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

The ePTFE Ringed GORE-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 document describes a medical device, the ePTFE Ringed GORE-TEX® Vascular Graft, and its clearance through the FDA's 510(k) process, which demonstrates substantial equivalence to predicate devices. This type of submission does not typically involve the detailed clinical studies with acceptance criteria, ground truth establishment, or human-AI performance comparisons that one would find for novel devices or software.

Therefore, many of the requested categories are not applicable to this document as it pertains to a traditional medical device demonstrating substantial equivalence based on material and mechanical properties, and in vivo performance compared to existing predicate devices, rather than a device with performance metrics based on, for example, image analysis or diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text:

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

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 explicitly stated. The document refers to "mechanical testing data" and "in vivo testing" but does not provide specific sample sizes or details on the test sets, data provenance, or study design (e.g., retrospective vs. prospective). This type of information is typically provided in detailed study reports, which are not part of this summary document.

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. The "ground truth" for this device's performance is established through material characterization, mechanical property testing, and animal (in vivo) studies, rather than expert consensus on diagnostic interpretations. The document does not mention human experts establishing ground truth in this context.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert review of images or clinical cases to establish a definitive diagnosis or outcome. This is not relevant for the type of testing described (material, mechanical, in vivo performance).

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-powered diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this submission.

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

• Not applicable. This device is a physical medical implant, not an algorithm, so standalone performance is not a relevant concept in this context.

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

• The ground truth for demonstrating substantial equivalence for this device would be based on:
  • Material specifications and established standards: For ePTFE biomaterial properties.
  • Mechanical engineering principles and test standards: For burst strength, suture retention, fatigue resistance, and other mechanical characteristics.
  • Histopathological analysis and physiological responses: From in vivo animal studies to assess biocompatibility, host tissue integration, and patency, as compared to predicate devices.
  • Clinical outcomes from predicate devices: The safety and effectiveness of the predicate GORE-TEX Vascular Grafts are already established.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

• Not applicable. As there is no training set, this question is irrelevant.

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