(193 days)
This membrane is intended for use in oral surgical procedures as a resorbable material for augmentation around implants placed in immediate extraction sockets, augmentation around implants placed in delayed extraction sockets; localized ridge augmentation for later implantation: alveolar ridge reconstruction for prosthetic treatment; filling of bone defects after root resection, cystectomy, removal of retained teeth; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
The TutoDent® Dental Membrane and CopiOs™ Pericardium Membrane are manufactured from bovine pericardium processed with the Tutoplast® process. These membranes are available in sizes ranging from 15 x 20mm to 30 x 40mm.
The provided text is a 510(k) summary for a medical device (TutoDent® Dental Membrane and CopiOs™ Pericardium Membrane) and the FDA's clearance letter. This type of regulatory document does not typically include detailed studies with acceptance criteria, sample sizes for test sets, ground truth establishment, or multi-reader multi-case studies as would be found in a clinical trial report for software or AI devices.
The core of this document is a claim of substantial equivalence to predicate devices, rather than a performance study against specific acceptance criteria. Therefore, most of the requested information regarding study design and performance metrics is not available in this document.
Here's an attempt to answer the questions based only on the provided text, highlighting what is missing:
Acceptance Criteria and Device Performance Study (as described in the document):
The document does not explicitly define acceptance criteria as a table of thresholds for performance metrics. Instead, "acceptance" in this context refers to the FDA's determination of substantial equivalence to legally marketed predicate devices. The study proving this "acceptance" is the 510(k) premarket notification process itself, where the applicant demonstrates that the new device has the same intended use and similar technological characteristics to existing devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Threshold (Implicit from Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate devices (TutoPatch membrane, Collagen Dental Membrane, Bio-Gide Resorbable Membrane, BioMend Extend) | "This membrane is intended for use in oral surgical procedures as a resorbable material for augmentation around implants placed in immediate extraction sockets... [and other uses listed]." This matches the intended uses of the predicate devices. |
| Technological Characteristics (Design & Function) | Similar to predicate devices (Collagen Dental Membrane, Bio-Gide Resorbable Membrane, BioMend Extend) | "The TutoDent® Dental Membrane, CopiOs™ Pericardium Membrane, Collagen Dental Membrane, Bio-Gide Resorbable Membrane and BioMend Extend have substantially equivalent design and function." |
| Material Composition & Processing | Same as predicate device (TutoPatch membrane) | "The TutoDent® Dental Membrane, CopiOs™ Pericardium Membrane and TutoPatch® membrane are composed of the same materials processed in the same manner." (Bovine pericardium processed with Tutoplast® process) |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided. This document is a regulatory submission for substantial equivalence based on material and functional comparison, not a clinical performance study with a "test set" in the context of an AI device. There is no mention of a test set, its size, or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. Ground truth establishment by experts for a test set is not part of a 510(k) submission for this type of device. The "ground truth" for substantial equivalence is the existence and characteristics of the predicate devices already on the market.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. There is no mention of a test set or an adjudication method. The FDA's review process is an adjudication of the submitted evidence by internal reviewers, but not in the context of a "test set" as typically understood for AI performance studies.
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
- No, a MRMC comparative effectiveness study was not done. This device is a resorbable membrane for oral surgery, not an AI-assisted diagnostic or imaging device. Therefore, the concept of "human readers improve with AI" is not relevant to this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device (membrane), not an algorithm or software. Therefore, "standalone algorithm performance" is not relevant.
7. The type of ground truth used
- The "ground truth" for this 510(k) submission is the documented characteristics and regulatory status of the legally marketed predicate devices. The applicant is demonstrating that their new device is fundamentally similar to these existing, cleared devices.
8. The sample size for the training set
- Not Applicable / Not Provided. This is not an AI device, so there is no training set in the computational sense. The "training" for the substantial equivalence claim comes from the existing knowledge and data regarding the predicate devices.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As this is not an AI device, the concept of a training set and its ground truth establishment does not apply.
§ 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.