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It is intended for use during the process of guided bone regeneration as a bioabsorbable membrane for supporting: augmentation around immediately placed endosseous implants or existing endosseous implants (e.g., dehiscence and fenestration defects, extraction sockets); ridge augmentation for later implantation of endosseous implants; and sinus procedures (e.g., sinus window, sinus lift).

These devices are composed of synthetic resorbable copolymers and have been designed to act in accordance with the accepted principles of wound healing and regenerative therapy. Specifically, the membranes are designed to be biocompatible, separate tissue (cell occlusive), clinically manageable, and allow for tissue integration. The fifth requirement for regenerative therapy is spacemaking, and bone grafting or bone filling materials may be used in conjunction with the membranes to assist in providing the space necessary for regenerative healing.

The provided document is a 510(k) premarket notification for a medical device (GORE BIOABSORBABLE Membranes) seeking substantial equivalence to existing predicate devices. It focuses on the device's intended use and technological characteristics rather than providing acceptance criteria and performance data for a new AI/software device. Therefore, much of the requested information cannot be extracted directly from this document.

However, I can provide what is available, infer where possible, and clearly state what information is not present in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document refers to a "preclinical in vivo study" but does not provide the number of subjects or samples used in this study.
• Data Provenance: The preclinical in vivo study was conducted internally or sponsored by W.L. Gore & Associates, Inc. The document also cites "Results from human studies reported in the literature," which implies external data, but specifics (country of origin, retrospective/prospective) are not provided.

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

• This information is not provided in the document. The study described is a preclinical in vivo study comparing device performance, which would likely involve histological analysis and imaging, but the role of "experts" in establishing a ground truth as typically understood for AI/software devices (e.g., radiologists reviewing images) is not mentioned.

4. Adjudication Method for the Test Set

• This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a MRMC comparative effectiveness study was not done as this is not an AI/software device designed to assist human readers. The study described is a preclinical in vivo study comparing the physical properties and biological outcomes of a medical membrane to a predicate device.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not done as this is not an AI/software device.

7. Type of Ground Truth Used

• For the preclinical in vivo study, the "ground truth" for the device's performance (e.g., new bone formation) would likely be established through histological examination, quantitative measurements of bone volume/density from imaging (e.g., micro-CT), and gross observation of the surgical sites by researchers or veterinarians specializing in animal models. The document states "new bone formation" as a key metric.

8. Sample Size for the Training Set

• This is not applicable as this is not an AI/software device, and therefore does not have a "training set" in the context of machine learning.

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

• This is not applicable as this is not an AI/software device.

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RESOLUT Regenerative Material is a bioabsorbable, implantable material intended to aid in the healing of periodontal defects. It may also be used as a membrane for bone graft containment. When used over a bone graft, RESOLUT Regenerative Material provides a stable barrier to graft material migration and provides a favorable environment for bone regeneration.

RESOLUT Regenerative Material is composed of a porous structure of synthetic bioabsorbable glycolide polymer fiber and an occlusive membrane of synthetic bioabsorbable glycolide and lactide copolymer. The porous structure is designed to attach to surrounding soft tissue and inhibit epithelial migration, while the occlusive membrane isolates the periodontal defect from gingival connective tissue during wound healing. RESOLUT Regenerative Material has been designed to act in accordance with the accepted principles of wound healing and guided tissue regeneration (GTR). Specifically, the device is designed to be biocompatible, cell occlusive, spacemaking, and clinically manageable, and allow for tissue integration.

This document describes a medical device, the RESOLUT Regenerative Material, and its intended use, as well as preclinical and clinical studies demonstrating its performance. However, it does not contain the information needed to answer your specific questions regarding acceptance criteria and a study proving a device meets those criteria in a structured format suitable for AI/ML inference.

Here's why and what information is missing:

• No Acceptance Criteria Table: The document doesn't provide a table of acceptance criteria. "Acceptance criteria" in the context of device performance usually refer to predefined quantitative thresholds (e.g., accuracy > 90%, sensitivity > 85%, etc.) that a device must meet to be deemed acceptable. The text describes the design principles of the device (biocompatible, cell occlusive, etc.) but not measurable performance criteria.
• No Reported Device Performance vs. Criteria: Since there are no explicit acceptance criteria, there's no direct comparison of reported device performance against them. The studies describe outcomes (bone regeneration, defect reduction) rather than performance metrics against predefined targets.
• No AI/ML Specifics: This device is a bioabsorbable implant, not a software or AI/ML-driven diagnostic or prognostic tool. Therefore, questions 2, 3, 4, 5, 6, 8, and 9, which are highly relevant to AI/ML device validation (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance), are not applicable to the information provided in this 510(k) summary.

