(121 days)
The VANTAGE™ Peripheral Dilatation Catheter is intended for use in Percutaneous Transluminal Angioplasty (PTA) of the Iliac, Femoral, and Popliteal arteries. The VANTAGE™ Peripheral Dilatation Catheter is not intended for use in the coronary arteries or in neurovasculature.
The 10 cm VANTAGE™ Peripheral Dilatation Catheter is a double-lumen catheter with a poly(ethylene)terephthalate (PET) balloon bonded to the shaft. The 10 cm VANTAGE™ Peripheral Dilatation Catheter has a range of balloon sizes from 3 mm to 7 mm in inflated diameter. The catheter is available in 75 cm to 125 cm shaft lengths.
The provided text describes a medical device, the VANTAGE™ Peripheral Dilatation Catheter, and its performance relative to established safety and effectiveness criteria. However, it does not include information on acceptance criteria for an AI/algorithm-based device, human expert involvement in ground truth establishment, or multi-reader multi-case studies. The study described focuses on physical performance and biocompatibility tests of a catheter, not on an AI algorithm's diagnostic or predictive capabilities.
Here's an attempt to structure the available information per your request, while highlighting the absence of AI-specific details:
Device: VANTAGE™ Peripheral Dilatation Catheter - Additional Sizes
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a physical medical device (catheter) and not an AI algorithm, the "acceptance criteria" are implied by the successful completion of various engineering and biocompatibility tests designed to ensure the device is safe and performs as intended. There aren't specific numerical "criteria" listed in the format you might expect for an AI algorithm's sensitivity/specificity, but rather that the device "passed" or "was found to be clinically acceptable."
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Physical Performance | Catheter Preparation Test | Clinically Acceptable | Passed |
| Balloon Minimum Burst Strength Test (Rupture) | Clinically Acceptable | Passed | |
| Balloon Compliance Test (Distensibility) | Clinically Acceptable | Passed | |
| Balloon Inflation/Deflation Tests | Clinically Acceptable | Passed | |
| Balloon Fatigue Test (Repeated Inflation) | Clinically Acceptable | Passed | |
| Tip Pulling Test | Clinically Acceptable | Passed | |
| Bonding Strength Test | Clinically Acceptable | Passed | |
| Catheter Body Burst Pressure Test | Clinically Acceptable | Passed | |
| Contrast Medium Flow Rate Test | Clinically Acceptable | Passed | |
| Dimensional Measurements (Tip Diameter, Profile) | Clinically Acceptable | Passed | |
| Biocompatibility | Cytotoxicity Elution | USP Class IV / Passed | Passed |
| Sensitization | USP Class IV / Passed | Passed | |
| USP XXII Plastics Test (Class IV) - Intracutaneous Test | USP Class IV / Passed | Passed |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The studies listed are laboratory or bench tests on the physical catheter, not analyses of data in the context of an AI algorithm. Therefore, concepts like "test set," "data provenance," "country of origin," and "retrospective/prospective" do not apply here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document describes physical device testing, not an AI algorithm requiring expert-established ground truth from clinical data.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not applicable. The document describes testing of a physical medical device, not an AI system that would assist human readers in interpretation. Therefore, there is no discussion of human readers improving with or without AI assistance, or any effect size.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the device is a physical catheter, not an algorithm.
7. The Type of Ground Truth Used
For the physical performance tests, the "ground truth" would be established engineering standards, material specifications, and regulatory requirements (e.g., burst pressure limits) for catheter performance. For biocompatibility, it's defined by the Tripartite Biocompatibility Guidelines and USP Class IV standards. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense of AI algorithm validation.
8. The Sample Size for the Training Set
This information is not applicable as the document describes a physical medical device, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above.
Summary of AI-Related Information in the Text:
The provided text describes a 510(k) submission for a conventional medical device (a catheter). It focuses on the physical and biological characteristics of the device. None of the information typically associated with the evaluation of an AI or algorithm-driven device is present in this document. The request's template is designed for AI/ML medical devices, which operate under a different set of evaluation criteria than traditional hardware devices.
§ 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).