For use when screw retention of a single or splinted prosthesis is desired, e.g., single crown, bars and bridges. Implants must be within 30° of parallelism to each other for a splinted prosthesis.

Device Description

The Spline Engaging Shouldered Abutment System provides an antirotational option for single or multiple tooth prosthetic restorations. The components of this system are supplied non-sterile, for use by licensed dentists.

AI/ML Overview

This document is a 510(k) summary for a medical device (dental implant abutment system). It is a regulatory submission for pre-market notification to the FDA, demonstrating substantial equivalence to a predicate device. This type of document does not contain the kind of study information requested in your prompt. Medical device 510(k) submissions primarily focus on comparing a new device to an already legally marketed one concerning technological characteristics, materials, and intended use. They are generally not accompanied by extensive clinical studies demonstrating performance against acceptance criteria in the way described in your request. Such studies are more typical for Premarket Approval (PMA) applications, which involve higher-risk devices or novel technologies.

Therefore, I cannot extract the following information from the provided text:

Table of acceptance criteria and reported device performance: This document does not establish or report performance against specific acceptance criteria.
Sample sized used for the test set and the data provenance: No test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: 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: This device is a mechanical dental implant component, not an AI-assisted diagnostic or therapeutic tool.
If a standalone performance study was done: Not applicable in the sense of an algorithm's standalone performance.
The type of ground truth used: Not applicable.
The sample size for the training set: This device is a mechanical component, not an AI system that requires a training set.
How the ground truth for the training set was established: Not applicable.

The document states:

Device Trade Name: Spline Engaging Shouldered Abutment System
Intended Use: For use when screw retention of a single or splinted prosthesis is desired, e.g., single crown, bars and bridges. Implants must be within 30° of parallelism to each other for a splinted prosthesis.
Technological Characteristics: A modification to the shouldered abutment and associated components. Both the implant/abutment and abutment/coping interface engage the spline tines, providing anti-rotation. No change to the materials of this device.
Comparison Analysis: The overall design of the prosthetic components are similar or identical to the predicate devices.
Predicate Device: Sulzer Calcitek's existing Spline Dental Implant System.

This submission is purely about regulatory clearance based on substantial equivalence, not performance studies as outlined in your prompt.

Summary

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JUN 23 1997

K970752

510(K) SUMMARY RELEASABLE THROUGH FREEDOM OF INFORMATION

Pursuant to 513(i) of the Federal Food, Drug, and Cosmetic Act, as Amended.

Company Name:	Sulzer Calcitek, Inc.
Address:	2320 Faraday Avenue, Carlsbad, CA 92008
Telephone Number:	(619) 431-9515
Registration Number:	2023141
Contact Person:	Joseph S. Shan
Date Summary Prepared:	February 27, 1997

Classification Name: Implant, Endosseous (76DZE) Common/Usual Name: Dental Implant Abutment Spline Engaging Shouldered Abutment System Device Trade Name:

The primary device used for comparison purposes in this summary is Sulzer Calcitek's existing Spline Dental Implant System. All implant systems are manufactured in the same facility located in Carlsbad, California.

1. Intended Use:

For use when screw retention of a single or splinted prosthesis is desired, e.g., single crown, bars and bridges. Implants must be within 30° of parallelism to each other for a splinted prosthesis.

2. Description:

3. Technological Characteristics:

There has been a modification to the shouldered abutment and associated components. Both the implant/abutment and abutment/coping interface engage the spline tines, providing anti-rotation. There has been no change to the materials of this device.

4. Comparison Analysis:

The overall design of the prosthetic components are similar or identical to the predicate devices.

SUMMARY INFORMATION - RELEASABLE THROUGH FOI

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUM 4 V SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 23 1997

Mr. Joseph S. Shan Requlatory Affairs Associate Sulzer Calcitek Incorporate-2320 Faraday Avenue Carlsbad, California 92008

K970752 Re : Spline Engaging Shouldered Abutment System Trade Name: . Regulatory Class: II Product Code: DZE February 28, 1997 Dated: March 3, 1997 Received:

Dear Mr. Shan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include reguirements 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Fractice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to beqin marketing your device as described in your 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 labelinq requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Smafl Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

Timothy A. 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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Spline Engaging Shouldered Abutment System

INDICATIONS FOR USE

Spline Engaging Shouldered Abutment System --

For use when screw retention of a single or splinted prosthesis is desired, e.g., single crown, bars and bridges. Implants must be within 30° of parallelism to each other for a splinted prosthesis.

Sulzer Calcitek Dental Implant Systems

Sulzer Calcitek Dental Implant Systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm.

Susan Runner

Division Sign-Off sion of Dantal, Infoction 9 a d General Hospital D 5 ´O!k! Number

Prescription Use
(Per 21 CFR 801.109)

CONFIDENTIAL

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.