(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 medical device submission seeking substantial equivalence to existing predicate devices. Consequently, the document does not contain information typically found in a study demonstrating how a device meets acceptance criteria through performance metrics. Instead, it focuses on demonstrating that the new device has "technological characteristics" and "performance data" that are "substantially equivalent" to predicate devices.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert ground truthing, and MRMC studies are not present in this type of regulatory submission. The goal of a 510(k) is to prove equivalence, not necessarily to perform a de novo clinical trial with new acceptance criteria.
However, I can extract the information that is available from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document indicates that testing was performed to demonstrate substantial equivalence to predicate devices, rather than against specific, quantitative acceptance criteria for superior performance.
| Acceptance Criterion Type (Inferred) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | "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." |
| Suitability for Intended Use | "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." |
| Compliance with Industry Standards | Testing conducted using methods recommended in ANSI/AAMI VP20-1994: Cardiovascular Implants - Vascular Prostheses and the 1993 FDA Draft Guidance: Guidance for the Preparation of Research and Marketing Applications for Vascular Graft Prostheses. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of a clinical study with a specific sample size. The performance data refers to "device testing" performed on the cuffed portion of the Venaflo Graft with Carbon and compared to predicate devices. The nature of this testing (e.g., in vitro, animal, or limited human experience) is not detailed, nor is the number of units tested.
- Sample Size: Not specified.
- Data Provenance: Not specified, but implied to be laboratory/bench testing and potentially pre-clinical (animal) evaluation based on the industry standards cited. There is no mention of human clinical trial data or retrospective/prospective study design in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. The document describes laboratory/bench testing against established standards and comparison to predicate devices, not an expert panel adjudicating clinical outcomes or images to establish ground truth for a diagnostic device.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of an adjudication method as would be used in a clinical study involving human assessment.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices assessing human reader performance, which is not relevant to a vascular graft.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This is a physical medical device (vascular graft), not an algorithm or software requiring performance evaluation in a standalone mode.
7. The Type of Ground Truth Used:
The "ground truth" in this context refers to the established performance characteristics and safety profiles of the predicate devices and compliance with recognized industry standards. This is not a "ground truth" derived from expert consensus, pathology, or outcomes data in the usual sense of a diagnostic or therapeutic clinical trial. It's about demonstrating physical and functional equivalence.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device. There is no "training set" as would be used for machine learning algorithms.
9. How the Ground Truth for the Training Set was Established:
Not applicable (see point 8).
§ 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.”