(85 days)
Dynamic Coronary Roadmap is intended to assist the physician during percutaneous coronary interventions in correlating the device position to the coronary vasculature, by providing a motion compensated overlay of this coronary vasculature.
The FFR/FR Roadmap feature is intended to assist the physician during percutaneous coronary interventions in relating the intravascular blood pressurement to its anatomical location. FFR/iFR roadmap visualizes the position of the pressure wire and the coronary artery on an X-ray image at the moment that an intravascular blood pressure measurement was performed as well as the intravascular blood pressure measurement values themselves.
Dynamic Coronary Roadmap is suitable for use with the entire adult human population.
Dynamic Coronary Roadmap is a software medical device intended to provide a real-time and dynamic angiographic roadmap of coronary arteries.
The angiographic roadmap is automatically generated from previously acquired diagnostic coronary angiograms during the same procedure.
Dynamic Coronary Roadmap overlays the angiographic roadmap on live 2D fluoroscopic images, thereby assisting the physician in navigating devices, e.g. (guide) wires, catheters, through the coronary arteries.
Dynamic Coronary Roadmap is to be used in combination with a Philips Interventional X-ray system.
When also used in conjunction with a compatible intravascular blood pressure measurement system, Dynamic Coronary Roadmap offers an FFR / iFR Roadmap feature. This feature co-registers the information of the blood pressure within a coronary artery with the corresponding X-ray image of the pressure wire within that coronary artery.
Here's a breakdown of the acceptance criteria and study information for the Dynamic Coronary Roadmap 2.0 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Software Verification | Implementation of all System Requirements Specification. | All executed tests passed. |
| Implementation of identified safety risk control measures. | All executed tests passed. | |
| Implementation of Privacy and Security requirements. | All executed tests passed. | |
| Usability Validation | Predefined criteria for mean task completion rates. | Exceeded predefined criteria. |
| Predefined criteria for system usability scores. | Exceeded predefined criteria. | |
| Predefined criteria for net promoter scores. | Exceeded predefined criteria. | |
| Expert Opinion Validation | Predefined acceptance criteria for expert analysis of preclinical datasets. | Actual acceptance scores exceeded predefined acceptance criteria. |
| In-house Simulated Use Validation | Successful execution of validation protocols for device navigation workflow, user needs, intended use, and safety/security effectiveness. | All executed validation protocols were passed. |
| Compliance with Consensus Standards | Adherence to a list of specified FDA-recognized consensus standards (e.g., IEC 62304, IEC 62366-1, ISO 14971, ISO 15223-1, NEMA PS 3.1-3.20). | Demonstrates compliance. |
| Compliance with FDA Guidance Documents | Adherence to a list of specified FDA guidance documents. | Demonstrates compliance. |
| Safety and Effectiveness | Comparable safety and effectiveness to the predicate device. | Substantially equivalent; does not raise new safety/effectiveness concerns. |
| Intended Use | Conforms to the stated intended use. | Conforms to intended use. |
| User Needs and Claims | Conforms to user needs and claims. | Conforms to user needs and claims. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "sample size" in terms of number of cases or images for the validation studies. It refers to:
- Usability validation: Performed with certified interventional cardiologists in a simulated environment.
- Expert opinion validation: Experts analyzed "a wide range of pre-clinical datasets" in a simulated environment.
- In-house simulated use validation: Performed with "experienced Clinical Marketing specialists."
Data Provenance: The studies were conducted in a simulated environment using pre-clinical datasets for the expert opinion validation. No information is provided about the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Usability validation: "Certified interventional cardiologists" were used. The number is not specified.
- Expert opinion validation: "Certified interventional cardiologists" were used. The number is not specified.
- In-house simulated use validation: "Experienced Clinical Marketing specialists" were used, who fulfill the intended user profile based on clinical knowledge gained from work experience and hospital visits. The number is not specified.
The specific "ground truth" establishment for a test set (e.g., expert consensus) isn't detailed for a diagnostic-style performance evaluation, as this a medical device assistance system rather than a diagnostic one. The focus is on usability, safety, and effectiveness in assisting physicians.
4. Adjudication Method for the Test Set
No specific adjudication method (e.g., 2+1, 3+1) is mentioned. The validation approaches (usability, expert opinion, in-house simulated use) suggest a qualitative assessment rather than a quantitative ground truth adjudicated by multiple experts for diagnostic performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The device's substantial equivalence was demonstrated through non-clinical performance testing and comparison to a predicate device, not by showing human readers improve with AI assistance. The device is for assistance, not a standalone diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study of the algorithm's diagnostic capabilities was not conducted or reported. The device is explicitly designed as an assistance tool for physicians during percutaneous coronary interventions, providing a "motion compensated overlay" and "visualization of the pressure wire." The testing focused on its function as an assistive device with human interaction (usability, expert opinion, simulated use).
The document states: "Algorithm verification was not warranted as there are no algorithms implemented for the FFR/iFR Roadmap feature and no changes have been made to the existing Roadmapping algorithm that impacted its performance compared to the currently marketed predicate device Dynamic Coronary Roadmap 1.0 (K170130)." This indicates that the core roadmapping algorithm was considered established from the predicate device and did not require re-verification, and the new FFR/iFR feature didn't involve new algorithms in the same way.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation can be best characterized as:
- User Performance Metrics: For usability testing (task completion rates, usability scores, net promoter scores).
- Expert Opinion/Consensus: For expert opinion validation, where certified interventional cardiologists analyzed preclinical datasets against predefined acceptance criteria.
- Conformance to User Needs/Intended Use: For in-house simulated use validation, ensuring the device met its intended purpose and user requirements.
This is distinct from a ground truth established for diagnostic accuracy, which would typically involve pathology, clinical outcomes, or comprehensive expert consensus on findings.
8. Sample Size for the Training Set
The document does not provide any information about the sample size used for a training set. Given that "Algorithm verification was not warranted" and no changes were made to the core roadmapping algorithm, it's implied that any algorithm training for the core functionality would have occurred for the predicate device (Dynamic Coronary Roadmap 1.0) and is not discussed here for 2.0. The new FFR/iFR feature is described as co-registration and visualization, rather than a new machine learning algorithm requiring a separate training set.
9. How the Ground Truth for the Training Set Was Established
Since no information is provided about a training set for Dynamic Coronary Roadmap 2.0's new features, or retraining of existing algorithms, the method for establishing ground truth for a training set is not detailed in this submission.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.