The HGIII Fixture 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. The HGIII Fixture System is for single and two stage surgical procedures. It is not for immediate load.

Device Description

The HGIII Fixture System is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.

AI/ML Overview

This 510(k) pertains to a dental implant system (HGIII Fixture System) and is a substantial equivalence submission, not a de novo submission. Therefore, the information provided focuses on demonstrating equivalence to a predicate device rather than presenting novel acceptance criteria or a study designed to prove the device meets specific performance criteria against pre-defined thresholds.

Here's a breakdown of why many of your requested items cannot be directly extracted from this document:

Acceptance Criteria & Device Performance Table: The document explicitly states: "The HGIII Fixture System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." However, it does not provide specific acceptance criteria or reported device performance metrics in a tabular format because the submission is based on demonstrating substantial equivalence to a predicate device (K082213), rather than proving performance against novel criteria. The assumption is that if it's substantially equivalent, it meets the same implicit performance as the predicate.
Sample sizes, data provenance, expert ground truth, adjudication, MRMC, standalone studies, type of ground truth, training set information: These are typically found in detailed performance studies for novel devices or when specific performance claims are being made. For a substantial equivalence claim, the focus is on comparing the new device's design, materials, and intended use to a legally marketed predicate device. The document states "The HGIII Fixture System is substantially equivalent in design, function and intended use to the HGIII Fixture System (K082213) of HiOSSEN Inc." and mentions that it "has same material and indication for use and similar design and technological characteristics as the predicate device." This indicates that the primary "study" is a comparison and justification of equivalence, not a clinical trial or performance study generating the detailed data you're asking for.

However, I can extract the information that is present in the document related to the study's nature:

Acceptance Criteria and Study for Hiossen Inc. HGIII Fixture System (K093352)

This 510(k) submission demonstrates substantial equivalence to a predicate device, rather than defining and meeting novel acceptance criteria through independent clinical or performance studies. Therefore, many standard elements of a performance study are not explicitly detailed.

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided as this is a substantial equivalence submission. The "acceptance criteria" for this type of submission are implicitly that the device is "substantially equivalent" to the predicate device (K082213) in terms of intended use, technology, materials, and performance characteristics.

Acceptance Criteria Category	Predicate Device Performance (Implicitly Met by HGIII)	Reported HGIII Fixture System Performance
Intended Use	Partially/fully edentulous mandibles/maxillae; support single/multiple-unit restorations; single/two-stage surgical procedures; not for immediate load.	Meets: Same as predicate device. (Stated in Section 5)
Material Composition	Titanium metal.	Meets: Titanium metal. (Stated in Section 4 & 6)
Design Characteristics	Specific design features of K082213.	Similar: "similar design" to predicate device. (Stated in Section 6)
Technological Characteristics	Specific technological features of K082213.	Similar: "similar technological characteristics" to predicate device. (Stated in Section 6)
Safety and Biocompatibility	Complies with international/US regulations.	Meets: "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." (Stated in Section 6)
Performance Validations	Product validations prior to release.	Meets: "product validations prior to release." (Stated in Section 6)

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

Sample Size: Not applicable/not specified. The submission is a comparison for substantial equivalence, not a clinical trial with a "test set" of patients or samples in the traditional sense for evaluating novel performance metrics.
Data Provenance: Not applicable/not specified. The document refers to prior safety, performance, and product validations conducted by the manufacturer, but does not detail their scope, data origin, or retrospective/prospective nature.

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

Not applicable/not specified. Ground truth establishment by experts for a test set is typically for performance claims against a reference standard, which is not the primary focus of this substantial equivalence submission. The review process by the FDA involves their own experts, but this is an internal regulatory process, not part of the manufacturer's performance study described here.

4. Adjudication method for the test set

Not applicable/not specified.

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

Not applicable. This device is a dental implant, not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This device is a physical dental implant.

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

Not applicable in the context of a "test set" for performance evaluation. The "ground truth" for this submission is the predicate device (K082213), against which the new device (HGIII Fixture System) is compared for substantial equivalence in design, materials, and intended use.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The manufacturer conducted internal "safety, performance, and product validations" but no details on sample sizes are provided.

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

Not applicable.

Summary

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Ko93352

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Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com 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.

Date : September 23, 2009

Company and Correspondent making the submission:

Submitter's Name :

HiOSSEN Inc.

Mr. Patrick Lim

Address :

85 Ben Fairless Dr. Fairless Hills PA 19030

Contact :

Device :

Trade or (Proprietary) Name : Common or usual name : Classification Name :

HGIII Fixture System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE

3. Predicate Device :

The HGIII Fixture System, HiOSSEN Inc, K082213

1. Description :
  The HGIII Fixture System is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.

The HGIII Fixture System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

The HGIII Fixture System is substantially equivalent in design, function and intended use to the HGIII Fixture System (K082213) of HiOSSEN Inc.

Indication for use :

The HGIII Fixture System is indicated for use in partially or fully edentulous mandibles and

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Hiossen Inc.

85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004

www.hiossen.com

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.

The HGШ Fixture System is for single and two stage surgical procedures. It is not for immediate load.

Review :

The HGIII Fixture System has same material and indication for use and similar design and technological characteristics as the predicate device.

The HGIII Fixture System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.

Conclusion :

Based on the information provided in this premarket notification HiOSSEN concludes that the HGIII Fixture System is safe and effective and substantially equivalent to the predicate device as described herein.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

NOV & 4 2009

Mr. Patrick Lim Quality Assurance/Regulatory Affairs Manager HiOSSEN Incorporated 85 Ben Fairless Drive Fairless Hills, Pensylvania 19030

Re: K093352

Trade/Device Name: HGIII Fixture System Regulation Number: 21CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 23, 2009 Received: October 27, 2009

Dear Mr. Lim:

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 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. Lim

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Wh far

Susan Runner, D.D.S., M.A. Acting 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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Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com

510(k) Number K 093352

Device Name : HGIII Fixture System

Indication for use : The HGI Fixture 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.

The HGIII Fixture System is for single and two stage surgical procedures. It is not for immediate load.

Prescription Use_ X (Per 21CFR801 Subpart D) OR

Over-The-Counter Use (Per 21CFR807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aber DDS for Dr. Kevin Mullin

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

510(k) Number: K093352

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.