The Zimmer Zfx Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and the Zimmer Zfx Abutment Coping or Crown as part of a straight or angled two piece abutment. The combination of the titanium base stock abutment and the abutment coping is designed for use as a terminal or intermediate abutment for cement or screw retained prostheses. The two-piece abutment is used for a single-unit or multi-unit (bridge) restoration. The Zimmer ZFx Abutment Coping shall be manufactured by an approved Zimmer Dental milling facility.

Device Description

The Zimmer Zfx Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and the Zimmer Zfx Abutment Coping or Crown as part of a two piece abutment. The abutment is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment is used for single unit restorations in the anterior and posterior regions. The abutment base will be made available in 3.5, 4.5 and 5.7mm platforms. The Zimmer Zfx Titanium Base serves as a bonding base that allows for cementation of a patient-specific restoration. Copings, crowns and bridges can be used with the Zimmer Zfx Titanium Base.

The Zimmer Zfx Abutment Coping is a zirconia mesostructure component that would be cemented onto the Zimmer Zfx Titanium Base Abutment to form the two-piece abutment. These componenents will be manufactured from zirconia or IPS e.Max. The maximum angulation that is allowed is 20°. The two piece abutment would then be able to be used as a terminal or intermediate abutment for cement or screw retained prostheses that is for a single or multi-unit (bridge) restoration. The Zimmer Zfx Abutment Coping would require a separate crown to be cemented onto the coping or direct veneering to be applied.

AI/ML Overview

The provided text is a 510(k) Pre-Market Notification for the Zimmer Zfx Titanium Base Abutment. This document is a regulatory submission to the FDA, not a study report. Therefore, it does not contain a typical "acceptance criteria" table or a detailed "study" proving the device meets specific performance criteria in the way an academic or clinical study would.

Instead, the submission aims to demonstrate substantial equivalence to existing legally marketed predicate devices. This means showing that the new device is as safe and effective as devices already on the market, rather than meeting novel performance metrics.

Here's an analysis based on the information provided, addressing your points where possible and noting where information is not applicable to this type of document:

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

This document does not present a formal "acceptance criteria" table with specific quantitative performance metrics like sensitivity, specificity, or accuracy that would be typical for an AI/algorithm-based medical device study.

Instead, the "performance" is demonstrated by showing "substantial equivalence" through:

Identical intended use, materials, and abutment/implant interface design when compared to predicate devices.
Non-clinical mechanical testing demonstrating equivalence in mechanical strength.

The table in Section 7 ("Technological Characteristics") compares features of the new device to predicate devices, showing similarities in:

Indications for Use
Implant Interface (Internal Hex)
Abutment Platform Diameter (3.5mm, 4.5mm, 5.7mm)
Material (Titanium 6Al-4V for base, Zirconia for coping/crown)
Compatibility with CAD/CAM and Traditional patient-specific restorations

The implied acceptance criteria are that the new device's characteristics and mechanical performance should be no worse than the predicate devices. The reported "performance" is that it meets or exceeds these aspects.

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

This information is not provided. The "tests" mentioned are non-clinical mechanical tests, not clinical trials with human subjects. Thus, there's no "test set" in the sense of patient data.

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 submission for a dental abutment, not an AI or diagnostic device that requires expert-established ground truth from images or patient data. The "ground truth" for mechanical testing would be engineering specifications and ASTM/ISO standards, assessed by engineers, not medical experts establishing diagnostic ground truth.

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

Not applicable. As above, this is mechanical testing of a physical device, not an AI or diagnostic device that involves human perception or interpretation requiring adjudication.

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 is a physical dental device, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant.

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

Not applicable. This device does not involve an algorithm.

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

For the non-clinical mechanical testing, the "ground truth" would be established by relevant engineering standards (e.g., ISO, ASTM for dental implants and abutments) and direct physical measurements of mechanical strength (e.g., fatigue strength, fracture resistance) evaluated against established benchmarks for similar devices, particularly the predicate devices. The text states:

"The first test consisted of the Titanium base portion of the new device assembled in an abutment test setup. A hemispherical test cap, representing a final restoration, was cemented directly to the Titanium base portion of the device. The results demonstrated that the Titanium base portion of the new device is equivalent to the currently marketed Zimmer Hex Lock Abutment (K011028)."
"The second test evaluated the new device as a two-piece abutment system... The results demonstrated that the two-piece abutment system is substantially equivalent to the currently marketed Zimmer Pre-Angled Ti Abutment (K011028)."

