(84 days)
GORE-TEX Regenerative Material is intended to provide a mechanism for the ingrowth of new hard and soft tissues into bony defects surrounding teeth and to augment ingrowth of hard and soft tissues on alveolar ridges. GORE-TEX Regenerative Material is a passive, non-load bearing material. It is NOT intended for use in load bearing, articulating situations such as temporal mandibular joint reconstruction.
The Titanium Reinforced Configurations of GORE-TEX Regenerative Material are designed to act in accordance with the accepted principles of wound healing and guided tissue regeneration (GTR). Specifically, the device is designed to be biocompatible, cell occlusive, spacemaking, and clinically manageable, and allow for tissue integration. The materials used in the manufacture of the Titanium Reinforced Configurations do not alter the biology of GTR therapy or the application for which the product is presently used.
GORE-TEX Regenerative Material is surgically placed beneath the mucoperiosteum to aid in the regenerative healing of (1) bone or (2) bone/periodontal ligament defects of the oral cavity. The material is designed to be a passive barrier which excludes epithelial and gingival connective tissue from the defect site so that only the desirable cells repopulate the space, allowing regeneration to occur.
The material is designed to be stiff enough to create and maintain a protected defect space into which new hard and soft tissues can form, but supple enough to drape smoothly over the defect margin. It is non-absorbable, thereby allowing for predictable isolation of the defect site.
This document is a 510(k) Summary of Safety and Effectiveness for the Gore-Tex Regenerative Material Titanium Reinforced Configurations. It aims to demonstrate substantial equivalence to a predicate device. However, it does not contain a detailed study with acceptance criteria and specific performance data in the format requested.
Here's a breakdown of what can be extracted and what is missing based on the provided text:
What can be extracted:
- Device Name: Gore-Tex Regenerative Material Titanium Reinforced Configurations
- Predicate Device: Gore-Tex Periodontal Material -- Titanium Reinforced Configurations
- Intended Use: To provide a mechanism for the ingrowth of new hard and soft tissues into bony defects surrounding teeth and to augment ingrowth of hard and soft tissues on alveolar ridges. It is a passive, non-load bearing material. Not intended for use in load bearing, articulating situations.
- Key Technological Characteristic (modified): The modified configurations have been designed according to the same five design criteria as the predicate device. The additional raw material has reduced the complexity of the manufacturing process.
- Performance Data Mentioned: Lamination bond strength was tested. The bond values for the modified configurations are comparable to or better than those of the current (predicate) configurations.
- Conclusion: Substantially equivalent to the current Titanium Reinforced Configurations of Gore-Tex Regenerative Material in design, manufacturing process, materials, and intended use.
What is explicitly missing from this document regarding a study, acceptance criteria, and detailed performance data:
The document describes the device, its intended use, and states that testing was performed on "lamination bond strength" found to be "comparable to or better than" the predicate. However, it does not provide:
- A specific table of acceptance criteria and reported device performance with numerical values.
- Sample sizes used for any test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts or their qualifications.
- Adjudication method.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study details or effect size.
- Standalone (algorithm-only) performance (not applicable, as this is a physical medical device, not AI).
- Type of ground truth used (if clinical data was collected, which is not detailed here).
- Sample size for the training set (not applicable, as this is a physical medical device, not AI).
- How the ground truth for the training set was established (not applicable, as this is a physical medical device, not AI).
Summary of available information vs. missing information:
| Information Requested | Available in Document |
|---|---|
| 1. Table of Acceptance Criteria & Device Performance | No. Only a qualitative statement: "Lamination is an important characteristic and testing of the lamination bond strength was performed. The bond values for the modified Titanium Reinforced Configurations are comparable to or better than those of the current Titanium Reinforced Configurations." |
| 2. Sample size & Data Provenance (test set) | No. |
| 3. Number & Qualifications of Experts (ground truth) | No. (Not applicable for physical device's technical testing documentation mentioned) |
| 4. Adjudication Method (test set) | No. (Not applicable for physical device's technical testing documentation mentioned) |
| 5. MRMC Comparative Effectiveness Study & Effect Size | No. (Not applicable for this type of device and submission) |
| 6. Standalone Algorithm Performance Study | No. (Not applicable; this is a physical medical device) |
| 7. Type of Ground Truth Used | No details. The "ground truth" for the lamination bond strength would be the measured physical properties based on standardized test methods, but the specifics are not provided. |
| 8. Sample Size for Training Set | No. (Not applicable) |
| 9. How Ground Truth for Training Set Was Established | No. (Not applicable) |
In conclusion, this document primarily serves as a 510(k) summary for substantial equivalence and refers to testing done on lamination bond strength without providing the detailed numerical acceptance criteria or performance results usually found in a comprehensive study report.
§ 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.