TDS Zirconia Abutment for Nobel Biocare Branemark is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
This device is compatible with the following implant systems which have an external hex with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare: Branemark System® Mk III Groovy, Branemark System® Mk III Shorty, Branemark System® Zygoma, NobelSpeedy Groovy, NobelSpeedy Shorty; 3i: Nano Tite External Hex Connection Implants, Full OSSEOTITE External Hex Connection Implants, OSSEOTITE External Hex Connection Implant; BioHorizons: Maestro - External Hex Implants; Lifecore: Restore External Hex Implant Systems.

Device Description

TDS Zirconia Abutment for Nobel Biocare Branemark are zirconia abutments made of yttria-stabilized zircona (Y-TZP) designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Zirconia Abutment for Nobel Biocare Branemark is compatible with the following implant systems which have an external hex with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.

AI/ML Overview

This looks like a 510(k) premarket notification for a dental implant abutment, not a study describing the acceptance criteria or performance of an AI medical device. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting clinical study data for an AI algorithm.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and AI performance metrics cannot be extracted from this document.

Here's an assessment based on the provided text:

A table of acceptance criteria and the reported device performance
- Not applicable. This document is for a physical medical device (dental abutment), not an AI algorithm. It focuses on demonstrating substantial equivalence to a predicate device, not performance against specific clinical acceptance criteria in a study.
Sample sizes 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 clinical data is presented for performance evaluation.
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 test set is discussed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth is discussed in the context of an AI algorithm evaluation.
The sample size for the training set
- Not applicable. This is not an AI device that requires a training set.
How the ground truth for the training set was established
- Not applicable.

In summary, the provided document is a regulatory submission for a dental implant abutment, a physical medical device. It does not contain information about AI algorithm performance, clinical studies, acceptance criteria, or ground truth establishment as would be relevant for an AI-based medical device.

Summary

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

ﺔ ﻓ

510(k) Summary Pou Yu Biotechnology Co., Ltd JUL 3 0 2009 TDS Zirconia Abutment for Nobel Biocare Branemark

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Pou Yu Biotechnology Co., Ltd. No. 6 Fugong Rd. Fusing Township Changhua County 506, Taiwan Telephone: +886-(0)4 768 5660 x5122 Fax: +886-(0)4 768 9032

Official Contact:

Daniel Tsao

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulations:

Product Code: Classification Panel: Reviewing Branch:

TDS Zirconia Abutment for Nobel Biocare Branemark, Dental implant abutment Endosseous dental implant abutment Class II, 21 CFR 872.3630 NHA Dental Products Panel Dental Devices Branch

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

INTENDED USE

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

Pou Yu Biotechnology Co. Ltd demonstrated that, for the purposes of FDA's regulation of medical devices, TDS Zirconia Abutment for Nobel Biocare Branemark is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is in a smaller, sans-serif font.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Daniel Tsao Manager Pou Yu Biotechnology Company, Limited No. 6 Fugong Road Fusing Township Changhua County 506 TAIWAN

JUL 30 2009

Re: K091693

Trade/Device Name: TDS Zirconia Abutment for Nobel Biocare Branemark Regulation Number: 21 CFR 872.3630 Regulation Name; Preformed Cusp Regulatory Class: II Product Code: NHA Dated: June 5, 2009 Received: June 10, 2009

Dear Mr. Tsao:

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 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.

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

Page 2- Mr. Tsao

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/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Russer

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

501(k) Premarket Notification

TDS Zirconia Abutment for Nobel Biocare Branemark

Indications for Use .

510(k) Number (if known): K.091693

Device Name: TDS Zirconia Abutment for Nobel Biocare Branemark

Indications for Use:

This device is compatible with the following implant systems which have an external hex with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare: Branemark System® Mk III Groovy, Branemark System® Mk III Shorty, Branemark System® Zygoma, NobelSpeedy Groovy, NobelSpeedy Shorty; 3i: Nano Tite External Hex Connection Implants, Full OSSEOTITE External Hex Connection Implants, OSSEOTITE External Hex Connection Implant; BioHorizons: Maestro - External Hex Implants; Lifecore: Restore External Hex Implant Systems.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

ce of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number

Page 1 of 1

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.)