The Internal Octa Implant System is intended for placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. The Internal Octa Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Description

An endosseous dental implant is a device made of Pure Titanium Grade 4. Internal Octa Implant System has been designed to accommodate the following dental implant restoration protocols; Immediate or Early loading, immediate placement or one or two stage placements. Internal Octa Implant Systems help patients who have partial or whole teeth loss mastication to chew as dental implant. The Internal Octa Implant System has an internal connection. The surface of the system has been treated with SLA (Sandblast, Large grit Acid etched).

There are 3different kinds of fixtures, BLT III, Precision III and LISA Implants. The only differences between these implants are designs and dimensions. The appearance of implants is different depending on the presence of cutting edge and taper. The Fixtures are supplied sterile.

AI/ML Overview

This document describes the regulatory approval for the "Internal Octa Implant System," a dental implant. It is a 510(k) submission, meaning the manufacturer is demonstrating that their new device is "substantially equivalent" to existing, legally marketed devices (predicates).

Therefore, the performance data presented here is related to demonstrating substantial equivalence, primarily through bench testing and comparison to predicates, rather than extensive clinical studies or AI model performance as would be seen for a novel diagnostic AI device.

Given that this document is for a dental implant system, and not an AI-based diagnostic device, it does not contain the information required to populate a table of acceptance criteria for AI performance metrics (like sensitivity, specificity, AUC), nor does it describe a study involving human readers or AI in the way your prompt defines. The performance data provided is focused on material biocompatibility and physical characteristics of the implant.

Let's break down why this document doesn't fit your prompt's requirements:

No AI Component: The document describes a physical medical device (dental implants made of titanium). There is no mention of artificial intelligence, diagnostic algorithms, or image analysis performed by an AI.
No Diagnostic Performance Metrics: Given the above, there are no references to sensitivity, specificity, AUC, or other metrics typically associated with AI diagnostic performance.
No Human Reader Studies: Since it's a physical implant, there are no studies detailed that involve human readers (like radiologists) interpreting images with or without AI assistance.
Ground Truth: The "ground truth" for a dental implant would be related to its physical properties, biocompatibility, and intended function in the human body, not an expert consensus on image interpretation.
Training/Test Sets for AI: These concepts are irrelevant as there is no AI model being trained or tested.

However, to answer your prompt in the context of this specific document, I will interpret "acceptance criteria and reported device performance" as the basis for substantial equivalence for this medical device, and then address the other points by stating their inapplicability to this type of device submission.

Acceptance Criteria and Reported Device Performance (as applied to Substantial Equivalence for a Dental Implant):

For this Traditional 510(k) submission, the "acceptance criteria" revolve around demonstrating that the Internal Octa Implant System is as safe and effective as its predicate devices. This is achieved through various forms of bench testing and comparison of physical and material characteristics.

1. Table of Acceptance Criteria and Reported Device Performance (Interpreted for a Dental Implant):

Acceptance Criterion (for Substantial Equivalence)	Reported Device Performance
Material: Fabricated from CP Titanium (Grade 4) conforming to ASTM F67.	The device is fabricated from CP Titanium (Grade 4) that conforms to ASTM F67.
Biocompatibility: Pass tests in accordance with ISO 10993-1:2009.	Biocompatibility Testing (cytotoxicity, sensitization, irritation, acute systemic toxicity) was performed and met the criteria of the standards.
Surface Characterization: Demonstrate surface roughness, SEM, and EDS.	Surface roughness demonstration, surface SEM, and surface EDS were performed. Results met the criteria of the standards.
Endotoxin Testing: Pass LAL Endotoxin testing in accordance with ANSI/AAMI ST 72:2011, USP <85> and <161>.	LAL Endotoxin testing was performed and met the criteria of the standards.
Sterilization: Demonstrate compliance with ISO 11137-1,-2,-3 (leveraged from predicate K073116).	Sterilization Test was leveraged from predicate K073116 and met the criteria. Device is Radiation Sterile.
Shelf Life: 5 years, demonstrated according to ISO 11607-1, -2, and ASTM F1980-07 (leveraged from predicate K073116).	Shelf life Validation Test was leveraged from predicate K073116 and met the criteria. Declared shelf life is 5 years.
Intended Use: Match predicate devices' intended use.	The Internal Octa Implant System has a substantially equivalent intended use to the identified predicates.
Design/Dimensions: Be within ranges comparable to predicate devices, with noted differences addressed.	Provides detailed tables comparing Body Diameters, Platform Diameters, Total Lengths, Connection Type, and Implant Type to predicate devices, stating similarity or addressing differences (e.g., LISA Implant concavity).
Fundamental Scientific Technology: Be similar in materials and design principles to predicates.	Stated to be similar in fundamental scientific technology in that they are designed, manufactured, and tested in compliance with "FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutment," and "all constructed of titanium."

