(97 days)
The DIASTAT® VASCULAR ACCESS GRAFT, intended for use as a vascular prosthesis in patients requiring vascular access, and which may be cannulated within one week of implantation
The DIASTAT Vascular Access Graft is essentially an expanded PTFE vascular graft with the addition of one or more externally applied cannulation seqments comprised of expanded PTFE fibers and an expanded PTFE covering. The graft is provided with or without external reinforcement in the form of FEP rings which may be fixed or removable, and in either extensible or non-stretch configurations.
The provided text does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of AI/ML or diagnostic performance. Instead, it describes a traditional medical device (vascular graft) and aims to establish substantial equivalence to predicate devices, focusing on mechanical and in vivo performance rather than diagnostic accuracy.
Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, device performance, ground truth, expert involvement, or AI study details because this information is not present in the provided submission.
Here's a breakdown of why the specific questions cannot be answered based on the provided text:
- Acceptance Criteria and Reported Device Performance (Table): The text mentions "reduced fluid leakage," "reduced times to hemostasis," "reduced blood loss in vivo," and "reduced incidence of hematoma" as performance characteristics. However, it does not provide specific quantitative acceptance criteria (e.g., "fluid leakage less than X mL/min") or quantitative reported device performance values against which such criteria would be measured. It only states that these characteristics were demonstrated or observed.
- Sample size for the test set and data provenance: No information on a "test set" in the context of diagnostic or AI performance. The studies mentioned are bench, animal, and "clinical setting observation." No sample sizes for these are given, nor is country of origin.
- Number of experts and qualifications: No experts are mentioned in the context of establishing ground truth for a test set.
- Adjudication method: Not applicable as there is no mention of a diagnostic test set requiring adjudication.
- MRMC comparative effectiveness study: No mention of human readers, AI assistance, or an MRMC study.
- Standalone study: No mention of an "algorithm only" performance study.
- Type of ground truth used: For the vascular graft, "ground truth" would relate to physiological outcomes (e.g., actual patency rates, infection rates) or observed mechanical performance. The text mentions "bench testing," "animal testing," and "clinical setting observation."
- Sample size for the training set: Not applicable as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
The document focuses on establishing substantial equivalence for a physical medical device (vascular graft) through comparisons of technological characteristics, bench testing, and animal studies, not AI/ML 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.”