JNE IMPLANT SYSTEM by GC AMERICA, INC.

The JNE Implant System is a titanium alloy screw-type endosseous dental implant and endosseous dental implant abutment, which is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for a prosthetic device, such as an artificial tooth, in order to restore a patient's chewing function.

Device Description

The JNE Implant System is an endosseous dental implant made of Ti-6Al-4V ELI alloy and consists of several components. Geometrically, the fixture is screw-type. An abutment is connected to the fixture through a tapered-joint. Fixtures are treated with sandblast and acid etching using scanning electron microscopy (SEM).

AI/ML Overview

The provided document is a 510(k) summary for the "GC JNE Implant System," a medical device cleared by the FDA. It declares substantial equivalence to previously cleared predicate devices. Unfortunately, the document does not contain specific acceptance criteria or a study that rigorously proves the device meets those criteria with quantitative performance metrics. The language used is general and refers to comparative performance.

Therefore, I cannot fulfill all the requirements of your request as the information is not present in the provided text. However, I will answer what I can based on the available information, noting where data is absent.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The document states: "Several tests were performed on the device. All tests demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate devices."

This is a general statement rather than specific, quantitative acceptance criteria and reported device performance. For medical devices, acceptance criteria are typically measurable thresholds for performance metrics (e.g., specific fatigue life in cycles, fracture strength in Newtons, precise biocompatibility test results, etc.). The document does not provide these details.

Acceptance Criteria (Not Explicitly Stated / Inferred from "Substantially Equivalent")	Reported Device Performance (Not Explicitly Stated / Inferred)
Mechanical Performance: - Comparable fatigue life to predicate devices. - Comparable fracture strength to predicate devices. - Comparable screw loosening/loosening torque. - Comparable biological performance (biocompatibility).	Mechanical Performance: - Device "performs comparably to and is substantially equivalent to the predicate devices" in terms of mechanical properties and function. - Passes "several tests" demonstrating safety and effectiveness.
Material Composition: - Ti-6Al-4V ELI alloy.	- Made of Ti-6Al-4V ELI alloy, same as specified.
Surface Treatment: - Sandblast and acid etching (using SEM for verification).	- Fixtures are treated with sandblast and acid etching, with SEM verification.
Intended Use: - Functionally equivalent for supporting prosthetic devices to restore chewing function.	- Intended use is consistent with predicate devices for supporting prosthetic devices to restore chewing function.

Study Details

Given the context of a 510(k) submission, the "study" referred to is a series of tests to demonstrate substantial equivalence to predicate devices, not an effectiveness study in the clinical trial sense. The document does not detail specific study methodologies, sample sizes, or ground truth establishment.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. "Several tests were performed" does not provide quantitative sample size.
- Data Provenance: Not specified. The manufacturer is "GC CORPORATION, TOKYO 174 - 8585 JAPAN," and the sterilization facility is in Japan. This suggests testing might have been done in Japan, but it is not explicitly stated. The document doesn't indicate if the data is retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. For this type of device (dental implant), "ground truth" typically refers to objective engineering measurements (e.g., fatigue cycles, material composition analysis, surface morphology) rather than expert interpretation of images or clinical outcomes. The document does not mention any expert panels or their qualifications for establishing ground truth for these engineering performance tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / None specified. Adjudication methods like 2+1 are relevant for studies involving human interpretation or clinical endpoints where there might be disagreement. This document describes engineering performance testing, which is objectively measured.
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. This is not an AI-assisted device, nor is it a diagnostic imaging device that would typically involve human readers. Therefore, an MRMC study is not relevant here.
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 AI. Standalone performance for an algorithm is not relevant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering Measurements/Industry Standards: The "ground truth" would be established by objective measurements against recognized engineering standards for dental implants (e.g., ISO standards for dental implants, ASTM standards for materials testing) and comparison to the performance of the predicate devices. This might include:
  - Mechanical testing results (fatigue, fracture resistance, torque out).
  - Material characterization (chemical composition, surface roughness, morphology).
  - Biocompatibility assays.
- The document does not specify the exact standards or specific measurement criteria used.
The sample size for the training set:
- Not applicable. This phrase typically refers to the data used to train a machine learning algorithm. This device is a physical dental implant, not an AI/ML product.
How the ground truth for the training set was established:
- Not applicable. As above, this concept refers to AI/ML development, which is not relevant to this device.

