The NobelActive 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.

Device Description

The NobelActive 3.0 GoldAdapt Abutment is an abutment intended to be used with the Nobel Biocare NobelActive 3.0 implant system. The abutments are made of a gold alloy.

AI/ML Overview

The provided text describes a 510(k) submission for a dental abutment. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy through clinical or standalone performance studies with specific acceptance criteria as you've outlined for AI/software devices.

Therefore, many of the requested categories (acceptance criteria, sample size, ground truth, experts, MRMC, standalone performance, training set) are not applicable to this document. The "device performance" in this context refers to non-clinical fatigue testing to ensure the device's mechanical strength is adequate and comparable to predicates.

Here's a breakdown based on the provided text, indicating where information is not available or not applicable for a traditional AI/software device evaluation:

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

Acceptance Criteria (Internal/Guidance-based)	Reported Device Performance
Withstand anticipated forces (Implied from FDA guidance: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments for fatigue testing).	"The testing indicates that the device is strong enough to withstand the anticipated forces."

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

Sample Size: Not specified. This typically refers to the number of physical abutments subjected to fatigue testing.
Data Provenance: Not applicable in the context of clinical data for this type of device. The testing is non-clinical/mechanical.

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. This is a non-clinical, mechanical device. "Ground truth" would refer to the physical properties and performance measured during fatigue testing, not expert interpretation.

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

Not Applicable. This is a non-clinical, mechanical device. Adjudication methods are typically used for expert review of clinical cases.

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

No. The document explicitly states: "No clinical testing was performed." MRMC studies apply to AI-assisted diagnostic tools involving human readers.

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

Not Applicable. This is a physical, non-AI dental abutment.

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

Not Applicable. The "ground truth" for this device's performance is determined by the physical results of fatigue testing, measured against established engineering standards (e.g., ability to withstand anticipated forces, as outlined in FDA guidance for dental implants).

8. The sample size for the training set

Not Applicable. This is a non-AI, physical medical device. There is no training set as would be found in machine learning.

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

Not Applicable. This is a non-AI, physical medical device. There is no training set or ground truth establishment relevant to AI/software development.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets its (implicit) acceptance criteria is a non-clinical fatigue testing study.

Methodology: The testing was conducted "in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." This guidance outlines the specific mechanical tests and acceptance criteria for demonstrating the durability and strength of such devices.
Results: The testing indicated "that the device is strong enough to withstand the anticipated forces."
Conclusion: Based on this non-clinical data, the device was deemed "substantially equivalent" to predicate devices, satisfying the requirements for 510(k) clearance by demonstrating comparable safety and effectiveness, particularly in terms of mechanical integrity.

Summary

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510(k) Summary of Safety and Effectiveness 1.4

Kl b2259

Submitted by:	Herbert CraneDirector, Global Regulatory Affairs	OCT 28 2011
Address:	Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887
Telephone:	(714) 282-5074
Facsimile:	(714) 998-9348
Date of Submission:	August 5, 2011
Classification Name:	Endosseous Dental Implant Abutment (21 CFR 872.3630)
Product Code:	NHA
Trade or Proprietaryor Model Name:	NobelActive 3.0 GoldAdapt Abutment
Legally Marketed Devices:	Nobel Biocare -- NobelActive 3.0 (K102436)

Device Description:

The NobelActive 3.0 GoldAdapt Abutment is an abutment intended to be used with the Nobel Biocare NobelActive 3.0 implant system. The abutments are made of a gold alloy.

Nobel Biocare - NobelActive GoldAdapt Abutment (K083100)

Indications for Use:

Non-Clinical Testing:

Non-clinical test data was used to support the decision of substantial equivalence. Non-clinical testing consisted of performance of fatigue testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing indicates that the device is strong enough to withstand the anticipated forces.

Clinical Testing;

No clinical testing was performed. Non-clinical test data was used to support the decision of safety and effectiveness.

Conclusions:

The testing indicates that the abutments are substantially equivalent to the identified predicates.

Nobel Biocare Special 510(k) Notification NobelActive 3.0 GoldAdapt Abutment August 2011

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510(k) Summary of Safety and Effectiveness 1.4

Substantial Equivalence Comparison to Predicate Devices

CHARACTERISTIC	PREDICATENobelActive GoldAdapt Abutment(K083100)	PREDICATENobelActive 3.0(K102436)	CANDIDATENobelActive 3.0 GoldAdaptAbutment
Trade Name	NobelActive	NobelActive	NobelActive
Anatomical Site	Oral Cavity	Oral Cavity	Oral Cavity
Abutment Material	Gold Alloy	Titanium Vanadium Alloy	Gold Alloy
Abutment angulation	0 deg	0 deg	0 deg
Implant/AbutmentConnection	Internal Hex	Internal Hex	Internal Hex
Indications for Use	Nobel Biocare's NobelActive implantsare endosseous implant intended tobe surgically placed in the bone of theupper or lower jaw arches to providesupport for prosthetic devices, suchas an artificial tooth, in order torestore patient esthetics and chewingfunction. Nobel Biocare's NobelActiveimplants are indicated for single ormultiple unit restorations in splinted ornon-splinted applications. NobelBiocare's NobelActive implants maybe placed immediately and put intoimmediate function provided that initialstability requirements detailed in themanual are satisfied.	The NobelActive 3.0mm implant isindicated for use in the treatment ofmissing maxillary lateral incisors or themandibular central and lateral incisorsto support prosthetic devices, such asartificial teeth, in order to restorechewing function in partially edentulouspatients. The NobelActive 3.0 implantsmay be put into immediate functionprovided that stability requirementsdetailed in the manual are satisfied.	The NobelActive 3.0mm implant isindicated for use in the treatment ofmissing maxillary lateral incisors orthe mandibular central and lateralincisors to support prostheticdevices, such as artificial teeth, inorder to restore chewing function inpartially edentulous patients. TheNobelActive 3.0 implants may be putinto immediate function providedthat stability requirements detailed inthe manual are satisfied.

Nobel Biocare Special 510(k) Notification
NobelActive 3.0 GoldAdapt Abutment
August 2011

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 2 8 2011

Nobel Biocare AB C/O Mr. Herbert Crane Director, Global Regulatory Affairs Nobel Biocare USA LLC 22715 Savi Ranch Parkwav Yorba Linda, California 92887

Re: K112259

Trade/Device Name: NobelActvie 3.0 GoldAdapt Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 27, 2011 Received: September 28, 2011

Dear Mr. Crane:

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. 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.

lf 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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Page 2- Mr. Crane

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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510(k) Number (if known):

Device Name: NobelActive 3.0 GoldAdapt Abutment

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumer

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 1

510(k) Number

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)