(259 days)
The software supports image guidance by overlaying vessel anatomy onto live fluoroscopic images in order to navigate guidewires, catheters, stents and other endovascular devices.
The device is indicated for use by physicians for patients undergoing endovascular PAD interventions of the lower limbs including iliac vessels.
The device is intended to be used in adults.
There is no other demographic, ethnic or cultural limitation for patients.
The information provided by the software or system is in no way intended to substitute for, in whole or in part, the physician's judgment and analysis of the patient's condition.
The Subject Device is a standalone medical device software supporting image guidance in endovascular procedures of peripheral artery disease (PAD) in the lower limbs, including the iliac vessels. Running on a suitable platform and connected to an angiographic system, the Subject Device receives and displays the images acquired with the angiographic system as a video stream. It provides the ability to save and process single images out of that video stream and is able to create a vessel tree consisting of angiographic images. This allows to enrich the video stream with the saved vessel tree to continuously localize endovascular devices with respect to the vessel anatomy.
The medical device is intended for use with compatible hardware and software and must be connected to a compatible angiographic system via video connection.
Here's a breakdown of the acceptance criteria and study information for the Vascular Navigation PAD 2.0, based on the provided FDA 510(k) clearance letter:
Acceptance Criteria and Device Performance for Vascular Navigation PAD 2.0
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Video Latency (Added) | $\le$ 250 ms | $\le$ 250 ms (for Ziehm Vision RFD 3D, Siemens Cios Spin, and combined) |
| Capture Process Timespan (initiation to animation start) | $\le$ 1s | Successfully passed |
| Stitching Timespan (entering stitching to calculation result) | $\le$ 10s | Successfully passed |
| Roadmap/Overlay Display Timespan (manual initiation / selection / realignment to updated display) | $\le$ 10s | Successfully passed |
| System Stability (Stress and Load, Anti-Virus) | No crashes, responsive application (no significant waiting periods), no significant latencies of touch interaction/animations, normal interaction possible. | Successfully passed |
| Level Selection and Overlay Alignment (True-Positive Rate for suggested alignments) | Not explicitly stated as a number, but implied to be high for acceptance. | 95.71 % |
| Level Selection and Overlay Alignment (Average Registration Accuracy for proposed alignments) | Not explicitly stated (but the stated "2D deviation for roadmapping $\le$ 5 mm" likely applies here as an overall accuracy goal). | 1.49 ± 2.51 mm |
| Level Selection Algorithm Failures | No failures | No failures during the test |
| Modality Detection (Prediction Rate in determining image modality) | Not explicitly stated ("consequently, no images were misidentified" implies 100% accuracy) | 99.25 % |
| Modality Detection (Accuracy for each possible modality) | Not explicitly stated (but 100% for acceptance) | 100 % |
| Roadmapping Accuracy (Overall Accuracy) | $\le$ 5 mm | 1.57 ± 0.85 mm |
| Stitching Algorithm (True-Positive Rate for suggested alignments) | $\ge$ 75 % | 95 % |
| Stitching Algorithm (False-Positive Rate for incorrect proposal of stitching) | $\le$ 25 % | 6.4 % |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a single number.
- For Latency Tests: Data from Siemens Cios Spin and Ziehm Vision RFD 3D.
- For Level Selection and Overlay Alignment: Images acquired with Siemens Cios Spin, Ziehm Vision RFD 3D, and GE OEC Elite CFD.
- For Modality Detection: Image data from Siemens Cios Spin, GE OEC Elite CFD, Philips Zenition, and Ziehm Vision RFD 3D.
- For Roadmapping Accuracy: Image data from Siemens Cios Spin.
- For Stitching Algorithm: Image data from Philips Azurion, Siemens Cios Spin, GE OEC Elite CFD, and Ziehm Vision RFD 3D.
- Data Provenance:
- Retrospective/Prospective: Not explicitly stated for all tests. However, the Level Selection and Overlay Alignment and Roadmapping Accuracy tests mention using "cadaveric image data" which implies a controlled, likely prospective, acquisition for testing purposes rather than retrospective clinical data. Other tests reference "independent image data" or data "acquired using" specific devices, suggesting a dedicated test set acquisition.
- Country of Origin: Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. The document mentions "manually achieved gold standard registrations" for Level Selection and Overlay Alignment and "manually comparing achieved gold standard (GS) stitches" for the Stitching Algorithm, implying human expert involvement in establishing ground truth, but specific details on the number or qualifications of these "manual" reviewers are absent. The phrase "if a human would consider the image pairs matchable" in the stitching section further supports human-determined ground truth.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly described. The ground truth seems to be established through "manually achieved gold standard" or "manual comparison," implying a single expert or a common understanding rather than a formal adjudication process between multiple conflicting expert opinions (e.g., 2+1 or 3+1).
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Was it done? No. The submission focuses on standalone technical performance measures and accuracy metrics of the algorithm rather than comparing human reader performance with and without AI assistance.
6. Standalone Performance Study
- Was it done? Yes. The entire "Performance Data" section details the algorithm's performance in various standalone tests, such as latency, stress/load, level selection and overlay alignment, modality detection, roadmapping accuracy, and stitching algorithm performance. The results are quantitative metrics of the device itself.
7. Type of Ground Truth Used
- Type of Ground Truth:
- Expert Consensus / Manual Gold Standard: For Level Selection and Overlay Alignment ("manually achieved gold standard registrations") and for the Stitching Algorithm ("manually comparing achieved gold standard (GS) stitches"). This implies human experts defined the correct alignment or stitch.
- Technical Metrics: For Latency, Capture Process, Stitching Timespan, Roadmap/Overlay Display Timespan, and System Stability, the ground truth is based on objective technical measurements against defined criteria.
- True Modality: For Modality Detection, the ground truth is simply the actual modality of the image (fluoroscopy vs. angiography) as known during test data creation or acquisition.
8. Sample Size for the Training Set
- Sample Size: Not provided. The submission focuses solely on the performance characteristics of the tested device and its algorithms, without detailing the training data or methods used to develop those algorithms.
9. How the Ground Truth for the Training Set Was Established
- How Established: Not provided. As with the training set size, the information about the training process and ground truth for training is outside the scope of the clearance letter's performance data section.
§ 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.