(59 days)
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
§ 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.