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"BoniPlus" Dental G-Mesh System is the non-absorbable membrane that is made of titanium metal to stabilize and support bone grafts in dento-alveolar bony defect sites.

The "BoniPlus" Dental G-Mesh System is a non-absorbable titanium screen made of pure Titanium (ASTM F-67), that helps in bone neoformation. They come in many different lengths, widths and thicknesses.

This document describes the "BoniPlus" Dental G-Mesh System, a non-absorbable titanium membrane designed to stabilize and support bone grafts in dento-alveolar bony defect sites. A 510(k) submission was made to the FDA to demonstrate its substantial equivalence to previously cleared predicate and reference devices.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are established through a series of non-clinical tests, and the device's performance is reported to meet these requirements, thus affirming its substantial equivalence to existing devices. The table below summarizes these criteria and the reported performance.

| Test Category | Acceptance Criteria/Requirement Description of Device Performance |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization | Compliance with ISO 11137-1, ISO 11137-2, ISO 11737-1, and ISO 11737-2 for gamma sterilization. | Sterilization verification successfully conducted according to the specified ISO standards for gamma sterilization. |
| Shelf Life | Compliance with ASTM F1980, ASTM F1929, ASTM F88/F88M, ASTM D882, BS EN 868-5, and ASTM F1140/F1140M for tensile, dye penetration, burst, and creep tests. | Shelf life determined to be 3 years based on successful completion of tensile test, dye penetration test, burst test, and creep test conforming to the listed ASTM and BS EN standards. |
| Biocompatibility | Compliance with ISO 10993-1, ANSI/AAMI/ISO 10993-5, ISO 10993-10, ISO 10993-2, ANSI/AAMI/ISO 10993-12, USP <85>, and USP <161> for in vitro cytotoxicity, sensitization, intracutaneous reactivity, and pyrogenicity. Pyrogen limit specification for endotoxin level set at 0.01 EU/device. | Biocompatibility tests (in vitro cytotoxicity, sensitization, intracutaneous reactivity, and pyrogenicity) were performed successfully according to the specified ISO, ANSI/AAMI/ISO, and USP standards. Endotoxin levels reported as: <0.002 EU/device for G-Mesh, <0.007 EU/device for Mesh Screw & Screw Cap, and <0.001 EU/device for Tack. All results meet the pyrogen limit specification of 0.01 EU/device. |
| Bench Performance | Compliance with ASTM F382, ISO 14704, and ASTM F543 for three-point bending, axial pullout strength, and torque tests for insertion and removal. | Bench performance tests, including three-point bending test, axial pullout strength test, and torque test for insertion and removal, were conducted. The device meets the requirements of its pre-defined acceptance criteria based on results conforming to ASTM F382, ISO 14704, and ASTM F543. |
| Material | G-Mesh: TiGr2 from pure grade 2 Titanium (ASTM F-67); Mesh Screw, Screw Cap, Tack: Ti-6Al-4V. Matching or equivalent to predicate devices. | Materials are confirmed to be TiGr2 for G-Mesh and Ti-6Al-4V for Mesh Screw, Screw Cap, and Tack, which is the same as or equivalent to the predicate/reference devices, meeting the material acceptance criteria. |
| Dimensional Similarity | The subject device dimensions (G-Mesh: Thickness: 0.1, 0.3mm; L1: 9.0, 25, 40, 50, 60 mm; L2: 9.5, 17, 20, 30, 50, 60 mm; Mesh Screw/Screw Cap: OD: 1.6mm, Hex: 2.5mm, L: 8, 12mm; Tack: Height: 2.5mm) are compared to predicate and reference devices, demonstrating similar intended use and comparative performance. | The comparative performance test results for dimensions of the subject device (G-Mesh, Mesh Screw & Screw Cap, Tack) are similar to and meet the pre-defined criteria when compared to the predicate and reference devices. Minor dimensional differences did not raise new issues of substantial equivalence for intended use. |
| Design | Design features of the "BoniPlus" Dental G-Mesh System, including the G-Mesh, Mesh Screw & Screw Cap, and Tack, are compared with predicate and reference devices to ensure substantial equivalence in intended use, surgical procedure, treatment effect, and fixation method. | The design of the subject device components (G-Mesh, Mesh Screw & Screw Cap, Tack) is found to be substantially equivalent to the predicate and reference devices. Differences (e.g., three claws on the G-Mesh) were determined not to raise any new issues of substantial equivalence, as they serve the same function of fixing bone graft and preventing gum overgrowth. |

Study Information

1. Sample sizes used for the test set and the data provenance: Not explicitly stated in the provided document. The document refers to "a series of safety and performance tests," and for some specific tests (e.g., pyrogenicity LAL test), it provides results per device. However, the exact sample sizes for each test are not detailed, nor is the country of origin of the data mentioned. The studies appear to be non-clinical bench and laboratory tests, not human or animal studies.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for the performance tests is established by recognized international and industry standards (ISO, ASTM, ANSI/AAMI, USP) for medical device evaluation. These are objective engineering and biological assessments, not expert consensus based on interpretation.

3. Adjudication method for the test set: Not applicable. The tests performed are objective, quantitative measurements against pre-defined pass/fail criteria from international standards.

4. 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 device is a physical dental mesh system, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would be relevant.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm. The non-clinical tests assess the physical and biological properties of the device itself.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the non-clinical tests is based on established international engineering and biological testing standards (e.g., ISO, ASTM, USP) which define acceptable ranges or criteria for material properties, sterilization efficacy, biocompatibility, and mechanical performance.

7. The sample size for the training set: Not applicable. This document does not describe an AI/ML device that requires a training set.

8. How the ground truth for the training set was established: Not applicable.

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