The ground truth here is the established mechanical performance of identical or very similar legally marketed devices.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for a physical device.

Summary of Acceptance Criteria and Proving Device Meets Them for this 510(k) Submission:

Acceptance Criteria (Implied - Substantial Equivalence):
- Indications for Use: Must be substantially similar to predicate devices.
- Technological Characteristics: Must have similar design features, materials, and dimensions to predicate devices.
- Safety & Effectiveness: Non-clinical mechanical testing must demonstrate performance (e.g., mechanical strength) equivalent to or better than predicate devices.
- No new questions of safety or effectiveness.
Study Proving Acceptance:
- Non-Clinical Mechanical Testing:
  - Device Tested: Zimmer Zfx Titanium Base Abutment (both as a single component and as a two-piece system with a zirconia mesostructure).
  - Methodology: Two distinct mechanical tests were conducted:
    1. One for the Titanium base portion with a cemented hemispherical test cap.
    2. One for the two-piece abutment system (Titanium base + 20-degree angulated Zirconia mesostructure).
  - Comparison: The results were compared to the already marketed predicate devices: Zimmer Hex Lock Abutment (K011028) for the base portion and Zimmer Pre-Angled Ti Abutment (K011028) for the two-piece system.
  - Results: The tests demonstrated that the new device (both components and the system) is equivalent or substantially equivalent in mechanical strength to its respective predicate devices.
- MRI Compatibility Evaluation: Zimmer Dental implant systems were evaluated for interactions with magnetic fields during MRI, in accordance with FDA guidance. (No specific results provided, but implying compliance).
- Clinical Testing: Not performed. The justification was that the device is not significantly different from the predicate device and shares the same design features, technological characteristics, and indications for use.

In essence, for a 510(k) submission like this, the "study" demonstrating that the device meets "acceptance criteria" is a comparative analysis and non-clinical mechanical testing to prove it is as safe and effective as a device already approved for market (a predicate device), rather than meeting novel, pre-defined performance thresholds for a new capability.

Summary

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Zimmer Dental

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

JUL 1 8 2014

Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)

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

1. Submitter's Information:

Name:	Zimmer Dental Inc.
Address:	1900 Aston Ave.Carlsbad, CA 92008
Phone:	760-929-4315
Contacts:	Melissa BurbageKerry Foote

Date Prepared: June 13, 2014

1. Device Name: Trade Name: Regulation Number: Classification Code: Device Classification Name:
  Zimmer Zfx Titanium Base Abutment 872.3630 NHA Endosseous Implant, Abutment

3. Predicate Device(s):

Predicate Device No. 1 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name:

Predicate Device No. 2 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name:

Predicate Device No. 3 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name: Hex Lock Abutment K011028 872.3630 NHA Endosseous Implant, Abutment

Zimmer Pre-angled Ti Abutment K011028 872.3630 NHA Endosseous Implant, Abutment

Strauman® Variobase™ Abutments K132219 872.3630 -NHA Endosseous Implant, Abutment

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4. Device Description:

న . Indications for Use:

6. Device Comparison:

The new device is substantially equivalent to the predicate device, in that it is manufactured with the same material, has the same intended use, and contains the same abutment/implant interface design. The function in the endosseous implant system remains the same as the predicate devices. The new device is fabricated from Titanium alloy and utilizes the hex implant/abutment interface, which is identical in size and shape (for a given platform diameter) to the predicate device. The new device will be affixed to the implant by a retaining screw. In addition, the new titanium base is similar to that of the predicate device. The new device will be utilized with the same Zimmer Dental Product Lines as the predicate device. The Zimmer Zfx Titanium Base is designed with a shorter and narrower cone, when compared to the predicate device. By minimizing

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the size of the cone on the Titanium Base, the amount of metal available to be seen through the final restoration is minimized producing a more aesthetic finish.

