(254 days)
For use in systemic vascular reconstructions, e.g., replacement in the case of aneurysmal or occlusive disease, in the peripheral region.
The HEMASHIELD VANTAGE™ Vascular Graft is a woven polyester graft, impregnated with bovine collagen.
The provided text describes a medical device, the HEMASHIELD VANTAGE™ Vascular Graft, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML or diagnostic device.
The document details product testing for physical and material properties of the graft (e.g., Burst Strength, Tensile Strength, Integral Water Permeability) to demonstrate equivalence to predicate devices. It also mentions biocompatibility testing. However, these are engineering and material science tests, not performance studies for an AI/ML diagnostic system or a study with a test set, ground truth, or expert readers.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them, as the provided text pertains to a different type of medical device assessment.
Here's a breakdown of why the requested information cannot be extracted from the given text:
- No AI/ML or Diagnostic Device: The HEMASHIELD VANTAGE™ Vascular Graft is a physical vascular graft for surgical replacement, not a diagnostic tool or an AI/ML system.
- No Acceptance Criteria for Diagnostic Performance: The "acceptance criteria" discussed in the text are implicitly related to the physical and chemical properties of the graft meeting established standards for similar devices, not to diagnostic performance metrics like sensitivity, specificity, or AUC.
- No "Study" in the Requested Sense: The "testing" mentioned (Burst Strength, Tensile Strength, etc.) are laboratory characterizations of a physical product, not clinical or reader studies involving patient data, ground truth, or human expert interpretation.
- No Test Set, Ground Truth, or Expert Readers: These concepts are entirely absent because the device is not a diagnostic or AI system.
- No MRMC or Standalone Performance: These are metrics specific to AI/ML diagnostic device evaluation.
- No Training Set: As it's a physical product, there's no training set in the context of machine learning.
§ 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.”