(88 days)
Sulzer Vascutek SEALPTFE™ grafts are intended for the creation of subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of occluded or diseased arterial blood vessels. Typical applications for standard wall grafts include systemic vascular repair, primarily for axillo-femoral/bifemoral bypass and femoral-popliteal reconstruction. Typical applications for thin wall grafts include systemic vascular repair, but not for axillo-femoral/bifemoral bypass reconstruction.
The Sulzer Vascutek SEALPTFE™ gelatin-sealed expanded polytetrafluoroethylene (PTFE) graft line is composed of PTFE, which has been fabricated in tubular form and expanded to impart porosity to the structure. The PTFE material has been impregnated with an absorbable mammalian gelatin that is intended to reduce intraoperative suture hole bleeding. The gelatin is of USP standard and is derived from bovine bone sourced exclusively in the United States. The gelatin used in the impregnation process is a non-antigenic and non-toxic protein. It has been crosslinked to control its dissolution rate. The gelatin hydrolyzes within approximately 14 days. The gelatin is identical to that used with Sulzer Vascutek's gelatin-sealed knitted and woven polyester grafts and knitted cardiovascular fabric.
This document is a 510(k) Summary for a medical device (Sulzer Vascutek SEALPTFE™ Vascular Prosthesis) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria, device performance against those criteria, or a detailed study design that would fit the requested format for AI/ML device studies. Instead, it describes in vitro and animal testing to show equivalence to existing devices.
Therefore, most of the requested information cannot be directly extracted or inferred from the provided text. I will address the points that can be, and explicitly state when the information is not available.
Description of the acceptance criteria and the study that proves the device meets the acceptance criteria:
The provided document describes the Sulzer Vascutek SEALPTFE™ Vascular Prosthesis and asserts its substantial equivalence to commercially distributed Impra grafts. The "acceptance criteria" in this context are not quantitative performance metrics as expected for AI/ML device studies, but rather demonstration of similar properties and safety to legally marketed predicate devices.
The study proving the device meets these "acceptance criteria" (i.e., substantial equivalence) involved:
- In vitro testing: Comparing the Sulzer Vascutek SEALPTFE™ graft line to Impra commercial grafts.
- Animal studies: Demonstrating the equivalence of Sulzer Vascutek standard wall grafts to Impra standard wall grafts.
- Biomaterial testing: Confirming that the Sulzer Vascutek SEALPTFE™ grafts are biocompatible and non-toxic.
The document concludes that "all testing demonstrates that the Sulzer Vascutek SEALPTFE™ graft line to be substantially equivalent to the grafts in commercial distribution by Impra, Division of C.R. Bard for the reconstruction and bypass of diseased or occluded systemic blood vessels and construction of subcutaneous a-v conduits for blood access."
1. A table of acceptance criteria and the reported device performance
As mentioned, quantitative acceptance criteria and performance metrics for an AI/ML device are not present in this document. The "performance" is substantial equivalence based on the types of tests listed above.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Implied) |
|---|---|
| Substantial equivalence to Impra commercial grafts | Demonstrated in vitro testing results. |
| Equivalence to Impra standard wall grafts | Demonstrated in animal studies for standard wall grafts. |
| Biocompatibility and non-toxicity | Demonstrated through biomaterial testing. |
| Mechanical properties (strength, suture retention, handling) | Substantially equivalent to products currently in commercial distribution (Impra). |
| Reduction of intraoperative suture hole bleeding | Intended function of the gelatin impregnation, which hydrolyzes within approx. 14 days. |
The following information is not available in the provided document:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for the in vitro or animal studies.
- Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned.
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)
- This information is not applicable and not present, as the "ground truth" here refers to physical and biological properties of the graft materials, evaluated through laboratory and animal testing, not expert interpretation of diagnostic data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable; this method is typically used for expert consensus in diagnostic imaging or clinical trials, not for material property 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
- Not applicable. This is a medical device (vascular prosthesis), not an AI/ML diagnostic or assistive tool.
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 (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context would be objective measurements of material properties (e.g., tensile strength, porosity, suture retention), results from standardized biocompatibility tests, and observations from animal implantation studies. Specific details are not provided beyond the general categories of "in vitro testing", "animal studies", and "biomaterial testing."
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.”