The CMI Implant IS System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. IS System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5 mm are indicated for molar regions.

Device Description

The CMI Implant IS System is a dental implant system made of titanium Grade s of ASTM F 67 intended to be surgically placed in the bone of the upper or lower jaw arches. The CMI Implant IS System is composed of submerged fixtures with straight & angled abutments. To cover all case of surgery, each component of dental implant set has various size and dimension.

AI/ML Overview

The provided text is a 510(k) summary for a dental implant system (CMI Implant IS System). It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for a medical imaging or AI device. Instead, it relies on substantial equivalence to a previously cleared device.

Here's an analysis of the information that is present and a clear statement of what is missing based on your request:

Acceptance Criteria and Reported Device Performance

This section is not explicitly present in the document for the device being approved (K113554). The submission primarily focuses on demonstrating substantial equivalence to a predicate device (K090825).

The only "performance" discussed for the subject device (K113554) is:

Fatigue testing: Performed in accordance with ISO 14801 standard. The results are not specifically reported, only that the test was done.
Risk analysis: Performed in accordance with ISO 14971 standard. Again, results are not reported.
Biocompatibility and Sterilization: Stated as "Yes" and "Gamma Sterilization" respectively, matching the predicate device.

Since this 510(k) is for a physical medical device (dental implant) and not a diagnostic software or AI product, the concepts of "acceptance criteria" and "reported device performance" are geared towards mechanical and material properties, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC which would be relevant for an AI study.

Missing Information: A table of specific acceptance criteria (e.g., minimum fatigue cycles, specific material strength thresholds) and the quantitative results for the CMI Implant IS System (K113554) that demonstrate it met these criteria. The document states that fatigue testing was done, but not what the acceptance criteria for fatigue were or what the device's actual performance was against those criteria.

Study Details (Relevant to AI/Diagnostic Devices - Not Applicable Here)

The provided document does not describe a study involving human readers, AI assistance, or ground truth establishment relevant to the type of device being approved (a dental implant). Thus, many of your requested points below are not applicable to this 510(k) submission.

Sample size used for the test set and the data provenance: Not applicable. This device is a physical implant, not a diagnostic system tested on data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of What This 510(k) Does Rely On:

The primary "study" or evidence for this 510(k) is the demonstration of substantial equivalence to an already cleared predicate device (CMI Implant IS System K090825). This means the manufacturer argued that their new device is as safe and effective as the predicate based on similarities in:

Intended Use: Identical.
Materials: Titanium Grade 4 of ASTM F 67 (same).
Surface Treatment: RBM (same).
General Shape, Structure, and Application Method Design: Stated as "same."
Biocompatibility and Sterilization: Stated as "Yes" and "Gamma Sterilization" (same).

The modifications in K113554 compared to K090825 primarily involve:

Addition of a "non-micro thread type" implant fixture.
Addition of more sizes/models for various components.
Change in shelf-life from 3 years to 5 years.

To support the substantial equivalence for these changes, the manufacturer submitted non-clinical test data related to:

Fatigue testing (in accordance with ISO 14801 standard).
Risk analysis (in accordance with ISO 14971 standard).

The approval letter confirms that the FDA reviewed this information and determined the device is substantially equivalent to the predicate.

Summary

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K113554

APR - 5 2012

510(k) Summary

Submitter:

Hee Seok Jeong neobiotech Co., Ltd. e-space #103, 104-1, 104-2, 105, 106, 205, 212, 312 509,511/10th floor, Guro-dong, Guro-gu, Seoul, Korea 152-789

Phone: 82-2-582-2885 Fax: 82-2-582-2883 Date of Submission: 10/7/2011 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

Device Information

Trade Name: CMI Implant IS System Common Name: Endosseous Dental Implant Classification Name: Implant, Endosseous, Root-Form Product Code: DZE, NHA Regulation Number: 21 CFR 872.3640 Date prepared: 4/3/2012

General Description

1. Fixture

It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). There are two types of Fixtures, Submerged implant design and non-micro thread design.

The diameters of submerged implant design fixtures are 3.5/4.0/5.0/6.0/7.0/8.0mm and the lengths are 7.0/8.5/10.0/11.5/13.0/15.0 mm. The diameters of Non-Micro thread design fixtures are 3.5/4.0/4.5/5.0/5.5/6.0/7.0/8.0mm and the lengths are 7.0/7.3/8.5/10.0/11.5/13.0/15.0mm.

