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Bonafix TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.

The Bonafix TiBase abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The dental restoration and mesostructure are fabricated using a CAD/CAM process. The subject device abutment platform diameters range from 3.0 mm to 5.7 mm, and the corresponding compatible implant body diameters also range from 3.3 mm to 7.0 mm. The apical end is prefabricated to match the compatible implant platform and is available with implant connections for crowns (engaging) or bridges (non-engaging). Each abutment is provided with a screw designed to match the compatible implant.

The titanium base abutment and screw are manufacturated from titanium alloy conforming to ASTM F136. The superstructure is to be manufactured from zirconia conforming to ISO 13356. The subject devices are provided non-sterile to the end user. All digitally designed superstructures, and/or hybrid crowns for use with Bonafix TiBase abutments are to be sent to a Zentek validated Milling center for manufacture. The zirconia superstructure in straight only and is not to be designed to provide an angle or divergence correction.

The provided text is related to a 510(k) premarket notification for a dental device called "Bonafix TiBase." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for a new clinical claim.

Therefore, the input document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes or data provenance for a test set.
• Number or qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Information on a standalone algorithm performance study.
• The type of ground truth used (beyond what might be inferred from the "Non-Clinical Testing Summary" referring to standards compliance).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on non-clinical testing for biocompatibility, sterilization, and engineering/dimensional analysis to support substantial equivalence.

The "Non-Clinical Testing Summary" mentions an "Engineering and dimensional analysis... for determination of compatibility" and compliance with ISO 10993-5 (cytotoxicity) and ANSI/AAMI/ISO 17665-1 (sterilization). It also refers to an MRI review based on scientific rationale and published literature. However, these are evaluations of the device's characteristics against standards and existing knowledge, not a study proving a specific performance metric against a defined acceptance criterion in the way an AI/ML device might be evaluated for diagnostic accuracy.

The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the Bonafix TiBase to its predicate device." This further confirms that the type of study you're asking about (e.g., related to diagnostic accuracy, clinical outcomes for a new claim, or AI performance) was not conducted or deemed necessary for this 510(k) submission.

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1. Cementation of all types of all ceramic, resin and metal-based inlays, onlays, crowns and bridges.
2. Cementation of metal, ceramic, fiber posts, and cast post and cores.
3. Cementation of all ceramic and composite veneers.
4. Final cementation of crowns and bridges on implant abutments.

G-CEM ONE is a dual-cured self-adhesive resin cement with a tooth primer, G-CEM ONE ADHESIVE ENHANCING PRIMER. The mixed cement hardens through polymerization. The adhesive component is an acidic monomer which also can polymerize with frame-forming monomers. This copolymerizing reaction provides higher physical strength than resin-modified glass ionomer cements. Using the primer on the prepared tooth, surface modification and cement polymerization are promoted and hardened along with the cement. The cement syringe consists of Paste A and B, which are filled in a one-body/two chamber syringe. Both pastes are automixed with a mixing tip and applied directly to restorations or prepared cavity.

I am sorry, but the provided text is a 510(k) premarket notification for a dental cement (G-CEM ONE) and does not contain information about an AI/ML device.

Therefore, I cannot extract the acceptance criteria or study details regarding AI performance as requested in your prompt. The document focuses on the physical and chemical properties of the dental cement and its biocompatibility, comparing it to predicate dental cements.

Specifically, the document includes:

• Acceptance Criteria and Reported Device Performance (for the dental cement): This is presented in the tables under "9. Performance Bench Tests" for G-CEM ONE and "G-CEM ONE ADHESIVE ENHANCING PRIMER" on pages 4 and 5. These criteria relate to properties like film thickness, working time, setting time, flexural strength, water sorption, solubility, radiopacity, appearance, coatability, color tone, and refractive index.
• Sample Size for Test Set and Data Provenance: Not specified for any AI/ML context. The performance tests are laboratory bench tests, not clinical studies with human subjects.
• Number of Experts and Qualifications: Not applicable as it's not an AI/ML device requiring expert ground truth for interpretation.
• Adjudication Method: Not applicable.
• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned as it's not an AI/ML device.
• Standalone Performance: Not applicable for an AI/ML device.
• Type of Ground Truth Used: Not applicable for an AI/ML device.
• Sample Size for Training Set & How Ground Truth for Training Set Was Established: Not applicable as it's not an AI/ML device.

Please provide a document related to an AI/ML device if you wish for me to extract information on its acceptance criteria and study data.

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