LEONE MONOIMPLANT FOR O-RING OVERDENTURE by LEONE SPA

The Leone Monoimplants for O-ring overdenture are indicated as therapy for the stabilization of removable prosthesis on lower arch. The Leone Monoimplants for O-ring overdenture are designed to be surgically inserted in the bone structure of the mouth, exclusively in the mandible at the level of the area between the two foramina, as an anchorage system for total removable prosthesis. To properly support a removable prosthesis, four monoimplants have to be inserted.

Device Description

The Leone Monoimplant for O-ring overdenture is a one-piece endosseous dental implant where an endosseous portion and an abutment portion are defined. The implant is composed of titanium alloy for surgical use. The endosseous portion is a self-tapping screw with a sandblasted surface, while the abutment portion is made of a smooth tapered neck favouring soft tissues healing and mucosal seal and a ball shape top for the connection to the overdenture's microhousing. The monoimplant is supplied in different sizes and is intended for use in the overdenture O-ring therapy in the treatment of the total lower edentulism.

AI/ML Overview

The provided text describes a medical device, the "Leone Monoimplant for O-ring overdenture," and its 510(k) summary for FDA clearance. This document is a premarket notification to establish substantial equivalence to predicate devices, not a study reporting on the device's performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be directly extracted from this type of regulatory submission.

The document focuses on demonstrating that the new device is as safe and effective as legally marketed predicate devices, primarily through comparison of intended use, materials, design, and functional performance. It does not contain a detailed report of a study designed to evaluate the Leone Monoimplant's performance against predefined quantitative acceptance criteria.

However, I can extract the information relevant to the device and its regulatory submission:

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

This document does not specify quantitative acceptance criteria or report specific device performance metrics in the way a clinical study or performance verification test report would. Instead, it claims substantial equivalence to predicate devices based on shared characteristics. The "performance" in this context refers to functional performance being "substantially equivalent" to the predicate devices.

Characteristic	Acceptance Criteria (implied by substantial equivalence)	Reported Device Performance
Intended Use	Equivalent to predicate devices (stabilization of removable prostheses on the lower arch)	The Leone Monoimplant is indicated for stabilization of removable prosthesis on the lower arch, inserted in the mandible between two foramina, requiring four monoimplants. This is equivalent to the long-term application of IMTEC Sendax MDI and MDI Plus for overdenture stabilization and the Leone Implant System's anchorage for removable prosthesis.
Material	Biocompatible Titanium Alloy for surgical use.	Composed of biocompatible titanium alloy for surgical use, identical to predicate devices.
Design	Substantially equivalent in design to predicate devices.	One-piece endosseous dental implant with endosseous and abutment portions; self-tapping screw with sandblasted surface; smooth tapered neck and ball-shaped top. Substantially equivalent to predicate devices.
Physical Characteristics	Substantially equivalent to predicate devices.	Offered in different sizes. Substantially equivalent to predicate devices.
Functional Performance	Substantially equivalent to predicate devices.	Functional performance is substantially equivalent to predicate devices.
Labeling	Substantially equivalent to predicate devices.	Substantially equivalent to predicate devices.
Potential Adverse Effects	No new issues of safety or effectiveness compared to predicate devices.	Raises no new issues of safety or effectiveness.
Sterility	Sterile	Supplied as sterile, equivalent to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No test set sample size or data provenance is mentioned as this is a 510(k) summary primarily focused on demonstrating equivalence based on design and material comparisons, not a specific performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This document does not describe a study involving expert review for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set adjudication method is mentioned.

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 device is a dental implant, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. The regulatory submission relies on comparison to predicate devices, not on establishing a "ground truth" through clinical or pathological assessment in the context of a new performance study. The "truth" here is essentially the established safety and effectiveness of the existing predicate devices.

8. The sample size for the training set:

Not applicable. This is a medical device, not an AI model requiring a training set.

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

Not applicable. This is a medical device, not an AI model.

