(30 days)
It is intended for use during the process of guided bone regeneration as a bioabsorbable membrane for supporting: augmentation around immediately placed endosseous implants or existing endosseous implants (e.g., dehiscence and fenestration defects, extraction sockets); ridge augmentation for later implantation of endosseous implants; and sinus procedures (e.g., sinus window, sinus lift).
These devices are composed of synthetic resorbable copolymers and have been designed to act in accordance with the accepted principles of wound healing and regenerative therapy. Specifically, the membranes are designed to be biocompatible, separate tissue (cell occlusive), clinically manageable, and allow for tissue integration. The fifth requirement for regenerative therapy is spacemaking, and bone grafting or bone filling materials may be used in conjunction with the membranes to assist in providing the space necessary for regenerative healing.
The provided document is a 510(k) premarket notification for a medical device (GORE BIOABSORBABLE Membranes) seeking substantial equivalence to existing predicate devices. It focuses on the device's intended use and technological characteristics rather than providing acceptance criteria and performance data for a new AI/software device. Therefore, much of the requested information cannot be extracted directly from this document.
However, I can provide what is available, infer where possible, and clearly state what information is not present in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| New bone formation for synthetic resorbable membranes | Statistically equivalent to or better than bone formation with the predicate device (BIO-GIDE® Resorbable Bilayer Membrane). |
| Ease of use | Evaluated via preclinical in vivo study (specific criteria not detailed). |
| Clinical performance | Evaluated via preclinical in vivo study (specific criteria not detailed). |
| Efficacy | Evaluated via preclinical in vivo study (specific criteria not detailed). |
| Acting in accordance with accepted principles of wound healing and regenerative therapy | Devices designed to be biocompatible, separate tissue (cell occlusive), clinically manageable, and allow for tissue integration (evaluation method for "acting in accordance" not fully detailed beyond 'design'). |
| Effective as a barrier to aid in wound healing and regenerate bone around defects associated with dental implants, and for ridge augmentation and sinus procedures. | Results from human studies reported in the literature for both synthetic resorbable membranes and resorbable collagen membranes are consistent with the preclinical in vivo study, supporting effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to a "preclinical in vivo study" but does not provide the number of subjects or samples used in this study.
- Data Provenance: The preclinical in vivo study was conducted internally or sponsored by W.L. Gore & Associates, Inc. The document also cites "Results from human studies reported in the literature," which implies external data, but specifics (country of origin, retrospective/prospective) are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The study described is a preclinical in vivo study comparing device performance, which would likely involve histological analysis and imaging, but the role of "experts" in establishing a ground truth as typically understood for AI/software devices (e.g., radiologists reviewing images) is not mentioned.
4. Adjudication Method for the Test Set
- This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done as this is not an AI/software device designed to assist human readers. The study described is a preclinical in vivo study comparing the physical properties and biological outcomes of a medical membrane to a predicate device.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone performance study was not done as this is not an AI/software device.
7. Type of Ground Truth Used
- For the preclinical in vivo study, the "ground truth" for the device's performance (e.g., new bone formation) would likely be established through histological examination, quantitative measurements of bone volume/density from imaging (e.g., micro-CT), and gross observation of the surgical sites by researchers or veterinarians specializing in animal models. The document states "new bone formation" as a key metric.
8. Sample Size for the Training Set
- This is not applicable as this is not an AI/software device, and therefore does not have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable as this is not an AI/software 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.