The ET IV SA Dental Implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented, screw or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide version is intended to be used in the molar region.

Device Description

The ET IV SA Dental Implants are dental implants made from medical grade pure titanium metal (ASTM F67) and is supplied sterile. It is intended to be surgically placed in the bone of the upper or lower jaw arches. The ET IV SA Dental Implant is available in various lengths from 7.0 to 15mm and diameters from 4.4 to 7.1mm. The surface is SA: Sand blasted and Acid etched.

AI/ML Overview

The provided text describes the ET IV SA Dental Implants, a dental implant system. The document is a 510(k) premarket notification summary from the FDA.

Here's an analysis of the provided text in relation to your request about acceptance criteria and studies:

Key Takeaway: This document does not contain specific acceptance criteria or an independently conducted study to prove the device directly meets acceptance criteria in the typical sense of a clinical trial or algorithm performance study. Instead, it argues for substantial equivalence to previously cleared predicate devices based on non-clinical testing and comparison of characteristics. Therefore, many of your requested points are not applicable or cannot be extracted directly from this type of FDA submission.

However, I will extract relevant information where available and note when information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, specific performance acceptance criteria and direct performance metrics in comparison to those criteria are not provided in this 510(k) submission. The document focuses on showing the new device is substantially equivalent to predicate devices. The "reported device performance" is essentially that it performs equivalently to the predicate devices in the tested categories.

Acceptance Criteria Category	Reported Device Performance (as argued for substantial equivalence)
Intended Use	The modifications do not affect the intended use of the device. Same indications for use as predicate devices.
Surgery Type	Same surgery type (one or two-stage surgery) as predicate devices.
Structure	Similar structure to predicate devices (internal hex connection, submerged fixture, tapered body shape, 3 sided cutting edge with self-tapping). The revision relates to the tapered body and thread compared to the primary predicate.
Material	Same material (Pure Titanium Grade 4 per ASTM F67) as predicate devices.
Surface	Same SA (Sand blasted and Acid etched) surface treatment as predicate devices.
Sterilization Method	Same radiation sterilization method as predicate devices.
Shelf Life	Same shelf life (8 years) as predicate devices.
Biocompatibility	Deemed not necessary to re-test due to same manufacturing process and material as predicate K140934, indicating biological safety is equivalent.
Sterilization Validation	Deemed not necessary to re-validate due to same manufacturing process, material, sterile barrier system, and gamma irradiation conditions as predicate K140934, indicating sterilization validity is equivalent.
Fatigue Testing	Deemed not necessary to re-test. Applicable fatigue test data of ø 3.5 Hiossen Implant System (K140934) conducted per ISO 14801:2007 is relied upon, as there is no new worst-case compared to K140934. This implies the device meets the fatigue performance standards of ISO 14801:2007 as demonstrated by the predicate.

The subsequent points (2-9) are largely for studies involving AI/ML algorithms or clinical trials with ground truth establishment, which are not present in this document. However, I will address them to indicate their absence or provide the most relevant information given the context.

2. Sample size used for the test set and the data provenance

Not applicable / Not provided: This document describes a medical device (dental implant) that underwent non-clinical performance testing (biocompatibility, sterilization validation, fatigue testing) based on existing data from predicate devices, rather than a new "test set" of patient data in the context of an algorithm or diagnostic study.

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

Not applicable / Not provided: Ground truth establishment by experts is typically relevant for diagnostic or AI/ML device studies. The assessments here are based on engineering comparisons and material properties, referencing established standards (e.g., ISO 14801:2007 for fatigue testing) rather than adjudicated expert interpretations of a dataset.

4. Adjudication method for the test set

Not applicable / Not provided: No multi-reader adjudication process is mentioned, as this is not a study involving interpretations by multiple readers.

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: No MRMC study was conducted or is relevant for this type of dental implant submission. This device does not involve AI assistance for human readers.

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

No: This device is a physical dental implant, not an algorithm. Standalone algorithm performance is not applicable.

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

Not applicable / Indirectly: For the non-clinical tests referenced:
- Biocompatibility: Ground truth is established by compliance with biocompatibility standards (e.g., ISO 10993 series), and relying on the predicate device's compliance.
- Sterilization Validation: Ground truth is compliance with sterilization standards (e.g., ISO 11137 for radiation sterilization), relying on the predicate device's compliance.
- Fatigue Testing: Ground truth is established by meeting the requirements of ISO 14801:2007 for dental implants, relying on the predicate device's test data.

8. The sample size for the training set

Not applicable / Not provided: This device did not involve a "training set" in the context of AI/ML or statistical modeling. The "data" relied upon consists of design specifications, material properties, manufacturing processes, and non-clinical test reports from the predicate devices.

