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MBA Biotech Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Wide Fixture System is intended to be used in the molar region.

The MBA Biotech Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of teeth. It is two stage endosseous screw type implant with internal hexagonal connection.

This system consists of the fixture, cover screw, and various abutments. Only the subject abutments can be used with the subject fixtures.

The Fixture is made of Pure Titanium of ASTM F67 and the surface of the fixture is treated with the SLA(Sand-blasted, Large grit, Acid-etched surface). Fixture is provided sterile.

The provided FDA 510(k) Clearance Letter for the MBA Biotech Implant System does not contain information related to a study proving the device meets acceptance criteria for an AI/ML medical device.

The document discusses the substantial equivalence of the MBA Biotech Implant System (a dental implant, a hardware device) to a predicate device, focusing on material, dimensions, surface treatment, sterilization, and non-clinical testing (fatigue, shelf-life, biocompatibility). It explicitly details how tests for the predicate device were leveraged for the subject device due to similar characteristics.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance data for an algorithm.
7. Type of ground truth used.
8. Sample size for a training set.
9. Ground truth establishment for a training set.

These points are relevant for the development and regulatory clearance of AI/ML-based medical devices, which are typically software devices. The MBA Biotech Implant System is a physical dental implant, and its clearance process relies on demonstrating substantial equivalence to existing physical devices through bench testing and material comparisons, not AI/ML performance studies.

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