(91 days)
The Wildcat Catheter is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Wildcat Catheter is contraindicated for use in the iliac, coronary, cerebral or carotid vasculature.
The Wildcat Catheter is a sterile, single-use, disposable catheter designed to cross chronic total occlusions (CTOs) and to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions in the peripheral vasculature.
The Wildcat Catheter consists of the distal tip, catheter shaft, and proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. The catheter is 6F guide compatible, 110 cm long, and intended for use with 0.035" guidewires. Two key elements of the device define the treatment modality - the distal tip and the bilateral wedges. Both elements are visible through fluoroscopy and allow for CTO crossing and facilitation of guidewire placement.
Subsequent to conventional guidewire placement, atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit.
The provided text describes the acceptance criteria and a clinical study (CONNECT Study) for the Wildcat Catheter. However, it focuses on the safety and effectiveness of a medical device, not an AI/ML powered device. Therefore, several of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable or cannot be extracted directly from this document.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Endpoint) | Reported Device Performance |
|---|---|
| Primary Safety Endpoint: Composite endpoint including site-reported MAEs and angiographic data (clinically significant perforations, embolizations, Grade C or greater dissections) | - 4 clinically significant perforations (4.8%) occurred at the time of the procedure (identified by independent angiographic reviewers). |
- No further sequelae reported prior to discharge.
- No occurrences of MAEs (0.0%).
- No unanticipated adverse events.
Conclusion: Primary safety endpoint was met. |
| Primary Effectiveness Endpoint: Successful CTO crossing by the Wildcat Catheter and subsequent guidewire positioning through the distal true lumen (confirmed by angiography) | Achieved in 89.3% of subjects.
Conclusion: Primary effectiveness endpoint was met. |
2. Sample size used for the test set and the data provenance:
- Sample Size: 84 subjects.
- Data Provenance: Multi-center, prospective, non-randomized study conducted at 15 sites in the United States.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The text mentions "independent angiographic reviewers" for assessing primary safety and effectiveness endpoints. However, the number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not specified.
4. Adjudication method for the test set:
- The text states "Primary safety and effectiveness endpoints were based on independent angiographic reviewers." It does not specify the adjudication method (e.g., 2+1, 3+1, none) used by these reviewers.
5. 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. This was a clinical study evaluating a medical device (catheter), not an AI/ML powered device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a catheter, used in a human-in-the-loop procedure. It is not an algorithm.
7. The type of ground truth used:
- Expert Consensus / Angiography: The ground truth for both safety and effectiveness endpoints was established through the assessment of "independent angiographic reviewers" and confirmed by angiography.
8. The sample size for the training set:
- Not applicable. This document describes a clinical study for a traditional medical device (catheter), not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML model was involved.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).