(72 days)
The Ultra-soft SV Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Ultra-soft SV Percutaneous Transluminal Angioplasty (PTA) catheter is a Monorail™ catheter with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The distal segment of the balloon catheter is dual lumen and coaxial. The outer lumen is used for inflation of the balloon. The wire lumen permits the use of guidewires (≤0.018 in / 0,46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated.
The provided text describes a medical device submission (510(k)) for the Boston Scientific Ultra-soft™ SV Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for a novel AI device or a clinical trial with primary endpoints.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable or not provided in this type of regulatory document.
However, I can extract information related to the safety and performance aspects as described:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Demonstrated through bench testing and biocompatibility testing. |
| "No new safety or performance issues were raised." | |
| Biocompatibility | Testing performed and results supported substantial equivalence. |
| Bench Testing (Design, Packaging, Technology) | Testing performed and results supported substantial equivalence; device conforms to requirements for intended use. |
| Manufacturing | Substantially equivalent to predicate Boston Scientific balloon catheters. |
| Sterilization | Substantially equivalent to predicate Boston Scientific balloon catheters. |
| Intended Use | The Ultra-soft SV Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of the iliac, femoral, iliofemoral, popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This aligns with the predicate device. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specifically stated. The document mentions "bench testing" and "biocompatibility testing," which are laboratory tests, not human subject studies with a "test set" in the context of AI or clinical trials.
- Data provenance: Not applicable in the context of clinical data provenance. The data comes from internal laboratory testing (bench and biocompatibility).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable. This document does not describe a study involving expert consensus for establishing ground truth.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication method: Not applicable. This document describes laboratory testing against design specifications and predicate device equivalence, not clinical test set adjudication.
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:
- MRMC study: No. This is a medical device (PTA catheter) submission, not an AI diagnostic/imaging device.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone performance: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Ground truth: For this type of device, "ground truth" would be established by engineering specifications, material standards, and performance characteristics of the predicate device. For example, balloon diameter, inflation pressure, burst pressure, and biocompatibility standards. The document states that the device was designed and tested "to assure conformance to the requirements for its intended use."
8. The sample size for the training set:
- Sample size for training set: Not applicable. This submission concerns a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established:
- Ground truth establishment for training set: 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).