(64 days)
The Vascusoft™ Plus Vascular Graft is indicated for systemic vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries. Coronary vascular repair and blood access fistula (e.g. hemodialysis) are contraindicated with this device.
The Vascusoft™ Plus Vascular Graft is a warp knitted polyester prosthesis with a porosity of 2591 ml/min/cm² which is available in a straight tube and bifurcated configurations.
This document is a 510(k) summary for a medical device (VASCUTEK VASCUSOFT™ PLUS VASCULAR GRAFT), not a study report describing the acceptance criteria and performance of an AI/ML powered device. Due to this, the questions you've asked about AI/ML device performance, such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details, are not applicable here.
However, I can extract the non-AI-specific acceptance criteria and general performance claims from the provided text as best as possible, interpreting your request in the context of this document.
Acceptance Criteria and Reported Device Performance (Non-AI Context)
| Acceptance Criteria Category | Specific Criteria/Tests | Device Performance (Vascusoft™ Plus) | Comparison Device (Vascusoft™) |
|---|---|---|---|
| Material Equivalence | Material composition | Polyester | Polyester |
| Intended Use Equivalence | Indication for use | Systemic vascular repair, replacement/bypass for aneurysmal and occlusive disease of arteries. | Systemic vascular repair, replacement/bypass for aneurysmal and occlusive disease of arteries. |
| Function Equivalence | General function (graft performance) | Safe & Effective | Safe & Effective |
| Physical Properties | Porosity | 2591 ml/min/cm² | Not explicitly stated for Vascusoft™ in document |
| In-vitro Performance | Burst Strength | Performed acceptably | Performed acceptably |
| Suture Retention | Performed acceptably | Performed acceptably | |
| Tensile Strength | Performed acceptably | Performed acceptably | |
| Water Permeability | Performed acceptably | Performed acceptably | |
| Resistance to Dilatation | Enhanced resistance (in-vitro studies) | Implied to be less resistant than 'Plus' version | |
| Biocompatibility | Biocompatibility | Thoroughly tested & characterized, suitable for intended use. | Thoroughly tested & characterized, suitable for intended use. |
| Sterilization | Method of Sterilization | Ethylene Oxide | Not explicitly stated for Vascusoft™ in document |
| Shelf-life | Shelf-life | 5 years | Not explicitly stated for Vascusoft™ in document |
| In-vivo Performance | Animal Evaluations | Acceptable for intended purpose. | Not explicitly stated for Vascusoft™ in document |
Responses to Specific Questions in the Context of this Document:
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A table of acceptance criteria and the reported device performance: See the table above. The "acceptance criteria" here are interpreted as the aspects that needed to be demonstrated for substantial equivalence or safety/effectiveness. The "reported device performance" reflects what the document states about the Vascusoft™ Plus.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for any of the in-vitro or animal tests. The document only states "Comprehensive performance testing has been performed" and "Animal testing has demonstrated acceptable in-vivo performance."
- Data Provenance: Not specified. It's a regulatory submission, so likely company-sponsored internal testing, but the country of origin or whether it's retrospective/prospective isn't mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. This document describes physical and biological testing of a vascular graft, not expert review of AI output.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is for AI model output adjudication, not physical device testing.
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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 traditional medical device, not an AI-powered one.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the physical and biological testing, the "ground truth" would be established by standardized measurement methods (e.g., using calibrated equipment for burst strength, standardized assays for biocompatibility) and observable biological responses in animal models. It's not a "ground truth" in the AI sense.
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The sample size for the training set: Not applicable. This device does not have a "training set."
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How the ground truth for the training set was established: Not applicable.
In summary, this document is a regulatory submission for a non-AI medical device. The concepts of acceptance criteria for AI performance, expert adjudication, training/test sets, and ground truth for AI models are not relevant to its content.
§ 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.”