(4 days)
The VascuTraK™ PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the iliac, femoral, popliteal, ilio-femoral, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The VascuTraK™ Catheter is a sterile single use device that consists of a flexible shaft with a single through lumen and a 24 cm distal lumen that accepts a 0.014" guidewire. The distal end of the catheter contains a semi-compliant balloon that is inflated via the central lumen. The balloon is available in various diameters and lengths,
The provided text is a 510(k) Premarket Notification for the VascuTraK™ PTA Dilatation Catheter. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not available in this document.
Here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table of acceptance criteria and reported device performance in the way typically found in a clinical study report for an AI/ML medical device. The 510(k) submission relies on demonstrating substantial equivalence to predicate devices based on design, materials, and established safety/performance characteristics, not specific performance metrics against pre-defined acceptance criteria for a novel algorithm.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This document does not describe a test set or data provenance for an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This document does not describe the establishment of a ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not provided. This document does not describe an adjudication method for a test set.
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 is for a medical device (a catheter) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided.
8. The sample size for the training set
Not applicable/Not provided.
9. How the ground truth for the training set was established
Not applicable/Not provided.
Summary of what can be extracted from the document:
The 510(k) summary focuses on demonstrating that the VascuTraK™ PTA Dilatation Catheter is substantially equivalent to existing, legally marketed predicate devices. The "Performance and Safety" section mentions:
- Biological safety: Demonstrated through biocompatibility studies of patient contact materials in accordance with ISO 10993-1.
- Physical testing: Performed to assure catheter integrity, including verification of balloon burst pressure.
- Sterility: Supplied sterile to a Sterility Assurance Level (SAL) of 10⁻⁶.
These points indicate the types of tests done for a physical device, but they are not presented as "acceptance criteria" against specific numerical performance targets in the context of an AI/ML study. The 510(k) process is about establishing equivalence through comparison to predicates and meeting general safety and performance standards for its device type.
§ 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).