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Ceramic abutments are indicated for use with endosseous dental implants, to extend the implant's coronal aspect through the mucosal tissues and into the oral cavity, for prosthetic attachment. Ceramic abutments are primarily indicated for use in the higher aesthetically required anterior regions of the oral cavity but are not restricted for that application.

The 3i ceramic abutment is comprised of three basic components: An outer cylinder or sleeve constructed from zirconium ceramic bonded to an inner machined titanium alloy core with a biocompatible, water-insoluble, apatite glass-ceranic seall.

Titanium alloy cores or inserts are machined. The ceranic sleeve is molded. The two components are bonded using proprietary process. After bonding, parts are cleaned, inspected, packaged and sterilized. Sterilization is accomplished by gamma irradiation to a SAL of 10 ° The 31 ceramic abutment is equivalent in physical strength characteristics as other devices.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/ML performance. The document is a 510(k) summary for a dental device (3i Ceramic Abutments) and discusses its physical strength characteristics and substantial equivalence to a predicate device.

Therefore, I cannot provide the requested table or answer the specific questions related to AI/ML study design, sample sizes, ground truth establishment, or multi-reader studies.

The document focuses on the following:

• Classification Name: Endosseous Dental Implant
• Common/Usual Names: Abutments; transmucosal abutments/elements
• Proprietary Name: No established marketing name at time of submission.
• Classification: Class III
• Performance Standards: No established performance standards for abutments
• Form and Construction: Details the components and manufacturing process of the 3i ceramic abutment.
• Performance Data (Physical Testing): Compares the 3i ceramic abutment's cyclical fatigue, static load, and torsional strength to an "Other device."
  • Cyclical Fatigue at 30° Angle (Average result):
    • Other device: 5000000 cycles @ 250 N
    • 3i: 5000000 cycles @ 300 N
  • Static load at 30° Angle (Average result):
    • Other device: 517 N
    • 3i: 695 N
  • Torsional Strength (Average result):
    • Other device: 79.5 Ncm (Abutment hex failed)
    • 3i: 166 Ncm (Implant hex failed)
  • Conclusion: "In all physical testing undertaken, the 3i ceramic abutment performed as well or better than equivalent other devices."
• Substantial Equivalence: States the 3i ceramic abutment is substantially equivalent to Nobel Biocare "CerAdapt" abutment based on appearance, basic design, and indications for use.
• Indications for Use: Specifies the intended use of the ceramic abutments with dental implants.
• Contraindications, Warnings, Precautions, and Adverse Effects: Details these aspects related to the dental device.

This is a regulatory submission for a physical medical device and does not involve AI/ML components or studies.

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