i-Gen is 3D Pre-Formed titanium membrane is intended for stabilizing and supporting bone graft in dento-alveolar bony defect sites. The devices are made of CP Ti Grade 2 (ASTM F67) and supplied in various sizes and shapes, non-coated, sterile, for single-use and disposable. i-Gen can be chosen according to the size and shape of bone defect. It has seven kind of buccal widths (9, 10, 11, 13, 15, 17, 22 mm) and four kind of buccal lengths (11, 15, 16, 17.5 mm). It has also four types (A B, C, D type), and three sizes (Small, Regular, Wide) for each type according to the location of the part used.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the i-Gen device:

It's important to note that the provided 510(k) summary is for a medical device (bone plate) and not an AI/ML (Artificial Intelligence/Machine Learning) device. Therefore, many of the typical acceptance criteria and study components associated with AI/ML systems (like those involving test sets, ground truth, expert consensus, MRMC studies, or standalone algorithm performance) are not applicable in this context.

This 510(k) focuses on demonstrating substantial equivalence to a predicate device, which is a common regulatory pathway for non-AI medical devices. The "study" described is primarily focused on non-clinical testing to ensure the device's safety and performance characteristics are similar to a previously approved device.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (i-Gen)
Intended Use	To stabilize and support bone grafts in dento-alveolar bony defect sites. (Implicit: must match predicate device's intended use).	Matches predicate: "To stabilization and support bone grafts in dento-alveolar bony defect sites"
Material Composition	CP Titanium Grade 2 (ASTM F67) (Implicit: must match predicate device's material)	CP Titanium Grade 2 (ASTM F67)
Design Characteristics	Similar design principle (3D Pre-Formed titanium membrane), various sizes and shapes for different bone defects. (Implicit: must be comparable to predicate's design without raising new safety/effectiveness concerns).	Described as a "3D Pre-Formed titanium membrane." Has seven buccal widths (9, 10, 11, 13, 15, 17, 22 mm) and four buccal lengths (11, 15, 16, 17.5 mm). Has four types (A, B, C, D) and three sizes (Small, Regular, Wide). Considered similar in size to predicate.
Sterilization	Sterile for single-use. (Implicit: must achieve and maintain sterility).	Sterile for single-use. Sterilization validation performed.
Biocompatibility	Non-toxic, non-irritating, etc., when in contact with biological tissues. (Implicit: must meet ISO 10993-5 standards).	Biocompatibility testing (cytotoxicity in accordance with ISO 10993-5) performed.
Shelf Life	Maintain integrity and sterility over a specified shelf life.	5 years. Shelf life validation performed.
Product Code	JEY (Bone Plate)	JEY
Regulatory Class	Class II	Class II
Overall Equivalence	Demonstrated substantial equivalence to the predicate device (Neo Titanium mesh K111761) such that no new questions of safety or effectiveness are raised. This is the overarching "acceptance criterion" for a 510(k) submission.	The submission concludes: "i-Gen has same device characteristics, material, and intended use as the predicate device, such as the Neo Titanium mesh." And "i-Gen is substantially equivalent to predicate devices as described herein."

Study Details (Non-Clinical Testing)

Given that this is a bone plate and not an AI/ML device, the following points are addressed in the context of typical medical device regulatory submissions rather than AI/ML-specific studies:

Sample size used for the test set and the data provenance:
- N/A (for AI/ML test sets). For physical device testing, specific sample sizes would be determined based on the testing standards (e.g., ISO, ASTM). The document states "biocompatibility testing," "sterilization validation," and "shelf life validation" were performed. These tests would involve a certain number of device samples, but the exact count isn't specified in this summary. The data provenance is from the manufacturer's internal testing as part of their regulatory submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This concept of "ground truth" established by experts for a test set is specific to performance evaluation of diagnostic or interpretive AI/ML systems. For a bone plate, performance is evaluated through physical and chemical testing against established standards, not expert interpretation of outputs.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are used in AI/ML studies to resolve discrepancies in expert ground truth labeling. This does not apply to non-clinical device testing.
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:
- No, an MRMC study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, which is not relevant for a bone plate.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device does not have an "algorithm" in the AI sense. Its performance is inherent in its physical and material properties.
The type of ground truth used:
- For the non-clinical tests, the "ground truth" would be established by compliance with recognized standards (e.g., ISO 10993-5 for biocompatibility, specific ASTM standards for material properties, and validated protocols for sterilization and shelf-life). These standards define acceptable parameters and methods for evaluating a device's performance.
The sample size for the training set:
- N/A. This device does not use a "training set" as it is not an AI/ML system.
How the ground truth for the training set was established:
- N/A. As there is no training set for this type of device, this question is not applicable.

