The abutment is placed into the dental implant to provide support for a prosthetic restoration such as a crown or bridge. The titanium temporary posts are screwed into the dental implants and serve as a base for a temporary prosthetic restoration. The plastic burn-out copings provide a cast inner surface for mating with the abutment and implant and are for use in casting restorations directly from porcelain- fused-to-metal alloy without the use of machined metal components. The healing cap and closure screw are titanium devices which are mounted onto the dental implant before the soft tissue is sutured in place around the implant and which are intended to protect the inner configuration of the implant. The healing cap also protects the outer 45° shoulder of the implant during the healing phase and helps stabilize and maintain the soft tissue.

Device Description

The ITI Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments, and surgical and prosthetic parts and instruments. The devices covered by this submission include several prosthetic accessories (abutment, titanium temporary posts, plastic burnout copings, and titanium healing caps).

AI/ML Overview

The provided text describes a 510(k) premarket notification for prosthetic accessories to the ITI Dental Implant System. It focuses on establishing substantial equivalence to previously cleared devices rather than on performing a new clinical study with acceptance criteria for a novel device performance.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not applicable. The document is a regulatory submission demonstrating that the new devices are similar in design, material, and intended use to existing, legally marketed devices.

Here's a breakdown of the information that can be extracted based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not contain explicit acceptance criteria or reported device performance in the way you might find for a diagnostic or AI-driven device. The basis for acceptance is "substantial equivalence" to predicate devices, meaning the new devices are considered safe and effective because they are fundamentally the same as devices already on the market.

Acceptance Criteria (Not explicitly stated, inferred from 510(k) process)	Reported Device Performance (Inferred from substantial equivalence claim)
Material Composition: Must be the same as or comparable to predicate devices.	"The subject devices have the same material composition as previously cleared ITI devices."
Design: Must be similar to or identical to predicate devices.	"the designs of the subject devices are similar to, and in some respects identical to, the previously cleared ITI devices."
Intended Use: Must be identical to predicate devices.	"The intended uses of the subject devices are identical to the predicate devices."

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

Not Applicable. This submission is not based on a clinical study with a test set of patient data. It is a comparison of product specifications (materials, design, intended use) against predicate devices.

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

Not Applicable. Ground truth in the context of a clinical test set is not established here. The FDA reviewers assess the substantial equivalence claim based on the provided documentation and their expertise in medical devices.

4. Adjudication Method for the Test Set:

Not Applicable. There is no test set or adjudication process as described for performance studies. The FDA's review process involves evaluation by agency experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This type of study is not mentioned or implied by the document. MRMC studies are typically used to assess the impact of a new diagnostic tool on human reader performance, which is not the purpose of this 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No. This refers to prosthetic accessories for dental implants, not a software algorithm or AI device.

7. The Type of Ground Truth Used:

Not Applicable. "Ground truth" as an outcome measure from a clinical study (e.g., pathology, long-term outcomes) is not the basis for this submission. The "ground truth" for the FDA's decision is the established safety and effectiveness of the predicate devices to which these new devices are compared.

8. The Sample Size for the Training Set:

Not Applicable. There is no training set mentioned, as this is not an AI/machine learning device or a clinical study.

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

Not Applicable. See point 8.

In summary: This document is a regulatory submission seeking clearance for medical devices based on their substantial equivalence to existing devices. It does not describe a clinical study with specific performance acceptance criteria, test sets, or ground truth establishment as would be found for a novel diagnostic or therapeutic device undergoing a performance evaluation.

Summary

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DEC 1 9 2001

ATTACHMENT 6 - 510(k) Summary

1. Applicant's Name and Address

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:

2. Name of the Device

Trade Name:

Common Name: Classification Name: Prosthetic Accessories to the ITI® DENTAL IMPLANT SYSTEM Endosseous dental implants Endosseous dental implants 21 CFR 872.3640

Director, Regulatory Affairs

3. to which Equivalence Claimed Legally Marketed Devices is (Predicate Devices)

ITI synOcta Abutment (K990342) ITI Temporary Posts (K990342) ITI Plastic Copings (K990342) ITI Healing Cap (K003271) ITI Closure Screw (K894844)

4. Description of the Device

5. Intended Use of the Device

510(k) ITI® Dental Implant System 1 1/07/01 Page 38 of 42

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Basis for Substantial Equivalence 6.

The subject devices are substantially equivalent to previously cleared ITI abutments, temporary posts, burn-out copings, healing caps, and closure screws. The intended uses of the subject devices are identical to the predicate devices.

The subject devices have the same material composition as previously cleared ITI devices. In addition, the designs of the subject devices are similar to, and in some respects identical to, the previously cleared ITI devices.

510(k) ITI® Dental Implant System 11/07/01 Page 39 of 42

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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 is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring a staff with a serpent entwined around it, representing health and medicine. The logo is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 92001

Institut Straumann AG C/O Ms. Linda Jalbert Straumann USA Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451

Re: K013798

Trade/Device Name: Prosthetic Accessories to the ITI Dental Implant System Regulation Number: Dental Implant Regulation Name: 872.3640 Regulatory Class: III Product Code: DZE Dated: November 7, 2001 Received: November 15, 2001

Dear Ms. Jalbert:

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

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Page 2 - Ms. Jalbert

of the Act or any Federal statutes and regulations administered by other Federal agencies. Of the Act of ally I ouchar stars requirements, including, but not limited to: registration Tourinust configry with and the rises ing (21 CFR Part 801); good manufacturing practice alle listing (21 OF R Pat 807), abolity 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 11ms letter will and w you is cognized and inding of substantial equivalence of your device to 310(K) promative nouricate 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 11 you dosire opveller FFR 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 Office of Confightance wee, 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 the rior nay of obtained 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,

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

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Page 1 of 1

510(k) Number (if known):

Prosthetic Accessories to the ITI® Dental Implant System Device Name:

Indications For Use:

The abutment is placed into the dental implant to provide support for a prosthetic restoration such as a crown or bridge. The titanium temporary posts are screwed into the dental implants and serve as a base for a temporary prosthetic restoration. The plastic burn-out copings provide a cast inner surface for mating with the abutment and implant and are for use in casting restorations directly from porcelain- fused-to-metal alloy without the use of machined metal components. The healing cap and closure screw are titanium devices which are mounted onto the dental implant before the soft tissue is sutured in place around the implant and which are intended to protect the inner configuration of the implant. The healing waren also protects the outer 45° shoulder of the implant during the healing phase and helps stabilize and maintain the soft tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

. Blackwell for M.S. Rumer

(Division Sian-Off Division of Dental, Infection Control. and General Hospital Devic 510(k) Number .

510(k) ITI® Dental Implant System 11/07/01 Page 42 of 42

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.