(63 days)
BioMesh® Biodegradable GTR Barrier is intended for use in the surgical management and treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures.
Indications for Use:
BioMesh® Biodegradable GTR Barrier is indicated for use in the treatment of the following specific conditions:
- Two or three wall vertical defects.
- Class II furcations.
- Circumferrential defects.
- Recession type defects.
- Dehisence defects associated with dental implants
BioMesh® Biodegradable GTR Barrier is provided as a single membrane type, but in a variety of precut shapes and sizes. Shapes and sizes. As noted on the graphic representation at the left, five different shapes are offered. The BioMesh® Biodegradable GTR Barrier is shape optimized to provide a ready made pattern well suited to the selected operative site needing a minimum of surgeon modification. If desired, the surgeon can trim any of the available shapes to fit unique or unusual circumstances. The BioMesh® Biodegradable GTR Barrier is made from polyglycolic acid with a coating of polylactic acid + polylactic glycolic acid copolymer. The membrane is constructed with interconnective pores with an embossed surface.
This is a 510(k) premarket notification for a dental device, not an AI/ML device, therefore, much of the requested information (e.g., sample sizes for training/test sets, expert qualifications, MRMC studies, standalone performance, etc.) is not applicable or available in the provided document. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study on performance against specific acceptance criteria in the context of AI.
I can, however, extract the acceptance criteria as presented in the "Summary Comparison Table" and the reported performance of the device against those criteria in the context of substantial equivalence.
1. Table of acceptance criteria and the reported device performance:
| Feature | Acceptance Criteria (Predicate Device - Resolut) | Reported BioMesh® Biodegradable GTR Barrier Performance | Substantial Equivalence (SE?) |
|---|---|---|---|
| Indications for Use: | Two or three wall vertical defects, Class II furcations, Circumferential defects, Recession type defects, Dehisence defects associated with dental implants | SAME | YES |
| Material: | Equivalent (to polyglycolic acid with a coating of polylactic acid + polylactic glycolic acid copolymer) | polyglycolic acid with a coating of polylactic acid + polylactic glycolic acid copolymer | YES |
| Structure: | Non-woven membrane, no interconnecting pores, no embossing | Microporous membrane made of biodegradable polyglycolide, polylactide and d,l-lactide/glycolide copolymer. The membrane is made up of interconnective pores with an embossed surface. | Equivalent |
| Tissue Integration: | Test result score 110 | Test result score 115 | YES |
| Biocompatibility: | Good | Good | YES |
| Toxicity: | Good | Good | YES |
| Stability: | 5 Years | 5 Years | YES |
| Clinical Data: | Good | Good | YES |
| K - Number: | K932866, K962624 & K973594 | Pending | YES |
Study that Proves the Device Meets the Acceptance Criteria:
The provided document describes a substantial equivalence comparison to predicate devices (Resolut Regenerative Material, K932866, K962624, and K973594) rather than a direct study with predefined acceptance criteria for a novel AI/ML device. The "study" here is essentially the comparison itself, as presented in the "Summary Comparison Table." The criteria are largely based on the characteristics and performance of the legally marketed predicate device.
The document states: "Comparison of BioMesh® Biodegradable GTR Barrier brand GTR barrier to the predicate device(s) identified above based on available labeling, promotional materials, comparison testing, demonstrates the substantial equivalence of Biodegradable GTR Barrier."
According to the table:
- Indications for Use, Material, Biocompatibility, Toxicity, Stability, Clinical Data, Manufacturer, and Product Code were deemed "SAME" or "Good" or identical to the predicate.
- For Structure, while the description differs (microporous with interconnective pores and embossing vs. non-woven without these features), the conclusion is "Equivalent," implying that these structural differences do not alter the safety or effectiveness to a degree that would preclude substantial equivalence. This likely relies on performance data where applicable, though extensive structural details are not provided.
- For Tissue Integration, BioMesh® showed a test result score of 115, which is numerically higher than the predicate's 110, leading to a "YES" for substantial equivalence. This suggests that a higher score is either equivalent or superior in this context.
Missing Information/Not Applicable for this specific document (as it's not an AI/ML device submission):
- Sample size used for the test set and the data provenance: Not explicitly stated for specific elements like tissue integration. The comparison is against predicate device characteristics and likely pre-existing data or tests, not a new clinical trial with a defined test set for this submission. The origin of "test result scores" for tissue integration is not detailed (e.g., in vivo animal study, in vitro, human data).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML device is not relevant here.
- Adjudication method: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For characteristics like material, stability, etc., the "ground truth" is established through standard material science and performance testing. For "clinical data," it likely refers to general acceptable clinical performance of such devices, but no specific ground truth definition is provided.
- The sample size for the training set: Not applicable.
- 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.