The Sulzer Dental Ceramic System - Spline is intended for use specifically for anterior and premolar, single-unit cement-retained restorations. This product should not be used in the molars and should not be splinted together for multiple unit cases. partials or bridgework.

Device Description

The Ceramic System-Spline uses a titanium Spline core (abutment) and a ceramic coping. The core is attached to the implant with a titanium retaining screw. The coping is comented to the core for a final restoration. The core will be offered in three implant interface diameters, 3.25mm, 4.0mm, and 5.0mm. The Ceramic System coping is available in six shapes: small incisor, 17º small incisor, large incisor, 17º large incisor, canine, and premolar.

AI/ML Overview

The provided document is a 510(k) summary for a dental implant abutment (Sulzer Dental Ceramic System - Spline) seeking substantial equivalence to existing predicate devices. It does not describe a study involving algorithms, AI, or performance metrics typically associated with device acceptance criteria in the context of AI/ML.

Instead, this document focuses on demonstrating that a new medical device (a physical dental implant component) is substantially equivalent to legally marketed predicate devices. The "acceptance criteria" here refer to the criteria for substantial equivalence under FDA regulations, which involve comparing the new device's intended use, technological characteristics, and safety/effectiveness concerns to those of existing devices.

Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, or training set details because this submission is not about an AI/ML device.

The "acceptance criteria" in this context are established by the FDA's regulatory framework for 510(k) submissions, primarily evaluating substantial equivalence. The "study that proves the device meets the acceptance criteria" is the comparison analysis presented in the document, which argues for substantial equivalence based on a comparison to predicate devices, rather than a clinical trial or AI model validation study.

Here's a breakdown of what the document does provide, reframing the request to fit the content:

1. Table of Acceptance Criteria (for Substantial Equivalence) and Reported Device Performance (Characteristics):

Feature	Acceptance Criteria (Predicate Characteristics)	Reported Device Performance (Sulzer Dental Ceramic System-Spline Characteristics)
Intended Use	Anterior/Posterior Single-Unit and Multi-Unit Restoration Cases (Gold Coping) OR Anterior Single Unit Restoration Cases (FRIALIT-2® CeraBase)	Anterior and premolar, single-unit cement-retained restorations
Abutment Body Geometry	Straight Retentive Wall	Tapered Retentive Wall
Abutment/Implant Interface Diameter	3.25mm, 4.0mm, and 5.0mm (Gold Coping) OR 3.8mm, 4.5mm, 5.5mm, & 6.5mm (FRIALIT-2® CeraBase)	3.25mm, 4.0mm, and 5.0mm
Abutment Cuff Flare Dimater	4.5mm and 6.5mm (Gold Coping) OR Variable (FRIALIT-2® CeraBase)	4.5mm
Abutment Body Material	Gold Alloy (Gold Coping) OR Pure Titanium grade II (FRIALIT-2® CeraBase)	Titanium Alloy (Ti-6A1-4V)
Implant/Abutment Interface	Spline anti-rotational interface (Gold Coping) OR Hex anti-rotational interface (FRIALIT-2® CeraBase)	Spline anti-rotational interface
Ceramic Coping Material	N/A (Gold Coping) OR Aluminum Oxide (FRIALIT-2® CeraBase)	Zirconia Toughened Alumina
Manufacturing Site	Carlsbad, CA (Gold Coping) OR Meinnheim, Germany (FRIALIT-2® CeraBase)	Carlsbad, CA
Packaging	PETG tray and Tyvek® lid (Gold Coping) OR Blister pack combined w/ cardboard outer wrap (FRIALIT-2® CeraBase)	PETG tray and Tyvek® lid
Sterile	No	No

The "study" demonstrating this device meets "acceptance criteria" is the comparison analysis itself, which asserts that differences do not raise new questions of safety or effectiveness.

The following points are not applicable to this document as it pertains to a physical device approval based on substantial equivalence, not an AI/ML model.