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

Not applicable / Not provided: As there is no training set mentioned in the context of an algorithm, there's no ground truth established for it. The ground truth for the non-clinical tests is based on established scientific and engineering principles and international standards.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 21, 2019

Hiossen, Inc. Peter Lee QA/RA Manager 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030

Re: K183242

Trade/Device Name: ET IV SA Dental Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: April 19, 2019 Received: April 22, 2019

Dear Peter 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Malvina Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K183242 Device Name

ET IV SA Dental Implants

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 807 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Service (301) 443-6740 EF

ET IV SA Dental Implants Special 510(k)

Confidential

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Image /page/3/Picture/0 description: The image contains a logo for Hiossen Implant. The logo features the word "Hiossen" in a stylized font, with the "H" in red and the rest of the letters in gray. Below the word "Hiossen" is the word "Implant" in a smaller, gray font. Below the logo is the text "K183242" in a bold, black font.

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(1) Submitter Information:Submitted by:	Hiossen, Inc.85 Ben Fairless DriveFairless Hills, PA 19030
Contact Person:Telephone Number:Fax Number:Email:	Peter Lee267-759-7031267-759-7031peter.l@hiossen.com
Date Prepared:	May 21, 2019
(2) Device Name:• Proprietary Name:• Classification Name:• CFR Number:• Device Class:• Product Code:	ET IV SA Dental ImplantsImplant, Dental, Endosseous872.3640Class IIDZE

(3) Predicate Device(s):

	Device	510(k)	Manufacturer
Primary Predicate	HIOSSEN Implant System	K140934	HIOSSEN, INC.
Reference Device	Osstem Implant System	K161604	Osstem Implant Co., Ltd.

(4) Description of Device:

The ET IV SA Dental Implant is available in various lengths from 7.0 to 15mm and diameters from 4.4 to 7.1mm, configurations are listed in the table below. The surface is SA: Sand blasted and Acid etched.

The ET IV SA Dental Implant is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

	Diameter (mm)	Length (mm)
ET IV SA	4.4	7.0, 8.5, 10.0, 11.5, 13.0, 15.0
ET IV SA	4.8	7.0, 8.5, 10.0, 11.5, 13.0, 15.0
ET IV SA	5.25	7.0, 8.5, 10.0, 11.5, 13.0, 15.0
ET IV SA Ultra Wide	6.2	7.0, 8.5, 10.0, 11.5, 13.0
ET IV SA Ultra Wide	7.1	7.0, 8.5, 10.0, 11.5, 13.0

(5) Indication For Use:

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Image /page/4/Picture/0 description: The image shows the logo for Hiossen Implant. The logo features the word "Hiossen" in a stylized font, with the "H" in red and the rest of the letters in gray. Below the word "Hiossen" is the word "Implant" in a smaller font. The number K183242 is located in the bottom right corner of the image.

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(6) Substantial Equivalence:

Hiossen, Inc. received premarket clearance for the primary predicate Hiossen implant System under premarket notification K140934. Hiossen. Inc modified the ETII SA Fixture and ETIII SA Ultra-wide Fixture of the Hiossen Implant System. This modified ET III SA Ultra-wide Fixture is herewith submitted as a new 510(k) under the name ET IV SA Dental Implants.

The revision to the ET III SA Fixture and ET III SA Ultra-wide Fixture relates to the tapered body and thread. Table 1 shows the similarities and difference between the proposed device, ET IV SA Dental Implant and the primary predicate Hiossen Implant System – ET III SA Fixture and ET III SA Ultra-wide Fixture cleared under K140934 and reference device, Osstem Implant System - TSIV SA Fixture and TSIV Ultra-wide SA Fixture cleared under K161604.

The differences in the Indications for Use statements between the subject device and the primary predicate device and reference device such as the identification of the trade name of the device, removal of the word "retained" from the Indications for Use Statement does not alter the intended use of the subject device. Additionally, the Indications for Use Statement of the refence device provides instruction on the clinical use of the ø3.25mm and smaller sized device. The subject device does not contain a device in this size range and is not applicable.

Throughout this submission we show that the modifications does not affect the intended use of the device, indication for use, surgery type, structure, material, surface, sterilization method, shelf life and the fundamental scientific technology of the device when compared to the primary predicate device Hiossen Implant System (K140934) and reference device, Osstem Implant System, K161604. Therefore, the proposed device, ET IV SA Dental Implant is substantially equivalent to the primary predicate, Hiossen Implant System, K140934 and reference Osstem Implant System, K161604.

