BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM by NOBEL BIOCARE UAS INC

The Nobel Biocare Branemark System - Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover Screws and Accessories.

Device Description

The Nobel Biocare BRANEMARK SYSTEM® Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover screws and accessories.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the Nobel Biocare BRÅNEMARK SYSTEM® Zygomaticus Fixture System. It is an older document from 1997, and the information provided is typical for devices seeking substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria through clinical studies in the way modern AI/ML medical devices would.

Therefore, many of the requested categories for AI/ML device studies (like sample sizes for test/training sets, ground truth establishment, MRMC studies, effect sizes, etc.) are not applicable or present in this document.

The core of this submission is a comparison of technological characteristics to predicate devices to establish substantial equivalence.

Here's an attempt to fill in the table and address the questions based on the provided text, highlighting where information is not available:

Acceptance Criteria and Device Performance Study Summary (K970499)

This 510(k) submission primarily relies on demonstrating substantial equivalence to existing predicate devices. Performance acceptance criteria for a "new" device, as would be expected for an AI/ML device, are not explicitly defined or tested in the way typically required today. Instead, the "acceptance criteria" here implicitly revolve around demonstrating that the new device's components are technologically identical to the predicate components and serve the same intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Implicit from 510(k))	Stated Acceptance Criteria (Implied)	Reported Device Performance (as per submission)
Material Composition	Components made of titanium (same as predicate).	The device system "consists of fixtures and numerous components to be used in conjunction with the BRÅNEMARK SYSTEM® Zygomaticus Fixture System, including Fixtures, Drills, Hand Instruments, Cover Screws and accessories specific to the Zygomaticus Fixture System" and "components made of titanium." This matches the implicit understanding of the predicate devices.
Intended Use	To be used as an endosseous implant in the upper jaw for prosthetic support and chewing function restoration (same as predicate).	"The Nobel Biocare BRÅNEMARK SYSTEM® Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function." This aligns with the stated intended use of similar existing devices.
Technological Characteristics	Identical to corresponding predicate products.	"The technological characteristics between the components of Zygomaticus Fixture System and the corresponding predicate products, comparable components in the BRÅNEMARK SYSTEM® and the drill guide manufactured by Ace Surgical Supply Co. are identical." This is the core claim of the submission regarding performance/safety equivalence. No specific quantitative performance metrics are provided because the claim is identity with already-cleared devices.

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

Sample Size for Test Set: Not applicable. This submission does not describe a clinical performance study with a "test set" in the context of an AI/ML device. The "test" here is the comparison of technological characteristics to predicate devices.
Data Provenance: Not applicable. No clinical or dataset-based performance data is presented.

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

Number of Experts: Not applicable. No "ground truth" was established for a test set as would be done for an AI/ML device. The "ground truth" for this submission is essentially the understanding of the design and materials of the predicate devices.
Qualifications of Experts: N/A

4. Adjudication method for the test set

Adjudication Method: Not applicable. No test set requiring expert adjudication was described.

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

MRMC Study: No. This is not an AI-assisted device.

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

Standalone Performance: Not applicable. This is not an algorithmic device.

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

Type of Ground Truth: Not applicable in the context of AI/ML. The "ground truth" for this 510(k) is the established technological characteristics and intended uses of the predicate devices.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not an AI/ML device.

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

Ground Truth for Training Set Establishment: Not applicable.

Summary

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K970499

OCT 1 6 1997

Pre-market Notification February 6, 1997 Page -3-..............................................................................................................................................................................

VII. 510(k) Summary of Safety and Effectiveness

A. Name and Address

This Summary of Safety and Effectiveness is being submitted by Nobel Biocare USA, Inc., 777 Oakmont Lane, Suite 100, Westmont, IL 60559., Their telephone Sort, Inc., 177 Calinon extern on 2002, and the contact person will be Betsy Brown, the Director, Regulatory Affairs.

B. Name of the Device

This device consists of fixtures and numerous components to be used in conjunction with the BRÅNEMARK SYSTEM® Zygomaticus Fixture System, including Fixtures, Drills, Hand Instruments, Cover Screws and accessories specific to the Zygomaticus Fixture System.

C. The Predicate Product

The predicate products used in this Premarket Notification are other components marketed by Nobel Biocare including the Fixtures, K925762, Drills, K925770, Fixture Mount, K925775, Cover Screws, K925771, and Hand Instruments, K925774, K925483 and a tray, K953774. The predicate products also include a Drill Guide, K951510 which is manufactured by Ace Surgical Supply Co.

D. Description of the Device

E. Intended Use of the Device

The Nobel Biocare BRANEMARK SYSTEM® Zygomaticus Fixture System is intended to be used as an endosseous implant to be surgically placed in the upper jaw to support prosthetic devices such as artificial teeth and to restore a patient's chewing function.

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Pre-market Notification February 6, 1997 Page -4-Page -4------------------------------------------

F. Comparison of Technological Characteristics

The technological characteristics between the components of Zygomaticus Fixture System and the corresponding predicate products, comparable components in the BRANEMARK SYSTEM® and the drill guide manufactured by Ace Surgical Supply Co. are identical.

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OCT 16 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Ms. Betsy A. Brown Vice President, Regulatory Affairs Nobel Biocare USA, Incorporated 777 Oakmont Lane, Suite 100 ୧୦୧5ର Westmont, Illinois

K970499 Re : Branemark System Zygomaticus Fixture System Trade Name: Regulatory Class: III Product Code: DZE July 18, 1997 Dated: Received: July 23, 1997

Dear Ms. Brown:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Brown

through 542 of the Act for devices under the Electronic enrough Siz or on Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

K. Alatriot

Timothy A. Ulatows Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_

Zygomaticus Fixture System Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDI

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russer

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.