(72 days)
Vascutek Cardiovascular Fabric is indicated for vascular patch grafting and for intracardiac patching. The Thin Wall Carotid Patch is, in addition, indicated for patch closure after endarterectomy, particularly of the carotid arteries.
The Vascutek Cardiovascular Fabric product line consists of a non-crimped Gelseal™ patch, Gelsoft™ patch, and a Thin Wall Carotid patch. Each patch product line is gelatin-sealed, knitted polyester, with a base fabric porosity of 1460 ml/min/cm2, 2118 ml/min/cm2 and 3515 ml/min/cm² respectively, and are available in various square or rectangular sizes. The polyester fabrics have been impregnated with an absorbable mammalian gelatin which seals the prostheses in the same manner as the fibrin deposited in traditional preclotting procedures. The gelatin sealant obviates the need for preclotting prior to implantation. The gelatin is of United States Pharmacopeia (USP) standard and is derived from bovine bone.
Here's an analysis of the provided text regarding the Vascutek Cardiovascular Fabric, focusing on acceptance criteria and study details.
Based solely on the provided text, it's clear that this document describes a traditional medical device submission (likely a 510(k)) and not an AI/ML powered device. Therefore, many of the requested fields related to AI/ML specific studies (like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance) are not applicable to this product.
The acceptance criteria here are for mechanical and material performance, and the "study" is a comparison to a predicate device through in-vitro and previously accepted in-vivo testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Metric | Acceptance Criterion (Implicit) | Reported Device Performance (Vascutek) | Related Predicate Device Performance (Meadox Hemashield® Microvel® Double Velour Fabric) |
|---|---|---|---|---|
| Mechanical Performance | Burst Strength | Substantially equivalent to predicate | Performance demonstrated to be substantially equivalent to predicate | N/A (implicit standard) |
| Suture Retention | Substantially equivalent to predicate | Performance demonstrated to be substantially equivalent to predicate | N/A (implicit standard) | |
| Tensile Strength | Substantially equivalent to predicate | Performance demonstrated to be substantially equivalent to predicate | N/A (implicit standard) | |
| Material/Porousity | Water Porosity (Gelseal™) | 1460 ml/min/cm² (knitted polyester base fabric porosity) | 1460 ml/min/cm² (base fabric porosity) | N/A (specific to product design) |
| Water Porosity (Gelsoft™) | 2118 ml/min/cm² (knitted polyester base fabric porosity) | 2118 ml/min/cm² (base fabric porosity) | N/A (specific to product design) | |
| Water Porosity (Thin Wall Carotid) | 3515 ml/min/cm² (knitted polyester base fabric porosity) | 3515 ml/min/cm² (base fabric porosity) | N/A (specific to product design) | |
| Biocompatibility | Safety and Effectiveness of Gelatin | Gelatin is of United States Pharmacopeia (USP) standard and derived from bovine bone. Proven safe/effective via PMA# P890045. | USP standard bovine bone derived gelatin. Proven safe/effective via PMA# P890045. | N/A (established via prior approval of component) |
| Sterilization | Method | Ethylene Oxide | Ethylene Oxide | N/A (standard method) |
| Shelf-Life | Duration | Established shelf-life of 4 years. | 4 years established. | N/A (device-specific) |
| In-Vivo Performance | Acceptable performance | Acceptable in-vivo performance for gelatin-sealed polyester material. | Demonstrated acceptable in-vivo performance through previously accepted animal testing. | N/A (established via prior testing of component) |
Notes on Acceptance Criteria:
- The primary acceptance criterion is "substantial equivalence" to the predicate device for in-vitro performance (burst strength, suture retention, tensile strength, water porosity). This means performance must be comparable to, and not worse than, the predicate for safety and effectiveness.
- For material composition and established components (like the gelatin sealant), the criterion is often meeting recognized standards (USP) or prior regulatory approval (PMA).
Study Information (as it pertains to this non-AI/ML device):
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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)
- Test Set Sample Size: Not specified in terms of number of physical units tested beyond "Comprehensive in-vitro performance testing" and "previously accepted animal testing." Testing would typically involve multiple samples per test (e.g., n=5 or n=10 per test for burst strength).
- Data Provenance:
- Country of Origin: Not specified for the in-vitro performance tests. The company location is Austin, Texas, USA.
- Retrospective or Prospective: The in-vitro testing would be prospective (conducted specifically for this submission). The "previously accepted animal testing" is retrospective in relation to this submission but was prospective during its original conduct.
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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 is a physical medical device. "Ground truth" is established by direct physical measurements according to validated test methods and comparison to a predicate device, not by expert interpretation of data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for subjective interpretations, often in image analysis. Here, performance is measured objectively.
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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 not an AI/ML device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For in-vitro performance: The "ground truth" is established by the objective, quantitative measurements obtained from validated mechanical and material tests (e.g., direct measurement of burst pressure, tensile strength, water porosity). The comparator "ground truth" is the performance of the predicate device.
- For biocompatibility/safety of gelatin: The "ground truth" is previous regulatory approval (PMA# P890045) and adherence to established standards (USP).
- For in-vivo performance: The "ground truth" was derived from animal testing outcomes, which were previously deemed acceptable.
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The sample size for the training set
- Not Applicable. This is not an AI/ML device.
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How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device.
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).