(279 days)
The Sulzer Vascutek® Gelweave Valsalva™ Vascular Prosthesis is indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation.
The Sulzer Vascutek Gelweave Valsalva™ Vascular Graft is a gelatin-sealed, woven polyester graft. The woven polyester material has been impregnated with an absorbable mammalian gelatin which seals the prosthesis in the same manner as the fibrin deposited in traditional preclotting procedures. The gelatin sealant obviates the need for preclotting prior to implantation. This gelatin has been shown to be safe and effective through PMA #P890045 on January 11, 1993.
The provided document, K013022, pertains to a 510(k) premarket notification for a medical device: Sulzer Vascutek® Gelweave Valsalva™ Vascular Prosthesis. This document describes substantial equivalence to a predicate device, not, a study against specific acceptance criteria for performance metrics that would typically apply to software or AI-based devices.
Therefore, many of the requested categories (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable to this type of device submission.
However, I can extract the information related to device testing and comparison to a predicate device, which serves a similar purpose in the context of a 510(k) submission for a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are implied by the performance of the predicate device (Sulzer Vascutek Gelweave™ Vascular Prosthesis: K952293) and the results of the in-vitro testing demonstrating substantial equivalence. The document doesn't list explicit numerical acceptance criteria for each test but rather states that the new device demonstrated substantial equivalence.
| Test Performed | Implied Acceptance Criteria (via predicate) | Reported Device Performance (Gelweave Valsalva™) |
|---|---|---|
| Base Graft Water Porosity | Equivalent to predicate | Demonstrated substantial equivalence to the Gelweave™ graft predicate device. |
| Blood Porosity | Equivalent to predicate | Demonstrated substantial equivalence to the Gelweave™ graft predicate device. |
| Burst Strength | Equivalent to predicate | Demonstrated substantial equivalence to the Gelweave™ graft predicate device. |
| Tensile Strength | Equivalent to predicate | Demonstrated substantial equivalence to the Gelweave™ graft predicate device. |
| Suture Retention | Equivalent to predicate | Demonstrated substantial equivalence to the Gelweave™ graft predicate device. |
| Hydrodynamic Testing | Equivalent to predicate | Demonstrated substantial equivalence to the Gelweave™ graft predicate device. |
| Flow Visualization | Reference made | Referenced, implies satisfactory performance. |
| Biocompatibility | Reference made | Referenced, implies satisfactory performance and safety. |
| Animal Testing | Reference made | Referenced, implies satisfactory performance and safety. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the publicly available 510(k) summary. For in-vitro testing of medical devices like vascular grafts, the sample size would typically be determined by statistical methods for materials testing, but the summary does not detail these.
- Data Provenance: The document implies the data was generated through in vitro testing performed by Sulzer Carbomedics Inc. and possibly by reference to prior animal testing and biocompatibility studies for the Gelweave™ series. The country of origin for the data is implicitly the USA (Austin, Texas) where the submitter is located. The testing is essentially prospective in the sense that it was conducted specifically to support this 510(k) submission to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a physical medical device. "Ground truth" in the context of expert consensus, pathology, or outcomes data typically refers to diagnostic or prognostic accuracy for imaging or AI devices. For this device, performance is established through physical properties testing, biocompatibility, and animal studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for subjective assessments or disagreements in data labeling/ground truth establishment, which isn't relevant for the objective measurements of physical properties of a vascular graft.
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 not an AI or imaging device involving human readers or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is based on objective measurements of physical properties (e.g., water porosity, burst strength) and biological evaluations (biocompatibility, animal testing) against established standards and the performance of a legally marketed predicate device.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established:
- Not applicable. This is not a machine learning or AI device.
§ 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.”