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

This document does not describe a "test set" in the context of an AI model evaluating data.
For the bench testing (biocompatibility, surface characterization, endotoxin), the sample sizes would refer to the number of individual implant units or material samples tested. These specific numbers are not provided in this summary document but would be detailed in the full test reports referenced (e.g., in the ISO 10993 reports).
Data Provenance: The bench testing would have been conducted in a laboratory setting, likely affiliated with the manufacturer (EBI Inc. in Republic of Korea) or a contract testing organization. The data is prospective in the sense that the tests were performed specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept is not applicable to this submission. "Ground truth" for a dental implant is established through engineering specifications, material science standards (ASTM, ISO), and regulatory requirements, not through expert consensus on images.
The judgment of substantial equivalence is made by reviewers at the FDA based on the submitted technical data and comparison to predicates.

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

This concept is not applicable to this submission, as there is no "test set" requiring adjudication by multiple readers or experts for diagnostic accuracy.

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:

No MRMC study was done. This is a submission for a physical dental implant, not an AI-assisted diagnostic device. Therefore, there is no "human-in-the-loop performance" or "effect size of human readers improving with AI" relevant to this document.

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

No standalone algorithm performance was done. This document describes a physical medical device, not a software algorithm.

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

The "ground truth" or standard for acceptance here is compliance with pre-defined engineering standards (ASTM, ISO), material properties, and biological compatibility as demonstrated through standardized bench testing. It's essentially a "comparison to technical specifications and regulatory standards" truth.

8. The sample size for the training set:

Not applicable. There is no AI model being trained, so no training set exists.

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

Not applicable. As there is no AI model, there is no training set and therefore no ground truth to be established for it.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid on three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

August 31, 2017

EBI Inc. % April Lee Consultant Withus Group Inc. 2531 Pepperdale Drive Rowland Heights, California 91748

Re: K170031

Trade/Device Name: Internal Octa Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: July 27, 2017 Received: August 3, 2017

Dear April 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 Federal Register.

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Page 2 - April 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Andrew I. Steen -S

for Lori A. Wiggins, MPT, CLT Acting 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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Indications for Use

510(k) Number (if known) K170031

Device Name Internal Octa Implant System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter

EBI Inc. Mi Sook Kim 124, Uisong-gil, Amnyang-myeon, Gyeongsan-si Gyeongsangbuk-do38493 Republic of Korea Email: dej@ebiimplant.com Tel. +82-53-817-7767 Fax. +82-53-817-7768

Official Correspondent

Withus Group Inc. April Lee 2531 Pepperdale Drive, Rowland Heights, CA 91748 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Device Information

Trade Name: Internal Octa Implant System .
Common Name: Dental Implant System
Classification Name: implant, endosseous, root-form
Product Code: DZE ●
Panel: Dental
Regulation Number: 872.3640 ●
Device Class: Class II
Date prepared: 08/31/2017

General Description

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	BLT III Implant	Precision III Implant	LISA Implant
Implant Type	Bone Level	Tissue Level	Bone Level
Platform Diameter	4.1, 4.8mm	4.8, 6.5mm	4.1, 4.8mm
Body Diameter	4.1, 4.8mm	3.3, 4.1, 4.8mm	4.1, 4.8mm
Length	7.2, 7.7, 8.2, 8.7, 9.2,9.7, 10.2, 10.7, 11.2,11.7, 12.2, 12.7, 13.2,13.7, 14.2 mm	8.3, 9.3, 10.3, 11.3,12.3, 13.3, 14.3, 15.3mm	11.2, 12.2 mm
Pitch	0.8mm	1.25mm	0.8mm
Unique features	It is made of PureTitanium Grade 4. Thesurface treated with SLA(Sandblast, Large gritAcid etched).	It is made of PureTitanium Grade 4.The surface treatedwith SLA (Sandblast,Large grit Acidetched).	It is made of Pure Titanium Grade4. The surface treated with SLA(Sandblast, Large grit Acidetched). It has a concaveappearance to be placed in thenarrow ridge area.

