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Southern Implants ZAGA Zygomatic System implants are intended to be implanted in the upper jaw arch to provide support for fixed dental prostheses in patially or fully edentulous maxillae. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

This submission includes partially threaded root-form dental implants and mating abutments designed for placement into the zygomatic bone. All implants are provided with an external hexagon abutment interface angled 55° at the head of the implants are provided in two designs: the ZAGA Regular zygomatic implant, coronally and apically threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in overall lengths ranging of 35 mm and 55 mm; and the ZAGA Advanced zygomatic implant, apically threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in overall lengths ranging from 30 mm to 52.5 mm, with a flat cut into the buccalfacing side of the implant body.

This submission includes designs of the ZAGA screw-retained abutments in four gingival heights (1.5, 2.5, 3.5, and 4.5 mm) for use with the ZAGA zygomatic implants. The subject device abutments are for support of screwretained overdenture prosthetic restorations.

All subject device implants are manufactured from unalloyed titanium conforming to ASTM F67. The apically threaded portions of the implants have the identical aluminum oxide grit-blasted surface as the implants cleared in K173343. The subject device ZAGA screw-retained abutments are manufactured titanium conforming to ASTM F67, and have the same anodized surface treatment as the healing abutments cleared in K163634. All of the subject device components are manufactured in the same facilities using the same manufacturing processes as used for the Southern Implants previously cleared in K173343 and K163634.

The provided text is a 510(k) Summary for the Southern Implants ZAGA Zygomatic System (K192651). This document assesses the substantial equivalence of a new medical device to existing, legally marketed predicate devices. It does not describe acceptance criteria for an AI/algorithm-based device, nor does it detail a study proving such a device meets acceptance criteria.

The document specifically states under "PERFORMANCE DATA": "No clinical data were included in this submission." This indicates that the evaluation was based on non-clinical data, primarily engineering analysis and comparison to predicate devices, rather than a human-in-the-loop or standalone algorithm study.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving a device meets these criteria, as the input document does not contain this type of data for an AI/algorithm-based device.

The "Performance Data" section in the document focuses on:

• Biocompatibility (referenced from K173343 and K163634)
• Engineering analysis
• Dimensional analysis
• Sterilization validation (according to ISO 11137-1, ISO 11137-2)
• Bacterial endotoxin (according to USP 39-NF34<85>)
• Sterile barrier shelf life (referenced from K173343)
• Static and dynamic compression-bending (according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants)

These are standard non-clinical tests for dental implants to demonstrate mechanical performance and safety, not for evaluating an AI algorithm's performance.

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