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SGS® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. SGS® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading. Narrow diameter implants (3.2) are intended for maxillary lateral incisors and mandibular lateral and central incisors.

SGS® Dental Implants System is consist of endosseous form dental implants, internal hex implants, tapered design; cover screws, healing caps and abutment systems; Dental Implants:

P7N Narrow Conical Implant, Internal Hex available as follow:

Diameter 3.2 mm Length 8 mm

P1D Conical Groovy Double Connection Implant, Internal hex Conical Connection available as follow:

Diameter 3.5, 3.75, 4.2, 5, 6 mm Length 8, 10, 11.5, 13, 16.

P5D Conical Groovy Double Connection Implant, Internal hex Conical Connection available as follow:

Diameter 3.5, 3.75, 4.2, 4.5, 5, 6 mm Length 8, 10, 11.5, 13, 16.

P7D Conical Groovy Double Connection Implant, Internal hex Conical Connection available as follow:

Diameter 3.5, 3.75, 4.2, 4.5, 5, 6 mm Length 8, 10, 11.5, 13, 16.

Dental Abutments consist of:

Healing Abutments, Anatomic Straight Abutments, Straight Abutments, Straight Abutments Narrow/Wide, PEEK Temporary Abutments for bars, Angular Anatomic Abutments Ti, Angular Abutments Slim/Narrow, Multi-Base Angular Abutment, Anqular Ball Attachment, S-lock Straight/Anqular Abutment, Easy-Fix Angular Abutment, Straight/One-piece angular Multi-unit Abutment, Ball Attachments, Abutment for temporary restoration, Easy Fix Abutments Straight/Angular, Smart Lock abutments Straight/Angular, Flat connection abutments for casting, overdenture attachments. Titanium abutments are CNC machined with no anodized surface.

The provided document is a 510(k) summary for the SGS® Dental Implants System, used for dental implants and abutments. It details the device's characteristics and its equivalence to previously cleared devices. However, this document does not describe a study involving an AI/Machine Learning device, human readers, or image analysis for diagnosis.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI or a study proving an AI device meets those criteria, as the document pertains to mechanical dental implants and abutments, not a software or AI-based medical device.

The document discusses performance in terms of:

• Biocompatibility: Demonstrated as equivalent to the primary predicate based on the material (Ti6Al4V ELI) and leveraging prior biocompatibility testing per ISO 10993-1.
• Sterilization: Validated per ISO 11137 and ISO 17665, achieving a Sterility Assurance Level (SAL) of 10^-6.
• Shelf Life: Validated per ASTM F-1980 for 5 years.
• Mechanical Integrity (Fatigue Testing): Performed per ISO 14801 to verify the strength of the implant/abutment connection. Results are stated to have "demonstrated the performance" but no specific numerical acceptance criteria or detailed results are provided in this summary.

In summary, based on the provided document, I cannot answer the specific questions related to AI/ML device performance, human reader studies, or image analysis, as the device is a physical medical device (dental implants and abutments) and not an AI/ML diagnostic tool.

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