LEONE ORTHODONTIC MINI IMPLANT by LEONE SPA

The Leone orthodontic mini implant is an implant device providing a fixed anchorage for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily in the maxillary and mandibular bone and must be removed after orthodontic treatment has been completed.

Device Description

The Leone orthodontic mini implant is a medical device made of stainless steel for surgical use (ISO 5832-1). The orthodontic mini implant is a one-piece endosseous mini implant where the endosseous portion is a right-hand thread screw, while the head section is made of a smooth tapered neck. It is available in different diameters, lengths and head shapes.

AI/ML Overview

Here's an analysis of the provided text regarding the Leone orthodontic mini implant.

Acceptance Criteria and Study for the Leone Orthodontic Mini Implant

The provided 510(k) summary for the Leone orthodontic mini implant (K071490) focuses on demonstrating substantial equivalence to a predicate device, rather than presenting specific performance acceptance criteria and a detailed study proving the device meets those criteria. In the context of a 510(k) submission, "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The "study" described herein is the comparison and testing performed to establish this substantial equivalence.

1. Table of Acceptance Criteria and the Reported Device Performance

As mentioned, explicit, quantitative acceptance criteria are not stated in this summary. Instead, the "acceptance" is based on the new device being comparable to the predicate device across several key characteristics. The reported device performance is presented through a direct comparison with the predicate.

Characteristic	Acceptance Criterion (Implicitly "Substantially Equivalent to Predicate")	Reported Device Performance (Leone Orthodontic Mini Implant)	Predicate Device Performance (Dentos AbsoAnchor)
Product Code	Must match the predicate device's product code.	DZE	DZE
Regulation No.	Must match the predicate device's regulation number.	872.3640	872.3640
Intended Use	Must be the same or highly similar to the predicate device.	Provide a fixed anchorage for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. Used temporarily in maxillary and mandibular bone, removable after treatment.	Provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth.
Material	Must be biocompatible and suitable for the intended use.	Surgical stainless steel ISO 5832-1	Surgical titanium alloy ISO 5832-3
Biocompatibility	Must be biocompatible.	Biocompatible.	Biocompatible.
Sterility	Must be provided in a state that allows for appropriate sterilization.	Non-sterile. Recommended to sterilize with steam autoclave before use.	Non-sterile. Steam sterilize before use.
Performance	Supported by results of testing performed to demonstrate equivalence.	Concluded to be substantially equivalent based on testing (details not provided in summary).	N/A (predicate device is already marketed)

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

The summary does not explicitly state the sample size used for any testing. It mentions "results of the testing performed" but does not detail the nature of these tests (e.g., mechanical, biocompatibility, in-vivo, etc.), their design, or the sample size of any materials or subjects involved.

Regarding data provenance, the summary does not provide this information. Given the nature of a 510(k) for a device like an orthodontic mini implant, the "testing performed" would typically involve laboratory (bench) tests to evaluate mechanical properties and biocompatibility.

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

This information is not applicable to this 510(k) summary. The submission is a regulatory filing demonstrating substantial equivalence to a predicate device, not a clinical study requiring expert consensus on a test set to establish ground truth for a diagnostic or AI device.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

This information is not applicable. The device is an orthodontic mini implant, not an AI-powered diagnostic or decision support system that would involve human readers or AI assistance.

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

This information is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to diagnostic or AI studies is not directly relevant here. For this type of medical device 510(k), the "truth" is established through:

Compliance with recognized standards: Such as ISO 5832-1 for surgical stainless steel, which inherently assumes material suitability.
Bench testing: To verify mechanical properties (strength, fatigue, etc.) of the implant. The "ground truth" for these would be the specified engineering requirements or comparison to the predicate.
Biocompatibility testing: To ensure the material is non-toxic and suitable for implantation. These tests have defined endpoints that serve as their "ground truth."

The summary states equivalence is "supported by the results of the testing performed," implying these types of tests were conducted, but the specific "ground truth" for each is not detailed.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an orthodontic mini implant's regulatory submission, as it is not an AI/machine learning device.

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

This information is not applicable as there is no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Leone. The logo is in an oval shape with the word "leone" written in a stylized font. The background of the oval is black, and the text is white. The logo has a distressed or vintage look.

K071490

510(k) SUMMARY

Submitter's name: Address:

Leone SpA 50 Via P. a Quaracchi Sesto Fiorentino, Italy I-50019 Phone +39.055.30441 Fax +39.055.374808

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Name of contact person:

Elia Ladani Leone SpA 50 Via P. a Quaracchi Sesto Fiorentino, Italy I-50019 quality@leone.it Phone +39.055.30441 Fax +39.055.304444

Date the summary was prepared: August 3, 2007

Name of the device: Trade or proprietary name: Common or usual name: Classification name:

Leone orthodontic mini implant Leone orthodontic mini implant Orthodontic implant Endosseous Dental Implant

The legally marketed device to which we are claiming equivalence [21 CFR 807.92(a)(3)):

Dentos Inc, Dentos AbsoAnchor orthodontic microimplant (K060126)

Description of the device:

Intended use:

Leone SpA, Sesto Fiorentino - Italy

SECTION 5B - Page 1 of 2

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maxillary and mandibular bone and must be removed after orthodontic treatment has been completed.

Summary of the technological characteristics of our device compared to the predicate device:

Device Name	Leone orthodontic mini	Dentos AbsoAnchor
	implant	orthodontic microimplant
Product code	DZE	DZE
Regulation no.	872.3640	872.3640
Applicant	Leone SpA (Italy)	Dentos, Inc (Korea)
510(k)	This submission	K060126
Intended use	Provide a fixed anchoragefor attachment of orthodonticappliances to facilitate theorthodontic movement of theteeth. It is used temporarilyin the maxillary andmandibular bone and mustbe removed after orthodontictreatment has beencompleted.	Provide a fixed anchoragepoint for attachment oforthodontic appliances tofacilitate the orthodonticmovement of the teeth
Material	Surgical stainless steel ISO5832-1	Surgical titanium alloy ISO5832-3
Biocompatibility	Biocompatible.	Biocompatible.
Sterility	Non-sterile. It isrecommended to sterilizewith steam autoclave beforeuse.	Non-sterile. Steam sterilizebefore use.

Conclusion:

According to the similarities specified in the above comparison table between the current device Leone orthodontic mini implant and the predicate device, in indications for use, technology and performance specifications as supported by the results of the testing performed we conclude that the Leone orthodontic mini implant is substantially equivalent to the Dentos AbsoAnchor orthodontic microimplant, device currently marketed in USA under the Federal Food, Drug and Cosmetic Act.

The Leone orthodontic mini implant raises no new issues of safety or effectiveness. Therefore, safety and effectiveness are reasonably assured, and substantial equivalence is supported, justifying 510(k) clearance of the Leone orthodontic mini implant.

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with flowing ribbons or streamers extending from its body. The logo is rendered in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 22 2008

Mr. Elia Ladani Quality Manager Leone SpA 50 Via P. a Quaracchi Sesto Fiorentino I-50019 ITALY

Re: K071490

Trade/Device Name: Leone Orthodontic Mini Implant Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: February 11, 2008 Received: February 14, 2008

Dear Mr. Ladani:

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.

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Page 2 - Mr. Ladani

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. 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 (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 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours.

Ques

Chiu Lin, Ph.D. 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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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Ko7 1490

Device Name: Leone orthodontic mini implant

Indications For Use:

Prescription Use 4 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runse
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K152749

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SECTION 4 - Page 1 of 1

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.