The Intermezzo TM Implant Systems are intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

Device Description

Intermezzo ™ Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Intermezzo ™ Implant System consists of Intermezzo ™ Implant Fixtures, Intermezzo Cap, and Implant System Surgery Tray. Implant Fixture Systems consist of one-stage, root-form dental implants, associated with protective cap, which provide the clinician to maintain the patients' gingival contour. The system also includes surgical and restorative instrumentation: lance drills, twist drills, unification drills, and handpiece drivers and hand drivers to provide the clinician to choose only those components required for each clinical situation. The devices covered by this submission are Intermezzo ™ Implant Fixtures, Intermezzo Protective Cap, and Intermezzo Implant System Surgery Tray.

AI/ML Overview

The provided text is a 510(k) summary for a dental implant system (Intermezzo™ Implant Systems). It does not describe an AI/ML device or a study assessing its performance against acceptance criteria in the way envisioned by your request.

The core of this document is to demonstrate "substantial equivalence" of the Intermezzo™ Implant Systems to already legally marketed predicate devices, not to prove its performance against specific acceptance criteria through a clinical study for an AI algorithm.

Therefore, I cannot populate the requested information regarding acceptance criteria and a study that proves the device meets them, specifically for an AI/ML context, because this document describes a traditional medical device (dental implants), not an AI-powered one.

Here's how the provided information relates to your template, highlighting the absence of AI/ML-specific details:

1. Table of acceptance criteria and the reported device performance

Cannot be provided. The document states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." However, it does not specify what those design input requirements (acceptance criteria) were or the results of this testing. The focus is on demonstrating "substantial equivalence" to predicate devices, not meeting novel performance criteria.

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

Cannot be provided. No test set or data provenance is mentioned in the context of performance evaluation, as this is a traditional medical device submission based on substantial equivalence and laboratory testing, not a clinical study to assess a diagnostic or predictive algorithm.

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)

Cannot be provided. Ground truth, in the context of AI/ML, refers to definitively established outcomes or labels for a dataset. This concept is not applicable to a submission for a dental implant system.

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

Cannot be provided. Adjudication methods are relevant for subjective interpretations in clinical trials or for establishing ground truth in AI/ML studies. This document does not describe such a process.

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

Cannot be provided. No MRMC study was done, as this is not an AI-assisted device.

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

Cannot be provided. This is not an algorithm.

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

Cannot be provided. The concept of "ground truth" as it applies to AI/ML clinical validation is not relevant to this device's submission.

8. The sample size for the training set

Cannot be provided. There is no AI model, therefore no training set.

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

Cannot be provided. Not applicable due to the absence of an AI model/training set.

In summary: The provided document is a 510(k) summary for a "Class II" dental implant system, demonstrating substantial equivalence to pre-existing predicate devices. It focuses on device description, intended use, materials, and manufacturing, rather than clinical performance data against specific acceptance criteria for an AI/ML algorithm.

Summary

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10. 510(K) SUMMARY

Koslois

Mega'Gen Co., Ltd. 114-8, Eupchun-Ri, Jain-Myun, Gyeongsan, Gyeongbuk South Korea Phone : 82-53-857-5770 Fax

510(K) Summary

510(K) SUMMARY AND CERTIFICATION

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR & 807.93

10-1. Submitter	Mega'Gen Co., Ltd.
	114-8, Eupchun-Ri, Jain-Myun,
	Gyeongsan, Gyeongbuk
	South Korea
	Phone : 82-53-857-5770, Fax : 82-53-857-5432
10-2. US Agent /Contact Person	Dae Kyu Chang
	13340 E. Firestone Blvd. Suites J
	Santa Fe Springs, CA 90670
	Phone : 562-404-8466, Fax : 562-404-2757
10-3. Date Prepared	April 14, 2005
10-4. Device Name	INTERMEZZOTM IMPLANT SYSTEMS
	IntermezzoTM Fixtures, IntermezzoTM Protective Cap, and
	IntermezzoTM Surgery Tray
10-5. Classification Name	Endosseous Dental Implant System
10-6. Device Classification	Class II
	Dental Devices panel
	21 CFR § 872.3640
	Regulation Number: 872.3640
10-7. Predicate Devices	IMTEC Sendax / MDI (Mini Dental Implant System) &
	Nobel Biocare / IPI (Immediate Provisional Implant System)
10-8. Performance	Laboratory testing was conducted to determine device
	functionality and conformance to design input requirements.

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10-9. Device Description

10-10. Packing / Labeling / Product Information

In a clean room that is Class 10,000 or less, put the product into a capsule, and then put the capsule in a pet container, which is 45mm by 75mm, then sealed the pet container with PERFECSEAL CR27 1073B Coated Tyvek®. Intermezzo ™ Implant Systems (Intermezzo ™ Implant Fixtures, Intermezzo Protective Cap, and Intermezzo Implant System Surgery Tray) will be packaged.

10-11. Intended Use

Intermezzo ™ Implant Systems is threaded one-piece implants designed for orthodontic one-stage surgical procedures in upper and lower jaw to provide a means of prosthetic attachment to restore a patient's chewing function. Intermezzo ™ Implant System consists of single-stage, root-form dental implants. The system is designed to provide immediate provisional implant to provide temporary support for prosthetic devices during the healing phase of permanent root form implants. Depends on a patient's quality of bone condition, Intermezzo ™ Fixtures are to be removed within six to ten weeks after the surgery. The system is intended for immediate placement in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations.

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10-12. Substantial Equivalence Comparison

Intermezzo ™ Implant Systems (Intermezzo ™ Implant Fixtures, Intermezzo ™ Protective Cap, and Intermezzo ™ Surgery Tools) and predicate implant systems share a substantially equivalent intended use. IMTEC Sendax / MDI (Mini Dental Implant System), Nobel Biocare / IPI (Immediate Provisional Implant System) and Intermezzo ™ Implant Systems (Intermezzo ™ Implant Fixtures, Intermezzo ™ Protective Cap, and Intermezzo ™ Surgery Tools) are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium with sandblasted surfaces. The subject and predicate devices are similar in size and materials. All three systems offer associated accessories and instruments. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the Intermezzo ™ Implant system.

10-13. Conclusion

The data submitted in this 510(K) Notification is to legally sale the following devices in U.S. market:

Intermezzo Fixtures (Sizes: 1.6mm, 2.0mm, 2.5mm, 3.1mm) .
. Intermezzo Protective Cap
Surgical Tools Drill (Lance Drill, Twist Drill, and Unification Drill) . - Driver (Handpiece Connector, and Hand Driver)

The Intermezzo ™ Implant Systems (Intermezzo ™ Implant Fixtures, Intermezzo ™ Protective Cap, and Intermezzo ™ Surgery Tools) are substantially equivalent to the products such as IMTEC Sendax / MDI (Mini Dental Implant System) and Nobel Biocare / IPI (Immediate Provisional Implant System).

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three abstract, wave-like shapes stacked vertically.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2005

MegaGen Company Limited C/O Mr. Dae Kyu Chang KoDent, Incorporated 13340 East Firestone Boulevard, Suites J Santa Fe Springs, California 90670

Re: K051018

Trade/Device Name: Intermezzo Implant Systems Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: July 29, 2005 Received: August 1, 2005

Dear Mr. Chang:

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. Chang

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 and incents 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,

Seattle Y.M.C.A.

Chíu 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): K051018

Device Name: INTERMEZZO ™ IMPLANT SYSTEMS

Indication 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Vurrr'

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

510(k) Number: K051018

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.