IMPLUS implant fixtures are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches in order to provide support for fixed and/or removal prosthetics in order to restore original features and masticatory functions. Implus implant fixtures are indicated for permanent use. Implus implant fixtures are disposable and are for one-time use only. These fixtures are not to be recleaned or re-sterilized.

Device Description

Leader Italia IMPLUS implants are available in cylindrical or tapered shape, with different dimensions; connection to abutments is made by internal or external hexagon. All implants are manufactured from medical titanium in grade 4 (Ref. ASTM F67) with a modified surface for optimum ostheointegration. The implants are all provided sterile in a packaging complete with mount transfer.

AI/ML Overview

This document is a 510(k) summary for the LEADER ITALIA S.r.l. IMPLUS Endosseous Dental Implant. It focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria and performance data in the format of a typical medical device study.

Therefore, providing a direct answer to all points of your request is not possible, as the provided text does not describe a study to prove acceptance criteria for a device. Instead, it outlines the device's characteristics and references tests performed to support its safety and effectiveness for substantial equivalence.

However, I can extract the relevant information regarding the tests performed to demonstrate safety and effectiveness.

Here's a breakdown of the existing information related to performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner as one would expect for a specific performance study (e.g., "sensitivity must be > X" or "fatigue life must exceed Y cycles at Z load").

Instead, the performance of the IMPLUS device is demonstrated through adherence to material standards, biocompatibility testing, and mechanical/fatigue testing, with the implicit "acceptance criterion" being that these tests confirm safety and effectiveness comparable to legally marketed predicate devices.

Acceptance Criteria (Implicit / Demonstrated by Compliance)	Reported Device Performance
Biocompatibility: Not cytotoxic.	IMPLUS Implants were tested and found to be not cytotoxic according to standard UNI EN ISO 30993 part 5 of September 2000 by "BIOLAB" laboratory (report nº SAM1282 dated 11th February 2003).
Material Use: Use of medical-grade titanium.	Implants are manufactured from medical titanium in grade 4 (Ref. ASTM F67). Abutments are made of Titanium grade 5 (ASTM F136-96). This material is commonly used and widely recommended for contact with human tissue.
Mechanical Strength & Durability: Demonstrated stiffness and durability.	Mechanical and fatigue tests performed by "Politecnico di Milano" - Structural Engineering Department - demonstrated stiffness and durability of Leader Italia implants and abutments. These tests were performed on IMPLUS implants diam.4 with 25° angled abutment (report 01/014/rel of 17th December 2001). Further Fatigue Tests are presently running according to standard ISO 14801 (foreseen completed April 2007).
Sterilization Effectiveness: Effective sterilization procedure.	Performance test and biological analysis demonstrated effectiveness of the sterilization procedure with gamma rays (report by BIOSTER laboratory issued on January 1998). New tests for validation performed (Report by BIOSTER laboratory issued on February 2nd 2007).
Packaging Duration: Specified duration of sterility.	Packaging duration (5 years) demonstrated according to results of report issued by BIOSTER on October 2003. New tests for validation performed (Report by BIOSTER laboratory issued on December 2006).

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

The document does not specify sample sizes for the test set in the context of a clinical trial or algorithm validation study.
The tests mentioned (biocompatibility, mechanical, fatigue, sterilization, packaging) are laboratory-based.
Data Provenance:
- Biocompatibility: BIOLAB laboratory, Vimodrone, Milano, Italy.
- Mechanical and Fatigue Tests: "Politecnico di Milano" - Structural Engineering Department.
- Sterilization and Packaging: BIOSTER laboratory.
- The overall context is for CE Mark and FDA 510(k) submission, suggesting the data is intended for regulatory purposes. The country of origin for the testing appears to be primarily Italy.
- The data would be considered prospective with respect to the intent of the device submission, even if some tests were conducted retrospectively from prior dates.

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

This is not applicable as the document describes laboratory tests for device components/properties, not a diagnostic device or a study requiring human expert ground truth.

4. Adjudication Method for the Test Set

Not applicable for laboratory performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, this document does not describe an MRMC study. The device is an implant, not an imaging or diagnostic AI tool that would involve human readers.