The ranges of the fixtures' dimensions are below:

Indication for Use

Materials:

The devices are fabricated from CP Titanium (Grade 4) that conforms to ASTM F67 for Dental Implant.

Performance Data (Bench Testing):

The subject device was tested to evaluate its substantial equivalence according to the following standards:

Biocompatibility Testing such as cytotoxicity, sensitization, irritation and acute systemic toxicity ● was performed in accordance with ISO 10993-1:2009
Surface roughness demonstration, surface SEM, and surface EDS
LAL Endotoxin testing in accordance with ANSI/AAMI ST 72:2011, USP <85> and <161>

Below test was performed for primary predicate devices and leveraged for the subject device:

Sterilization Test according to ISO 11137-1,-2,-3 referenced in K073116 .
Shelf life Validation Test according to ISO 11607-1, -2, and ASTM F1980-07 referenced in . K073116

The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device.

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Predicate Devices:

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

1. BLT III Implants

	Subject Device	Primary Predicate	Reference Predicate
Company	EBI Inc.	EBI Inc.	OSSTEM ImplantCo.,Ltd.
Device Name	Internal Octa ImplantSystem	EBI Internal Implant	ETIII SA Fixture
510(k) Number	NA	K073116	K101096
Device ClassificationName	Implant, Endosseous, Root-form	Implant, Endosseous,Root-form	Implant, Endosseous,Root-form
Classification ProductCode	DZE	DZE, NHA	DZE
Regulation Number	21 CFR872.3640	21 CFR872.3640	21 CFR872.3640
Intended Use	The Internal Octa ImplantSystem is intended forplacement in the maxillaryand/or mandibular archesto support crowns, bridges,or overdentures inedentulous or partiallyedentulous patients. TheInternal Octa ImplantSystem is intended forimmediate loading whengood primary stability isachieved and withappropriate occlusalloading.	EBI Implant System isintended for immediate,delayed, or conventionalplacement in themaxillary and/ormandibular arches tosupport crowns, bridges,or overdentures inedentulous or partiallyedentulous patients.	ET III Fixture System isindicated for use inpartially or fullyedentulous mandibles andmaxillae, in support orsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and terminalor intermediate abutmentsupport for fixedbridgework.
Material	Titanium Gr.4	Titanium Gr.4	Titanium Gr.4
Design	Image: Implant Design 1	Image: Implant Design 2	Image: Implant Design 3
Body Diameters	4.1, 4.8mm	3.3 - 4.8 mm	3.5 – 5.0 mm
Platform Diameters	4.1, 4.8mm	4.8, 6.5mm	3.5 - 5.0 mm
Total Lengths	7.2-14.2 mm	6-15.3 mm	7-15 mm
Connection Type	Internal Octa	Internal Octa	Internal Octa
Surface Treatment	SLA	RBM	SLA
Gamma Sterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile
Shelf Life	5 years	5 years	5 years
Implant Type	Bone Level	Bone Level	Bone Level

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2) Precision III Implant

	Subject Device	Primary Predicate
Company	EBI Inc.	EBI Inc.
Device Name	Internal Octa Implant System	EBI Internal Implant
510(k) Number	NA	K073116
Device Classification Name	Implant, Endosseous, Root-form	Implant, Endosseous, Root-form
Classification Product Code	DZE	DZE, NHA
Regulation Number	21 CFR872.3640	21 CFR872.3640
Intended Use	The Internal Octa Implant System isintended for placement in themaxillary and/or mandibular archesto support crowns, bridges, oroverdentures in edentulous orpartially edentulous patients. TheInternal Octa Implant System isintended for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading.	EBI Implant System is intended forimmediate, delayed, orconventional placement in themaxillary and/or mandibular archesto support crowns, bridges, oroverdentures in edentulous orpartially edentulous patients.
Material	Titanium Gr.4	Titanium Gr.4
Design	Image: Implant	Image: Implant
Body Diameters	Regular: 3.3, 4.1, 4.8 mmWide: 4.8 mm	Regular: 3.3, 4.1, 4.8 mmWide: 4.8 mm
Platform Diameters	4.8, 6.5 mm	4.8, 6.5 mm
Total Lengths	8.3-15.3 mm	6-15.3 mm
Connection Type	Internal Octa	Internal Octa
Surface Treatment	SLA	RBM
Gamma Sterilization	Radiation Sterile	Radiation Sterile
Shelf Life	5 years	5 years