Cover Screw, Healing Abutment

: It is used to stop up hole of fixture to prevent inside of hole from being contaminated by germ and from being covered by teethridge during osseointegration.

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: It is used to stop up hole of fixture to prevent inside of hole from being contaminated by germ and from being covered by teethridge for term of making upper prostheses and establishing proper emergence profile after osseointegration.

3. Abutment

It is intermediate component placed between the implant (fixture) and restoration (Crown, gold or ceramic) providing support. D Device is made of gold alloy or unalloyed titanium which can be used coated with TiN or non-coated state. There are Cemented(Hex/non-Hex), Angled, SCRP, Solid, UCLA Gold/Plastic, Ball, and Temporary Abutment in this system.

The system is similar to the commercially available product based on the intended use, the technology used, the material composition employed and performance characteristics. IS System is made from pure titanium and the surface treatment is done with R.B.M.

Indication for use

Device Description & Technological Characteristics

*The purpose of the device modification to purpose the variety of products for users' preference

. Addition of Implant Fixture (non-micro thread type)
. Addition of the number of models according to the addition of sizes of Two IS Fixtures, Cover Screw, Healing Cap, Solid Abutment, Protective Cap, Cemented abutment, Cemented SCRP Abutment, Cemented non-Hex Abutment- Non Sterilized, UCLA Abutment, Ball Abutment, Temporary Abutment, and Combination Screw.
. Shelf-Life change : 3years -> Syeaes

Materials

This device is manufactured from Ti G4 and Ti-6A1-4V ELI alloy following ASTM and ISO standards.

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Non-clinical test data

Fatigue testing was performed in accordance with ISO 14801 standard and risk analysis was performed in accordance with ISO 14971 standard.

Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

CMI Implant IS System (K090825)

Comparison to Predicate Devices:

The CMI Implant System have the same device characteristics as the predicate device, CMI Implant IS System (K090825), intended use, surface treatment, composition of material, general shape, structure and application method design are same. Comparisons have established that the subject device, CMI Implant IS System is substantially equivalent to the cleared Premarket Notification Device, CMI Implant IS System (K090825).

		Subject Device	Predicate Device
Product Name		CMI Implant IS System	CMI Implant IS System
510(k)		N/A	K090825
Manufacturer		neobiotech Co., Ltd.	neobiotech Co., Ltd.
Design		Submerged Implant designnon-micro thread design	Submerged Implant design
Intended use		Identical to the predicate	for use in partially or fullyedentulous mandibles andmaxillae, in support of single ormultiple-unit restorationsincluding; cemented retained,screw retained, or overdenturerestorations, and terminal orintermediate abutment support forfixed bridgework.
Composition ofMaterial		Titanium Grade 4 of ASTM F 67	Titanium Grade 4 of ASTM F 67
Devicedesign	Dia(Ø)	3.5/4.0/4.5/5.0/5.5/6.0/7.0/8.0	3.5/4.0/5.0/6.0/7.0/8.0
Devicedesign	Length(L)	7.0/7.3/8.5/10.0/11.5/13.0/15.0	7.0/8.5/10.0/11.5/13.0/15.0

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K113554

Surface treatment	RBM	RBM
Biocompatibility	Yes	Yes
Sterilization	Gamma Sterilization	Gamma Sterilization

Conclusion

. The CMI Implant IS System has the same device characteristics as the predicate device, CMI Implant IS System (K090825). The intended use, surface treatment, composition of material, general shape, structure, and application method design are same.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

Neobiotech Company, Limited C/O Ms. April Lee Kodent, Incorporated 325 North Puente Street Unit B Brea, California 92821

2012

Re: K113554

Trade/Device Name: CMI Implant IS System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 1, 2012 Received: March 7, 2012

Dear Ms. Lee:

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. 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 Eederal 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indication for Use

K11355

510(K) Number (if known):

Device Name: CMI Implant IS System

Indication for Use:

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

510(k) Number:

AND/OR

Prescription Use _ ਮ Over-The-Counter

(Part 21 CFR 801 Subpart D) (Per 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)

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.