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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Implied by Substantial Equivalence Goal)	Reported Device Performance (as demonstrated in submission)
Indications for Use: Identical to Predicate K192651	Identical to Predicate K192651
Technological Characteristics: Similar to Predicate K192651 (Implant design, diameter, platform angle, prosthetic diameter, interface, material, endosseous surface, sterility method, usage)	Identical in most aspects (design, diameter, platform angle, prosthetic diameter, interface, material, endosseous surface, sterility, usage). Differences in implant lengths are addressed by clinical and non-clinical data.
Material: Unalloyed titanium (ASTM F67) Grade 4	Manufactured from unalloyed titanium conforming to ASTM F67.
Sterilization Method: Gamma irradiation	Sterilized via Gamma irradiation.
Mechanical Performance: Meet ISO 14801 standards (for dynamic compression-bending fatigue)	Referenced from K192651 on worst-case constructs; additional lengths do not warrant new testing as per rationale. Existing data demonstrates performance exceeds indication.
Biocompatibility: Compliant	Referenced from K192651; materials are identical.
Sterile Barrier Shelf Life: Compliant	Referenced from K192651.
Bacterial Endotoxin: Compliant	Compliant with USP 39-NF34.
MR Safety: Compliant with FDA Guidance	MR Conditional labeling based on scientific rationale and published literature.
Clinical Performance: Support additional lengths	A clinical case report and two published articles support the use of longer zygomatic implants, including the new lengths.

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.

Summary

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Southern Implants (Pty) Ltd Leith Cumming Acting Head of Regulatory Affairs and Quality 1 Albert Road Irene, Gauteng 0062 SOUTH AFRICA

Re: K222497

Trade/Device Name: Zaga Zygomatic System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: August 17, 2022 Received: August 18, 2022

Dear Leith Cumming:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K222497

Device Name

ZAGA Zygomatic System

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )	☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

ZAGA Zygomatic System

Southern Implants (Pty) Ltd

K222497

November 9, 2022

ADMINISTRATIVE INFORMATION

Manufacturer Name	Southern Implants (Pty) Ltd1 Albert RoadIrene, Gauteng, 0062 South Africa
	Telephone: +27 12 667 1046Fax: +27 12 667 1029
Official Contact	Leith C. CummingActing Head of Regulatory Affairs and QualityEmail: leith.c@southernimplants.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	ZAGA Zygomatic System
Common Name	Dental implant
Classification Name	Endosseous dental implant
Classification Regulation	21 CFR 872.3640, Class II
Product Code	DZE
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

PREDICATE DEVICE INFORMATION The primary predicate device is K192651.

INDICATIONS FOR USE STATEMENT

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

SUBJECT DEVICE DESCRIPTION

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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.

PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K192651); comparison and features; sterilization validation according to ISO 11137-1, ISO 11137-2, ISO 17665-1, ISO TS 17665-2; bacterial endotoxin according to USP 39-NF34; sterile barrier shelf life (referenced from K192651); MR safety evaluation and MR Conditional labeling as per the recommendations of the FDA Guidance Document "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment''; and static and dynamic compression-bending according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants (referenced from K192651 as the surgical protocol of the implants did not warrant the additional subject device lengths as a new worst-case for fatigue testing).

Non-clinical worst-case MRI review was performed to evaluate the metallic Straumann® ZAGA Zygomatic Implant System devices in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795; and Oriso, Kenta, Takuya Kobayashi, Makoto Sasaki, Ikuko Uwano, Hidemichi Kihara, and Hisatomo Kondo. "Impact of the static and radiofrequency magnetic fields produced by a 7T MR imager on metallic dental materials." Magnetic Resonance in Medical Sciences 15, no. 1 (2016): 26-33), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.

Clinical data submitted, referenced or relied upon to demonstrate substantial equivalence include: a clinical case report demonstrating the use of 60mm length zygomatic implants in a patient, and two published articles utilizing, among other implants, 60mm length zygomatic implants for patient rehabilitation. These articles are summarized below:

Parel et al. (Remote implant anchorage for the rehabilitation of maxillary defects. The Journal of . prosthetic dentistry 86.4 (2001): 377-381) presented a rationale for the use of remote bone sites and zygomatic implants for rehabilitating patients with maxillary defects. Parel et al. provide clinical data on the use of 59 zygomatic implants in lengths ranging from 25 to 60mm.
Fernández-Ruiz et al. (Evaluation of quality of life and satisfaction in patients with fixed prostheses on . zygomatic implants compared with the all-on-four concept: a prospective randomized clinical study. International Journal of Environmental Research and Public Health 18.7 (2021): 3426) present a prospective randomized clinical study comparing patient quality of life and satisfaction with their prosthesis on zygomatic implants versus the All-on-Four with conventional implants. This study reported 40 zygomatic cases in which zygomatic implants of lengths 35 - 60mm were used.

