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The ePTFE Ringed GORE-TEX® Vascular Graft is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients suffering occlusive or aneursymal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

The ePTFE Ringed GPRE-TEX® Vascular Graft is an expanded polytetrafluoroethylene (ePTFE) vascular graft base tube with ePTFE reinforcing film and optional manufacturing modifications. The proposed modifications consist of replacing external, semi-rigid reinforcing rings of fluorinated ethylene propylene (FEP) with rings created within the graft wall of the ePTFE. These ring structures alternate with a typical graft structure the entire length of the graft. Additionally, small gold dots may be placed at intervals anywhere along the graft, in conjunction with, or as an alternative to the blue orientation markers. The proposed modifications do not present new issues of safety and effectiveness compared to predicate vascular grafts.

The provided text describes a medical device, the ePTFE Ringed GORE-TEX® Vascular Graft, and its clearance through the 510(k) premarket notification process. This process focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the provided document.

Here's an analysis based on the available information:

Device: ePTFE Ringed GORE-TEX® Vascular Graft

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. The provided document is a 510(k) clearance letter, which does not typically include a table of acceptance criteria and reported performance in the way a clinical study report would. The clearance is based on demonstrating "substantial equivalence" to predicate devices, not on meeting predefined performance metrics through a new clinical trial.

The document states:

• "Mechanical testing data demonstrate the applicant device has mechanical characteristics substantially equivalent to the predicate devices."
• "In vivo testing demonstrates that applicant device performance is substantially equivalent to the predicate devices."

However, the specific acceptance criteria for these "mechanical" and "in vivo" tests, and the exact reported performance values, are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Not available. The document mentions "mechanical testing data" and "in vivo testing" but does not specify the sample sizes (number of devices or animals/patients) used for these tests. The provenance of the data (country of origin, retrospective/prospective) is also not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable/Not available. Since the clearance is based on substantial equivalence to predicate devices and likely pre-clinical testing, the concept of "ground truth" established by experts in a clinical trial context (e.g., radiologists interpreting images) is not relevant or not detailed here.

4. Adjudication Method for the Test Set

Not applicable/Not available. No information is provided regarding an adjudication method. This type of methodology is typically associated with clinical studies involving human interpretation of data, which is not the focus of this 510(k) summary.

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 device is a vascular graft, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not explicitly detailed for substantial equivalence. The "ground truth" for demonstrating substantial equivalence for a medical device like a vascular graft typically revolves around established performance characteristics of the predicate devices, pre-clinical testing (e.g., animal studies, mechanical fatigue tests, biocompatibility), and manufacturing quality validations. The document mentions "mechanical testing data" and "in vivo testing" showing substantial equivalence to predicate devices, but the specific "ground truth" methods (e.g., histological analysis in animal models, specific mechanical properties benchmarks) are not provided in this summary.

8. The Sample Size for the Training Set

Not applicable/Not available. The concept of a "training set" is usually associated with machine learning or AI algorithm development, which is not relevant to this device. For a traditional medical device, data would be collected for verification and validation, not model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not available. As explained in point 8, a "training set" as commonly understood in AI/ML is not relevant here.

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