NobelZygoma 0° implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Description

Nobel Biocare's NobelZygoma 0° implants are threaded, root-form titanium dental implants intended to be integrated in the Zygomaticus bone to support prosthetic devices, such as artificial teeth, in order to restore chewing function. The NobelZygoma 0° implants typically pierces the oral mucosa in the premolar region and passes through the sinus along the lateral wall of the maxilla. Depending on the contour of the lateral maxillary wall, the mid-portion of the implant may also pass lateral wall. The NobelZygoma 0° implants are available in lengths between 30 and 50 mm and have a 4.5 mm external hex connection. They are made of commercially pure titanium and have the Nobel Biocare TiUnite surface treatment.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding a dental implant, the NobelZygoma 0°. The key finding is that the submission is for a packaging modification of an already cleared device, not a new or modified device itself. Therefore, the questions related to AI/algorithm performance, training/test sets, ground truth establishment, expert consensus, and MRMC studies are not applicable to this document. The provided text does not describe an AI medical device or a study proving its performance against acceptance criteria in the way envisioned by the prompt.

However, I can extract information related to the "acceptance criteria" and "study" for the packaging modification as presented in this 510(k) summary.

Here's the analysis based on the provided text, focusing on the packaging modification:

1. A table of acceptance criteria and the reported device performance

For a packaging modification, the "acceptance criteria" relate to the ability of the new packaging to maintain sterility and device integrity over its shelf life. The "reported device performance" refers to the successful testing against these criteria.

Acceptance Criteria (for Packaging)	Reported Device Performance (from "Summary of Non-Clinical Testing")
Sterilization Efficacy	The sterilization method (Gamma radiation) is the same as the predicate device and has been validated in accordance with ANSI/AAMI/ISO 11137-1.2 & ISO 11737-1.2.
Package Integrity	Package integrity tests were performed on the modified packaging in accordance with ISO 11607-1 and ASTM F2096. No specific numerical performance values are given, but the conclusion states it was "evaluated for substantial equivalence."
Biocompatibility of Packaging	Biocompatibility of packaging was performed in accordance with ISO 11607-1 and ASTM F2096. No specific numerical performance values are given, but the conclusion states it was "evaluated for substantial equivalence."
Shelf Life (Stability)	Accelerated aging was performed on the new 3-layer packaging system as per ASTM F1980, F2096, and ISO 11607-1 to support a 5-year expiration date. Real-time aging is planned to validate the 5-year expiration date.

2. Sample sized used for the test set and the data provenance

The document does not specify the exact sample sizes (e.g., number of packages) used for the non-clinical tests (package integrity, accelerated aging). It states that "NobelZygoma 0° implant represents a worst case and data from the predicate device was leveraged to demonstrate substantial equivalence."

Sample Size: Not explicitly stated (e.g., how many packages were tested for integrity or aging).
Data Provenance: The tests are non-clinical, likely conducted in a lab setting by the manufacturer (Nobel Biocare AB/USA LLC). The document doesn't specify country of origin for the test data itself, but the applicant is based in Sweden and the US. The "study" is a non-clinical verification/validation testing process, not a clinical study on patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The "ground truth" for packaging validation is established by adherence to recognized international and national standards (ISO 11607-1, ASTM F2096, ISO 11137-1.2, ISO 11737-1.2). There is no "expert blinding and consensus" process for establishing ground truth in this context; it's about meeting pre-defined physical and biological performance standards for packaging.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials, especially for assessing image interpretations or outcomes where subjective judgment plays a role. Packaging performance is evaluated against objective, measurable standards.

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 document does not describe an AI device or a study involving human readers.

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

Not applicable. This document does not describe an AI algorithm or device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the packaging, the "ground truth" for performance is defined by the requirements of the standards cited:

ISO 11607-1 (Packaging for terminally sterilized medical devices)
ASTM F2096 (Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization)
ANSI/AAMI/ISO 11137-1.2 (Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices)
ISO 11737-1.2 (Sterilization of Medical Devices - Microbiological Methods - Part 1: Determination of a Population of Microorganisms on Products)
ASTM F1980 (Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices)

The "ground truth" is therefore adherence to these internationally recognized and standard-based performance metrics for medical device packaging and sterilization.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

December 4, 2018

Nobel Biocare AB Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887

Re: K183069

Trade/Device Name: NobelZygoma 0° Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: November 2, 2018 Received: November 5, 2018

Dear Charlemagne Chua:

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.

{1}------------------------------------------------

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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

for

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K183069

Device Name NobelZygoma 0°

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)	☐

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary K183069

Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden

Submitted by: Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887

Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348

Date Prepared: November 28, 2018

DEVICE

Name of Device: NobelZygoma 0°

Common or Usual Name: Endosseous Dental Implant Classification Name: Endosseous Dental Implant (21 CFR 872.3640) Regulatory Class: II Primary Product Code: DZE

PREDICATE DEVICE

Primary predicate Nobel Biocare - NobelZygoma 0º (K161598)

DEVICE DESCRIPTION

Implants:

The NobelZvgoma 0° implants typically pierces the oral mucosa in the premolar region and passes through the sinus along the lateral wall of the maxilla. Depending on the contour of the lateral maxillary wall, the mid-portion of the implant may also pass lateral wall.

