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The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The GM Easy Pack System is indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.

• Intended for single use;
• The subject GM Helix Implants are available in diameters of 3.5, 3.75, 4.0 and 4.3 mm and in heights of 8, 10, 11.5 and 13 mm;
• The subject GM Smart Abutments are available in diameters of 3.5 and 4.5 mm and gingival heights of 1.5, 2.5 and 3.5 mm. The GM Smart Abutments can be customized respecting a minimum post height of 4 mm. The GM Smart Abutments are being presented for the first time for FDA's evaluation;
• . All digitally designed copings and/or crowns to be used with the GM Smart Abutments are intended to be sent to Straumann for manufacture at a validated milling center;
• . The subject GM Healing Abutments are available in diameters of 3.5 and 4.5 mm and gingival heights of 1.5, 2.5 and 3.5 mm;
• . Implant and Cover Screw delivered sterile via Gamma Radiation;
• Sterile Abutments provided sterile via Ethylene Oxide;
• The subject implant is manufactured of unalloyed titanium grade 4, according to ASTM F67;
• . The GM Cover Screw, GM Smart Abutment, GM Healing Abutment and the Removable Screw are manufactured in titanium alloy Ti6Al4V-ELI according to ASTM F136;
• The GM Helix Implants, Acqua and Neoporos, the GM Cover Screw and the Healings subject of this submission are exactly the same devices already cleared to market per K163194;
• . The GM Smart abutments, subject of this submission, are new abutments being introduced in this premarket notification;
• . The implant to abutment interface is a Grand Morse (GM) connection.

The provided document is a 510(k) premarket notification for a dental implant system. It does not describe a study involving an AI/Machine Learning (AI/ML) device, nor does it present acceptance criteria or performance data for such a device.

The document discusses the substantial equivalence of the Neodent Implant System - Easy Pack to previously cleared predicate devices (K163194, K191191, K182620, K193592). The data presented is related to the physical and biological characteristics of the dental implants and abutments.

Therefore, I cannot extract the information required in your request regarding acceptance criteria and performance data for an AI/ML device, as the document does not pertain to such a device. All the acceptance criteria mentioned and the "results" describe testing for traditional medical device characteristics such as sterilization, shelf life, biocompatibility, pyrogenicity, MRI compatibility, and mechanical properties (torsion, insertion) of the implants and abutments.

Specifically, points 2 through 9 of your request are not applicable to the content of this document, as they relate to AI/ML device studies (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance).

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