(86 days)
GORE RESOLUT XT 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, GORE RESOLUT XT Regenerative Material provides a stable barrier to graft material migration and provides a favorable environment for bone regeneration.
GORE RESOLUT™ XT Regenerative Material is composed of a porous structure of synthetic bioabsorbable glycolide and trimethylene carbonate copolymer 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. GORE RESOLUT™ XT 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. GORE RESOLUT™ XT Regenerative Material is surgically placed beneath the 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.
The provided document describes the K973594 submission for the GORE RESOLUT™ XT Regenerative Material. Here's a summary of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Composition | Composed of a porous structure of synthetic bioabsorbable glycolide and trimethylene carbonate copolymer fiber and an occlusive membrane of synthetic bioabsorbable glycolide and lactide copolymer. |
| Biocompatibility | Demonstrated in preclinical studies. |
| Cell Occlusivity | Designed to be cell occlusive. |
| Space-making capability | Designed to be space-making. |
| Clinical manageability | Designed to be clinically manageable. |
| Tissue integration | Designed to allow for tissue integration. |
| GTR Principles Adherence | Designed to act in accordance with accepted principles of wound healing and guided tissue regeneration (GTR). |
| Space Maintenance in Bone Regeneration | Preclinical studies in rat mandibles indicated GORE RESOLUT™ XT provided space maintenance suitable for regeneration of intramembranous bone. |
| Tissue Tolerance for Bone Regeneration | Preclinical studies in rat mandibles indicated GORE RESOLUT™ XT provided tissue tolerance suitable for regeneration of intramembranous bone. |
| Functional Integrity (Time to Absorption) | Consistent with clinical goals of GTR, as observed in preclinical studies. |
| Substantial Equivalence to Predicate Device | Determined to be substantially equivalent to the current GORE RESOLUT™ Regenerative Material based on shared indication statements and the long history of safe and effective use of trimethylene carbonate in bioabsorbable, implantable medical devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions preclinical studies conducted in critical size defects of the rat mandible.
- Sample Size: Not explicitly stated.
- Data Provenance: Retrospective, as these were animal studies. The country of origin is not specified, but given W.L. Gore & Associates, Inc. is an American company, it's highly likely the studies were conducted in the US or a region with similar regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the given document. The preclinical studies were likely evaluated by researchers and veterinary pathologists, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set:
This information is not provided in the given document. For preclinical animal studies, adjudication typically involves histological analysis and quantitative measurements performed by researchers, often with independent verification.
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:
An MRMC comparative effectiveness study was not performed. This device is a physical bioabsorbable material, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
A standalone performance study as described (algorithm only without human-in-the-loop performance) was not applicable as this is a physical medical device and not an algorithm. The preclinical animal studies can be considered standalone performance assessments of the material itself.
7. The Type of Ground Truth Used:
The ground truth for the preclinical studies was likely based on direct histological examination and quantitative measurements of bone regeneration and tissue integration in the rat mandible defects. This falls under outcomes data and pathological analysis in an animal model.
8. The Sample Size for the Training Set:
This information is not provided in the given document. The concept of a "training set" is generally applicable to machine learning models, which is not what this device is. For a physical device, development and testing might involve multiple iterations, but the term "training set" doesn't directly apply in the same way.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided and is not directly applicable to this type of device. The development process would involve materials science, biomaterial testing, and potentially pilot animal studies to optimize the material's properties before definitive preclinical studies. The "ground truth" for these stages would be based on established scientific principles, laboratory measurements, and observations from early animal models.
§ 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.