The HC-Bios Dental Implant System 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, and to restore the patient's chewing function.

This may be accomplished by either a two-stage surgical procedure or a single surgical procedure. If a single surgical procedure is used, single or multiple implants may be inserted (type I, II or III bone) provided good initial stability (> 40 Ncm) is achieved. Not intended for immediate loading.

Device Description

The HC-Bios Dental Implant System is a device made of pure titanium metal and titanium alloy 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, and to restore the patient's chewing function. It consists of fixture, abutment, mount screw, cover screw, impression coping, analog, impression coping screw and plastic impression cap. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the HC-Bios Dental Implant System, focusing on acceptance criteria and the study proving adherence:

The provided document describes a traditional 510(k) submission for a dental implant system. As such, the "study" proving the device meets acceptance criteria is primarily non-clinical testing demonstrating substantial equivalence to a predicate device. This is typical for Class II devices like dental implants. There is no mention of clinical studies involving human patients, AI components, or complex ground truth establishment for diagnostic performance.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	Adherence to recognized standards for biological evaluation of medical devices (ISO 10993 series).	"A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests were performed... The tests were conducted in accordance with ISO 10993-10, ISO 10993-10, ISO 10993-11, ISO 10993-12." (Note: ISO 10993-10 is listed twice, likely a typo.) These tests demonstrate the device "meets the requirements of its pre-defined acceptance criteria." The material is pure titanium and titanium alloy, which are well-established biocompatible materials for dental implants. The predicate uses titanium metal and titanium alloy; the proposed device uses Grade 4 titanium and AISI 316L Stainless Steel.
Physical/Mechanical	Adherence to recognized standards for mechanical testing of dental implants (ISO 14801, ASTM F 543, ASTM F 1980). Demonstrated performance comparable to the predicate device.	"A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests were performed... The tests were conducted in accordance with ISO 14801, ASTM F 543, and ASTM F 1980." These tests demonstrate the device "meets the requirements of its pre-defined acceptance criteria." The document states, "The result of bench testing indicates that the new device is substantially equivalent to the predicate device."
Sterilization	Adherence to recognized standards for sterilization of medical devices (ISO 11137-1).	"The tests were conducted in accordance with... ISO 11137-1." These tests demonstrate the device "meets the requirements of its pre-defined acceptance criteria."
Substantial	Similar intended use, design, technology/principles of operation, materials, and performance to the predicate device, with no new issues of safety or effectiveness raised by any differences.	The document explicitly states the "HC-Bios Dental Implant System is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the Dentium Co., Ltd Implantium which is the subject of K041368." Bench testing results support substantial equivalence. The predicate and proposed devices share identical intended use, classification, and regulatory code. While materials differ (Grade 4 Ti & AISI 316L SS vs. Ti & Ti alloy), these are all standard biocompatible materials for implants, and this difference is implicitly covered by the biocompatibility and mechanical testing. Dimensions have slightly larger ranges for the proposed device, but this is also addressed by testing.
Initial Stability	Achieve > 40 Ncm upon insertion for single surgical procedures (for Type I, II, or III bone).	This is an explicit indication for use criterion. While no specific test result is provided for this exact metric, the overall bench testing, particularly mechanical tests (ISO 14801, ASTM F 543), supports the device's ability to achieve appropriate initial stability, as it is deemed substantially equivalent for its intended use.

Note: For medical devices seeking 510(k) clearance, the primary "acceptance criterion" is generally demonstrating substantial equivalence to a legally marketed predicate device. The performance data presented here is to support that claim of equivalence, often by showing the proposed device meets relevant performance standards and has similar characteristics to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated as a number of devices or cases. The "test set" refers to the samples of the HC-Bios Dental Implant System that underwent non-clinical (in vitro and in vivo preclinical) testing. These are typically representative samples of the manufactured device. The common practice for such testing involves a sufficient number of samples to achieve statistical significance or meet the requirements of the specific test standard (e.g., a certain number of fatigue test samples).
Data Provenance: The tests were "in vitro and in vivo preclinical" and "bench testing." This refers to laboratory and possibly animal testing. The location of the testing laboratories is not specified, but the manufacturer is based in Taiwan. The data is entirely retrospective relative to the 510(k) submission, meaning the tests were completed before the submission. There is no indication of human patient data provenance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable in the context of this 510(k) submission.

No Human Experts for Ground Truth: Since this is non-clinical testing of a physical medical device (dental implant), there is no 'ground truth' established by a panel of human experts in the way one would for an AI diagnostic algorithm. The "truth" or "correctness" of the device's performance is determined by its adherence to established engineering, material, and biocompatibility standards (e.g., ISO, ASTM).
Qualifications: The tests would have been performed by engineers, materials scientists, and toxicologists familiar with the respective ISO/ASTM standards and Good Laboratory Practices (GLP), but they are not acting as "experts establishing ground truth" in a diagnostic sense.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical device testing described in this 510(k). Adjudication methods like 2+1 or 3+1 refer to processes for resolving disagreements among multiple human readers when establishing ground truth, typically in imaging or clinical diagnostic studies. For physical device testing, the results are objectively measured against predefined standard criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improving with AI vs. Without AI Assistance

This information is not applicable.