7. Technological Characteristics

Feature	New Device	Predicate 1	Predicate 2	Predicate 3
	Zimmer Zfx Titanium BaseAbutment for Zimmer TaperedScrew-Vent Implant System	Zimmer Hex LockAbutment 510(k)K011028	Zimmer Pre-Angled TiAbutmentK011028	Strauman® Variobase™AbutmentsK132219
Indications	The Zimmer Zfx Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and the Zimmer Zfx Abutment Coping or Crown as part of a straight or angled two piece abutment. The combination of the titanium base stock abutment and the abutment coping is designed for use as a terminal or intermediate abutment for cement or screw retained prostheses. The two-piece abutment is used for a single-unit or multi-unit (bridge) restoration. The Zimmer ZFx Abutment Coping shall be manufactured by an approved Zimmer Dental milling facility.	For use as a terminal abutment for cemented prosthesis. Abutments are for single unit restorations. Single use.	For use as a terminal abutment for cemented prosthesis. Abutments are for single unit restorations. Single use.	Strauman® Variobase™ Abutments are pre-manufactured (stock) abutments intended to be placed onto Strauman dental implants to provide support for customized prosthetic restorations such as crown and bridges. Strauman® Variobase™ Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
ImplantInterface	Internal Hex	Internal, Hex	Internal, Hex	Various
AbutmentPlatformDiameter	3.5mm, 4.5mm, 5.7mm	3.5mm, 4.5mm, 5.7mm	3.5, 4.5, 5.7 mm	Various
Material	Titanium 6Al-4V (base)Zirconia (coping/crown)	Titanium 6Al-4V	Titanium 6Al-4V	Titanium 6Al-7Nb (base)Zirconia/Zerion(coping/crown)Acrylic/polycon(coping/crown)
Packaging	PETG tray	Cap/Vial	Cap/Vial	Not identified
Compatiblewith CAD/CAMpatient-specificrestorations	Yes	Yes	Yes	Yes
Compatiblewith Traditionalpatient-specificrestorations	Yes	Yes	Yes	Yes

Non-Clinical Testing:

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Zimmer Dental implant systems were evaluated for interactions with magnetic fields during Magnetic Resonance Imaging (MRI) in accordance with the FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment.

Additionally, in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments, nonclinical mechanical testing of the Zimmer Zfx Titanium Base Abutment was performed. Two different tests were conducted in order to characterize the mechanical strength of the new device. The first test consisted of the Titanium base portion of the new device assembled in a abutment test setup. A hemispherical test cap, representing a final restoration, was cemented directly to the Titanium base portion of the device. The results demonstrated that the Titanium base portion of the new device is equivalent to the currently marketed Zimmer Hex Lock Abutment (K011028). The second test evaluated the new device as a two-piece abutment system. The testing was performed with the Titanium base portion of the new device and a 20 degree angulated Zirconia mesotructure cemented together. The results demonstrated that the two-piece abutment system is substantially equivalent to the currently marketed Zimmer Pre-Angled Ti Abutment (K011028).

Clinical Testing:

In accordance with the FDA guidance Class II Special Controls Guidance Document: Rootform Dental Implants and Endosseous Dental Implant Abutments, clinical testing of the Zimmer Zfx Titanium two piece Abutment was not performed. The device is not significantly different from the predicate device and also contains the same design features, technological characteristics and indications as the currently marketed Zimmer Hex Lock Abutment (K011028).

9. Conclusion:

Based on our analysis, the device is substantially equivalent to the predicate.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle faces to the left. 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 Center - WO66-G609 Silver Spring, MD 20993-0002

July 18, 2014

Zimmer Dental, Inc. Melissa Burbage Associate Director, Regulatory Affairs 1900 Aston Ave. Carlsbad, CA 92008

Re: K133551

Trade/Device Name: Zimmer Zfx Titanium Base Abutments for Tapered Screw-Vent Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 16, 2014 Received: June 18, 2014

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. 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 - 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); medical device reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.lda.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 Industry and Consumer Education 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 yours,

Image /page/5/Figure/8 description: The image shows the name Tejashri Purohit-Sheth, M.D. twice, along with the acronym FDA in a stylized font. The text below the name indicates that Tejashri Purohit-Sheth, M.D. is a Clinical Deputy Director. The acronym DAGRID/ODE/CDRH is also present, followed by the word FOR.

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/2 description: The image shows a logo with the letter "Z" inside a circle at the top. Below the circle, the word "zimmer" is written in a bold, sans-serif font. Underneath "zimmer", the word "dental" is written in a smaller, less bold font.

Indications for Use

510(k) Number (if known): K133551

Device Name: Zimmer Zfx Titanium Base Abutments for Tapered Screw-Vent Implant System

Indications For Use:

The Zimmer Zfx, Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and the Zimmer Coping of Crown as part of a straight of a straight of a straight of a straight of a straight of a straight of
the abutment coping is designe cement or screw retained prostheses. The two-piece abutment is used for a single unit or multi-unit (bridge) restoration. The Zimmer ZFx Abutment Coping shall be manufactured by an approved Zimmer Dental milling facility!

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)

Lauren M. 2014.07.18
Giles-S 15:58:56
-04'00"

for SAG

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.)