(89 days)
The Twillweave™ Vascular Graft is indicated for repair or replacement of damaged and diseased vessels of the arterial system in cases of aneurysmal or occlusive disease.
The Twillweave™ vascular graft is a woven polyester graft, with a porosity of 350 ml/min/cm² which is available in a straight tube and bifurcated configurations.
This document is a 510(k) summary for a medical device called the "VASCUTEK TWILLWEAVE™ VASCULAR GRAFT." It describes the device and claims substantial equivalence to a predicate device. However, this document does not contain the type of AI/ML performance evaluation information requested in your prompt (acceptance criteria, study details, ground truth, expert involvement, etc.).
The provided text discusses:
- Device Description: Woven polyester graft for repair/replacement of damaged arterial vessels.
- Materials: Polyester, history of use in medical applications, tested for biocompatibility.
- Sterilization: Ethylene Oxide.
- Shelf-life: 5 years.
- Substantial Equivalence Claim: To the Vascutek Gelweave™ vascular graft.
- Performance Testing Mentioned:
- In-vitro performance testing: Burst strength, suture retention, tensile strength, base graft (water) porosity. This testing was performed side-by-side with the predicate device to show equivalence.
- Animal testing: Demonstrated acceptable in-vivo performance.
- Predicate Device: Vascutek Gelweave™ vascular graft (K952293).
Therefore, I cannot fulfill your request for: "A table of acceptance criteria and the reported device performance, Sample sized used for the test set, Number of experts used, Adjudication method, MRMC study, Standalone performance, Type of ground truth, Sample size for the training set, How the ground truth for the training set was established."
This document describes a traditional medical device (vascular graft) and its regulatory submission, not an AI/ML-driven device with the associated performance study criteria you've outlined.
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1300 East Anderson Lane, Austin, Texas 78752-1793 ♥ 512 435 3200 ♥ 512 435 3350 FAX
ત્ત્વપૂર્વ વિદ્યા
510(k) SUMMARY VASCUTEK TWILLWEAVE™ VASCULAR GRAFT
MAR 1 0 1997
The Twillweave™ vascular graft is a woven polyester graft, with a porosity of 350 ml/min/cm² which is available in a straight tube and bifurcated configurations. The Twillweave™ Vascular Graft is indicated for repair or replacement of damaged and diseased vessels of the arterial system in cases of aneurysmal or occlusive disease.
The Twillweave™ vascular graft is manufactured from materials that have an extensive history of use in cardiovascular and other medical applications. This polyester material has been thoroughly tested and characterized with regard to biocompatibility and suitability for its intended use. The Twillweave™ vascular graft is supplied sterile and must be preclotted prior to use. The method of sterilization used is Ethylene Oxide. A shelf-life of 5 years has been established for the Vascutek Twillweave™ vascular graft.
CarboMedics considers the Vascutek Twillweave™ vascular graft to be substantially equivalent to the Vascutek Gelweave™ vascular graft in intended use, base material (polyester), and function. Side-by-side in-vitro performance testing has been performed on the Vascutek Twillweave™ straight and bifurcated vascular grafts and the predicate device. Invitro performance testing performed on the Twillweave™ including burst strength, suture retention, tensile strength and base graft (water) provides evidence that the Twillweave™ vascular graft is substantially equivalent to the Vascutek Gelweave™ vascular graft. Animal testing has demonstrated acceptable in-vivo performance for the Twillweave™ graft's intended purpose.
CarboMedics considers the Vascutek Twillweave™ vascular graft safe, effective, and substantially equivalent in intended use, base material (polyester), and function to the Vascutek Gelweave™ vascular graft which received marketing clearance on December 19, 1995 510(k) via K952293.
| Common name of the device: | Prosthesis, Vascular Graft |
|---|---|
| Trade or Proprietary name: | Vascutek Twillweave™ vascular graft |
| Submitter and Contact name: | Teena M. Augostino, Manager, Regulatory Affairs1300 E. Anderson Lane, Austin, TX 78752Phone: (512) 435-3225Fax: (512) 435-3350 |
Submission Prepared/Submitted on: December 10, 1996.
CarboMedics Prosthetic Heart Valve - Celebrating a Decade of Clinical Performance
§ 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.”