Table 1 Device Comparison
Device	Proposed DeviceET IV SA Dental Implant	Primary PredicateHiossen Implant System*ET III SA Fixture and ETIII SA Ultra-wide Fixture(K140934)	Reference DeviceOsstem Implant System*TSIV SA Fixture & TSIVSA Ultra wide Fixture(K161604)
Manufacturer	Hiossen, Inc.	Hiossen, Inc.	Osstem Co., Ltd.
Indication forUse	The ET IV SA DentalImplants are indicated foruse in partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cemented, screw oroverdenture restorations,and final or temporaryabutment support for fixedbridgework. It is intendedfor delayed loading. Ultrawide version is intended tobe used in the molarregion.	The Hiossen ImplantSystem is indicated for usein partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It is intendedfor delayed loading. ETIIISA Ultra Wide Fixture isintended to be used in themolar region.	The Osstem ImplantSystem is indicated for usein partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It is intendedfor delayed loading. Ultrawide Fixture System isintended to be used in themolar region. Productswith diameter of less than3.25mm should be used

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Image /page/5/Picture/0 description: The image shows the logo for Hiossen Implant. The logo is in red and gray. Below the logo is the number K183242.

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SurgeryType	One or two stage surgery	One or two stage surgery	One or two stage surgery
Structure	• Internal hex connection• Submerged fixture• Tapered body shape• 3 sided cutting edge withself-tapping• SA surface treatment	• Internal hex connection• Submerged fixture• Tapered body shape• 3 sided cutting edge withself-tapping• SA surface treatment	• Internal hex connection• Submerged fixture• Tapered body shape• 3 sided cutting edge withself-tapping• SA surface treatment
BodyDiameter (D)(mm)	4.4, 4.8, 5.256.2* and 7.1*	3.5, 3.75, 3.77, 4.2, 4.25,4.45, 4.6, 4.63, 4.9, 5.0,5.05, 5.08, 5.1, 5.92, 5.95,6.0, 6.8	4.4, 4.8, 5.25, 6.2, 7.1
Length (mm)	7.0, 8.5, 10.0, 11.5, 13.0,15.0* the 6.2 and 7.1mm bodydiameter are not available inthe 15mm length	6.2, 7.2, 8.7, 10.2, 11.7,13.2, 15.2, 18.2	7.0, 8.5, 10.0, 11.5, 13.0,15.0
Material	Pure Titanium Grade 4(ASTM F67)	Pure Titanium Grade 4(ASTM F67)	Pure Titanium Grade 4(ASTM F67)
Surface	SA	SA	SA
SterilizationMethod	Radiation sterilization	Radiation sterilization	Radiation sterilization
Shelf life	8 years	8 years	8 years

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Image /page/6/Picture/0 description: The image shows the logo for Hiossen Implant. The logo has the word "Hiossen" in a stylized font, with the "H" in red and the rest of the letters in gray. Below the word "Hiossen" is the word "Implant" in a smaller, gray font. Below the word "Implant" is the number "K183242" in black.

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Non-Clinical Performance Testing

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include data from the following tests:

Biocompatibility Testing

The ET IV Dental Implants is manufactured using the same manufacturing process and material as the predicate device, Hiossen Implant System, K140934, therefore it was deemed not necessary to re-test biocompatibility in order to support the biological safety of the ET IV Implants System as there is no new worst-case as compared to K140934.

Sterilization Validation

The ET IV Dental Implants (manufactured using the same manufacturing process, material and utilizes the same sterilize barrier system) is gamma irradiated under the same conditions and process as the predicate device. Hiossen Implant System. K140934. therefore was deemed not necessary to re-validate in order to support the sterilization validity of the ET IV Dental Implants System as there is no new worst-case as compared to K140934.

Fatigue Testing

The ET IV Dental Implants is manufactured using the same manufacturing process, material and structure, as the predicate device, Hiossen Implant System, K140934, we deemed it was not necessary to re-test fatigue testing. The fatigue test data of the ø 3.5 Hiossen Implant System, K140934 which was conducted per ISO 14801:2007 Dentistry - Implants - Dynamic Fatigue Test for Endosseous Dental Implants, is applicable to the ET IV Dental Implants as there is no new worst-case as compared to K140934.

Conclusion

The ET IV SA Dental Implants are modified Hiossen Implant System – ET III SA Fixture and ET III SA Ultrawide Fixture (K140934) where the modification does not affect or change the intended use of the device or the fundamental scientific technology of the device. It has the same indication for use, surgery type, structure, material, surface, sterilization method, and shelf life with the primary predicate device Hiossen Implant System (K140934). Based on the testing provided, biocompatibility, sterilization and fatique, support that the ET IV SA Dental Implants is substantial equivalent to the predict device, Hiossen Implant System, K140934 and reference device, Osstem Implant System, K161604. Any differences in characteristics between the proposed device and the primary predicate and reference does not raise different or additional questions of substantial equivalence.

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.