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Indications for Use for Zygoma-S GM Implant:

Zygomatic implants are indicated for intraoral surgical procedures in the zygoma region in cases of severe maxilla bone resorption, to restore the patient's chewing function and aesthetics. Zygomatic Implants may be used in one or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load.

Indications for Use for GM Mini Conical Abutment 52° and 45°:

Product indicated for surgical procedures in zygomatic bones, making possible the rehabilitation with screw-retained abutments over the implant, thus restoring the chewing function. It may be used in one- or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load. Multiple rehabilitations may be splinted rigidly.

Indications for Use for Coping for Removable Prosthesis:

The product, when used with non-zygomatic implants, 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 multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with approprate occlusal loading. Multiple tooth applications may be rigidly splinted. When used with zygomatic implants, the product is indicated for surgical procedure only in upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used in two-stage procedures (delayed loading protocol) and for multiple unit restorations. Multiple rehabilitations may be splinted rigidly.

The subject devices implants are single use devices, provided sterile by Gamma Radiation, made of commercially pure Titanium grade 4 (ASTM F67). The Zygomatic Implant is a long implant with a nominal diameter of 3.50 and 3.75mm, conical apex with rounded tip, 3 helical chambers, trapezoidal thread and GM prosthetic interface. The cervical portion in both models has Ø 4.3 mm. The length varies from 30 to 55 mm. Zygomatic Implants are intended to provide support for a fixed prosthesis in patients with severe atrophy in the maxillary region. They are extra-long to allow bone anchorage in the zygomatic bone. The subject implants consider the Zygoma Anatomy-Guided approach (ZAGA) for planning the surgical steps, being indicated for extrasinus and extra maxillary installation technique (ZAGA-4).

The subject abutments are single use devices, provided sterile by Ethylene Oxide, made of Titanium alloy (Tl6Al4V-ELI). They are intermediate prosthetic components angled at 52 and 45 degrees with gingiva heights 1.5 and 2.5 mm, to be installed on the implant, offering a structure to support the screw-retained multiple prosthesis. The abutments present GM prosthetic interface and are available in the anti-rotational form in the implant to abutment interface, and rotational form in the abutment to prosthesis interface, presenting different transmucosal heights.

The subject coping is single use device, provided sterile by Ethylene Oxide, made of titanium alloy (Ti6Al4V-ELI). It presents a NEO torque interface for torque application. The subject device has diameter 4.80 mm and total height 4.60 mm. They are indicated for removable prostheses with fitting over Mini Conical Abutment installed in the maxilla or mandible and can be used in partial removable prostheses or over dentures. They are compatible with all previously cleared GM Mini Conical abutments.

The provided document is a 510(k) premarket notification for a medical device (Neodent Implant System - GM Zygomatic Implant System). It focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, technological characteristics, and performance data, primarily bench testing, sterilization validation, shelf life validation, and biocompatibility.

Crucially, this document does not contain information about an AI/ML algorithm or a study validating its performance, nor does it detail acceptance criteria for software or AI/ML components. The product being cleared is a set of dental implants and abutments. Therefore, I cannot extract the acceptance criteria and study details for an AI-powered device as requested.

The document discusses performance data in the context of the physical dental implants and abutments, which includes:

• Performance Testing – Bench: Dynamic fatigue testing (ISO 14801), insertion tests, torsion tests, and microscopic analysis of the implant body.
• Surface treatment: Discussion of the NeoPoros surface.
• MR Compatibility testing: Assessment of safety in MRI environments.
• Sterilization validation: Conformance to ISO standards for Gamma Irradiation (implants) and Ethylene Oxide (abutments).
• Shelf Life validation: Based on packaging integrity and physical stability.
• Biocompatibility: Testing per ISO 10993 standards.
• Clinical data: A review of published literature on zygomatic implants, including survival rates and observed complications (not a specific clinical study conducted for this device clearance).

If you are looking for information regarding acceptance criteria and study data for an AI/ML medical device, this document does not provide it, as it pertains to a different type of medical device.

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