(75 days)
- covering of implants placed in immediate or delayed extraction sockets;
- localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants;
- alveolar ridge reconstruction for prosthetic treatment;
- guided tissue regeneration procedures in recession defects for root coverage
MUCOGRAFT® is a pure collagen membrane obtained by a standardized controlled manufacturing process. The membrane is made of collagen type I and type III without further cross-linking or chemical treatment. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. MUCOGRAFT® is sterilized in double blisters by gamma irradiation. MUCOGRAFT® has a bilayer structure with one smooth, non-permeable layer and one porous. The "outer," smooth side has a smooth surface which is cell occlusive and prevents cell adhesion and acts as a barrier. It allows tissue adherence favoring wound healing. This side is turned towards the soft tissue. The smooth texture has appropriate elastic properties to accommodate i suturing to the host mucosal margins and to protect the graft material from oral trauma during biode radation and healing. The "inner" porous layer consists of collagen fibers in a loose, porous arrangement to enable cell invasion. This porous layer is made from pig skin. This side is turned toward the bone defect and/or soft tissue to encourage boneforming cells and tissue growth and to stabilize the blood clot.
The provided text describes the MUCOGRAFT® Collagen Matrix, a pure collagen membrane for dental grafting procedures. It establishes substantial equivalence to previous versions and other collagen membranes, rather than presenting a study to prove acceptance criteria for a new AI-powered medical device. Therefore, much of the requested information regarding AI device testing is not applicable.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of quantitative metrics for a device's performance that would typically be seen in an AI device study (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to predicate devices and evidence of safety and efficacy through preclinical and clinical studies for specific indications.
Acceptance Criteria (Implied for Substantial Equivalence):
| Criterion | Reported Device Performance (MUCOGRAFT®) |
|---|---|
| Similar Material Composition | Pure collagen type I and type III, derived from veterinary certified pigs. |
| Similar Bilayer Structure | Smooth, non-permeable layer (cell occlusive) and porous layer (cell invasion). |
| Similar Manufacturing Process | Standardized controlled manufacturing, gamma irradiation sterilization. |
| Similar Intended Use & Indications | Revised indications are similar to existing MUCOGRAFT® and DYNAMATRIX® products. |
| Safety and Efficacy in Preclinical Studies | Uneventful healing, normal-appearing tissue, similar revascularization and epithelialization to autogenous graft (in animal models). |
| Safety and Efficacy in Clinical Studies | Safe and effective for gingival augmentation (increase KT/tissue thickness) and root coverage, with results similar to DynaMatrix. |
2. Sample Size Used for the Test Set and Data Provenance
- Preclinical Studies:
- Wehrhan et al. 2010: Porcine model (sample size not specified).
- Herford and Boyne 2002: Primate model (sample size not specified).
- Clinical Studies:
- Multiple clinical studies are mentioned, but specific sample sizes for each are not provided in this document. The studies are cited as "clinical studies have been conducted" and are not detailed within this summary.
- Data Provenance: The document implies an international scope given the sponsor's location (Switzerland) and the cited authors. Some cited studies (e.g., Herford and Boyne, McGuire and Scheyer) are from the US. The studies are assumed to be prospective clinical trials, but this is not explicitly stated for all.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This information is typically relevant for studies using expert-labeled data as ground truth for AI algorithms. For this medical device (a collagen matrix), the "ground truth" is established through clinical and histological outcomes observed by researchers and clinicians in the preclinical and clinical studies, rather than a separate expert review panel for a test set.
4. Adjudication Method for the Test Set
N/A. This is relevant for studies where multiple annotators or reviewers might disagree on ground truth labels, necessitating an adjudication process. This is not applicable to the preclinical and clinical studies evaluating a physical implantable device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. This concept is specific to evaluating AI's impact on human performance (e.g., radiologists interpreting images with and without AI assistance). The MUCOGRAFT® device is a biomaterial, not an AI diagnostic/interpretive tool, so an MRMC study is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Done
N/A. As MUCOGRAFT® is not an algorithm, this question is not applicable.
7. Type of Ground Truth Used
For the preclinical and clinical studies, the "ground truth" is based on:
- Histological and pathological examination: For outcomes like uneventful healing, normal-appearing tissue, revascularization, and epithelialization (e.g., in animal models).
- Clinical observation and measurement: For outcomes like gingival augmentation (increase in keratinized tissue width/thickness) and root coverage, assessed by clinicians based on established dental criteria.
8. Sample Size for the Training Set
N/A. The concept of a "training set" applies to machine learning algorithms. This document describes a medical device tested through traditional scientific studies (preclinical and clinical), not an AI system.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set mentioned for an AI algorithm, this question is not applicable.
§ 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.