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

Not applicable. This is a physical medical device (dental implant), not an algorithm or software-as-a-medical-device (SaMD).

7. The Type of Ground Truth Used

The "ground truth" for the tests performed are laboratory standards and measurements:
- Biocompatibility: ISO 30993 part 5 (presumably against a control for cytotoxicity).
- Material Composition: ASTM F67, ASTM F136-96 (material specifications).
- Mechanical & Fatigue: Standard ISO 14801 (implied as ongoing/completed), and internal methods detailed in a specific report (01/014/rel). This would involve physical measurement of force, cycles, and structural integrity.
- Sterilization: Performance against accepted microbiological sterility standards.
- Packaging: Performance against accepted standards for maintaining sterility over time.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary of Limitations in the Provided Document for Your Request:

The provided text is a 510(k) Summary, which is designed to demonstrate "substantial equivalence" of a new device to predicate devices already on the market. It does not typically contain the detailed information of a full clinical trial or a detailed AI/ML performance study as implied by your request. It focuses on:

Device description
Comparison to predicate devices
Indications for use
Summary of key safety and effectiveness tests (often laboratory-based for implants)

Therefore, many of your questions, especially those related to "test sets," "expert ground truth," "adjudication," "MRMC studies," "standalone performance," and "training sets" are not applicable to the type of information presented here for an endosseous dental implant.

Summary

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K062931

Section 5 - 510(k) Summary Additional Information

Image /page/0/Picture/2 description: The image shows the word "LEADER" with vertical lines separating each letter. Below each letter is another letter, "J T A L I A". The letters are all in a sans-serif font and are black on a white background. The image is simple and clear.

KOLO 2931

510(k) Summary (21 CFR 807.92) LEADER ITALIA IMPLANTS

I General Information

Submitter:	LEADER ITALIA S.r.l.Via Aquileja, 49Cinisello Balsamo (MILANO) ITALY
Telephone:	+39 02 618651 - Company Number+39 02 61865368 - Contact Person
Fax:	+39 02 61290676
Contact Person:	Mariaelena CostantinExport Manager	NOV 2 8 2007
Summary Preparation Date:	March 22nd, 2007
Names
Device Name:	IMPLUSEndosseous Dental Implant
Primary Classification Name:	DZE - Implant, Endosseous, Root-Form

III Predicate Devices

प्र

• Sulzer Dental Screw-Vent Dental Implant System (K011028)	vs IMPLUS
• Branemark Integration Endosseous Implant (K021355)	vs IMPLUS

IV Product Description

LEADER ITALIA Srl Via Aquileja 49 20092 Cinisello Balsamo (MI) Phone (+39) 02 618651 Fax (+39) 02 61290676 E-mail export@leaderttalia.it

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The implants are all provided sterile in a packaging complete with mount transfer.

IMPLUS Implants List:

SHAPE	HEXAGON	DIAMETER	LENGTH
Cylindrical	Internal	3,3 mm	8-10-11,5-13-16 mm
Cylindrical	Internal	3,75 mm	8-10-11,5-13-16 mm
Cylindrical	Internal	4,5 mm	8-10-11,5-13-16 mm
Cylindrical	Internal	5,5 mm	8-10-11,5-13 mm
Cylindrical	External	3,3 mm	10-11,5-13-15 mm
Cylindrical	External	3,75 mm	8-10-11,5-13-15-18-20 mm
Cylindrical	External	5 mm	8-10-11,5-13 mm
Tapered	Internal	4 mm	8-10-11,5-13-16 mm
Tapered	Internal	5 mm	8-10-11,5-13-16 mm
Tapered	Internal	6 mm	8-10-11,5-13 mm
Tapered	External	4 mm	8-10-11,5-13-15 mm
Tapered	External	5 mm	8-10-11,5-13 mm

V Indications for Use

IMPLUS implant fixtures are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches in order to provide support for fixed and/or removal prosthetic in order to restore original features and masticatory functions. Implus implant fixtures are foreseen for permanent use. These fixtures are disposable and are for one-time use only. These fixtures are not to be re-cleaned or re-sterilized.

Leader Italia Implus implants can support a single tooth, more dental elements or total prosthesis.