In summary, the provided document is a regulatory filing for substantial equivalence. It confirms that the device was tested and found to perform comparably to predicate devices, thus demonstrating safety and effectiveness for its intended use. However, it does not offer the granular detail of specific acceptance criteria, quantitative performance metrics from a defined study, or the methodologies for establishing ground truth as one might expect from a full clinical trial report or a detailed engineering validation protocol.

Summary

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	Regulation: 21 CFR 872.3640 and 21 CFR 872.3630

Identification ofPredicates and Summaryof SubstantialEquivalence	The JNE Implant System is substantially equivalent withrespect to the intended use, design, risks, devicecharacteristics and performance aspects to numerous cleareddevices, including:510(k) / Product / Manufacturer- K971196 / ENDOPORE ENDOSSEOUS DENTALIMPLANT SYSTEM / INNOVA CORP.- K002513 / ASTRA TECH IMPLANTS - DENTALSYSTEM / ASTRA TECH, INC.
	- K033984 / STRAUMANN DENTAL IMPLANTSYSTEM / INSTITUT STRAUMANN AG
Device Description	The JNE Implant System is an endosseous dental implantmade of Ti-6Al-4V ELI alloy and consists of severalcomponents. Geometrically, the fixture is screw-type. Anabutment is connected to the fixture through a tapered-joint.Fixtures are treated with sandblast and acid etching usingscanning electron microscopy (SEM).
Intended Use andIndications	The JNE Implant System is a titanium alloy screw-typeendosseous dental implant and endosseous dental implantabutment, which is intended to be surgically placed in thebone of the upper or lower jaw arches to provide support for aprosthetic device, such as an artificial tooth, in order to restorea patient's chewing function.
Performance Testing	Several tests were performed on the device. All testsdemonstrated that the device is safe and effective, performscomparably to and is substantially equivalent to the predicatedevices.

510(k) Summary

Page 5.2 of 5.2

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5. 510(k) Summary

Submitter/ContactPerson	H. Carl JenkinsThe Wood Burditt GroupFDA Regulatory Counseling1025 W. Everett Rd., Suite 100Lake Forest, IL 60045(ph) (847) 234-7500 x 205(fax) (847) 574-0728(email) hcjenkins@woodburditt.com
Applicant	GC America, Inc.3737 W. 127th StreetAlsip, IL 60803800.323.3386 x4042708.897.4042708.897.4031 (fax)
Manufacturer	GC CORPORATION.76 - 1 HASUNUMA - CHO,ITABASHI - KUTOKYO 174 - 8585 JAPAN
Sterilization Facility	RADIA INDUSTRY CO., LTD168 OOYAGI, TAKASAKIGUNNMA 370 - 0072 JAPAN
Device Name	JNE Implant System
Common Name	Root-form Endosseous Dental Implant and EndosseousDental Implant Abutment
Classification	Class IIProcode DZE and NHA

510(k) Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GC America, Incorporated C/O Mr. H. Carl Jenkins The Wood Burditt Group 1025 Everett Road, Suite 100 Lake Forest, Illinois 60045

MAR 1 0 2008

Re: K072425

Trade/Device Name: GC JNE Implant Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 28, 2008 Received: January 29, 2008

Dear Mr. Jenkins:

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. Jenkins

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.

Sydite Y. Michien Omd.

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):

Device Name: GC JNE Implant

Indications for Use:

Prescription Use X (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)
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Susan Turner

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

510(k) Number:

Indications For Use

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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.