(39 days)
The Sterling™ Monorail™ PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, renal, and carotid arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
The Sterling™ Monorail™ PTA Balloon Dilatation Catheter is a Monorail brand rapid exchange catheter with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014 in / 0.018 in (0.36 mm/ 0.46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures to and through the stenosis. Two radiopaque marker bands, in conjunction with fluoroscopy, enable accurate positioning of the balloon. The working lengths of the balloon catheter are 80 cm and 135 cm. A needle with a luer port is included for flushing the distal inner lumen prior to the insertion of appropriate guidewires.
The provided text describes a 510(k) summary for the Boston Scientific Sterling™ Monorail™ PTA Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than providing acceptance criteria and performance data from a specific study designed to meet those criteria.
Therefore, many of the requested details cannot be extracted from this document, particularly those related to a clinical study with detailed acceptance criteria, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The 510(k) summary reports "Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence." However, it does not elaborate on specific acceptance criteria for these tests nor provide detailed performance results against those criteria. The focus is on stating that the proposed device has been designed and tested to assure conformance to requirements.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not provided. The document mentions "Bench testing and biocompatibility testing" but does not give sample sizes for these tests.
- Data provenance: Not provided. No information about country of origin or whether data was retrospective/prospective is given, as most of the testing was likely bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Not provided. As the described testing is primarily bench and biocompatibility, there is no mention of "ground truth" in the clinical sense established by experts.
4. Adjudication method for the test set:
Not applicable/Not provided. This is not relevant for the type of testing described (bench and biocompatibility).
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:
Not applicable/Not provided. This document describes a medical device (a balloon catheter), not an AI or imaging diagnostic device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable/Not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
Not applicable/Not provided. For bench testing, the "ground truth" would be engineering specifications and measurements. For biocompatibility, it would be established biological and toxicological endpoints. Clinical ground truth (e.g., pathology, outcomes data) is not discussed.
8. The sample size for the training set:
Not applicable/Not provided. As it's a physical device and not an AI algorithm, there is no "training set."
9. How the ground truth for the training set was established:
Not applicable/Not provided. As there is no "training set," this question is not applicable.
§ 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).