(82 days)
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the descending aorta. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
The IOPS Viewpoint Catheters are sterile, single use 6 Fr catheters intended for use with the Intra-Operative Positioning System (IOPS), manufactured by Centerline Biomedical. They are designed to be inserted into the femoral artery, brachial artery, or axillary artery and navigate through vasculature in the descending aorta to access branch vessels near to, or involved in, the lesion during endovascular procedures. The IOPS Viewpoint Catheters are available in two tip shape configurations (Simple and Double). Each tip shape is available in two lengths (75cm and 125cm). All models are equipped with multiple tracking sensors allowing the loPS to detect and visualize the catheter tip position and shape, in real time, on a 3D rendent's vascular map. The catheters have a radiopaque marker near the distal tip and a luer locking hub on the proximal end.
The provided text describes a 510(k) premarket notification for the Intra-Operative Positioning System (IOPS®) Viewpoint Catheters. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria for an AI/algorithm-based diagnostic device.
Therefore, many of the requested details regarding acceptance criteria, study design for AI evaluation (e.g., sample sizes for training/test sets, expert ground truth establishment, MRMC studies, standalone performance), and ground truth methodologies are not available within this document. The document primarily reports on non-clinical testing to ensure the physical and functional aspects of the catheter meet safety and performance standards for a medical device.
Here's a breakdown based on the provided text, highlighting what is and isn't available:
Acceptance Criteria and Device Performance
The document does not present a table of specific acceptance criteria for an AI/algorithm's performance (e.g., sensitivity, specificity, accuracy targets). Instead, it lists various non-clinical tests performed on the catheter device itself to establish its safety and effectiveness. The "device performance" reported is the successful completion of these tests, indicating the catheter performs as intended.
Table of Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing of the Catheter):
| Acceptance Criteria Category (Test Performed) | Reported Device Performance/Conclusion |
|---|---|
| Evaluation per ISO 10555-1 (Peak tensile force, freedom from leakage, radio-detectability, hubs, visual inspection) | Achieved equivalency to predicate device in safety and effectiveness |
| Dimensional analysis | Successful |
| Simulated use in an abdominal aorta model | Successful |
| Sensor functionality, placement, and accuracy | Successful (for real-time tip position visualization on a 3D vascular map, as per the device's function) |
| Hub to connector cable bond | Successful |
| Particulate testing per USP | Successful |
| Radiopacity per ASTM F640 | Successful |
| Accuracy testing with IOPS per ASTM F2554 | Successful (presumably for the catheter's tracking accuracy within the IOPS system) |
| IEC 60601 and Applied Part Testing | Successful |
| Hub compliance with ISO 80369 | Successful |
| Biocompatibility per ISO 10993 | Successful |
| Sterilization per ISO 11135 and ANSI/AAMI TIR 28 | Successful |
| EO/ECH residuals per ISO 10993-7 | Successful |
| Bacterial endotoxins per USP | Successful |
| Simulated distribution per ISTA Procedure 3A and ASTM D4169 | Successful |
| Packaging integrity per ASTM F2096 and ASTM F88/F88M | Successful |
| Overall Conclusion | "The successful completion of non-clinical testing demonstrates that the IOPS Viewpoint Catheters perform as intended and are substantially equivalent to the predicate." |
Details Not Available in the Provided Text (Pertaining to AI/Algorithm Performance):
The document describes the IOPS Viewpoint Catheters, which are "sensor-equipped compatible catheters and guidewires" used with the "Intra-Operative Positioning System (IOPS)". The IOPS system itself "visualize[s] the catheter tip position and shape, in real time, on a 3D renders vascular map." This suggests that the "IOPS" has an underlying algorithm for positioning and navigation, but the provided text focuses on the catheters as the subject devices for the 510(k) submission. Therefore, information typical for an "AI/algorithm performance study" is absent.
- Sample size used for the test set and the data provenance: Not applicable/not provided for AI algorithm evaluation. The document mentions "simulated use in an abdominal aorta model" as a test for the catheter, but not as an AI test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not provided.
- 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: Not applicable/not provided. The device is an "adjunct to fluoroscopy" for real-time tip positioning and navigation, not a diagnostic AI system assisting human readers in interpreting medical images.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not provided explicitly for the algorithm. The "Sensor functionality, placement, and accuracy" and "Accuracy testing with IOPS per ASTM F2554" of the catheter itself imply testing of the system's ability to track the catheter, but not a standalone AI diagnostic performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/not provided for an AI algorithm. For the catheter, the ground truth for testing would be physical measurements and established engineering standards.
- The sample size for the training set: Not applicable/not provided.
- How the ground truth for the training set was established: Not applicable/not provided.
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).