Summary regarding the "study" for this device:

The "study" for the i-Gen bone plate consisted of non-clinical tests to ensure its safety and performance characteristics are equivalent to the predicate device. These tests included:

Biocompatibility testing: Performed "in accordance with ISO 10993-5" to ensure the material is safe for contact with human tissue.
Sterilization validation: To confirm the device can be consistently sterilized and maintain its sterility.
Shelf life validation: To demonstrate the device remains safe and effective for its declared shelf life (5 years).

These tests are standard for implantable medical devices to demonstrate that the new device does not raise new safety or effectiveness concerns compared to a legally marketed predicate. The FDA's determination of "substantial equivalence" is based on the satisfactory completion of these types of non-clinical tests and a comparison of the device's characteristics and intended use to the predicate.

Summary

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Submitter:

Dong Guk Ha MegaGenImplant Co., Ltd. 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si Gyeongbuk, South Korea Email: kodentinc@gmail.com Phone: 82-53-857-5770 Fax: 82-53-857-5432

Device Information:

Device Name: i-Gen Common Name: Plate, Bone Regulation number: 21 CFR 872.4760 Classification Name: Bone Plate Product Code: JEY Classification: Class II Date Prepared: 8/23/2013

Contact /US agent: April Lee KoDent, Inc. 325 N. Puente St. Unit B Brea, CA 92821 Email: kodentinc@gmail.com Phone: 714-525-0114 Fax: 714-525-0116

SEP 25 2013

General Description

Indication for use

i-Gen is a titanium bone plate device intended to stabilization and support bone grafts in dento-alveolar bony defect sites.

Predicate devices

neobiotech Neo Titanium mesh (K111761)

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510(k) Number

Device Name

Manufacturer

Indications for Use

grafts in dento-

Subject Device	Predicate Device
Not available yet	K111761
i-Gen	Neo Titanium mesh (CTi-mem)
Megagen Implant Co., Ltd.	neobiotech Co., Ltd.
To stabilization and support bonegrafts in dento-alveolar bony defectsites	To stabilize and support of bonegraft in dento-alveolar bony defectsites

Design	Image: Design 1	Image: Design 2
Material	CP Titanium Grade 2 (ASTM F67)	CP Titanium Grade 2 (ASTM F67)
Sterilization	Sterile	Sterile
Width	9, 10, 11, 13, 15, 17, 22 mm	8, 9, 10, 12 mm
Length	11, 15, 16, 17.5 mm	6, 8, 10, 15, 20 mm
Product Code	JEY	JEY
Shelf life	5 years	-
SE	i-Gen has same device characteristics, material, and intended use as thepredicate device, such as the Neo Titanium mesh.

Substantial Equivalence Comparison

i-Gen has a substantially equivalent in intended use and device characteristics as the predicate device, such as the Neo Titanium mesh. The subject and predicate device are similar in size and materials. When compared with predicate device, no new questions of safety or effectiveness have been raised for i-Gen.

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Non-Clinical Test Data

The biocompatibility testing such as cytotoxicity in accordance with ISO 10993-5, sterilization validation, and shelf life validation were performed on this subject device.

Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Megagen Co., Ltd. concludes that i-Gen is substantially equivalent to predicate devices as described herein.

し

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 25, 2013

Megagen Implant Company, Limited C/O Ms. April Lee Consultant Kodent 325 North Puente Street Unit B BREA CA 92821

Re: K131289

Trade/Device Name: i-Gen Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: August 23, 2013 Received: August 27, 2013

Dear Ms. Lec:

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 cnacunent 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 I he general connoto practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Lee

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Richard C.
Chapman for

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation · Center for Devices and Radiological Health

Enclosure

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510(k) Submission

Indication for Use

510(K) Number (if known): _ < 131289

Device Name: i-Gen

Indications for Use:

i-Gen is a titanium bone plate device intended to stabilization and support bone grafts in dentoalveolar bony defect sites.

Prescription Use AND/OR OverThe-Counter Use X (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)

Andrew I. Steen -S 2013.09.24 14:43:14-04-00

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

510(k) Number: 3/2 89

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.