(90 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 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.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Biocompatibility | The device is designed to be biocompatible. |
| Cell Occlusive (inhibit epithelial migration) | The porous structure is designed to inhibit epithelial migration; the occlusive membrane isolates the periodontal defect from gingival connective tissue. The device is designed to be cell occlusive. |
| Spacemaking (for tissue regeneration) | The device is designed to be spacemaking. |
| Clinically Manageable | The device is designed to be clinically manageable. |
| Allow for Tissue Integration | The device is designed to allow for tissue integration. |
| Contain Bone Grafting Materials | A preclinical study in canine mandibular defects demonstrates that RESOLUT Regenerative Material can be used as a membrane to contain bone grafting materials. When used over a bone graft, it provides a stable barrier to graft material migration. (This appears to be a key performance claim for the modification.) |
| Provide Favorable Environment for Bone Regeneration | Like CAPSET Calcium Sulfate Bone Graft Barrier, it can provide a favorable environment for bone regeneration. |
| Aid in Healing of Periodontal Defects | (Implicit in intended use) |
| Substantial Equivalence to Predicate Devices | 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. |
Information not applicable or not available from the provided text:
- 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."
- 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.
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 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.
- The sample size for the training set: Not applicable. This is not an AI/software device.
- 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.
§ 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.