(71 days)
IMTEC Biobarner is a temporarily implantable material intended to be used as a space maintaining barrier over bone. It is intended for use in the oral cavity. The material is conformable to a variety of shapes as required for specific anatomical limitations.
A long history exists for the safe and effective use of some nonresorbable biocompatible synthetic materials when implanted into the human body. The material most documented as safe and effective is a polymer known as polytetrafluoroethylene or PTFE. This material, first patented in 1941 and better known as "TEFLON" is composed of long chains of linked Carbon-Fluoride units. Over 100 (1) to 150 (2) publications by independent researchers in peer-reviewed scientific journals have established the material as a suitable material for reconstructive surgical procedures such as cardiovascular and hernial patches, vascular grafts, sutures and periodontal repairs. In periodontal procedures a technique known as "Guided Tissue Repair (GTR)" was introduced in 1982 by Nyman, et al (3). They first described the use of nonresorbable "Millipore Filter" in the procedure. The GTR principle is based on the isolation of incised oral epithelial and gingival connective tissue from treated root surfaces or from Alveolar bone in the case of osseointegrated dental implants. In the latter case the isolation allows osteoblasts and endothelial cell to repopulate the wound, consequently enhancing the closure of a bony defect around the implant. PTFE membranes have subsequently been used with success to exclude those cells without osteogenic potential (4-6).
The provided text is a 510(k) premarket notification for the IMTEC Biobarrier Membrane. It focuses on establishing substantial equivalence to existing devices based on the material's long history of safe and effective use, particularly expanded polytetrafluoroethylene (PTFE). The study described is a pre-clinical animal study, and the primary evidence for the device's efficacy relies on references to other scientific literature. The request asks for information relevant to AI/ML device evaluations, which rely on defined acceptance criteria, test sets, ground truth establishment, and often multi-reader multi-case studies or standalone performance evaluations.
Given the nature of the provided text, it's about a medical device (a membrane), not an AI/ML diagnostic or predictive device. Therefore, many of the requested categories for AI/ML device testing and evaluation are not applicable to this document.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it relies on demonstrating the material's historical efficacy and safety through existing literature and a pre-clinical animal study. The "performance" is qualitative, showing the material's ability to promote bone growth.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safe and Biocompatible | "long history exists for the safe and effective use of some nonresorbable biocompatible synthetic materials" (specifically PTFE) |
| Effective for Guided Tissue Regeneration (GTR) | Demonstrated success of PTFE membranes in periodontal procedures (Nyman et al., Gottlow et al., Pontoriero et al.) |
| Promotes bone growth in peri-implant osseous repairs | In canine study (Becker et al.): "implants covered by the membranes showed marked bone growth when compared to controls." Success in humans also cited (Becker & Becker, Nyman et al., Mellonig & Triplett, Jovanovic et al.). |
| High-density PTFE can be exposed without compromising bone grafting | Bartee (12) suggested this, and subsequent studies (13-15) confirmed this observation. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size (Animal Study): In the Becker et al. (7) study referenced for peri-implant osseous repairs, implants were placed in the mandibles of "dogs". The specific number of dogs or implants is not provided in this extract.
- Data Provenance: The referenced studies are from peer-reviewed scientific journals, suggesting international academic research. For the specific animal study mentioned, it was likely prospective research. However, the document draws heavily on a retrospective review of existing literature rather than a single prospective study specifically for the IMTEC Biobarrier Membrane.
- The human studies referred to (8-11) are also from peer-reviewed literature, but no specific details on their sample sizes or countries of origin are given for this device's approval process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable as the evaluation is not based on a diagnostic AI/ML device requiring expert ground truth for interpretation. The "ground truth" here is histological assessment of bone growth in the animal study and clinical outcomes reported in existing scientific literature. The "experts" are the authors and reviewers of the cited scientific papers.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML diagnostic or image-based evaluation requiring adjudication of expert interpretations.
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 is a medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth relies on:
- Pathology/Histology: For the animal study, the "marked bone growth" would have been assessed via histological analysis of tissue samples.
- Clinical Outcomes Data: For the human studies referenced, the ground truth is derived from reported clinical success, such as new attachment formation and successful bone regeneration.
- Scientific Consensus: The broader claim of safety and efficacy for PTFE is based on over 100-150 publications from independent researchers, reflecting a scientific consensus over time.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The "training" in a broad sense comes from the cumulative scientific knowledge and experience with PTFE.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the AI/ML context.
§ 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.