Search Results

The VascuTraK™ 2 PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the illiac, femoral, poplited, illio-femoral, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The YMed VascuTraK™ 2 PTA Dilatation Catheter is a modification to the VascuTraK™ 2 PTA Dilatation Catheter cleared under K073025. The device is fabricated of the same materials as the unmodified device and has the same intended use. The distal balloon sizes for the modified device include diameters from 5.0 - 7.0 mm and lengths up to 300mm.

This appears to be a 510(k) summary for a medical device modification, specifically the VascuTraK™ 2 PTA Dilatation Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical trial data that would be associated with therapeutic software or AI devices. As such, several of the requested categories for AI/software studies will not be applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for the mechanical tests (tensile strength, fatigue, compliance, burst). It only states that "The modified device was tested using the same test procedures that were used for the unmodified device."

• Test Set Size: Not explicitly stated for each test; however, for medical devices undergoing mechanical testing, sample sizes are typically determined by statistical methods to achieve sufficient confidence in the results (e.g., n=3, n=5, n=10 per batch, etc., depending on the test and criticality).
• Data Provenance: Not specified, but generally, these types of tests are performed in a laboratory setting by the manufacturer (YMed, Inc.) or a contracted testing facility. This would be prospective testing of the manufactured device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable to the evaluation of a physical medical device like a dilatation catheter. "Ground truth" in this context would refer to objective measurements obtained from laboratory testing, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication method" concept is typically used in clinical studies or studies involving human interpretation (e.g., expert readers adjudicating discrepancies in image diagnosis). For physical device testing, results are typically objective measurements against predefined specifications.

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. This is a physical medical device (catheter), not an AI/software device intended to assist human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established through objective engineering and laboratory testing based on predefined specifications and standards (e.g., ISO 10993-1 for biocompatibility). For example:

• Tensile strength is measured mechanically.
• Balloon fatigue is tested by repeatedly inflating and deflating the balloon.
• Compliance refers to the balloon's dimensional changes under pressure.
• Burst pressure is the pressure at which the balloon ruptures.
• Sterility is verified through bioburden testing and sterilization validation.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/software device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a physical medical device.

Ask a specific question about this device

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.

Ask a specific question about this device