(104 days)
GORE PROPATEN VASCULAR GRAFT is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.
The GORE PROPATEN Vascular Graft is constructed from the same materials used in the predicate devices: the GORE-TEX Vascular Graft, the GORE-TEX Stretch Vascular Graft, and the FEP Ringed GORE-TEX Stretch Vascular Graft with Removable Rings, which have a successful history of clinical use and were cleared for use in the United States through the Premarket notifications K830806, K903931 and K933943.
The GORE PROPATEN Vascular Graft is a biocompatible device comprised of expanded polytetrafluoroethylene (ePTFE) with covalently bound, luminal, bioactive heparin. The heparin used in creating this device has been derivatized by a proprietary process established by Carmeda AB, Stockholm, Sweden. The heparinization process is based upon the Carmeda Bioactive Surface (CBASTM) technology. Heparin activity is retained in a binding process that does not interfere with the heparin active site.
The provided document is a 510(k) summary for the GORE PROPATEN Vascular Graft, not a study report. It states that the device has been tested to meet applicable sections of AAMI/ANSI/ISO 7198:1998/2001(R) 2004, which is a performance standard for cardiovascular implants, specifically vascular prostheses. However, the document does not contain the acceptance criteria or reported device performance in a table format, nor does it describe a specific study proving the device meets those criteria.
Therefore, I cannot extract the information required for your request. The document focuses on demonstrating substantial equivalence to predicate devices based on material composition and intended use, rather than detailing a specific performance study with acceptance criteria and results.
To directly answer your numbered points based on the absence of this information in the provided text:
- A table of acceptance criteria and the reported device performance: Not provided in the document. The document states only that "The GORE PROPATEN VASCULAR GRAFT has been tested, or rationale has been provided, to meet all applicable sections of Cardiovascular Implants-Vascular Prostheses AAMI / ANSI / ISO 7198:1998/2001(R) 2004." The specific criteria and results are not detailed.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving expert-established ground truth.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This document does not describe a study involving adjudication.
- 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 graft), not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the document. The document refers to meeting a performance standard but does not detail how compliance was verified beyond general "testing or rationale."
- The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.
- 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.”