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3) LISA Implant

	Subject Device	Primary Predicate	Reference Predicate
Company	EBI Inc.	EBI Inc.	DIO Department, DSI, Inc
Device Name	Internal Octa ImplantSystem	EBI Internal Implant	SM® IMPLANT SYSTEMS
510(k) Number	NA	K073116	K061797
DeviceClassificationName	Implant, Endosseous,Root-form	Implant, Endosseous,Root-form	Implant, Endosseous, Root-form
ClassificationProduct Code	DZE	DZE, NHA	DZE, NHA
RegulationNumber	21 CFR872.3640	21 CFR872.3640	21 CFR872.3640
Intended Use	The Internal OctaImplant System isintended forplacement in themaxillary and/ormandibular arches tosupport crowns,bridges, oroverdentures inedentulous orpartially edentulouspatients. The InternalOcta Implant Systemis intended forimmediate loadingwhen good primarystability is achievedand with appropriateocclusal loading.	EBI Implant System isintended for immediate,delayed, or conventionalplacement in the maxillaryand/or mandibular archesto support crowns,bridges, or overdentures inedentulous or partiallyedentulous patients.	The SM® Implant System isanendosseous dental implant isindicated for surgical placement intheupper and lower jaw arches, toprovide a root form means for single ormultiple units' prostheticapplianceattachment to restorea patient's chewingfunction. Implants can be placedwithconventional two stage surgicalprocess with an option fortransmucosalhealing or they can beplaced in a singlestage surgical process for immediateloading. Immediate loading isrestrictedtothe anterior mandible, based on foursplinted interforminal placed implants,and notindicated forsingle, unsplintedimplants. Patients must besubject fordental treatmentwithendosseousimplants.
Material	Titanium Gr.4	Titanium Gr.4	Titanium Gr.4
Design	Image: Implant design	Image: Implant design	Image: Implant design
Body Diameters	4.1, 4.8mm	Regular: 3.3, 4.1, 4.8 mmWide: 4.8 mm	3.8, 4.5, 5.3 mm
PlatformDiameters	4.1, 4.8mm	4.8, 6.5 mm	3.8, 4.5, 5.3 mm
Total Lengths	11.2, 12.2 mm	6-15.3 mm	8-14 mm

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ConnectionType	Internal Octa	Internal Octa	Internal Octa
SurfaceTreatment	SLA	RBM	RBM
GammaSterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile
Shelf Life	5 years	5 years	5 years
Implant Type	Bone Level	Tissue Level	Bone Level

Substantial Equivalence Discussion

The Internal Octa Implant System has a substantially equivalent intended use as the identified predicates. The subject device is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutment, and they are all constructed of titanium.

The subject and primary predicate devices are similar in indications, design, technology, functions, dimensions, and material.

The differences between the subject device and the primary predicate are:

1. Surface Treatment Method
  The surface treatment method of the subject device is SLA (Sandblast, Large grit Acid etched) and the surface treatment method of the primary predicate device is RBM (Resorbable Blasted Media). To support this discrepancy, the predicate, K101096 is selected as reference and biocompatibility testing, surface roughness demonstration, surface SEM, and surface EDS were performed on the subject device.
1. Slight differences in fixture designs, especially LISA Implant LISA Implant has a concave appearance to be placed in the narrow ridge area, which is difference of the shape between the subject and primary predicate, K073116. To support this discrepancy, the predicate, K061797 is selected as reference.
  Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the predicates and do not raise different questions of safety and effectiveness than the predicate.

Conclusion

The Internal Octa Implant System, subject device of this submission, constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. The risks of using the device as recommended pose no greater risks than any other implant systems. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, Internal Octa Implant System and its predicates are substantially equivalent.

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.