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Cortex CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom- milled in accordance with a patient- specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with Cortex Dental Implants with internal hex- connection mating platform and conical connection platform diameters.

All digitally designed abutments and/or copings for use with Cortex CAD/CAM Abutments are intended to be sent to a Cortex-validated milling center for manufacture. Cortex abutments designed using CAD/CAM techniques must fulfill the Cortex allowable range of design parameters.

Cortex CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom- milled in accordance with a patient- specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant.

This document is an FDA 510(k) clearance letter for Cortex CAD/CAM Abutments. This type of document typically shows that a device is substantially equivalent to a predicate device and provides information on its intended use. It does not contain information about specific acceptance criteria or detailed study results proving a device meets those criteria from an AI/ML perspective.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance study results
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

This document is a regulatory approval, not a technical performance report or a clinical study report for an AI/ML device.

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