Summary of what can be extracted about performance and studies from the provided text (though it doesn't fit your requested table format):

The document primarily focuses on demonstrating the device's ability to facilitate bone regeneration and contain bone graft materials.

Key Performance Observations from Studies:

• Preclinical Study (Canine mandibular defects): Demonstrates RESOLUT Regenerative Material can be used as a membrane to contain bone grafting materials and provides a favorable environment for bone regeneration, similar to CAPSET Calcium Sulfate Bone Graft Barrier.
• First Clinical Study (Human - endosseous implant placement):
  • Method: Comparative histological study evaluating resorbable and non-resorbable barrier membranes, and untreated controls.
  • Finding: Bone regeneration occurred in membrane-treated sites. More regeneration with non-resorbable barriers, but concluded resorbable membranes might need to be associated with osteoconductive/osteoinductive space-maintaining materials for complete regeneration.
  • Importance: Provides histological evidence of bone regeneration.
• Second Clinical Study (Human - utilizing autogenous bone grafts):
  • Method: Utilized autogenous bone grafts to maintain space under barrier membranes.
  • Finding: Showed a **highly significant reduction in defect (p

Ask a specific question about this device

RESOLUT Regenerative Material is a bioabsorbable, implantable material intended to aid in the healing of periodontal defects. It may also be used as a membrane for bone graft containment. When used over a bone graft, RESOLUT Regenerative Material provides a stable barrier to graft material migration and provides a favorable environment for healing.

RESOLUT Regenerative Material is composed of a porous structure of synthetic bioabsorbable glycolide polymer fiber and an occlusive membrane of synthetic bioabsorbable glycolide and lactide copolymer. The porous structure is designed to attach to surrounding soft tissue and inhibit epithelial migration, while the occlusive membrane isolates the periodontal defect from gingival connective tissue during wound healing. RESOLUT Regenerative Material has been designed to act in accordance with the accepted principles of wound healing and guided tissue regeneration (GTR). Specifically, the device is designed to be biocompatible, cell occlusive, spacemaking, and clinically manageable, and allow for tissue integration.

This document describes a 510(k) premarket notification for the RESOLUT Regenerative Material, focusing on its substantial equivalence to previously cleared devices. It is not a study report that would typically include detailed acceptance criteria and performance metrics for a novel AI/software device. Therefore, much of the requested information regarding AI device evaluation (sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not applicable or cannot be extracted from the provided text.

However, I can extract information related to the device's performance assessment as described in the 510(k) summary.

Acceptance Criteria and Device Performance (as inferred from the provided text):

The acceptance criteria are not explicitly stated in a quantifiable manner as one might find for an AI device's performance metrics (e.g., accuracy, sensitivity, specificity). Instead, the performance assessment focuses on demonstrating that the RESOLUT Regenerative Material meets biological and functional objectives consistent with its intended use and guided tissue regeneration principles.

Information not applicable or not available from the provided text:

1. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/software device. The performance data comes from a "preclinical study in canine mandibular defects." The sample size for this study is not provided, nor is location information beyond "canine."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/software validation is not relevant here. The "ground truth" for the preclinical study would relate to histological and imaging assessments of bone regeneration and graft containment, performed by trained animal researchers, veterinarians, and pathologists, but specific numbers or qualifications are not provided.
3. Adjudication method for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: For the preclinical study, the ground truth would likely be based on histological analysis, imaging (e.g., radiographs) of the healed defects, and macroscopic observation by veterinary specialists or researchers.
7. The sample size for the training set: Not applicable. This is not an AI/software device.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The primary study mentioned in the 510(k) summary is a preclinical study in canine mandibular defects. This study was conducted to demonstrate the ability of the RESOLUT Regenerative Material to contain bone grafting materials and provide a favorable environment for bone regeneration in the context of periodontal defects. The purpose of this study, as presented in the 510(k) summary, was to support the expanded indications for use, particularly for bone graft containment, and establish substantial equivalence to predicate devices (CAPSET Calcium Sulfate Bone Graft Barrier and Micro Titanium Augmentation Mesh).

Key Takeaway: This 510(k) focuses on the substantial equivalence of an existing medical device (RESOLUT Regenerative Material) with minor modifications to its indications for use. The performance assessment relies on a preclinical animal study rather than a clinical trial with human subjects or a validation study for an AI-powered medical device. The format of your questions is tailored for AI/software devices, which is why most fields are not applicable to the provided text.

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