(23 days)
The HU II / HS II 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 HU II / HS II Fixture System is for one and two stage surgical procedures. It is not for immediate load.
The HU II / HS II Fixture System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
The provided text is a 510(k) summary for a dental implant system (HU II / HS II Fixture System). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a study with the detailed structure you've requested.
The document states that "The HU II /HS II 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 detailed study information in the way that would typically be presented for an AI/ML medical device's performance evaluation.
Therefore, I cannot extract the information to fill out your table and answer your specific questions in the context of an AI/ML device study.
Here's why and what the document does provide:
- Substantial Equivalence: This 510(k) focuses on demonstrating that the HU II / HS II Fixture System is "substantially equivalent" to existing predicate devices (The US System, K062030, and The SS System, K062051). This means proving it has similar materials, indications for use, design, and technological characteristics, and that it doesn't raise new questions of safety or effectiveness.
- Safety and Performance Validations: The document broadly states that safety, performance, and product validations were performed, including biocompatibility. However, it does not detail:
- Specific acceptance criteria (e.g., a target accuracy, sensitivity, specificity).
- The methodology of these validations (e.g., what specific tests were done, what data was used).
- The results of these validations in a quantitative manner.
In summary, the provided text does not contain the information required to populate your table or answer your questions about acceptance criteria, study details, sample sizes, ground truth, experts, or MRMC studies, as it pertains to the performance evaluation of an AI/ML device. This document describes a traditional medical device (dental implant) approval process, not an AI/ML product.
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Image /page/0/Picture/2 description: The image shows a handwritten sequence of characters. The sequence starts with the letters 'Ko', followed by the numbers '80387'. The characters are written in a bold, dark font, which makes them stand out against the white background. The handwriting appears somewhat irregular, with varying stroke widths and slight inconsistencies in the shapes of the characters.
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: January 31, 2008
- Company and Correspondent making the submission:
| - Submitter's Name : | OSSTEM Implant Co., Ltd. |
|---|---|
| - Address : | #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea |
| - Contact : | Mr. JongHyuk Seo |
- Device :
| Trade or (Proprietary) Name : | HU II / HS II Fixture System |
|---|---|
| Common or usual name : | Dental Implant |
| Classification Name : | Endosseous Dental Implant21CFR872.3640Class IIDZE |
3. Predicate Device :
The US System, Osstem Implant Co., Ltd, K062030 The SS System, Osstem Implant Co., Ltd, K062051
4. Description :
The HU II / HS II Fixture System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
The HU II / HS II 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 HU II / HS II Fixture System is substantially equivalent in design, function and intended use to the US System(K062030) and SS System(K062051) of Osstem Implant Co., Ltd.
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Image /page/1/Picture/0 description: The image shows the logo for Osstem. The logo consists of a stylized circular design with two curved lines forming an incomplete circle. Below the circular design, the word "osstem" is written in lowercase letters with a horizontal line underneath it.
OSSTEM Implant Co., Ltd #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
5. Indication for use :
The HU II / HS II 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 HU II / HS II Fixture System is for one and two stage surgical procedures. It is not for immediate load.
6. Review :
The HU II /HS II Fixture System has similar material, indication for use, design and technological characteristics as the predicate device.
The HU II /HS II 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.
7. Conclusion :
Based on the information provided in this premarket notification Osstem concludes that the HU II/HS II Fixture System is safe and effective and substantially equivalent to the predicate device as described herein.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 7 2008
OSSTEM Implant Company, Limited C/O Mr. Min Joo Kim Manager OSSTEM Incorporated 1 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K080387
Trade/Device Name: HU II/ HS II Fixture System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: February 4, 2008 Received: February 13, 2008
Dear Mr. Kim:
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. Kim
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 vours.
Soufie Y. Micham 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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Image /page/4/Picture/0 description: The image shows a logo with the word "osstem" in lowercase letters below a circular graphic. The graphic consists of two concentric circles, with the inner circle being incomplete, resembling a crescent shape. The text is in a simple, sans-serif font, and the overall design appears clean and modern.
510(k) Number K ______________________________________________________________________________________________________________________________________________________________
Device Name: HUI/HSII Fixture System
Indication for use : The HU II / HS II 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 HUII / HS II 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)
Susa Ruar
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: N040387
§ 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.