The Zimmer Patient Specific Ceramic Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for single or multipleunit restorations in anterior and pre-molar regions.

Device Description

The Zimmer® Patient-Specific Ceramic Abutment is a zirconia abutment for use with endosseous dental implants to provide support for prosthetic devices. The abutment is manufactured using individual patient-specific requirements to create a design that facilitates functional, as well as, esthetic restoration.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, specifically a dental abutment. It establishes substantial equivalence to a predicate device, which is a regulatory pathway to market a device without a full clinical trial for safety and effectiveness.

This document does not describe a study that uses acceptance criteria and reports device performance in the way that would typically be done for a diagnostic or AI-driven device. Instead, it focuses on demonstrating equivalence through material and general design features, and mechanical testing to establish substantial equivalence to a legally marketed predicate device.

Therefore, many of the requested categories for a study involving acceptance criteria, expert ground truth, sample sizes for test/training sets, and AI performance metrics are not applicable to this type of regulatory submission.

However, I can extract the relevant information where it exists:

Acceptance Criteria and Device Performance (Not Applicable in the traditional sense for this 510(k))

For a 510(k) submission like this, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device, rather than meeting specific performance metrics against a defined ground truth for a diagnostic task. The study mentioned is "mechanical testing" to show equivalence.

Acceptance Criteria Category	Reported Device Performance (Zimmer® Patient-Specific Ceramic Abutment)
Material composition equivalence to predicate device	Reported as "substantially equivalent to the predicate relative to material"
General design features equivalence to predicate device	Reported as "substantially equivalent to the predicate relative to... general design features"
Mechanical performance equivalence to predicate device	Reported as "substantially equivalent to the predicate as evidenced in mechanical testing"

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

As established, the criteria are for "substantial equivalence" rather than performance against a diagnostic gold standard.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated for mechanical testing in this summary. Mechanical testing typically involves a number of units sufficient to provide statistical confidence in the material and design properties.
Data Provenance: The mechanical testing would have been conducted by Zimmer Dental Inc. or a contracted lab. The document does not specify country of origin for the data or if it was retrospective/prospective, but mechanical testing is generally prospective in nature for a new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is not a study assessing diagnostic performance against expert opinion. Mechanical testing results are objective measurements.

4. Adjudication method for the test set:

Not Applicable. Mechanical testing does not involve adjudication of expert opinions.

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 device is a physical dental abutment, not an AI or diagnostic software.

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

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

7. The type of ground truth used:

Not Applicable in the context of expert consensus/pathology/outcomes data. For mechanical testing, the "ground truth" would be established engineering standards and the measured physical properties of the device (e.g., strength, durability, fatigue resistance) as compared to the predicate device.

8. The sample size for the training set:

Not Applicable. This device does not involve a "training set" in the context of AI or machine learning.

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

Not Applicable. This device does not involve a "training set" or "ground truth" in the AI sense.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo consists of a large, stylized letter Z inside of a circle. Below the circle, the word "zimmer" is written in a bold, sans-serif font, and below that, the word "dental" is written in a smaller, lighter font.

Zimmer Dental

510k No.: K080164

Page No .: A5-1

1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)

SEP 2 5 2008

Traditional 510(k) PRE-MARKET NOTIFICATION

510(k) SUMMARY (21CFR807.92(a))

Submitter's Information:

Name:	Zimmer Dental Inc.
Address:	1900 Aston Ave.
	Carlsbad, CA 92008-7308
Phone:	760-929-4300
Contact:	Melissa Burbage
Date Prepared:	September 16, 2008

1. Device Name: Zimmer® Patient-Specific Ceramic Abutment
  Device Classification Name: Endosseous Dental Implant Abutment
Predicate Device: ASTRA Tech, ZirDesign™ Ceramic Abutment 3.
1. Device Description:

1. Intended Use:
  The Zimmer® Patient Specific Ceramic Abutment is used as a terminal or intermediate abutment for a cemented prosthesis. The abutment can be used for a single or multiple-unit restoration in anterior and pre-molar regions.
1. Device Comparison:
  The new device is substantially equivalent to the predicate relative to material and general design features. In addition, the new device is substantially equivalent to the predicate as evidenced in mechanical testing.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 2008

Ms. Melissa Burbage Manager, Regulatory Affairs Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008

Rc: K080164

Trade/Device Name: Zimmer® Patient-Specific Ceramic Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 16, 2008 Received: September 19, 2008

Dear Ms. Burbage:

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 - Ms. Burbage

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Chiu S. Lin. Ph. D Division 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):

K080164

Zimmer® Patient-Specific Ceramic Abutment Device Name:

Indications For Use:

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumores

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

510(k) Number: Kos0164

Page 1 of 1

Page: Section A4-1

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.)