(243 days)
Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
The Prosthetic System is device made of titanium, titanium alloy, Gold alloy, POM and PC intended for use as an aid in prosthetic restoration. It consists of Abutments, Protect caps and Abutment Screws. Its surfaces are partially Tin coated and uncoated.
The provided document describes a 510(k) submission for a medical device, the "Prosthetic System," which is a dental abutment. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics.
Therefore, the requested information elements related to acceptance criteria, diagnostic performance, sample sizes, expert involvement, and ground truth for a study proving device performance are largely not applicable (N/A) in the context of this 510(k) submission.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as diagnostic performance metrics. Instead, the acceptance criteria are based on demonstrating substantial equivalence to predicate devices in terms of:
- Material composition
- Intended use
- Design
- Technological characteristics
- Performance characteristics
- Safety (biocompatibility)
- Mechanical fatigue testing according to relevant standards.
- Reported Device Performance:
Performance Aspect Description Substantial Equivalence The device is deemed substantially equivalent to the HU/HS/HG Prosthetic System (K081575) and HS/HG Prosthetic System (K100245) of Osstem Implant Co., Ltd. for the intended use and technological characteristics. Fatigue Testing Conducted for Custom Abutment and Multi Angled Abutment according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801. Results are reported to be in compliance. Biocompatibility Performed to ensure compliance with applicable international and US regulations. Results implied compliance. Other Safety/Performance The Prosthetic System has been "subjected to safety, performance, and product validations prior to release," with an overall conclusion that it is "safe and effective."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. No diagnostic performance test set is described as this is not a diagnostic device and the submission focuses on mechanical and material equivalence, not clinical diagnostic accuracy. The fatigue testing would involve a certain number of samples, but the specific sample size is not detailed in this summary. The tests were likely conducted in a lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. Not applicable as there is no diagnostic test set or ground truth established by experts in the context of diagnostic accuracy. The "ground truth" for the fatigue test would be the standard's pass/fail criteria, derived from engineering principles and industry consensus, not expert medical opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable as there is no diagnostic test set requiring expert adjudication.
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
- N/A. This is a dental prosthetic system (abutment), not a software or AI-enabled diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical prosthetic device, not an algorithm, so standalone performance in the context of AI/software is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- N/A for diagnostic ground truth. For the fatigue testing, the "ground truth" would be the engineering specifications and pass/fail criteria defined by ISO 14801 and FDA guidance documents. For biocompatibility, it would be the compliance with relevant international and US regulations.
8. The sample size for the training set
- N/A. There is no "training set" in the context of an AI/machine learning model for this physical medical device.
9. How the ground truth for the training set was established
- N/A. Not applicable, as there is no training set for an AI/machine learning model.
In summary: The provided 510(k) summary is for a physical medical device (dental abutment) and focuses on demonstrating substantial equivalence to existing predicate devices through material, design, and limited performance (fatigue, biocompatibility) testing, rather than a clinical study evaluating diagnostic accuracy against specific performance criteria. Therefore, most of the requested information regarding AI/diagnostic performance studies is not applicable.
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Image /page/0/Picture/1 description: The image shows the word "OSSTEM" in a stylized font, with the word "IMPLANT" written below it in a smaller font. The letters are black and the background is white. The word "OSSTEM" appears to be a logo or brand name.
TEM Implant Co., L 07-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea el: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.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: January 20, 2011
ОСТ 3 2011
- Company and Correspondent making the submission:
-
Submitter's Name :
-
Address :
OSSTEM Implant Co., Ltd.
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea
82-51-850-2574 - Telephone No. :
Mr. JongHyuk Seo
- Contact :
- Device :
Trade or (Proprietary) Name : Common or usual name : Classification Name :
Prosthetic System Dental Device Abutment, implant, dental, endosseous 21CFR872.3630 Class II NHA
3. Predicate Device :
The HU/HS/HG Prosthetic System, Osstem Implant Co., Ltd, K081575 The HS/HG Prosthetic System, Osstem Implant Co., Ltd, K100245
- Description :
-
- The Prosthetic System is device made of titanium, titanium alloy, Gold alloy, POM and PC intended for use as an aid in prosthetic restoration. It consists of Abutments, Protect caps and Abutment Screws. Its surfaces are partially Tin coated and uncoated.
-
- The Prosthetic 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.
QS-QI-505-3(Rev.0)
Letter(8.5 X 11in)
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Image /page/1/Picture/0 description: The image shows the logo for Osstem Implant. The logo is in a sans-serif font and is black. The word "OSSTEM" is on the top line, and the word "IMPLANT" is on the bottom line. The logo is simple and modern.
2°C
K110308
- Substantial Equivalence Matrix
| Prosthetic System | HU/HS/HG Prosthetic System (K081575) | HS/HG Prosthetic System (K100245) | |
|---|---|---|---|
| Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd |
| 510(k)Number | New | K081575 | K100245 |
| Intended use | Prosthetic System isintended for use with adental implant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures. | HU/HS/HG ProstheticSystem is intended foruse with a dentalimplant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures. | HS/HG ProstheticSystem is intended foruse with a dentalimplant to providesupport for prostheticrestorations such ascrowns, bridges, oroverdentures. |
5. Indication for use :
Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
6. Review :
The Prosthetic System has similar material, indication for use, design and technological characteristics as the predicate device.
The Prosthetic 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. Summary of nonclinical testing
The Fatigue testing for Custom Abutment and Multi Angled Abutment were conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801 Dentistry - Fatigue test for endosseous dental implants. The results are in compliance with it.
-
- Summary of clinical testing No clinical studies are submitted
-
- Conclusion :
Based on the information provided in this premarket notification Osstem concludes that the Prosthetic System is safe and effective and substantially equivalent to the predicate device as described herein.
QS-QI-505-3(Rev.0)
Letter(8.5 X 11in)
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Osstem Implant Company, Limited C/O Mr. Patrick Lim Regulatory Affairs Quality Assurance Manager Hossen, Incorporated 82 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
0CT - 3 2011
Re: K110308
Trade/Device Name: Prosthetic System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 6, 2011 Received: September 7, 2011
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. 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 F-1 feral 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 clectronic 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 115809.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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd., a company based in Busan, Republic of Korea. The address is 107-8 Geoje3-Dong Yeonje-Gu Busan, 611-804. The phone number is +82 51 850-2500, the fax number is +82 51 850-4341, and the website is www.osstem.com. There is also a code K110308 and the number 1011 on the right side of the image.
510(k) Number K
Device Name : Prosthetic System
Indication for use : Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
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)
Sisan Penson
Division Sign-Off) Tivision of Anesthesiology, General Hospital ifection Control, Dental Devices
510(k) Number: K110308
QS-QI-505-2(Rev.0)
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)