(44 days)
The Venaflo Graft with Carbon is indicated for use as a subcutaneous arteriovenous conduit for blood access only.
The Venaflo Graft with Carbon is an expanded polytetrafluoroethylene (ePTFE) vascular graft with a cuffed venous end and a carbon-lined lumenal surface.
The provided text describes a 510(k) premarket notification for the "VENAFLO™ Vascular Grafts," specifically the "Venaflo Graft with Carbon." This is a regulatory submission for a medical device and not a detailed study report describing acceptance criteria and device performance in the manner of a clinical trial or algorithm validation study.
Therefore, much of the requested information (like specific quantifiable acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance metrics, or ground truth establishment details) is not present in the provided document.
The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a quantitative sense.
Here's a breakdown of what can be extracted and what is missing:
Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Suitable for use as a subcutaneous arteriovenous conduit for blood access. | "The results of all testing indicated that the Venaflo Graft with Carbon is suitable for use as a subcutaneous arteriovenous conduit for blood access and the anticipated conditions of use imposed on the device." |
| Designed to perform in a manner substantially equivalent to predicate devices. | "The results demonstrated that the Venaflo Graft with Carbon has been adequately designed to perform in a manner substantially equivalent to that of the predicate devices." |
| Compliance with ANSI/AAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses. | "Testing was conducted using methods recommended in ANSI/AAMI VP20-1994." |
| Compliance with 1993 FDA Draft Guidance: Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses. | "Testing was conducted using methods recommended in... the 1993 FDA Draft Guidance." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only states "Device testing was performed on the cuffed portion of the Venaflo Graft with Carbon and compared to the results of testing performed on the Venaflo ePTFE Vascular Graft." This implies laboratory or bench testing rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the performance assessment appears to be based on physical device testing against recognized standards, not on expert-adjudicated clinical data.
4. Adjudication method for the test set
- Not applicable for this type of device testing.
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
- No. This is a vascular graft, not an AI or imaging diagnostic device.
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 this device appears to be defined by established industry standards (ANSI/AAMI VP20-1994) and FDA guidance for vascular prostheses, as well as the performance characteristics of the predicate devices. The document implies that physical/mechanical tests were conducted to demonstrate compliance with these standards and equivalence.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI model.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device, not an AI model.
Summary of Device and Performance Information Provided:
- Device Name: Venaflo™ Vascular Graft (specifically Venaflo Graft with Carbon)
- Intended Use: Subcutaneous arteriovenous conduit for blood access only.
- Predicate Devices: Venaflo Vascular Graft, Venaflo ePTFE Vascular Graft, IMPRA Carboflo® Vascular Graft.
- Performance Basis: Device testing on the cuffed portion, compared to results from the Venaflo ePTFE Vascular Graft.
- Testing Standards: ANSI/AAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses and the 1993 FDA Draft Guidance for Vascular Graft Prostheses.
- Conclusion: The testing indicated suitability for intended use and substantial equivalence to predicate devices.
§ 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.”