The NobelZygoma 0° implants are available in lengths between 30 and 50 mm and have a 4.5 mm external hex connection. They are made of commercially pure titanium and have the Nobel Biocare TiUnite surface treatment.

{4}------------------------------------------------

INDICATIONS FOR USE

NobelZygoma 0º implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Characteristic		CANDIDATE	PREDICATE	Comparison
		NobelZygoma 0°	NobelZygoma 0° (K161598)
Features	ThreadDesign	Single lead thread	Single lead thread	Same
	ImplantBodyDesign	Parallel wall with 3 diameterstransition- 4.5 mm at the platform- 4.3 mm without thread at 9.5 mmfrom the platform- 5.0 mm at the apex at 18 mm fromthe apexThread starts from the apex andextends for 18 mm	Parallel wall with 3 diameterstransition- 4.5 mm at the platform- 4.3 mm without thread at 9.5 mmfrom the platform- 5.0 mm at the apex at 18 mm fromthe apexThread starts from the apex andextends for 18 mm	Same
	Implant TipDesign	Tapered with cut out flutes.	Tapered with cut out flutes.	Same
	ImplantLength	30, 35, 37.5, 40, 42.5, 45, 47.5, 50mm	30, 35, 37.5, 40, 42.5, 45, 47.5, 50mm	Same
	ConnectionType	0° straight, regular platform	0° straight, regular platform	Same
	Platformdesign	External hex, 4.5 mm	External hex, 4.5 mm	Same
	DeviceMaterial	CP Titanium grade 4 (ASTM F67)	CP Titanium grade 4 (ASTM F67)	Same
	Surface	TiUnite	TiUnite	Same
Intended Use/Principles ofOperation		Nobel Biocare's Zygoma implants areendosseous implants and areintegrated in the zygomatic bone(osseointegration). They are intendedto be used for anchoring orsupporting tooth replacements torestore chewing function.	Nobel Biocare's Zygoma implants areendosseous implants and areintegrated in the zygomatic bone(osseointegration). They are intendedto be used for anchoring orsupporting tooth replacements torestore chewing function.	Same
Indications forUse		NobelZygoma 0º implants areendosseous dental implants intendedto be surgically placed in the bone ofthe upper jaw arches to providesupport for prosthetic devices, suchas artificial teeth, in order to restorepatient esthetics and chewingfunction. The NobelZygoma Implantsare appropriate for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading	NobelZygoma 0º implants areendosseous dental implants intendedto be surgically placed in the bone ofthe upper jaw arches to providesupport for prosthetic devices, suchas artificial teeth, in order to restorepatient esthetics and chewingfunction. The NobelZygoma Implantsare appropriate for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading.	Same

Comparison of Technological Characteristics

Nobel Biocare Special 510(k) Notification NobelZygoma 0° November 2018

{5}------------------------------------------------

Analysis of Differences between Subiect Device and Predicate

The subject NobelZygoma 0° implant is same as the predicate device (K161598). The modification is made to the packaging of the subject device. The original shrink wrap and outer label on the vial is modified by adding a blister as a second sterile barrier and a carrier cardboard box for the label. The new NobelZygoma 0° implant packaging is composed of 3 packaging layers - tertiary packaging, secondary packaging and primary packaging. The subject device is not being modified.

The packaging modification does not affect the intended use of the device or alter the fundamental scientific technology of the device. The intended use of the subject device, as described in its labeling, has not changed as a result of the packaging modifications.

PERFORMANCE DATA

Summary of Non-Clinical Testing:

The following verification/validation testing was performed on the modified implant packaging system. NobelZygoma 0° implant represents a worst case and data from the predicate device was leveraged to demonstrate substantial equivalence.

Sterile Device Information
- The sterilization method of the subject device is the same as the predicate o device. The sterilization method is Gamma radiation and has been validated in accordance with ANSI/AAMI/SO 11137-1.2 & ISO 11737 1.2.
Device Packaging .
- o The packaging for the subject device is modified from the predicate device. Therefore, package integrity test, sterilization and biocompatibility of packaging was performed in accordance to: ISO 11607-1and ASTM F2096.
. Shelf Life
- o The packaging for the subject device is modified from that of the predicate with a 5-year expiration date labeled. Stability test - Accelerated aging was performed, on the new NobelZygoma 0° implant packaging composed of 3 packaging layers as per ASTM F1980, F2096 and ISO 11607-1 and real time aging is planned to validate 5 years expiration date.

CONCLUSIONS

The NobelZygoma 0° packaging system was evaluated for substantial equivalence using standard and/or comparative testing. Based on technological characteristics and non-clinical test data summarized in this submission, the subject NobelZygoma 0° has been shown to be substantially equivalent to the predicate NobelZygoma 0° Implant (K161598).

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.