(84 days)
FortaGen Oral Membrane is intended to be used during guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures as a biodegradable barrier membrane for:
- Ridge augmentation for later implant insertions;
- . Simultaneous ridge augmentation and implant insertions;
- . Ridge augmentation around implants inserted in delayed extraction sites;
- . Ridge augmentation around implants inserted in immediate extraction sites;
- . Alveolar ridge preservation consequent to tooth (teeth) extraction(s);
- Over the window in lateral window sinus elevation procedures; .
- . In implants with vertical bone loss due to infection, only in cases where satisfactory debridement and implant surface disinfection can be achieved;
- . In intra bony defects around teeth;
- . For treatment of recession defects, together with coronally positioned flap;
- . In furcation defects in multi-rooted teeth.
FortaGen Oral Membrane consists of a multi-laminate sheet predominantly of Type I porcine collagen. The device is supplied hydrated in sheet form in sizes ranging from 13 mm x 25 mm to 40 mm x 50 mm in sterile double layer peelable packaging.
The provided text describes a 510(k) premarket notification for the FortaGen Oral Membrane. This document focuses on demonstrating substantial equivalence to pre-existing devices rather than outlining specific acceptance criteria and a detailed study proving performance against those criteria.
Therefore, many of the requested sections (Table of acceptance criteria, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) cannot be fully addressed from the provided text.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state a table of acceptance criteria with numerical targets. Instead, it relies on demonstrating "substantial equivalence" to predicate devices based on technological characteristics and performance data. The reported "performance" is qualitative, asserting similarity to existing devices.
| Acceptance Criteria Category | Reported Device Performance (FortaGen Oral Membrane) |
|---|---|
| Biocompatibility | "FortaGen Oral Membrane has been shown to be biocompatible." |
| Resorption Profile | "designed to resorb within six months. Its handling characteristics and resorption profile are substantially equivalent to those of its predicate devices." |
| Handling Characteristics | "Its handling characteristics and resorption profile are substantially equivalent to those of its predicate devices." |
| Equivalency to Predicates | "should function equivalently to Ossix-Plus and Bio-Gide when used as intended for GTR and GBR procedures." |
| Material/Composition | "consists of a multi-laminate sheet predominantly of Type I porcine collagen." (Matches predicate's collagen-based nature). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a specific "test set" in the context of a clinical study with a defined sample size. The substantial equivalence argument appears to be based on pre-clinical data (biocompatibility) and material characteristics, implicitly compared against established knowledge of the predicate devices. No information on data provenance (country of origin, retrospective/prospective) is provided in relation to a formal test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document does not describe a clinical study with a "test set" requiring expert-established ground truth. The demonstration of equivalence primarily relies on material science and manufacturing process attributes, and general biological function.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no described test set requiring adjudication is present.
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
Not applicable. This device is a resorbable dental barrier membrane, not an AI software or diagnostic imaging device that would involve human readers or 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, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the FortaGen Oral Membrane appears to be based on:
- Material properties and composition: Verified through standard material characterization tests to confirm it's primarily Type I porcine collagen.
- Biocompatibility: Demonstrated through standard biocompatibility testing methods (likely in-vitro and/or in-vivo animal studies, although specific details are not provided in this summary).
- Resorption profile: Assessed through in-vitro or in-vivo studies (likely animal models) to determine the timeframe for resorption.
- Handling characteristics: Likely evaluated during manufacturing and potentially in pre-clinical settings.
The "truth" is that these characteristics are "substantially equivalent" to predicate devices, which are already accepted as safe and effective.
8. The sample size for the training set
Not applicable. This refers to training data for algorithms, which is not relevant for this physical device.
9. How the ground truth for the training set was established
Not applicable. This refers to ground truth for training data for algorithms, which is not relevant for this physical 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.