2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of AI/ML validation is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML-based test set is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for the substantial equivalence claim is the performance and characteristics of the legally marketed predicate devices.
8. The sample size for the training set: Not applicable. No AI model is being trained.
9. How the ground truth for the training set was established: Not applicable.

Summary

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MAR 1 9 2002

510(K) Summary

Pursuant to 510 (i) of the Federal Food, Drug, and Cosmetic Act, as Amended.

Company Name: Sulzer Dental Inc. Address: 1900 Aston Avenue, Carlsbad, CA 92008-7308 Telephone Number: 760-929-4300 Registration Number : 2023141 Contact Person: Sean Hariri Date Summary Prepared: December 17, 2001 Classification Name: Endosseous Dental Implant Common/Usual Name: Abutment for Dental Implant System Device Trade Name: Sulzer Dental Ceramic System-Spline

The Primary device used for comparison in this summary is the Gold Coping Abutment (K943180) and the FRIALIT®-2 CeraBase Abutment (K980630)

1. Intended Use:

2. Description:

3. Technological Characteristics:

The Ceramic System-Spline is an additional abutment design for the Spline Dental implant system. The system consists of two parts, the titanium alloy abutment and the ceramic coping. The abutment will be fixed to the implant with a titanium alloy screw. The net ceramic coping will be bonded with porcelain by the laboratory to fabricate the finalized coping. The finished restoration is then cemented to the abutment,

4. Comparison Analysis:

The abutment of the Ceramic System-Spline is similar to the Sulzer Dental Gold Coping Abutment and the FRIALIT@-2 CeraBase Abutment. The ceramic coping of the Ceramic

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System is similar to commercial crowns used to fabricate a restoration. See Table 1 System is simmal to confinereial crown. System and the predicate systems.

and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contributi

Feature	Sulzer DentalCeramic System-Spline	Predicate: SulzerDental Gold CopingAbutment	Predicate:FRIALIT-2®CeraBaseAbutment
Intended Use	Anterior SingleUnit RestorationCases	Anterior/PosteriorSingle-Unit andMulti-UnitRestoration Cases	Anterior SingleUnit RestorationCases
Abutment BodyGeometry	Tapered RetentiveWall	Straight RetentiveWall	StraightRetentiveWall
Abutment/ImplantInterface Diameter	3.25mm, 4.0mm,and 5.0mm	3.25mm, 4.0mm,and 5.0mm	3.8mm, 4.5mm,5.5mm, &6.5mm
Abutment Cuff FlareDimater	4.5mm	4.5mm and 6.5mm	Variable
Abutment BodyMaterial	Titanium Alloy(Ti-6A1-4V)	Gold Alloy	Pure Titaniumgrade II
Implant/AbutmentInterface	Spline anti-rotational interface	Spline anti-rotationalinterface	Hex anti-rotationalinterface
Ceramic CopingMaterial	ZirconiaToughenedAlumina	N/A	Aluminum Oxide
Manufacturing Site	Carlsbad, CA	Carlsbad, CA	Meinnheim,Germany
Packaging	PETG tray andTyvek® lid	PETG tray andTyvek® lid	Blister packcombined w/cardboard outerwrap.
Sterile	No	No	No

Table: 1 Summary of Comparison

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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 consists of a stylized eagle or bird symbol, with three curved lines forming its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2002

Mr. Sean Hariri Regulatory Affairs Associate Sulzer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308

Re: K014214

Trade/Device Name: Sulzer Dental Ceramic System-Spline Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: December 20, 2001 Received: December 21, 2001

Dear Mr. Hariri:

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.

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.

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Page 2 - Mr. Hariri

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 and instills (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirelate as 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ti. A. Ulatowski

Timo Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Sulzer Dental Ceramic System-Spline______________________________________________________________________________________________________________________________

Indications for Use: The Sulzer Dental Ceramic System - Spline is intended for use specifically for anterior and premolar, single-unit cement-retained restorations. ase specifically for antorior and prother and should not be splinted together for multiple unit cases, partials or bridgework.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR	Over-The-Counter-Use
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

Signature

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

Number	K014214
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Page 3 of 3

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.