(71 days)
GORE DRAPEABLE ST and LT Regenerative Membranes are bioabsorbable, implantable materials intended to aid in the healing of periodontal and bone defects. They may also be used as a membrane for bone graft containment. When used over a bone graft, GORE DRAPEABLE ST and LT Regenerative Membranes provide a stable barrier to prevent migration of bone graft material and provides a favorable environment for bone regeneration. When used in the treatment of non-spacemaking defects, GORE DRAPEABLE ST and LT Regenerative Membranes should be used in combination with spacemaking bone graft materials (e.g., autogenous bone, bone substitutes).
GORE DRAPEABLE ST and LT Regenerative Membranes are composed of a porous structure of synthetic resorbable glycolide and trimethylene carbonate copolymer fiber. The fiber web is designed to allow attachment to surrounding tissues, stabilize the wound and blood clot, inhibit epithelial downgrowth, and isolate the healing defect during the initial phases of wound healing. GORE DRAPEABLE ST and LT Regenerative Membranes 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. GORE DRAPEABLE ST and LT Regenerative Membranes are surgically placed beneath the mucoperiosteum to aid in the regenerative healing of bone and periodontal ligament defects of the oral cavity or, when placed over bone graft material, to prevent graft material migration.
The provided document does not describe a study that uses acceptance criteria and reports device performance in the way typically seen for AI/ML devices or diagnostic tools. Instead, it is a 510(k) summary for a medical device called "GORE DRAPEABLE ST and LT Regenerative Membranes," which is a bioabsorbable barrier membrane for oral surgical applications.
The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a specific performance against acceptance criteria in a quantitative manner. The assessment is based on preclinical studies and the device's functional characteristics.
Therefore, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.
However, I can provide information based on what is available:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Integrity (Time to Absorption) | Consistent with the clinical goals of regenerative therapy. |
| Tissue Tolerance | Suitable for regeneration of bone. |
| Protection of Regenerative Environment | Provided protection of the regenerative environment. |
| Biocompatibility | Designed to be biocompatible. |
| Separate tissue (cell occlusive) | Designed to separate tissue (cell occlusive). |
| Clinically Manageable | Designed to be clinically manageable. |
| Allow for Tissue Integration | Designed to allow for tissue integration. |
| Similarity to Predicate Devices (GORE RESOLUT XT and GORE OSSEOQUEST Regenerative Membranes) | Device has an indication statement similar to, and intended use is the same as, predicate devices. The modified wording is consistent with other legally marketed resorbable regenerative membranes. |
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 for Test Set: The document mentions "Preclinical studies conducted in critical size defects of the rat mandible." It does not specify the exact animal sample size.
- Data Provenance: Preclinical studies, likely conducted by the manufacturer. No country of origin is explicitly stated, but the submission is to the US FDA. The studies would be considered prospective for the animals involved.
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/Not mentioned. The assessment is primarily based on preclinical animal study observations and material characteristics, not human expert interpretation of data like images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. This typically applies to human interpretation of data, which is not the primary assessment method described here.
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 not an AI/ML device related to human interpretation of data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical, implantable membrane, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the preclinical studies would be based on histological and morphological assessment of tissue regeneration and integration within the animal models, along with observations of the membrane's degradation and functional properties.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/ML device for this physical product.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.