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.

Device Description

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.

AI/ML Overview

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 < 0.001), with an average bone fill per defect of 93%.
- Importance: Provides confirmatory evidence that barrier membranes, when used for bone graft containment, provide a favorable environment for bone regeneration.

In conclusion, this 510(k) summary is for a physical medical implant and does not contain the type of acceptance criteria or study details (especially related to AI/ML) that your questions are designed to elicit.

Summary

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Ka70884

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant Name, Address: W.L. Gore & Associates, Inc. 1500 North Fourth Street P.O. Box 2500 Flagstaff, AZ 86003-2500

MAY -8 1997

Contact Person, Telephone: John W. Nicholson (520) 779 - 2771

Date of Summary: March 6, 1997

1. Classification Name:Resorbable Barrier Membrane Common or Usual Name: Regenerative Material Proprietary Name: RESOLUT Regenerative Material
RESOLUT Regenerative Material, CAPSET .3. . Predicate Device Calcium Sulfate Bone Graft Barrier, and Micro Titanium Augmentation Mesh.

Device Description: 4.

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RESOLUT Regenerative Material is surgically placed beneath the mucoperiosteum to aid in the regenerative healing of bone/periodontal ligament defects of the oral cavity or, when placed over bone graft material, to prevent graft material migration.

Intended Use: 5.

റ. Technological Characteristics:

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.

7. Assessment of Performance Data:

A preclinical study in canine mandibular defects demonstrates that RESOLUT Regenerative Material can be used as a membrane to contain bone grafting materials. Like CAPSET Calcium Sulfate Bone Graft Barrier, it has been shown to provide a favorable environment for bone regeneration.

In the first clinical study, the investigators used a comparative histological study to evaluate the regenerative capabilities of both resorbable and non-resorbable barrier membranes in defects associated with endosseous implant placement. Additionally, they included untreated controls (i.e., no barrier membrane) in this study. They found that there was bone regeneration in the membrane-treated sites, but there was more in the defects treated with the non-resorbable barrier RESOLUT BONE GRAFT

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membrane. However, they concluded that "to achieve complete regeneration, it may be necessary to use resorbable membranes in association with osteoconductive/osteoinductive space maintaining material, such as autogenous grafts". The importance of the first clinical study is that it provides histological evidence of bone regeneration.

The second clinical study tests their hypothesis further and utilized autogenous bone grafts to maintain an adequate space under the barrier membranes. The overall study results showed a highly significant reduction in defect (p < 0.001), with an average bone fill per defect of 93%. This study provides confirmatory evidence that barrier membranes, when used as membranes for bone graft containment, provides a favorable environment for bone regeneration.

రు Conclusion:

There have been no changes to RESOLUT Regenerative Material in terms of its design, manufacturing process, materials, and intended use. The modifications to the indications for use are substantially equivalent to the indications for use of CAPSET Calcium Sulfate Barrier Graft, Micro Titanium Augmentation Mesh, and the predicate RESOLUT Regenerative Material.

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.