(78 days)
The Edwards Lifespan ePTFE Vascular Grafts are indicated for use as a vascular prosthesis only. The grafts are intended for bypass or reconstruction of diseased or occluded blood vessels, or for arteriovenous shunts for blood access.
The subject devices are vascular grafts consisting of a base tube of expanded PTFE that is wrapped with PTFE tape for better strength. Externally supported grafts have a monofilament of PTFE wrapped over the tape for added crush and kink resistance. The stepped grafts have a 4 mm diameter end with a step up to the 7 mm diameter end. All models of the graft have a printed black orientation line consisting of "Edwards Lifesciences" printed repeatedly along the length of the qraft.
Here's an analysis of the provided text regarding the Edwards Lifespan Reinforced Expanded PTFE Vascular Graft.
Crucially, the provided text describes a traditional medical device (a vascular graft), not a software-based AI/ML device. Therefore, many of the questions related to AI/ML device performance (like "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "training set size") are not applicable to this type of submission.
The summary focuses on preclinical (in vitro) and biocompatibility testing for a physical product, demonstrating equivalence to predicate devices for regulatory clearance.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Burst Pressure | Met acceptance criteria |
| Suture Retention | Met acceptance criteria | |
| Internodal Distance | Met acceptance criteria | |
| Water Entry Pressure | Met acceptance criteria | |
| Labeling/Legibility | Printing legibility | Met acceptance criteria |
| (at printing, after sterilization, after aging) | ||
| Biocompatibility | Biocompatibility evaluations | Met acceptance criteria |
1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this type of device. The testing performed was in vitro performance testing and biocompatibility evaluations of physical material properties, not an AI/ML model evaluated against a clinical dataset. The sample sizes for these specific engineering tests are not provided in this summary but would be standardized for such material characterization.
2. 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. "Ground truth" in the AI/ML sense (e.g., expert labels on images) is not relevant for in vitro mechanical and biocompatibility testing of a physical graft. Performance is determined by established engineering and biological standards.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used for resolving disagreements in expert labeling of data, which is not part of this device's testing.
4. 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 device is a physical vascular graft, not an AI/ML system designed to assist human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the in vitro performance tests (burst pressure, suture retention, etc.), the "ground truth" is defined by established engineering standards and specifications for vascular grafts.
- For biocompatibility, the "ground truth" is defined by regulatory standards and guidelines for biological response to materials.
7. The sample size for the training set
- Not applicable. This is a physical product, not an AI/ML model that requires a training set.
8. How the ground truth for the training set was established
- Not applicable. See point 7.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study conducted was a non-clinical performance and biocompatibility evaluation.
- Non-Clinical Tests: In vitro performance testing included:
- Burst pressure
- Suture retention
- Internodal distance
- Water entry pressure
- Legibility of printed markings (at printing, after sterilization, and after aging)
- Biocompatibility Evaluations: These tests assess the biological response to the device material.
- Conclusion: "All testing demonstrated that the subject device met its acceptance criteria."
- Clinical Tests: "No clinical tests specific to the subject device have been conducted." The submission relies on substantial equivalence regarding risks and benefits to predicate devices.
The information primarily focuses on demonstrating that the physical properties of the Edwards Lifespan Reinforced Expanded PTFE Vascular Graft meet the required mechanical and biological standards relevant for its intended use and are comparable to its 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.”