(29 days)
Venaflo ™ II Vascular Grafts are indicated for use as subcutaneous arteriovenous conduits for blood access only.
Venaflo II arteriovenous vascular grafts have a pre-formed venous cuff to promote venano II atterrovenous variate at the venous anastomosis. Venaflo II grafts are available in various lengths and diameters, in straight and stepped configurations, with and without external support.
The provided Venaflo II Vascular Graft 510(k) Summary of Safety and Effectiveness document describes a medical device, not a software algorithm or AI. Therefore, most of the requested information (like sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, etc.) is not applicable to this type of submission.
This document pertains to a physical medical device – a vascular graft – and its substantial equivalence to a predicate device. The "study" mentioned is a design verification process based on industry standards and FDA guidance for physical implants, which differs significantly from studies performed to evaluate AI/software performance.
Here's an attempt to address the applicable parts of your request based on the provided text, while clearly indicating where information is not relevant:
Acceptance Criteria and Device Performance for Venaflo™ II Vascular Graft
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implied from document) | Reported Device Performance |
|---|---|---|
| Design / Functionality | Optimization of venous cuff sizing for veins 8mm and smaller. | |
| Improved hemodynamic performance at the venous anastomosis. | The modified device (Venaflo™ II) is described as having "printed trim lines on a more pronounced venous cuff profile to enhance the good hemodynamic performance of the predicate design." The changes "optimize venous cuff sizing... and improve hemodynamic performance at the venous anastomosis." | |
| Technological Equivalence | Substantial equivalence to predicate device in intended use, operation, user population, basic design, performance, labeling, packaging, and sterilization method. | "The technological characteristics of Venaflo II vascular grafts are substantially equivalent to those of the predicate Venaflo vascular graft in terms of intended use, operation, user population, basic design, performance, labeling, packaging, and sterilization method." |
| Non-Clinical Performance | Conformance to or evaluation based on specific FDA guidance and industry standards for vascular prostheses and biocompatibility. | "All test results confirm the modified device to be substantially equivalent to the predicate device." "Venaflo II Vascular Grafts met all predetermined acceptance criteria of design verification and validation as required by the risk analysis, and as specified by applicable standards, guidance's, test protocols and/or customer inputs." |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes a 510(k) submission for a physical medical device (vascular graft) which is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study with a "test set" in the context of an AI algorithm. The performance evaluation is based on non-clinical performance data which refers to engineering and laboratory testing (e.g., in vitro, material characterization, mechanical stress tests). There's no mention of human patient data "test sets" or data provenance in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. As above, there is no "test set" in the AI sense, and therefore no ground truth established by experts for such a set. The "ground truth" here is the established safety and effectiveness of the predicate device and the conformance to recognized industry standards and guidance documents.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or direct expert adjudication in the context of AI evaluation is described. The "validation" is implied through meeting the requirements of specified guidance documents and standards.
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 vascular graft, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. As mentioned, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is implicitly the established safety and effectiveness of the predicate device (IMPRA Venaflo™ Vascular Graft, K981079) and conformance to recognized industry standards and FDA guidance documents related to vascular prostheses and biocompatibility (e.g., ANSI/AAMI VP20-1994, ANSI/AAMI/ISO 7198: 1998/2001, ISO 10993 series). The modified device is deemed safe and effective because it meets these standards and is substantially equivalent to a device already deemed safe and effective.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of AI development for this physical device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" for AI.
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”