(670 days)
InterGard Collagen Coated and Heparin Bonded vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.
The InterGard Knitted Collagen Coated & Heparin Bonded Vascular Prostheses including The InterGard Knitted Ultra-Thin, are Vascular Grafts made of Dacron fabric and coated with bovine collagen. These products are offered in numerous lengths and diameters exceeding 6 mm.
The provided text is a 510(k) summary for the InterGard Knitted Collagen Coated & Heparin Bonded Vascular Prosthesis. It does not describe an AI medical device or a study proving its performance against acceptance criteria in the way requested.
Instead, the document details a medical device (vascular prostheses/grafts) and aims to demonstrate its substantial equivalence to previously marketed predicate devices. The "study" mentioned refers to bench and animal studies to validate specifications and published clinical data, which are typically part of a traditional medical device clearance process, not an AI performance study measuring metrics like sensitivity, specificity, or AUC.
Therefore, I cannot provide the requested information in the format of AI acceptance criteria and study details because the document refers to a non-AI medical device and a different type of regulatory submission.
Here's a breakdown of what the document does describe, aligning with the general themes of your request but not specific to AI:
- Device Type: InterGard Knitted Collagen Coated & Heparin Bonded Vascular Prostheses.
- Purpose: Surgical repair, bypass, or replacement of arteries for aneurysmal and occlusive disease.
- Regulatory Pathway: 510(k) submission, confirming substantial equivalence to predicate devices (InterGard Knitted Collagen Coated Vascular Prostheses and InterGard Knitted Ultra-Thin Collagen Coated Vascular Prostheses).
- Performance Claim (Substantial Equivalence): The device has similar technological characteristics (underlying fabric, collagen coating material) and meets the same strength (circumferential probe burst and radial strength), collagen adherence, and water permeability specifications as the predicate devices.
- Validation: These results were validated by bench and animal studies and further supported by published clinical data.
To directly answer your specific questions in the context of the provided document (even though it's not applicable to AI):
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Table of acceptance criteria and the reported device performance:
- Acceptance Criteria (from document): Same strength (circumferential probe burst and radial strength), collagen adherence, and water permeability specifications as the predicate devices.
- Reported Device Performance (from document): "[The products] meet the same strength (circumferential probe burst and radial strength), collagen adherence, and water permeability specifications as the predicate devices."
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Sample sized used for the test set and the data provenance: Not specified in the provided summary for bench/animal/clinical studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. The performance is based on physical/material properties compared to predicate devices.
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Adjudication method: Not applicable/specified.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is a traditional medical device, not an AI-assisted diagnostic tool.
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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: For the device's technical characteristics, the "ground truth" would be established physical and material property standards and performance benchmarks set by the predicate devices, likely through laboratory testing. For "clinical data," it would refer to patient outcomes from previous studies.
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The sample size for the training set: Not applicable to this type of device and submission.
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How the ground truth for the training set was established: Not applicable to this type of device and submission.
§ 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.”