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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.

The ZAGA zygomatic implants are partially threaded root-form dental implants with an external hexagonal abutment interface angled 55° at the head of the implant, and are threaded internally for attachment of mating abutments. The ZAGA zygomatic implants are provided in two designs: the ZAGA Round zygomatic implant (previously named the ZAGA Regular), coronally and apically threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in overall lengths ranging of 30 mm and the ZAGA Flat zygomatic implant (previously named the ZAGA Advanced), apically threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in overall lengths ranging from 30 mm, with a flat cut into the buccal-facing side of the implant body. Only the length 30, 32.5, 57.5 and 60 mm ZAGA Round zygomatic implants and length 55, 57.5 and 60 mm ZAGA Flat zygomatic implants are a subject of this submission. All ZAGA zygomatic 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 K192651. The subject device implants are manufactured in the same facilities using the same manufacturing processes as used for the Southern Implants predicate device previously cleared in K192651.

The provided text is a 510(k) Summary for the Southern Implants ZAGA Zygomatic System, a dental implant device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive independent clinical study data to meet specific numerical acceptance criteria for device performance.

Therefore, the document does not contain a table of acceptance criteria and reported device performance in the typical sense of directly measurable performance metrics (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence is demonstrated through a comparison of technological characteristics, materials, and intended use with a predicate device, supplemented by non-clinical and limited clinical data to support similarities or address differences.

However, based on the information provided, here's a breakdown of the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, this document does not present acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, or specificity) that a diagnostic AI device would typically have. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device, specifically:

• Identical Indications for Use: The subject device must have the same indications for use as the predicate.
• Similar Technological Characteristics: The subject device must have comparable design principles, materials, and other characteristics to the predicate.
• Safety and Effectiveness: Demonstrated through non-clinical data (biocompatibility, sterilization, MR safety, mechanical testing) and limited clinical data, showing that any differences do not raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and the Data Provenance

This is not a traditional test set/training set scenario for an AI device. The submission relies on non-clinical testing and existing clinical literature.

• Non-clinical Data:
  • Mechanical Testing (ISO 14801): Referenced from K192651. The sample sizes are not explicitly stated in this document but are implied to be sufficient for the prior clearance. It's a lab-based, engineering test.
  • Biocompatibility, Sterilization Validation, Shelf Life, Bacterial Endotoxin, MR Safety: These are typically in-vitro or bench tests with specific sample sizes per standard, but the exact numbers are not detailed here. Much of this is "referenced from K192651," meaning the data was established for the predicate device.
• Clinical Data:
  • Clinical Case Report: 1 patient for the 60mm length zygomatic implant. The country of origin and whether it's retrospective or prospective are not specified, but case reports are typically retrospective observations.
  • Parel et al. (2001): 59 zygomatic implants (lengths 25-60mm). This is a published article; details on provenance (country, retrospective/prospective) are not provided in this summary but are usually available in the full publication.
  • Fernández-Ruiz et al. (2021): 40 zygomatic cases (lengths 35-60mm). This is reported as a "prospective randomized clinical study." Details on country of origin are not included here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable to this type of 510(k) submission. This is not an AI diagnostic device where expert ground truth for interpretation is established. The "ground truth" for the device's function is its mechanical integrity, biocompatibility, and clinical performance as an implant, supported by engineering standards and clinical observations/studies.

4. Adjudication Method for the Test Set

Not applicable. As there is no "test set" requiring interpretation or classification by experts, no adjudication method (like 2+1, 3+1) was used.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device, so MRMC studies comparing human readers with or without AI assistance are not relevant here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm. It is a physical medical device (dental implant).

7. The Type of Ground Truth Used

The "ground truth" for this medical device submission is established through:

• Engineering Standards: Bench testing against established international standards like ISO 14801 for mechanical properties.
• Regulatory Standards: Compliance with biocompatibility, sterilization, and MR safety guidelines.
• Clinical Outcomes/Acceptance: Historical clinical use data (from published literature and case reports) demonstrating successful rehabilitation and patient satisfaction with similar zygomatic implants, particularly at the extended lengths.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device that uses a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable.

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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)
• 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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