NOBELREPLACE HEXAGONAL IMPLANT by NOBEL BIOCARE USA LLC

Nobel Biocare's NobelReplace Hexagonal Implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace Hexagonal Implants are indicated for single or multiple unit restorations. The NobelReplace Hexagonal Implants can be used in splinted or non-splinted applications. The NobelReplace Hexagonal Implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

Device Description

NobelReplace Hexagonal Implants are threaded, root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients.

The NobelReplace Hexagonal Implants are similar in design to the implants cleared under NobelReplace Tapered Conical Connection, K062566. The predicate internal square was changed to internal bexagonal connection.

AI/ML Overview

This document is a 510(k) summary for a medical device called "NobelReplace Hexagonal Implants." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials with pre-defined acceptance criteria for performance metrics like sensitivity, specificity, or accuracy.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the context of typical AI/diagnostic device performance studies.

Here's why and what information is available:

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

Not Applicable. The document is a 510(k) summary for a dental implant. It aims to show that the new implant (NobelReplace Hexagonal Implant) is substantially equivalent in design and intended use to a previously cleared implant (NobelReplace Tapered Conical Connection, K062566).
The "performance" described relates to the design changes (internal square was changed to internal hexagonal connection) and how these changes do not alter the fundamental safety and effectiveness of supporting prosthetic devices for esthetics and chewing function. There are no performance metrics like sensitivity or specificity because it's a physical implant, not a diagnostic algorithm.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. No test set or data of this nature is mentioned or required for this type of device submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No ground truth establishment for a diagnostic test is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable.

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 a diagnostic device that would involve human readers or AI assistance.

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

Not Applicable. This is a physical implant, not an algorithm.

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

Not Applicable. For this device, "ground truth" would be related to the established clinical efficacy and safety of the predicate device and the new device's ability to maintain those characteristics through design equivalency.

8. The sample size for the training set

Not Applicable. No training set is involved for this type of device submission.

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

Not Applicable.

Summary Pertaining to the Provided Document (KO-73142):

The document is a US FDA 510(k) summary for a dental implant. Its purpose is to demonstrate substantial equivalence to a predicate device, not to present performance data from a clinical study on diagnostic accuracy or AI performance. The key points from the document are:

Device Name: NobelReplace Hexagonal Implant
Predicate Device: NobelReplace Tapered Conical Connection (K062566)
Key Change: The internal connection was changed from a square to a hexagonal design.
Demonstration of Performance/Equivalence: The submission implies that this design change does not alter the fundamental indications for use or the safety and effectiveness of the device compared to the predicate. The FDA's review and clearance indicate their agreement with this assessment of substantial equivalence.
Acceptance Criteria (Implied for 510(k)): The "acceptance criteria" in this context are primarily regulatory – demonstrating that the device is as safe and effective as a legally marketed predicate device, and that any technological differences do not raise different questions of safety and effectiveness. This is achieved through detailed device descriptions, comparison tables (which are not in the provided snippet but would be part of a full 510(k)), and potentially mechanical testing (though not explicitly detailed in this short summary) rather than clinical performance metrics for a diagnostic algorithm.

Summary

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KO-73142

1.4 510(k) Summary of Safety and Effectiveness

Submitted by:	Kam Leung, Ph.D., RACSenior Regulatory Affairs Specialist
Address:	Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887
Telephone:	(714) 282-4800, ext. 7842	JAN 11 2008
Facsimile:	(714) 282-9023
Date of Submission:	November 6, 2007
Classification Name:	Endosseous dental implant (21CFR872.3640)
Trade or Proprietaryor Model Name:	NobelReplace Hexagonal Implant

Legally Marketed Device(s): NobelReplace Tapered Conical Connection (K062566)

Device Description:

Indications for Use:

Nobel Biocare's NobelReplace Hexagonal Implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace Hexagonal Implants are indicated for single or multiple unit restorations. The NobelReplace Hexagonal Imvlagonal be used in splinted or non-splinted applications. The NobelReplace Hexagonal Implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with healthcare, consisting of a staff with two snakes entwined around it. The seal is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

JAN 11 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nobel Biocare AB C/O Kam Leung, Ph.D., RAC Senior Regulatory Affairs Specialist Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K073142

Trade/Device Name: NobelReplace Hexagonal Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: DZE Product Code: II Dated: January 7, 2008 Received: January 8, 2008

Dear Dr. Leung:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Dr. Leung

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Snyte y. Michie Omd.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1.3 Indication for Use

510(k) Number (if known):

Device Name: NobelReplace Hexagonal Implants

Indication For Use:

(Division Sign-Off) Susen Runno

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Prescription Use
(21 CFR Part 801 Subpart D)

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

And/Or

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.