No AI Component: The HC-Bios Dental Implant System is a physical dental implant. There is no mention of any AI component, software, or diagnostic capabilities that would involve human readers or AI assistance.
No MRMC Study: Consequently, an MRMC comparative effectiveness study, which is typically performed for AI-powered diagnostic devices, was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. As stated above, there is no AI algorithm or software product in this submission. This is a physical medical device.

7. The Type of Ground Truth Used

For this device and submission type, the "ground truth" is defined by:

Established Industry Standards: ISO 10993 (biocompatibility), ISO 14801 (mechanical testing for dental implants), ASTM F 543, ASTM F 1980, and ISO 11137-1 (sterilization).
Predicate Device Performance: The performance characteristics and safety profile of the legally marketed Dentium Co., Ltd Implantium (K041368). The "ground truth" for substantial equivalence is that the proposed device performs comparably to this predicate given its intended use.
Material Properties: The established safety and performance characteristics of Grade 4 titanium and AISI 316L Stainless Steel in medical applications.

8. The Sample Size for the Training Set

This information is not applicable. There is no machine learning or AI component to this device, and therefore no "training set." The device is a physical implant, not a data-driven model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

Summary

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K11 0425

Hung-Chun Bio-S Co., Ltd. 510(k) Notification

HC-Bios Dental Implant System

510(k) Summary

5.1 Type of Submission: Traditional
5.2 Submission Date: Dec 28, 2010

5.3 Revised Date: May 21, 2012

5.4 Submitter: Hung Chun Bio-S Co., Ltd.

5F, No.98, Luke 5th Rd., Lujhu Township, Kaohsiung Country, 82151 Address: Taiwan Phone: 4886-7-6955369 +886-7-6955379 Fax: Contact person: Ken Liu Establishment Registration Number: N/A

5.5 Identification of the Device:

Proprietary/Trade Name:	HC-Bios Dental Implant System
Common Name:	Implant, Endosseous, Root-form
Classification Name:	Implant, Endosseous, Root-form
Device Classification:	II
Regulation Number:	872.3640
Panel:	Dental
Product Code:	DZE

5.6 Identification of the Predicate Device:

Predicate Device Name: Dentium Co., Ltd Implantium Dentium Company Limited Manufacturer: K041368 510(k) Number:

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5.7 Intended Use and Indications for Use of the subject device:

5.8 Device Description

5.9 Non-clinical Testing

A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the HC-Bios Dental Implant System. The tests were conducted in accordance with ISO 10993-10, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 11137-1, ISO 14801, ASTM F 543, and ASTM F 1980. All the test results demonstrate the performance of HC-Bios Dental Implant System meets the requirements of its pre-defined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the HC-Bios Dental Implant System is substantially equivalent to the predicate devices.

5.10Safety and Effectiveness

The result of bench testing indicates that the new device is substantially equivalent to the predicate device.

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Hung-Chun Bio-S Co., Ltd. 510(k) Notification

5.11Substantial Equivalent Devices

The HC-Bios Dental Implant System submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the Dentium Co., Ltd Implantium which is the subject of K041368. Differences between the devices cited in this section do not raise any new issue of safety or effectiveness.

Item	Predicate Device(Dentium Co., Ltd Implantium)	Proposed Device(HC-Bios Dental Implant System)
Classification	Class II	Class II
Code or FederalRegulations	872.3640	872.3640
Prescription MedicalDevices	Yes	Yes
Intended Use	The device is intended to besurgically placed in the bone of theupper or lower jaw arches toprovide support for prostheticdevices, and to restore the patient'schewing function.	The device is intended to besurgically placed in the bone of theupper or lower jaw arches toprovide support for prostheticdevices, and to restore the patient'schewing function.
ConsistedInstruments	Fixture(implant)AbutmentCover screwHealing abutmentAttachment(impression part)	Dental ImplantsCover/Healing ScrewAbutmentAbutment Impression partsImplant impression parts
Material	titanium metaltitanium alloy	Grade 4 titaniumAISI 316L Stainless Steel
Dimensions ofImplants	Four diameters (3.4 to 4.8 mm)Four lengths (8, 10, 12, 14 mm)	Five diameters (3.5 to 7.0 mm)Five lengths (7, 8, 9.5, 11, 14 mm)
Performance	ISO 10993	ISO 10993-5, ISO 10993-10, ISO
Standard	ISO 14801	10993-11, ISO 10993-12, ISO11137-1, ISO 14801, ASTM F 543,ASTM F 1980

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・

5.12 Conclusion

After analyzing safety and performance testing data, it can be concluded that HC-Bios Dental Implant System is substantially equivalent to the predicate device.

・

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JUL 2 7 2012

Hung Chun Bio-S Company, Limited C/O Mr. Michael Lee Acmebiotechs Company, Limited No.45 Minsheng Road Danshui Town Taipei County China Taiwan 251

Re: K110425

Trade/Device Name: HC-Bios Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 22, 2012 Received: May 22, 2012

Dear Mr. 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 - Mr. 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/ ucm 1 1 5809.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

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11 0425

Hung-Chun Bio-S Co., Ltd. 510(k) Notification

HC-Bios Dental Implant System

Indications for Use

510(k) Number (if known):

Device Name: HC-Bios Dental Implant System

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 ŁINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K110425

Page 1 of _

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.