(90 days)
Standard Wall EXXCEL™ Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (iliac, femoral, popliteal, infrageniculate vessels, axillary, renal) and to provide vascular access. Thin Wall Exxcel™ Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (iliac, femoral, popliteal, infrageniculate vessels, axillary, renal).
EXXCEL™ Soft ePTFE Vascular Grafts are synthetic vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE). EXXCEL™ Soft ePTFE Vascular Grafts feature a GUIDELINE® stripe to facilitate proper graft alignment.
The provided text describes a 510(k) summary for the MAQUET GETINGE GROUP's EXXCEL™ Soft ePTFE Vascular Grafts. As such, the study described is a non-clinical study focused on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating the performance of an AI/ML device. Therefore, many of the requested categories related to AI/ML device evaluation (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable.
Here's the information extracted and formatted according to your request, with a clear indication of non-applicability for categories that don't fit this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria (Implicit: Substantial Equivalence to Predicate Device) | Reported Device Performance |
|---|---|---|
| Kink Diameter | Met specified acceptance criteria | Results met specified acceptance criteria and were substantially equivalent to predicate device. |
| Longitudinal Tensile Strength | Met specified acceptance criteria | Results met specified acceptance criteria and were substantially equivalent to predicate device. |
| Wall Thickness | Met specified acceptance criteria | Results met specified acceptance criteria and were substantially equivalent to predicate device. |
| Oblique Suture Retention Strength | Met specified acceptance criteria | Results met specified acceptance criteria and were substantially equivalent to predicate device. |
| Longitudinal Suture Retention Strength | Met specified acceptance criteria | Results met specified acceptance criteria and were substantially equivalent to predicate device. |
| Relaxed Internal Diameter | Met specified acceptance criteria | Results met specified acceptance criteria and were substantially equivalent to predicate device. |
| Usable Length | Met specified acceptance criteria | Results met specified acceptance criteria and were substantially equivalent to predicate device. |
| Water Entry Pressure (WEP) | Met specified acceptance criteria | Results met specified acceptance criteria and were substantially equivalent to predicate device. |
| Radial Burst Strength (Burst Pressure) | Met specified acceptance criteria | Results met specified acceptance criteria and were substantially equivalent to predicate device. |
| Strength After Repeated Puncture | Met specified acceptance criteria | Results met specified acceptance criteria and were substantially equivalent to predicate device. |
| Pressurized Internal Diameter | Met specified acceptance criteria | Results met specified acceptance criteria and were substantially equivalent to predicate device. |
| Biocompatibility Testing: Cytotoxicity | Met specified acceptance criteria | Results met specified acceptance criteria and were substantially equivalent to predicate device. |
| Biocompatibility Testing: Hemolysis | Met specified acceptance criteria | Results met specified acceptance criteria and were substantially equivalent to predicate device. |
Note: The acceptance criteria for each test are implicitly defined as achieving results that allow a determination of "substantial equivalence" to the predicate device, as explicitly stated in the document: "The results of these non-clinical tests met the specified acceptance criteria and were substantially equivalent to the predicate device."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text, as this is a bench testing and biocompatibility study, not a clinical study involving a "test set" of patient data.
- Data Provenance: Not applicable. The data comes from "bench testing and biocompatibility testing," which are laboratory-based studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Ground truth for bench and biocompatibility testing is established through standardized laboratory methods and measurements, not expert review of a test set.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No adjudication method is described for this type of non-clinical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study Done: No. This is a non-clinical study for a physical medical device (vascular graft), not an AI/ML diagnostic or prognostic tool.
- Effect Size of Human Readers Improvement: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is not an algorithm.
7. The Type of Ground Truth Used
- Ground Truth Type: For the bench tests (e.g., Kink Diameter, Tensile Strength, WEP, Burst Strength), the ground truth is based on measurements against established engineering specifications and performance characteristics of the predicate device. For biocompatibility, the ground truth is established through standardized biological assays (cytotoxicity, hemolysis) with predefined pass/fail criteria.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: 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.”