(295 days)
Sulzer Vascutek Gelsoft™ Vascular Prosthesis is indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries.
The Sulzer Vascutek Gelsoft™ Vascular Prosthesis is a gelatin-sealed, woven polyester graft with a base graft porosity of 2118 ml/cm³/min. The knitted polyester material has been impregnated with an absorbable mammalian gelatin that seals the prosthesis in the same manner as the fibrin deposited in traditional procedures. The gelatin sealant obviates the need for preclotting prior to implantation. The gelatin is of USP standard and is derived from bovine bone sourced exclusively in the United States. The result is a vascular prosthesis that does not require preclotting even when patients have been anticoagulated or when bleeding is a prime concern.
The Sulzer Vascutek Gelsoft™ Vascular Prosthesis is a gelatin-sealed, woven polyester graft. It is indicated for abdominal and peripheral vascular repair, specifically for replacement or bypass in aneurysmal and occlusive disease of arteries.
Here's an analysis of the provided text regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Metric | Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|---|---|
| In Vitro Performance | Burst Strength | Not explicitly stated, implied to be comparable to predicates | Acceptable structural characteristics, comparable to predicate devices (Meadox Hemashield Vantage, Meadox Hemashield Microvel Double Velour Knitted, Impra ePTFE) | Side-by-side in vitro testing performed. |
| Suture Retention | Not explicitly stated, implied to be comparable to predicates | Acceptable structural characteristics, comparable to predicate devices | Side-by-side in vitro testing performed. | |
| Tensile Strength | Not explicitly stated, implied to be comparable to predicates | Acceptable structural characteristics, comparable to predicate devices | Side-by-side in vitro testing performed. | |
| Nominal Wall Thickness | Not explicitly stated, implied to be comparable to predicates | Acceptable structural characteristics, comparable to predicate devices | Side-by-side in vitro testing performed. | |
| Clinical Performance | Graft Patency | Non-inferiority to predicate (Impra ePTFE) | No difference in graft patency between Gelsoft™ and Impra ePTFE grafts | Clinical trial performed. |
| Biocompatibility | General Biocompatibility | Established for intended use | Thoroughly tested and characterized; materials have extensive history of use in medical applications. | Gelatin sealant previously approved (PMA P890045, P890045/SI). |
| Sterilization | Sterilization Method | Ethylene Oxide compatibility | Device supplied with Ethylene Oxide sterilization. | Standard method. |
| Shelf-Life | Device Shelf-Life | 5 years | A shelf-life of 5 years has been established. | Clear numerical criterion and performance. |
| Preclotting Requirement | Need for Preclotting | Not required | Does not require preclotting even when patients have been anticoagulated or when bleeding is a prime concern. | Key design feature and performance claim. |
2. Sample Size Used for the Test Set and the Data Provenance:
- In Vitro Testing: The text does not specify the sample size for the in vitro tests (burst strength, suture retention, tensile strength, nominal wall thickness).
- Clinical Trial: The text mentions a "prospective randomized clinical trial" but does not specify the sample size (number of patients or grafts) used for this trial.
- Data Provenance:
- In Vitro Testing: Performed using the Sulzer Vascutek Gelsoft™ graft and predicate devices. No specific geographic origin of the data is mentioned, but typically such testing would occur at the manufacturer's facility or an accredited lab.
- Clinical Trial: Described as a "prospective randomized clinical trial." The country of origin for the clinical trial is not explicitly stated. Given the submission to the FDA, it's plausible it involved US sites or was a multi-center international trial where data was compiled for US submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- For the Clinical Trial: The text states, "The investigators concluded that there was no difference in graft patency between the two grafts." "Investigators" typically refers to medical professionals (e.g., surgeons, vascular specialists) involved in the trial. However, the exact number of experts, their specific qualifications (e.g., years of experience, subspecialty), and how they established the "ground truth" (e.g., patency assessment method) are not specified in this document.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
- The document does not specify any adjudication method for either the in vitro testing or the clinical trial. For clinical trials, blinding, independent core labs, or expert committees are often used for outcome adjudication, but this information is not present.
5. 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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human interpretation of images or data is involved. This document describes a vascular prosthesis, which is a physical medical device, not a diagnostic AI tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. As mentioned above, this is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- For In Vitro Testing: The "ground truth" for these engineering properties (burst strength, suture retention, tensile strength, nominal wall thickness) would be the objective measurements obtained through standardized laboratory testing methods, likely guided by international or national standards for medical devices or vascular grafts.
- For the Clinical Trial: The "ground truth" for graft patency (the primary outcome) would be based on outcomes data from the patients in the trial, likely assessed through objective diagnostic methods such as ultrasound, angiography, or clinical examination over time. The "investigators" would have collectively determined this outcome.
8. The Sample Size for the Training Set:
- This device is not an AI algorithm, so there is no "training set" in the context of machine learning. The term "training set" is not applicable here. The device's design and manufacturing are based on established engineering principles and prior material knowledge, not a data-driven training process.
9. How the Ground Truth for the Training Set Was Established:
- As there is no "training set," this question is not applicable.
§ 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.”