If we loose a tooth, we can replace it without damaging the two close teeth when building the so called traditional "bridge". The use of the implant allows us to obtain an optimal aesthetic and functional result. In fact, once the implant has been inserted in the bone, it rapidly becomes an integral part of it and it will become the artificial root on which the artificial tooth will be fastened.

If the missing teeth are more than one, the use of multiple implants allows us a sufficient number of artificial roots on which to fasten the necessary artificial teeth to complete the dental arch. In this way, the use of removable prosthesis with metal base (the so - called "plate") is avoided as well as the use of healthy teeth as abutment for a bridge. In this

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L E A D E R

situation, the obtained results offers more comfort for the patient together with aesthetics and functionality and less reduction of tooth structure.

The choice of the implants is recommended also in case of total teeth absence on one or both of the dental arches. According to circumstances the dentist will consider how many implants should be inserted in the bone and whether to use a fixed or a movable prosthesis. In both cases, the prosthesis on implants have complete stability in all functions - such as speaking, smiling, chewing - and reduce the precarious stability problems that can be found in the traditional total prosthesis.

Safety and Effectiveness Information VI

Leader Italia implants have been manufactured and marketed in several countries (Italy, India, Poland Spain, Philippines, Estonia, Lithuania and more others) for years, and our customers found them to be safe and effective products, substantially equivalent to similar devices manufactured by competitors .

Biocompatibility: Implus Implants are made of Medical Titanium grade 4 (ASTM F67), abutments are made of Titanium grade 5 (ASTM F136-96).

This material is commonly used by manufacturer of dental implants following the widely recommended as the most suitable raw materials for contact with human tissue.

Leader's implants were also tested and found to be not cytotoxic according to standard UNI EN ISO 30993 part 5 of September 2000 by "BIOLAB" laboratory, Vimodrone, Milano, Italy (report nº SAM1282 dated 11th February 2003)

Mechanical and fatigue tests performed by "Politecnico di Milano" - Structural Engineering Department - demonstrated stiffness and durability of Leader Italia implants and abutments.

The tests were performed on IMPLUS implants diam.4 with 25° angled abutment (report 01/014/rel of 17th December 2001); test method is detailed in Section 18 pages 2, 3, 5 and 6. Performance test and biological analysis demonstrated effectiveness of the sterilization procedure with gamma rays (report by BIOSTER laboratory issued on January 1998) and the packaging duration (5 years) according to results of report issued by BIOSTER on October 2003.

Additional information:

Following the start-up of the new production plant and clean room, new tests for validation of the sterilization procedure and of the packaging duration were performed (Report by BIOSTER laboratory issued on February 2nd 2007 and December 2006 respectively).

In accordance with standard ISO 14801 issued on 2003, laboratory tests were requested to Politecnico di MIlano. Further Fatigue Tests are presently running according to standard ISO 14801; final results are foreseen next April 2007

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Image /page/3/Picture/2 description: The image shows the word "LEADER" with a vertical line separating each letter. The letters are in a bold, sans-serif font. Below each letter is a smaller letter, which appears to be a key or label for the letter above.

VII Conclusion

Based on comparison to the predicate devices, we conclude that the products are substantially equivalent to currently marketed devices under the Federal Food, Drug and Cosmetic Act and presents no concerns about safety and effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to serving all Americans. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a sans-serif font. The text is arranged around the top and left side of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 8 2007

LEADER Italia S.r.1. C/O Mr. Henry J. Vogelstein Consultant 1349 Lexington Avenue New York, New York 10128

Re: K062931

Trade/Device Name: IMPLUS Regulation Number: 21 CFR 872,3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 19, 2007 Received: October 22, 2007

Dear Mr. Vogelstein:

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. Vogelstein

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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu-Ling, Ph.D.

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

510(k) Number (if known):

IMPLUS Device Name:

Indications for Use:

Implus implant fixtures are indicated for permanent use.

Implus implant fixtures are disposable and are for one-time use only. These fixtures are not to be recleaned or re-sterilized.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Part 21 CFR 801.109)

AND/OR

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

Ken Ruby for MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K062931

LEADER ITALIA Srl Via Aquileja 49 20092 Cinisello Balsamo (MI) Phone (+39) 02 618651 Fax (+39) 02 61290676 E-mail export@leaderitalia.it

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.