The Nobelpharma 17° Angulated Abutment is an abutment used with an endosseous implant. The abutment sits upon the implanted fixture and is used to support prosthetic devices and restore chewing functions in edentulous patients. The only modification is the narrowing of the base and external diameter of the abutment; and narrowing of the diameters of the abutment screws, adding one series of abutments to fit the smaller diameter fixtures previously cleared.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for a medical device called the "BRANEMARK SYSTEM® 17° Angulated Abutment." This submission is a modification of an already cleared device, K944962. The key information for your request is largely absent because this is a 510(k) submission for a modification to an existing device, and the documentation focuses on demonstrating substantial equivalence rather than presenting new performance study data with acceptance criteria for a novel device.

Here's an analysis based on the provided text, highlighting what is and isn't available:

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

Not provided. The document states that the "technological characteristics between the modified version of the 17° Angulated Abutment and the earlier version are identical." The changes are described as "minor dimensional changes to the diameter of the abutment and abutment screw." For a 510(k) for a minor modification, extensive performance testing with defined acceptance criteria is typically not required if the changes are deemed to not affect the safety or effectiveness. The submission relies on the predicate device's established safety and effectiveness.

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/Not provided. No new performance testing data (and therefore no test set sample size or provenance) is mentioned, as the device is a minor modification of an already cleared product.

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/Not provided. As no new performance studies are described, there's no mention of experts establishing a ground truth for a test set.

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

Not applicable/Not provided. No new performance studies are described, so no adjudication method is mentioned.

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 describes a dental implant abutment, not an AI-powered diagnostic device. Therefore, MRMC comparative effectiveness studies or human-in-the-loop performance details are irrelevant and not present.

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

Not applicable. This pertains to an abutment for an endosseous implant, which is a physical medical device, not an algorithm or software.

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

Not applicable/Not provided. Since no new performance studies are detailed, there is no mention of how "ground truth" was established. The effectiveness of the device is inferred from the predicate device through substantial equivalence arguments.

8. The sample size for the training set

Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no concept of a "training set."

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

Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no concept of a "training set" or establishing ground truth for it.

Summary of Device and 510(k) Context:

Device: BRANEMARK SYSTEM® 17° Angulated Abutment, an abutment for endosseous dental implants.
Modification: Narrowing of the base and external diameter of the abutment, and narrowing of the diameters of the abutment screws, to fit smaller diameter fixtures.
Predicate Device: The previous version of the same device, K944962.
Basis for Clearance: Substantial equivalence to the predicate device, based on the argument that the "technological characteristics... are identical" and the changes are "minor dimensional changes" that do not affect safety or effectiveness.
Intended Use: To be used in edentulous patients as an anchor to support a prosthesis.

In essence, this 510(k) submission for K961736 is for a minor modification of an already cleared device. The "study" proving it meets acceptance criteria is the argument of substantial equivalence to the predicate device, rather than new, extensive performance testing with explicit acceptance criteria. The FDA's clearance letter (SEP 17 2010) confirms the device's substantial equivalence to legally marketed predicate devices.

Summary

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

K961736

JUL 18 1996

Pre-Market Notification May 1, 1996 Page 2

510(k) Summary of Safety and Effectiveness VI.

A. Name and Address

This Summary of Safety and Effectiveness is being submitted by Nobelpharma USA, Inc., 777 Oakmont Lane, Suite 100, Westmont, IL 60559. Their telephone number is (708) 654-9100. The contact person will be the Director, Regulatory Affairs. This summary was prepared on May 1, 1996.

B. Name of the Device

This device is generally known as an abutment to an endosseous implant with the trade name BRANEMARK SYSTEM® 17° Angulated Abutment. This submission is a modification to an previously cleared device subject to K944962.

C. The Predicate Product

The predicate product used in this Premarket Notification is the previous version of the same device, 17° Angulated Abutment, K944962.

D. Description of the Device

E. Intended Use of the Device

The Nobelpharma 17° Angulated Abutment is intended to be used in edentulous patients as an anchor to support a prosthesis.

F. Comparison of Technological Characteristics

The technological characteristics between the modified version of the 17° Angulated Abutment and the earlier version are identical. The changes are minor dimensional changes to the diameter of the abutment and abutment screw.

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

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird-like figure in blue, with three distinct head profiles suggesting a sense of community or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem, with the words oriented to follow the curve of the circle.

Public Health Service

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

SEP 1 7 2010

Ms. Phuong Nguyen Son Regulatory Affairs Manager Nobel Biocare USA. LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K961736

Trade/Device Name: 17 Angulated Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHZ Dated: July 28, 2010 Received: July 29, 2010

Dear Ms. Nguyen Son:

This letter corrects our substantially equivalent letter of July 28, 2010.

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 (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 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.

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

Page 2- Ms. Nguyen Son

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/ucm115809.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

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

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

K961736 J(k) Number (if known):

Device Name: 170 Angulated Abutment

Indications For Use:

Intended to be used in edentulous patients as an anchor to support a prosthesis.

(PLEASE DO NOT WELTE BILOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(D sion Sign-Off) Susan Quo
Dsion of Dental, Infection Central,
ann General Hospital Deviced
510(k) Number ka la 1731,

Rx iption Use
(Per 21 CFR 801.109)

Over-The-Counter Usc

TO2

(Optional Format 1-2-96)

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.)