-based), rules-based expert software system for the long-term management of patients undergoing warfarin anticoagulation therapy. The system is an accessory to prescription home-use prothrombin time devices that measure International Normalized Ratios (INRs), and it facilitates remote clinical management between patient and caregiver.
The CoagCare system is a software accessory to prescription-home use prothrombin time (INR) devices for effective anticoagulation management with warfarin. System Overview: The system consists of two components, the CoagCare Patient Interface and the CoagCare Caregiver Interface, both of which are accessed through an internet browser. The interface provides a structured therapeutic regimen developed for the individual patient. It prompts the patient for INR values, symptoms, and other disease related data, and provides the patient with recommended doses of warfarin and an INR testing schedule that can be adjusted based on parameters specified by the patient's caregiver. The patient is given recommendations for warfarin doses for each day until the next time of required INR testing. In cases of marked abnormal INR readings or disease signs or symptoms suggestive of over-treatment, the Patient Interface instructs the patient to contact his/her healthcare provider for further instructions.
The second component of the CoagCare system is the Caregiver Interface. The caregiver monitoring the patient's anticoagulant therapy accesses the Caregiver Interface at least daily. The Caregiver Interface is programmed to automatically identify patient problems such as patients who report thromboembolic or hemorrhagic symptoms, failure to check their INR on a prescribed day, etc. The Caregiver Interface prioritizes problems requiring the caregiver's attention. Once patients have checked their INRs and transmitted their results, if the caregiver agrees with the warfarin dosing instructions provided by the patient interface, no further interventions are required for that day. Patients with markedly abnormal results or recurrent problems are prioritized for caregiver intervention, whereas stable patients are listed with their results, eliminating the need for direct patient contact by the caregiver. The Caregiver Interface also allows the caregiver to override therapeutic instructions provided by the Patient Interface, or send a text message to the patient through the Patient interface. (For more emergent issues, the patient can be contacted directly by the caregiver by telephone.)
Here's an analysis of the CoagCare Anticoagulation Management System based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Improvement in Time in Therapeutic Range (TTR) for warfarin anticoagulation therapy. (Implicit. The core utility of such a system is to better manage anticoagulation, and TTR is a key metric.) | Increase in TTR from 62.5% (prior to CoagCare) to 73.5% (during CoagCare study), representing an 11% increase. This improvement was statistically significant (p = 0.008). The site effect was non-significant (p=0.87), indicating consistent improvement across sites. |
| Efficiency for Caregivers in managing patients. | Caregivers at all 3 sites reported that it took between 15 and 25 minutes a day to manage between 20 and 58 patients. The report notes, "Due to the automation provided by CoagCare, managing 48 patients with CoagCare did not take much more time than managing 20." This indicates an improvement in efficiency, though a specific quantitative target (e.g., reduce time by X%) is not explicitly stated as an acceptance criterion. |
| Patient Satisfaction with home management using CoagCare. | Between 92% and 100% of all patients reported: |
| * They preferred home management with CoagCare to traditional point-of-care treatment. | |
| * They felt they were being monitored more closely with CoagCare. | |
| * Their INRs were in better control with home management. | |
| Safety and Effectiveness for intended use. | The clinical studies demonstrated that patients and caregivers can successfully use the CoagCare system to produce improved outcomes and a high degree of patient satisfaction, leading to the conclusion that the system is safe and effective for its intended use. (This is a summary conclusion based on the observed improvements and patient feedback). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 100 patients
- 58 patients at Duke University Medical Center
- 22 patients at the University of New Mexico Medical Center
- 20 patients from a private practice in Miami
- Data Provenance: United States (Duke University, University of New Mexico, Miami private practice). The study was prospective, as patients were "switched to home INR monitoring and followed with the CoagCare system for six months" or "remained on the system from 3 to 4 months." Data on TTR prior to CoagCare was retrospective (likely collected from patient records before the intervention).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not explicitly state the number or qualifications of experts used to establish a "ground truth" for the test set in the traditional sense of diagnostic accuracy studies. The study evaluates the effectiveness of the system in managing anticoagulation, where the "ground truth" is inferred from patient INR values (measured by home INR devices) and the resulting time in therapeutic range. The "caregivers" (physicians, nurses, pharmacists, or licensed professionals) monitoring the patients are the experts involved in overseeing the system and making clinical judgments.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method for the test set as would typically be done for diagnostic interpretations. The CoagCare system provides recommendations, and caregivers monitor and can override instructions. The "ground truth" for TTR is derived from INR measurements and the patient's adherence to the warfarin dosing recommendations generated by the system (or overridden by the caregiver).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
This was not a traditional MRMC study. It was a comparative effectiveness study comparing patient outcomes with the CoagCare system to their outcomes without the system (their historical TTR). The "readers" (caregivers) involved in managing the patients using the CoagCare system had their efficiency and satisfaction assessed.
- Effect Size of Human Readers Improve with AI vs. without AI assistance: The study primarily focuses on patient outcomes (TTR) and caregiver efficiency.
- Patient Outcome (TTR): The TTR increased by 11% (from 62.5% to 73.5%) with the CoagCare system (which includes AI-like capabilities for dosing recommendations and problem prioritization) compared to prior management. This suggests the system assists caregivers in achieving better patient outcomes.
- Caregiver Efficiency: Caregivers managing between 20-58 patients reported it took only 15-25 minutes a day. The note "managing 48 patients with CoagCare did not take much more time than managing 20" strongly suggests an improvement in caregiver efficiency due to the system's automation, but a specific "effect size" of improvement (e.g., X% more patients managed per hour) is not quantified or compared to an unassisted baseline.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
No, a standalone performance study was not done. The CoagCare system is explicitly described as a "software accessory" that facilitates "remote clinical management between patient and caregiver." The system provides recommendations, but "caregivers have the ability to override therapeutic instructions" and "requires tight professional oversight." It is a human-in-the-loop system.
7. The Type of Ground Truth Used
The primary "ground truth" or outcome measure used was:
- Outcomes Data: Specifically, the Time in Therapeutic Range (TTR) for International Normalized Ratios (INR) in warfarin-treated patients. This is a direct clinical outcome measure.
- Patient Feedback/Satisfaction: Self-reported patient preferences and perceptions of monitoring and control.
- Caregiver Reports: Reports on the time taken to manage patients.
8. The Sample Size for the Training Set
The document does not mention a distinct "training set" for the CoagCare system. The system "utilizes published and generally accepted algorithms to adjust medication doses and make treatment decisions." This implies that the algorithms were developed based on existing medical knowledge and clinical guidelines, rather than being trained on a specific, separate dataset within the context of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
As no specific training set is mentioned for the algorithm (which is described as rule-based using "published and generally accepted algorithms"), the concept of "ground truth for the training set" as it relates to machine learning models is not applicable here. The "ground truth" for these general algorithms would have been established through extensive medical research, clinical trials, and expert consensus over many years, leading to the "published and generally accepted algorithms" mentioned.
§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.