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 Angled Abutment is an angled abutment intended to be used with the Nobel Biocare NobelActive 3.0 implant system. The abutments are made of titanium vanadium alloy.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the NobelActive 3.0 Angled Abutment. This submission primarily relies on non-clinical testing to demonstrate substantial equivalence to a predicate device. It does not involve a study of an AI/ML powered medical device with acceptance criteria in the traditional sense of evaluating algorithmic performance.

Here's an analysis of why the requested information cannot be fully provided based on the given text, followed by the information that can be extracted:

No AI/ML Component: The device described is a dental implant abutment, a physical medical device made of titanium vanadium alloy. There is no mention of any artificial intelligence or machine learning component.
No "Acceptance Criteria" for Algorithmic Performance: The "acceptance criteria" here refer to satisfying the requirements of the FDA guidance for dental implants/abutments, specifically fatigue testing. These are not performance metrics for an algorithm (e.g., sensitivity, specificity).
No "Study that proves the device meets the acceptance criteria" in terms of algorithmic performance: The "study" mentioned is non-clinical fatigue testing, not a clinical or standalone study of an algorithm.
No Ground Truth, Experts, or Adjudication for Algorithms: These concepts are entirely irrelevant to a physical dental device.

Information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from FDA Guidance)	Reported Device Performance (from Non-Clinical Testing)
Withstand anticipated forces (as per 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."

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

Sample Size for Test Set: Not explicitly stated. The document mentions "non-clinical testing consisted of performance of fatigue testing," but does not provide details on the number of samples tested.
Data Provenance: Not applicable in the context of device performance data location; it's a non-clinical, laboratory-based test.

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 relates to interpretation of data for ground truth establishment. For a physical device, performance is typically measured through engineering tests, not expert interpretation of data.

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

Not applicable. No expert adjudication process is described for non-clinical fatigue testing.

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. This is a physical dental device, not an AI/ML powered device, so no MRMC study with AI assistance was performed.

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

No. This is a physical dental device, not an algorithm.

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

Not applicable. For this type of device, "ground truth" would be the measured physical properties and performance characteristics against established engineering standards and safety requirements. The "ground truth" for meeting acceptance criteria is the successful completion of the fatigue testing described in the FDA guidance document.

8. The sample size for the training set

Not applicable. No training set for an algorithm is mentioned or relevant.

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

Not applicable. No training set or associated ground truth establishment is mentioned or relevant.

Summary

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K111581

JUN 2 3 9

510(k) Summary of Safety and Effectiveness 1.4 ·

Submitted by:	Herbert CraneDirector, Global Regulatory Affairs
Address:	Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887
Telephone:	(714) 282-5074
Facsimile:	(714) 998-9348
Date of Submission:	June 6, 2011
Classification Name:	Endosseous Dental Implant Abutment (21 CFR 872.3630)
Trade or Proprietaryor Model Name:	NobelActive 3.0 Angled Abutment
Legally Marketed Devices: Nobel Biocare - NobelActive 3.0 (K102436)

Device Description:

The NobelActive 3.0 Angled Abutment is an angled abutment intended to be used with the Nobel Biocare NobelActive 3.0 implant system. The abutments are made of titanium vanadium alloy.

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 ال 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 Angled Abutments June 2011

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51υ(k) Summary of Safety and Effectivenes 1.4

Substantial Equivalence Comparison to Predicate Devices

CHARACTERISTIC	PREDICATE	CANDIDATE
	NobelActive 3.0(K102436)	NobelActive 3.0 Angled Abutments
Trade Name	NobelActive	NobelActive
Anatomical Site	Oral Cavity	Oral Cavity
Abutment Material	Titanium Vanadium Alloy	Titanium Vanadium Alloy
Abutment angulation	0 deg	15 deg
Implant/Abutment Connection	Internal Hex	Internal Hex
Indications for Use	The NobelActive 3.0mm implant is indicated for use in thetreatment of missing maxillary lateral incisors or themandibular central and lateral incisors to support prostheticdevices, such as artificial teeth, in order to restore chewingfunction in partially edentulous patients. The NobelActive3.0 implants may be put into immediate function providedthat stability requirements detailed in the manual aresatisfied.	The NobelActive 3.0mm implant is indicated for use in thetreatment of missing maxillary lateral incisors or themandibular central and lateral incisors to support prostheticdevices, such as artificial teeth, in order to restore chewingfunction in partially edentulous patients. The NobelActive3.0 implants may be put into immediate function providedthat stability requirements detailed in the manual aresatisfied.

Nobel Biocare Special 510(k) Notification
NobelActive 3.0 Angled Abutments
June 2011

000019

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Performance Standards 1.5

The Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments; Guidance for Industry and FDA Staff (May 12, 2004) was identified as applicable to this submission.

Nobel Biocare Special 510(k) Notification NobelActive 3.0 Angled Abutments June 2011

000020

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

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

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

JUN 2 3 2011

Re: K111581

Trade/Device Name: NobelActive 3.0 Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Il Product Code: NHA Dated: June 6, 2011 Received: June 7, 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.

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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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 (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely vours

Susan Runne

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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Indications for Use

510(k) Number (if known): KINSB)

Device Name: NobelActive 3.0

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 Runner

(Division Sign-Off) 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.)