Intermezzo ™ Plus are designed for use in dental implant surgery and are intended to be used in a manner in which the implants integrate with the bone (osseointegration). The system is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures.

Device Description

Intermezzo ™ Plus Implant System is an integrated system of endosseous dental implants which are intended for use in partially or fully edentulous mandibles and maxillae in support of overdentures.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the way typically seen for AI/ML-based medical devices with performance metrics like sensitivity, specificity, or AUC.

Instead, this document is a 510(k) Summary for a dental implant system (Intermezzo™ Plus), which is a physical medical device. For such devices, "acceptance criteria" are usually related to manufacturing quality, material properties, mechanical performance, and demonstrated equivalence to a predicate device. The "study" typically refers to laboratory testing and comparison to an already approved device.

Based on the provided text, here's what can be extracted and inferred:

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

The document implicitly defines "acceptance" as demonstrating substantial equivalence to a predicate device (Intermezzo™ Implant Systems, K051018) in terms of indications for use, fundamental scientific technology, materials, size, and safety/effectiveness.

Characteristic	Acceptance Criteria (Based on Predicate)	Reported Device Performance (Intermezzo™ Plus)
Indications for Use	Mandible and Maxilla, Endosseous Dental Implant, Support for overdentures	Mandible and Maxilla, Endosseous Dental Implant, Support for overdentures
Endosseous Implant Material	C.P Titanium Gr.3	C.P Titanium Gr.3
Implant Sterile	Yes	Yes
Sterilization Method	Gamma	Gamma
Implant Diameters	1.6 – 3.1 mm (Predicate ranges from 1.6mm)	2.5 – 3.1 mm (Within the range of the predicate's larger diameters)
Implant Lengths	10.0 – 15.0 mm	10.0 – 15.0 mm
Fundamental Scientific Technology	Threaded, root form implants constructed of titanium	Threaded, root form implants constructed of titanium (Implicitly confirmed by "similar in fundamental scientific technology")
Safety and Effectiveness	No new questions of safety or effectiveness raised compared to the predicate	"Any differences between the two devices do not raise new questions of safety and effectiveness."
Functionality & Design Conformance	Conforms to design input requirements	"Laboratory testing was conducted to determine device functionality and conformance to design input requirements."

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

Sample size for test set: Not specified in the provided text. The "test" in this context refers to laboratory testing of the physical implant device, not a test set of data for an algorithm.
Data provenance: Not explicitly stated for specific test raw data. The manufacturer is Mega'Gen Co., Ltd., located in Gyeongsan, Gyeongbuk, South Korea. The testing would presumably have been conducted there or by a contracted lab.

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):

This information is not applicable to this type of device and submission. "Ground truth" established by experts in this manner (e.g., for diagnostic imaging) is not a component of a 510(k) for a dental implant. The "ground truth" for a physical device like this is objective measurements from laboratory tests and conformance to material standards, typically verified by engineers and quality control personnel.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of medical data, particularly in AI algorithm validation. This document describes a physical medical device.

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 is not applicable. MRMC studies are used for evaluating the impact of AI on human reader performance in diagnostic tasks. This document is for a dental implant.

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

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

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

For this physical device, the "ground truth" (or basis for verification) isn't established by expert consensus on medical images or pathology in the typical sense. Instead, it would be based on:
- Engineering specifications and standards: Material properties, dimensions, mechanical strength, biocompatibility, sterility.
- Performance metrics derived from laboratory testing: For example, fatigue testing, torque resistance, surface roughness, integration with bone (though this is more of an in-vivo outcome, the design facilitates it).
- Demonstrated equivalence to a legally marketed predicate device: This is the primary "ground truth" for a 510(k) submission like this, meaning it performs as safely and effectively as the existing device.

8. The sample size for the training set:

This is not applicable. There is no "training set" in the context of a physical dental implant device.

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

This is not applicable as there is no training set.

