Implant Innovation, Inc., 3i, Dental Implants and Accessories are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.

3i Dental Accessories are indicated for use in surgical and restorative applications when placing dental implants.

Device Description

Dental implants are surgically inserted into the upper and/or lower jawbone and are left to heal (osseointegrate) with the bone for a period of up to six months. Upon healing and integration with the bone, the cover screw or healing abutment (if used) is removed, impressions are taken, and either a transmucosal abutment (which will later be attached to a custom prosthesis) or an emergence profile (EP) healing abutment is attached to the implant. The soft tissues are allowed to heal around the abutment forming the soft tissues to the contours of the abutment "emergence" profiling. The implant becomes the artificial root structure for a prosthetic tooth or as an abutment structure for bridge work and/or denture retention.

Implant Innovation's dental accessories are available in a wide range of sizes; and are manufactured from various materials.

This premarket notification relates to marketing previously non-sterile 31 dental accessories as sterile for user convenience. The devices are packaged in sterilizationcompatible packaging (heat-sealed nylon pouch) and sterilized by gamma irradiation.

There are no changes to the design, materials, or the Indications for Use for the accessories.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "3i Dental Accessories" seeking to market previously non-sterile dental accessories as sterile for user convenience. The acceptance criteria and the study to prove the device meets these criteria are outlined in the "PERFORMANCE DATA" section.

Here's a breakdown of the requested information:

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

Acceptance Criteria	Reported Device Performance
Mechanical strength after multiple exposures to gamma irradiation.	An analysis of the data demonstrated there were no significant differences in the materials pre- vs. post-sterilization.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated. The text mentions "multiple exposures of gamma irradiation" and "an analysis of the data," implying a set of accessories were tested, but the specific number (sample size) is not provided.
Data Provenance: This was an internal study conducted by the manufacturer, Implant Innovations, Inc., as part of their premarket notification. It's a prospective study designed to evaluate the impact of sterilization on their existing accessories. The country of origin is implicitly the USA, where the company is based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This study focused on the mechanical strength of the dental accessories after sterilization, not on interpreting diagnostic images or clinical outcomes that would require expert consensus for ground truth. The "ground truth" here is the objective measurement of mechanical strength.

4. Adjudication method for the test set

Not applicable. Since the study involves objective mechanical testing rather than interpretation by human readers, no adjudication method was used.

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-powered diagnostic device, and therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This is not a software device, but a physical medical device (dental accessories). The performance evaluation was a physical test on the devices themselves.

7. The type of ground truth used

The ground truth used was objective mechanical strength measurements. The "no significant differences in the materials pre- vs. post-sterilization" implies that the mechanical properties of the accessories before sterilization served as the baseline or ground truth against which the post-sterilization properties were compared.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a "training set." The study involved testing the physical properties of the dental accessories.

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

Not applicable, as there is no training set for this type of device and study.

Summary

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Image /page/0/Picture/1 description: The image is a logo for 3i Implant Innovations, Inc., a Biomet company. The logo features a large, bold "3" next to a stylized "i" that resembles a rectangular block. Below the numbers, the text "IMPLANT INNOVATIONS, INC." is written in a smaller, sans-serif font, with a line above it. Underneath that, the text "A BIOMET COMPANY" is written in an even smaller font.

COMPANY:

CONTACT:

SEP 1 9 2002

K 022113

Summary of Safety & Effectiveness

Implant Innovations, Inc. 4555 Riverside Drive Palm Beach Gardens, FL 33410

Jeannette G. Dailey, RAC Regulatory Affairs Manager Telephone: 561-776-6913 Fax: 561-776-6852 E-mail: jdailey@3implant.com

DATE PREPARED:

NAME OF THE DEVICE:

CLASSIFICATION:

COMMON NAME:

PREDICATE DEVICES:

June 27, 2002

3i Dental Accessories

DZE Class III

Endosseous Dental Accessories

3i Dental Accessories cleared for marketing via the following premarket notifications:

K935544 3i Implants ●
K952811 -- 3i Oral/Maxillofacial . Bone Fixation System
K962014 3i Single Use, . Disposable Drills, Taps, Burs
K962465 TIL313 Abutment and . Retaining Screw System
K965077 -- Single Tooth Abutment . System
. K992334 - Endosseous Implants and Abutments
K012911 3i Locater Abutment . System
K013570 OSSEOTITE® Dental . Implant System

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DEVICE DESCRIPTION:

Implant Innovation's dental accessories are available in a wide range of sizes; and are manufactured from various materials.

There are no changes to the design, materials, or the Indications for Use for the accessories.

INDICATIONS FOR USE:

PERFORMANCE DATA:

The accessories were subjected to multiple exposures of gamma irradiation and analyzed for mechanical strength. An analysis of the data demonstrated there were no significant differences in the materials pre- vs. post-sterilization.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jeanette G. Dailey Regulatory Affairs Manager Implant Innovations. Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

SEP 1 9 2002

Re: K022113

Trade/Device Name: 3i Dental Implant Accessories Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: III Product Code: DZE Dated: June 27, 2002 Received: June 28, 2002

Dear Ms. Dailey:

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 - Ms. Dailey

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 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.

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,

Patricia Cicerityfor

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

Enclosure

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Page 1 of 1

510(k) Number (if known): K022113_

Device Name: 3i Dental Accessories

Indications for Use:

3i Dental Accessories are indicated for use in surgical and restorative applications when placing dental implants.

(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:_

Susan Russo

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division Of Anton Dental Devices

510(k) Number: K081113

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.