(448 days)
The Dental Barrier Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier membrane for:
- · Ridge augmentation for later implant insertion
- · Augmentation around implants placed in immediate/delayed extraction sockets
- · Localized ridge augmentation
- · Alveolar ridge preservation/reconstruction
- · Osseous fill around implants in peri-implantitis bone defects
- · Over the window in lateral window sinus elevation procedures
- · Intra-bony defects around teeth
- · Treatment of recession defects, together with coronally positioned flap
- · In furcation defects in multi-rooted teeth.
The Matricel Dental Barrier Membrane is an intraoral porcine membrane intended to be used in dental applications as a barrier membrane for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) to support the growth of new tissue and bone. The Dental Barrier Membrane is composed of a network of highly purified porcine collagen (predominantly Type I with some Type III) and elastin fibers.
The Dental Barrier Membrane is offered in three sizes (15x20mm, 25x30mm and 30x40mm) with Rough and Smooth surfaces to accommodate physician preferences. The Smooth version is further processed to achieve a flattened surface, whereas the Rough version retains the natural fibrillar structure of the membrane. The Rough and Smooth membrane have identical technological, mechanical and chemical characteristics.
The product is packaged in double blister packs and sterilized by ethylene oxide. The Dental Barrier Membrane is supplied sterile and is indicated for single use.
Here's a breakdown of the acceptance criteria and study information for the Matricel Dental Barrier Membrane, based on the provided text:
Matricel Dental Barrier Membrane Acceptance Criteria and Study Information
The acceptance criteria for the Matricel Dental Barrier Membrane are primarily based on achieving substantial equivalence to its predicate devices, Bio-Gide and Ossix Plus, through non-clinical testing. No clinical testing was submitted.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate devices. The reported device performance is demonstrated through various bench and animal tests, designed to show that the Matricel Dental Barrier Membrane's characteristics are comparable to the predicates and meet established standards.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Matricel Dental Barrier Membrane) |
|---|---|
| Material Source: Porcine | Porcine |
| Composition: Collagen Types I and III, and elastin | Collagen Types I and III, and elastin |
| Form: Membrane | Membrane |
| Resorbable: Yes | Yes (Comparable resorption characteristics to Bio-Gide) |
| Conformability: Flexible and conforms to defect site | Flexible and conforms to the defect site |
| Biocompatibility: Yes | Yes (Biocompatibility testing to ISO 10993-1 performed) |
| Sterilization: By ETO or Gamma Radiation | Ethylene oxide (Predicate Bio-Gide is Gamma radiation, Ossix Plus is ETO) |
| Shelf Life: 3 years | 3 years (Comparable to Bio-Gide) |
| Packaging: Double blister package | Double blister package |
| Mechanical Properties: (e.g., tensile strength) | Met specifications (Bench testing to ASTM F2212-11) |
| Physical Properties: (e.g., peak denaturation temp, expansion after wetting) | Met specifications (Bench testing to ASTM F2212-11) |
| Biostability (Enzymatic Resistance): Comparable to predicates | Behaves as stable as predicate Bio-Gide |
| Inflammatory Response: Minimal/None | Does not elicit an inflammatory response (Animal Test) |
| Surface Weight: Typically >10 mg/cm² | >10 mg/cm² and within specifications of Bio-Gide |
| Non-pyrogenic: Yes | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as this was not a clinical study involving human patients. For the bench and animal tests:
- Bench testing details (e.g., number of membranes tested for tensile strength) are not specified.
- Animal testing involved a comparison to the predicate Bio-Gide, but the specific number of animals or samples is not provided.
- Data Provenance: The studies were non-clinical (bench and animal tests). The country of origin for the data is implicitly Germany, where Matricel GmbH is located, as they are the submitter. The data is prospective for these specific tests conducted for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a non-clinical submission relying on bench and animal testing against established standards and comparisons to predicate devices, not on human expert interpretation of data like images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. There was no expert adjudication process as it was a non-clinical study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states, "No clinical testing was submitted in support of this 510(k) premarket notification." Therefore, there is no information on human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical medical device (dental barrier membrane), not an AI algorithm. Therefore, "standalone" performance in the context of AI does not apply.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was based on:
- Established Specifications: Meeting predefined physical and mechanical specifications (e.g., tensile strength, peak denaturation temperature, expansion after wetting) as characterized in accordance with ASTM F2212-11.
- Biocompatibility Standards: Adherence to ISO 10993-1 for biological safety.
- Comparative Performance to Predicate Devices: Demonstrating comparable performance (e.g., enzymatic resistance, resorption characteristics) to the legally marketed predicate device Bio-Gide in animal studies.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as it is not an AI/ML device.
§ 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.