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The OsteoSync™ Ti Dental Mesh is intended for stabilization and support of bone grafts in dento-alveolar bony defect sites.

The OsteoSync™ Ti Dental Mesh is a system of dental membranes intended for permanent fixation in adults and designed to aid in the reconstruction and augmentation of the alveolar ridges of the maxilla and mandible. They are available in a variety of sizes and shapes and can be contoured to accommodate the individual anatomic and clinical circumstances of each patient. The implants are sold sterile.

The provided document is a 510(k) Summary for the OsteoSync™ Ti Dental Mesh, which is a medical device. This type of document is concerned with demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study in the way one might for a novel diagnostic AI algorithm.

Therefore, many of the specific questions about acceptance criteria, study types, sample sizes, and expert adjudication as they pertain to algorithm performance are not directly applicable to this device submission. The device is a physical dental mesh, and its evaluation focuses on material properties, mechanical performance, biocompatibility, sterilization, and shelf-life, typically compared against standards and known predicate devices.

However, I can extract information related to the device's "acceptance criteria" in the context of its non-clinical testing and the "studies" that support its substantial equivalence.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table of acceptance criteria and device performance in the format typically used for AI algorithm evaluation (e.g., sensitivity, specificity). Instead, it lists non-clinical tests and their outcomes, indicating that the device "met the predetermined acceptance criteria."

2. Sample Size Used for the Test Set and Data Provenance

• Mechanical Testing: "worst-case devices were evaluated." (Specific sample size not provided, but implies a selection of device configurations).
• Biocompatibility/Preclinical Animal Studies: Not specified, but animal studies (in a canine model) were leveraged from an FDA-authorized master file. Data provenance is implied to be from these leveraged studies.
• Sterilization Validation: Not specified.
• Shelf-Life Validation: Not specified, but "sterile integrity was verified by visual, seal strength and seal integrity evaluations."
• Pyrogenicity (Bacterial Endotoxin Testing): Not specified.

It is important to note that these are not "test sets" in the context of validating an AI algorithm, but rather samples used for physical and biological testing of the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable as there is no "ground truth" to be established by experts in the context of an AI algorithm's diagnostic performance for this physical medical device submission. The "ground truth" for the non-clinical tests is determined by standardized test methods and criteria (e.g., ASTM standards for mechanical testing, ISO standards for sterilization).

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as #3. There are no "test sets" in the AI sense, and thus no adjudication of expert opinions.

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

This question is not applicable. The device is a physical dental mesh, not an AI-powered diagnostic tool used with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical dental mesh, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests:

• Mechanical Testing: Ground truth is defined by performance against industry standards (e.g., ASTM F564).
• Biocompatibility: Ground truth is established through biological risk assessment and preclinical animal studies.
• Sterilization: Ground truth is a measured sterility assurance level (S.A.L.) meeting ISO 11137-1 and ISO 11137-2 standards.
• Shelf-Life: Ground truth is the maintenance of sterile integrity and functional properties over time, evaluated against ASTM F1886, ASTM F88, ASTM F1929 and ASTM F2096.
• Pyrogenicity: Ground truth is the measured bacterial endotoxin level against ANSI/AAMI ST72 standards.
• Dimensional/Technological Characteristics: Ground truth is the physical measurements and properties of the device compared to predicate devices, and the established safety and effectiveness of those predicates.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical dental mesh, not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established

This question is not applicable for the same reason as #8.

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