Summary of the "Study" mentioned:

The document states:

"Laboratory testing was conducted to determine device functionality and conformance to design input requirements." (Section 13-8)
The comparison data in Section 13-13 provides evidence for "substantial equivalence" to the predicate device (Intermezzo™ Implant Systems, K051018). This comparison serves as a key part of the "study" demonstrating the device meets the regulatory acceptance criteria for 510(k) clearance. The comparison focuses on:
- Indications for Use
- Material (C.P Titanium Gr.3)
- Sterility and Sterilization Method (Gamma)
- Dimensions (Implant Diameters and Lengths)
- Fundamental technology (threaded, root form)

In essence, the "study" for this dental implant is primarily laboratory-based physical testing and a detailed comparison against an already approved predicate device to demonstrate that it is equally safe and effective.

Summary

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APR 1 3 2006

12. 510(K) SUMMARY

Mega'Gen Co., Ltd. 114-8, Eupchun-Ri, Jain-Myun, Gyeongsan, Gyeongbuk South Korea Phone: 82-53-857-5770, Fax: 82-53-857-5432

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

13-1. 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

13-2. US Agent /Contact Person	Dae Kyu Chang
	13340 E. Firestone Blvd. Suite JSanta Fe Springs, CA 90670Phone : 562-404-8466, Fax : 562-404-2757

13-3. Date Prepared November 30, 2005

13-4. Device Name Intermezzo TM Plus
13-5. Classification Name Endosseous Dental Implant System

13-6. Device Classification	Class IIDental Devices panel21 CFR § 872.3640Regulation Number: 872.3640
13-7. Predicate Devices	Intermezzo Implant Systems (K051018)
13-8. Performance	Laboratory testing was conducted to determine device

functionality and conformance to design input requirements.

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13-9. Device Description

Intermezzo ™ Plus Implant System is an integrated system of endosseous dental implants which are intended for use in partially or fully edentulous mandibles and maxillae in support of overdentures.

13-10. 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 TM Plus will be packed.

13-11. Intended Use

13-12. Substantial Equivalence Comparison

Intermezzo ™ Plus (Intermezzo ™ Fixtures ) and predicate implant systems share a substantially equivalent intended use. Intermezzo ™ Plus (Intermezzo ™ Implant Systems K051018 ) are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium. Any differences between the two devices do not raise new questions of safety and effectiveness. The subject and predicate devices are similar in size and materials. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the Intermezzo ™ Plus Fixture.

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13-13. Comparative Data

Comparison between the Intermezzo ™ Plus and Intermezzo ™ Implant System,

Characteristic	IntermezzoTM Plus	IntermezzoTM Implant Systems(K051018)
Manufacturer	MegaGen Co., Ltd.	MegaGen Co., Ltd.
Indications for Use	Mandible and MaxillaEndosseous Dental ImplantFixture	Mandible and Maxilla EndosseousDental Implant & Accessories
Endosseous ImplantMaterial	C.P Titanium Gr.3	C.P Titanium Gr.3
Implant Sterile	Yes	Yes
Sterilization Method	Gamma	Gamma
Implant Diameters	2.5 – 3.1 mm	1.6 – 3.1 mm
Implant Lengths	10.0 – 15.0 mm	10.0 – 15.0 mm
Product Code	DZE	DZE

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. 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

APR 1 3 2006

Mega'Gen Company, Limited C/O Mr. Dac Kyu Chang President Kodent, Incorporated 13340 East Firestone Boulevard, Suite J Santa Fe Springs, California 90670

Re: K053354

Trade/Device Name: Intermezzo Plus Fixture Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 30, 2006 Received: April 3, 2006

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 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-Lin, 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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Ko53354

Indication for Use

510(K) Number (if known): K053354

Device Name: Intermezzo Plus Fixture

Indications for Use:

Prescription Use AND/OR Over -- The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Robert Burrows for Dr. Susan Kummer

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.