In summary: The provided document is a 510(k) premarket notification for a dental implant. It aims to demonstrate substantial equivalence to already-marketed predicate devices, not to present a new performance study with specific acceptance criteria, test sets, or ground truth assessments. The "acceptance criteria" are implicitly met by demonstrating this substantial equivalence in terms of intended use, materials, design, and functional performance.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Leone. The logo is white text on a black oval background. The text is stylized and appears to be a brand name.

Image /page/0/Picture/2 description: The image shows a handwritten alphanumeric string "K070483" with a line underneath it. Below the line, there is another handwritten string that appears to be "1 of 2". The handwriting is in black ink on a white background, and the overall image has a simple, unadorned appearance.

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

APR 1 9 2007

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: February 8, 2007

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

Leone Monoimplant for O-ring overdenture Leone Monoimplant for O-ring overdenture Dental implant Endosseous Dental Implant

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

Imtec Corporation, IMTEC Sendax MDI and MDI Plus (K031106) Leone SpA, Leone Implant System (K050586)

Description of the device:

Intended use:

The Leone Monoimplants for O-ring overdenture are indicated as therapy for the stabilization of removable prosthesis on lower arch. The Leone Monoimplants for O-ring overdenture are designed to be

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surgically inserted in the bone structure of the mouth, exclusively in the mandible at the level of the area between the two foramina, as an anchorage system for total removable prosthesis. To properly support a removable prosthesis, four monoimplants have to be inserted.

predicate devices:
DeviceName	LeoneMonoimplant forO-ringoverdenture	IMTEC SendaxMDI and MDI Plus	LeoneImplant System
Product code	DZE	DZE	DZE
Regulation no.	872.3640	872.3640	872.3640
Applicant	Leone SpA(Italy)	Imtec Corporation(USA)	Leone SpA(Italy)
510(k)	This submission	K031106	K050586
Intended use	The LeoneMonoimplantsfor O-ring overdentureare designed to besurgically inserted inthe bone structure ofthe mouth, exclusivelyin the mandible at thelevel of the areabetween the twoforamina, as ananchorage system fortotal removableprosthesis.	The IMTEC SendaxMDI and MDI PLUSare self-tappingtitanium threadedscrews indicated forlong-term intra-bonyapplications.Additionally, the MDImay also be used forinter-radiculartransitionalapplications.	The Leone ImplantSystem is designedto be surgicallyinserted in the bonestructure of themouth in order toreplace missingteeth. It can work asan abutment systemfor partial/totalprostheticrestorations or as ananchorage systemfor removableprosthesis.
Material	Titanium Alloy	Titanium Alloy	Titanium Alloy
Biocompatibility	Biocompatible	Biocompatible	Biocompatible
Sterility	Sterile	Sterile	Sterile

Summary of the technological characteristics of our device compared to the redicato davings:

Conclusion:

The Leone Monoimplant for O-ring overdenture intended use is equivalent to the IMTEC Sendax MDI and MDI Plus long-term application and to the Leone Implant System anchorage for removable prosthesis in case of the stabilization of an overdenture. The Leone Monoimplant for O-ring overdenture and the predicate devices are composed of the same biocompatible titanium alloy for surgical use, they are substantially equivalent in design, physical characteristics, functional performance, labelling, potential adverse effects. Based on the information provided herein, we conclude that the Leone Monoimplant for O-ring overdenture is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. The Leone Monoimplant for O-ring overdenture 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 Monoimplant for O-ring overdenture.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three bars representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

APR 1 9 2007

Re: K070483

Trade/Device Name: Leone Monoimplant for O-ring Overdenture Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: April 10, 2007 Received: April 12, 2007

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 (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). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sayite Y. Michuomd
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

K070483

510(k) Number (if known):

Device Name: Leone Monoimplant for O-ring overdenture

Indications For Use:

Prescription Use (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)

Kei Muly for MSR

Memorial Hospital
ion Control, Central Devices

Page _ of _

Leone SpA, Sesto Fiorentino - Italy

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.