(266 days)
The MEADOX® EXXCEL™ ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Mid-Flex grafts are specifically indicated for vascular access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externerally Supported Grafts are used where kinking and compression resistance are desired.
The unwrapped version of the MEADOX® EXXCEL" ePTFE Vascular Graft is comprised of an expanded polytetraffuoroethylene (ePTFE) core tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.
The provided text describes the safety and effectiveness of the MEADOX® EXXCEL™ ePTFE Vascular Graft. It does not describe an AI device or a study involving human readers or algorithms. Therefore, much of the requested information regarding AI performance, human-in-the-loop studies, ground truth establishment for training data, and expert qualifications is not applicable.
However, I can extract the acceptance criteria and performance related to the device itself based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" for this medical device are based on compliance with ISO-10993 standards for biocompatibility and AAMI standards (or equivalent) for physical performance. The reported device performance indicates that the device passed all these tests.
| Test Description | Acceptance Criteria Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | ISO 10993 | Pass |
| Cytotoxicity | ISO 10993 | Pass |
| Sensitization | ISO 10993 | Pass |
| Irritation or Intracutaneous reactivity | ISO 10993 | Pass |
| Systemic Toxicity (acute) | ISO 10993 | Pass |
| Sub-chronic toxicity (sub-acute) | ISO 10993 | Pass |
| Genotoxicity / Mutagenicity | ISO 10993 | Pass |
| Implantation | ISO 10993 | Pass |
| Hemocompatibility (Hemolysis) | ISO 10993 | Pass |
| Chronic Toxicity | ISO 10993 | Pass |
| Carcinogenicity | ISO 10993 | N/A (not performed, as a non-toxic prop was established) |
| Physical Performance Tests | AAMI Standard Equivalence (reference) | Pass |
| Internodal Distance | (8.2.1.3) | Pass |
| Water Entry Pressure | (8.2.4) | Pass |
| Radial Tensile Strength | (8.3.1) | Pass |
| Longitudinal Tensile Strength | (8.3.2) | Pass |
| Burst Strength | (8.3.3.3) | Pass |
| Suture Retention Strength (longitudinal) | (8.8.4.1) | Pass |
| Suture Retention Strength (oblique) | (8.8.4.2) | Pass |
| Suture Hole Elongation | N/A (Standard not specified) | Pass |
| Kink Diameter | (8.9) | Pass |
| Crush Resistance | N/A (Standard not specified) | Pass |
| Burst After Repeated Puncture (12 months) | (8.3.4) | Pass |
| Burst After Repeated Puncture (18 months) | (8.3.4) | Pass |
| Relaxed Internal Diameter | (8.5) | Pass |
| Usable Length | (8.4) | Pass |
| Nominal Wall Thickness | (8.7) | Pass |
The study that proves the device meets these acceptance criteria is detailed in the "SUMMARY OF SAFETY & E" document provided. The document itself is the report of these tests.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes (number of grafts or test articles) used for each individual biocompatibility or physical performance test.
- Data Provenance: The tests were performed by "Meadox Medicals, Inc." and conducted according to international (ISO-10993) and national (AAMI) standards, implying data generated within a controlled laboratory setting. The country of origin is not explicitly stated for the data generation location, but the sponsor is "Meadox Medicals, Inc." and the submission is to the FDA (implying US jurisdiction). The data would be considered prospective for the purpose of demonstrating device compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. This document describes engineering and biological testing of a physical medical device, not an AI device requiring expert ground truth in the diagnostic sense. The "ground truth" here is objective measurement against established physical and biological standards.
4. Adjudication Method for the Test Set:
- Not Applicable. As per point 3, this is not an AI study requiring adjudication of expert opinions. The adjudication is based on whether the measured performance of the device meets the predefined quantitative and qualitative criteria of the relevant standards (ISO and AAMI).
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:
- Not Applicable. This document does not describe an AI device or any human reader studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This document does not describe an AI algorithm.
7. The Type of Ground Truth Used:
- For Biocompatibility: The ground truth is adherence to the scientific and safety principles outlined in the ISO-10993 standard, demonstrated through in-vitro and in-vivo biological tests.
- For Physical Performance: The ground truth is the quantitative and qualitative specifications defined by the AAMI standards for vascular graft prostheses.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI device requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. This is not an AI device requiring a training set.
§ 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.”