EQUIVALENCE TO MARKETED DEVICE

Southern Implants (Pty) Ltd submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

K192651, ZAGA Zygomatic System, Southern Implants (Pty) Ltd.

A comparison of the technological characteristics of the subject devices and the primary predicate devices is provided in the following table.

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	Subject Device	Primary Predicate Device
Comparison	Additional lengths of ZAGA Zygomatic Implant SystemSouthern Implants (Pty) Ltd	K192651ZAGA Zygomatic Implant SystemSouthern Implants (Pty) Ltd
Implant
Indications for Use Statement	Straumann® Zygomatic implants are intended to be implanted in the upper jaw arch to provide support for fixed dental prostheses in patients with partially or fully edentulous maxillae.All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.	Straumann® Zygomatic implants are intended to be implanted in the upper jaw arch to provide support for fixed dental prostheses in patients with partially or fully edentulous maxillae.All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product Code	DZE	DZE
Intended Use	Functional and esthetic rehabilitation of the edentulous maxilla.	Functional and esthetic rehabilitation of the edentulous maxilla.
Reason for Predicate/Reference	Not applicable	Implant design
Implant Design	Partially threaded root-form implants for placement into the zygoma.	Partially threaded root-form implants for placement into the zygoma.
Implant Diameter	ZAGA Round: 4.3 mm (coronal) taper to 3.4 mm (apical)ZAGA Flat: 4.3 mm (coronal with 3.35 mm flat) taper to 3.4 mm (apical)	ZAGA Round: 4.3 mm (coronal) taper to 3.4 mm (apical)ZAGA Flat: 4.3 mm (coronal with 3.35 mm flat) taper to 3.4 mm (apical)
Implant Length	ZAGA Round: 30, 32.5, 57.5, 60 mmZAGA Flat: 55, 57.5, 60 mm	ZAGA Round: 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 55 mmZAGA Flat: 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5 mm
Platform Angle, Relative to orthogonal to implant long axis	55° angulation at head of implant	55° angulation at head of implant
Implant Prosthetic Diameter	4.07 mm	4.07 mm
Implant Interface	External Hex	External Hex
Implant Material	Unalloyed titanium (ASTM F67) Grade 4, and UTS ≥ 900MPa (cold-worked)	Unalloyed titanium (ASTM F67) Grade 4, and UTS ≥ 900MPa (cold-worked)
Implant Endosseous Surface	Grit-blasted	Grit-blasted
How Provided
Sterility	Provided sterile	Provided sterile
Sterilization	Gamma irradiation	Gamma irradiation
Usage	Single-patient, single-use	Single-patient, single-use

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The Indications for Use Statement for the subject device is identical to the predicate device K192651.

The primary predicate device K192651 is for substantial equivalence of the subject device implant designs. The subject device implants have the same external hex connection, identical implant diameters, prosthetic platform angulation and diameter, material, endosseous surface, sterility status method, usage and compatible prosthetic components. The clinical evidence, in the form of a clinical case report and two publications, is for the substantial equivalence of the subject device implant lengths (see clinical performance data).

Substantial equivalence of the subject device implants in terms of biocompatibility is supported by the fact that materials are identical in formulation, processing, component interactions, and storage conditions to the predicate devices in K192651.

In support of substantial equivalence of the additional lengths of ZAGA zygomatic implants in terms of mechanical performance, dynamic compression-bending testing to ISO 14801 are referenced from K192651. Dynamic testing (referenced from K192651) was performed on worst-case subject device constructs. The additional lengths of the ZAGA zygomatic implants does not influence the results of this fatigue testing and so additional fatigue testing was not warranted for this submission. The results from the testing provided in K192651 are thus valid for the subject devices and demonstrates the fatigue performance of the subject device exceeds its indication.

CONCLUSION

The subject device and the predicate device have the same intended use and indications for use, have similar technological characteristics, and are made of the same materials. The subject device and the predicate device encompass a similar range of physical dimensions, including the same diameter of the implants, same prosthetic platform and same compatible abutment range. The differing total lengths of the subject device is supported by clinical data provided. The subject device and the predicate devices are packaged in similar materials and sterilized using the same methods.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.