ITI® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.

Device Description

The ITI tapered implant is an addition to the currently distributed ITI Dental Implant System. The tapered implant is a solid screw with a TPS (titanium plasma sprayed) coating or an SLA surface (grit blasted then acid etched). The implants are composed of Grade 4 commercially pure titanium and is available in a range of lengths and diameters. This submission also includes abutments and healing caps which are used as accessories to dental implants.

AI/ML Overview

The provided documentation describes a 510(k) premarket notification for the ITI® Dental Implant System, specifically the ITI tapered implant. This submission focuses on establishing substantial equivalence to previously cleared devices rather than providing a detailed study proving performance against acceptance criteria. Therefore, several aspects of your request, such as specific acceptance criteria and detailed study results, cannot be fully addressed from the given text.

Based on the provided information, here's an analysis:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Intended Use	Identical intended use to predicate device.	The ITI tapered implant's intended use is identical to the cleared ITI self-tapping implant: "immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges or overdentures in edentulous or partially edentulous patients."
Material Composition	Same material composition as previously cleared ITI implants.	The subject tapered ITI implant has the same material composition (Grade 4 commercially pure titanium) as previously cleared ITI implants.
Surface Treatment	Same surface treatment as previously cleared ITI implants.	The tapered implant has the same surface treatment (TPS coating or SLA surface) as previously cleared ITI implants.
Design	Similar design to previously cleared ITI self-tapping implant.	The design of the tapered implant is similar to, and in some respects identical to, the previously cleared self-tapping ITI implant.
Substantial Equivalence	Demonstrated substantial equivalence to identified predicate devices (K003271, K990342).	The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Explanation: The "acceptance criteria" in this context are primarily based on demonstrating substantial equivalence to predicate devices, as this is a 510(k) submission. Therefore, the "reported device performance" is essentially the applicant's claim and the FDA's concurrence that the new device meets the criteria for substantial equivalence in terms of intended use, materials, design, and surface treatment. No specific quantitative performance metrics from a formal study are provided in this document.

2. Sample Size Used for the Test Set and Data Provenance

This document describes a 510(k) submission for substantial equivalence. It does not present a clinical study with a "test set" or data provenance in the way one would for a new clinical efficacy or safety trial. The assessment is based on a comparison to existing predicate devices and their known performance, along with material and design similarities.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This document does not describe the establishment of a "ground truth" through expert review for a clinical test set. The "ground truth" for a 510(k) is effectively the established safety and efficacy profile of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication method is described in this document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not mention or present any MRMC comparative effectiveness study, nor does it discuss AI assistance in the context of human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This document is about a physical dental implant device and does not involve an algorithm or AI.

7. Type of Ground Truth Used

The "ground truth" in the context of this 510(k) submission is the established safety and effectiveness profile of the legally marketed predicate devices (ITI Self-Tapping Implants K003271 and ITI Temporary Abutment K990342). The new device's characteristics (intended use, materials, design, surface treatment) are compared against these known, approved devices to demonstrate substantial equivalence.

8. Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/algorithm submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set described in the document.

In summary: This 510(k) document is a regulatory submission focused on demonstrating that a new dental implant (ITI tapered implant) is substantially equivalent to existing, legally marketed predicate devices. It achieves this by showing identical intended use and similar material composition, surface treatment, and design. It does not present data from a new clinical study with acceptance criteria, test sets, or ground truth establishment as would be seen in a clinical trial report or an AI device submission.

Summary

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AUG 2 2 2001

ATTACHMENT 7 - 510(k) Summary

Applicant's Name and Address 1.

Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 781-890-0001 Telephone Number: Fax Number: 781-890-6464 Linda Jalbert Contact Person: Director, Regulatory Affairs

Name of the Device 2.

Trade Name: Common Name: Classification Name: ITI® DENTAL IMPLANT SYSTEM Endosseous dental implants Endosseous dental implants 21 CFR 872.3640

Legally Marketed Devices to which Equivalence is Claimed (Predicate 3. Devices)
ITI Self-Tapping Implants (K003271) ITI Temporary Abutment (K990342)

Description of the Device 4.

This submission also includes abutments and healing caps which are used as accessories to dental implants.

5. Intended Use of the Device

The ITI tapered implant is intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges or overdentures in edentulous or partially edentulous patients.

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Basis for Substantial Equivalence 6.

The subject ITI self-tapping tapered dental implant is substantially equivalent to the previously cleared ITI self-tapping implant. The intended use is identical to the predicate device. The self-tapping implant is cleared for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges or overdentures in edentulous or partially edentulous patients. This is the identical intended use as the subject ITI tapered implant.

The subject tapered ITI implant has the same material composition and the same surface treatment as previously cleared ITI implants. In addition, the design of the tapered implant is similar to, and in some respects identical to, the previously cleared self-tapping ITI implant.

510(k) ITI® Dental Implant System 08/10/01 Page 53 of 56

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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 eagle with three stripes representing the agency's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2001

Ms. Linda Jalbert Director of Regulatory Affairs Straumann USA Reservoir Place, 1601 Trapelo Road 02154 Waltham, Massachusetts

Re : K012757 ITI Dental Implant System Trade/Device Name: 872.3640 Requlation Number: III Requlatory Class: Product Code: DZE Dated: August 15, 2001 August 17, 2001 Received:

Dear Ms. Jalbert:

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 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). 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 (Premarket Approval), 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 895. ਬੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory

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Page 2 - Ms. Jalbert

In addition, FDA may publish further announcements action. concerning your device in the Federal Register. 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.

This letter will allow you to begin 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 labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 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,

Olin S. Bair

Timothy A. Ulatowsk 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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Page 1 of 1

K012757 510(k) Number (if known):

Device Name: ITI® Dental Implant System

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ V (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-Herallel

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.