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GORE TEX Vascular Grafts and GORE-TEX Stretch Vascular Grafts are intended for use for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requireing vascular replacement, or for other vascular procedures.

GORE-TEX® Vascular Grafts and GORE-TEX® Stretch Vascular Grafts are composed of expanded polytetrafluoroethylene (ePTFE), and utilize an ePTFE basetube radially reinforced with a thin layer of ePTFE film wrapped around the basetube circumference. The device modification that is the subject of this Special 510(k) involves an alternative thin ePTFE film wrapped around the basetube circumference for use on vascular grafts configured for pediatric shunt.

The provided text describes a Special Premarket Notification (510(k)) for a medical device: GORE-TEX® Vascular Graft; GORE-TEX® Stretch Vascular Graft. This type of submission is used to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device.

Key takeaway for your request: A 510(k) submission, especially one for a modification to an existing device, typically does not include detailed clinical studies with acceptance criteria, test sets, or ground truth establishment in the way you might expect for a novel or high-risk device requiring a PMA (Premarket Approval).

Instead, the documentation focuses on demonstrating that the modified device is equivalent to the predicate device in terms of design, materials, and intended use, and that the modification does not raise new safety and effectiveness issues.

Given this context, I will address your points based on the information typically available in a 510(k) summary and what can be inferred from the provided text.

Here's an analysis of the provided text with respect to your questions:

1. A table of acceptance criteria and the reported device performance

   • No explicit acceptance criteria or performance table is provided in this 510(k) summary. For a 510(k) of this nature (a modification to an existing, well-established device), the "acceptance criterion" is primarily substantial equivalence to the predicate device. This is demonstrated by showing that the design change (alternative thin ePTFE film for pediatric shunts) does not alter the fundamental safety or effectiveness and that the materials and intended use remain largely the same.
   • The "reported device performance" is essentially that the modified device performs comparably to the predicate GORE-TEX® Vascular Grafts and GORE-TEX® Stretch Vascular Grafts. The text states: "No new types of safety and effectiveness issues are raised by the proposed modification." This is the core "performance" statement for a 510(k) of this kind.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not applicable / Not provided. The text does not mention a "test set" in the context of clinical data for performance evaluation in the way one would for a diagnostic or AI device. This 510(k) is for a physical implantable device (vascular graft). The "test set" would likely refer to engineering and biocompatibility testing, not human-in-the-loop clinical performance testing.
   • For such a device, bench testing (e.g., burst strength, suture retention, porosity) and biocompatibility testing would be performed to ensure the modified device meets established standards for vascular grafts, and that the material change does not adversely affect these properties. These tests are typically conducted in a lab environment.

3. 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 / Not provided. The concept of "ground truth" established by experts is not relevant in the context of this 510(k) for a vascular graft. Ground truth is typically used in the evaluation of diagnostic devices or AI systems where expert interpretation is compared against the device's output.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable / Not provided. Adjudication methods are used to resolve discrepancies in expert opinions when establishing ground truth, which isn't part of this 510(k) submission described.

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 physical vascular graft, not an AI software or a diagnostic imaging system that would be evaluated with MRMC studies or AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This device is a physical vascular graft, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • Not applicable. As established, "ground truth" in this context is not relevant. The safety and effectiveness are established through material characterization, mechanical testing, biocompatibility testing, and comparison to the well-established predicate device. For vascular grafts, long-term clinical performance is typically tracked through post-market surveillance or larger clinical trials for novel designs, but not usually provided as "ground truth" for a premarket notification of a modification.

8. The sample size for the training set

   • Not applicable. This is not an AI device, so there is no "training set."

9. How the ground truth for the training set was established

   • Not applicable. As above, no training set or ground truth in this context.

In summary, the provided 510(k) documentation is for a modification to a physical medical implant (vascular graft), not a diagnostic or AI-driven device. Therefore, the detailed performance criteria, test sets, expert ground truth, and AI-specific study methodologies requested are not presented because they are not typically part of a 510(k) submission for this type of device.

The "study that proves the device meets the acceptance criteria" in this context refers to the demonstration of substantial equivalence through:

• Comparison of materials and manufacturing processes to the predicate device.
• Likely extensive bench testing and biocompatibility testing to ensure the modification (alternative ePTFE film) does not negatively impact the graft's mechanical properties or biological compatibility.
• Confirmation that the intended use remains the same or within the scope of the predicate device.

The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This statement confirms that the device met the acceptance criteria for a 510(k) submission, which is substantial equivalence.

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