(52 days)
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Bridge Restoration is a permanent abutment intended for placement on the Straumann Narrow Neck CrossFit (NNC) tissue level Implant with a diameter : of 3,3mm. The abutment is made of a non-oxiding gold alloy.
Here's an analysis of the provided text regarding the Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Bridges, focusing on acceptance criteria and supporting studies:
It's important to note that the provided documents are a 510(k) summary and an FDA clearance letter. These documents typically summarize the results of testing rather than providing the full study reports. Therefore, some details you requested may not be explicitly stated.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly detailed in terms of specific numeric thresholds within the public 510(k) summary. However, the document states that the device was evaluated against the FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." This guidance document would define the performance requirements, including fatigue testing parameters.
The reported device performance is a general statement that the device "met the pre-determined acceptance criteria" and "functions as intended." This implies that the device successfully passed the fatigue testing outlined in the FDA guidance.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Compliance with FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" for fatigue testing. | "Met the pre-determined acceptance criteria." |
| Device functions as intended. | "Functions as intended." |
| Substantial equivalence to predicate device (Straumann Narrow Neck CrossFit (NNC) Gold Abutment for crown restoration). | "Substantially equivalent to the Straumann Narrow Neck CrossFit (NNC) Gold Abutment for crown restoration." |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample size: The specific number of abutments used for fatigue testing is not provided in this summary. The FDA guidance typically specifies the number of samples required for such tests (e.g., a certain number of devices for specific load levels).
- Data provenance: The document indicates that the testing was performed by Straumann US (on behalf of Institut Straumann AG), suggesting internal testing. The country of origin of the data is not specified beyond "Straumann US." It is a prospective study in the sense that the testing was planned and executed for the purpose of demonstrating device performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device and study. The "ground truth" for mechanical performance tests like fatigue testing is established by the physical testing itself and the engineering specifications/standards, not by human expert consensus or clinical assessment.
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Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving human assessment (e.g., image interpretation). Mechanical testing does not involve human adjudication in this manner; the pass/fail criteria are based on objective measurements from the testing equipment.
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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 study is for a dental abutment, a passive mechanical component, not an AI-powered diagnostic device or a system that involves human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical component, not an algorithm.
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The type of ground truth used:
- The "ground truth" for this performance testing is the objective measurement of mechanical properties (e.g., resistance to fatigue failure) as defined by the FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." This guidance provides the scientific basis and methodology for determining acceptable performance. It's essentially a set of engineering standards and test protocols.
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The sample size for the training set:
- Not applicable. There is no "training set" for this type of mechanical device performance testing. Training sets are relevant for machine learning algorithms.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
Summary of what is known from the provided text:
- The device underwent fatigue testing as per FDA guidance.
- The testing demonstrated the device met predetermined acceptance criteria and functions as intended.
- The device was deemed substantially equivalent to a predicate device (NNC Gold Abutment for crown restoration).
- The study was a bench test evaluating mechanical performance.
- Many of the requested details (e.g., sample sizes, expert qualifications, MRMC studies, AI performance) are not applicable or not provided in this specific 510(k) summary, as they relate to different types of medical devices or study designs (e.g., diagnostic AI, clinical trials).
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510(k) Summary Narrow Neck CrossFit (NNC) Gold Abutment for Bridges
1. Applicant's Name and Address
JAN 2 7 2012
Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 978-747-0023 Fax Number: Contact Person: Elaine Alan Senior Regulatory Affairs Specialist
2. Date of Submission: December 5, 2011
Name of the Device 3.
| Trade Name: | Straumann Narrow Neck CrossFit (NNC) GoldAbutment for Bridge Restorations |
|---|---|
| Common Name: | NNC Gold Abutment for Bridge Restorations |
| Classification Name: | Endosseous Dental Implant Abutments |
| Regulation Number: | §872.3630 |
Legally Marketed Device to which Equivalence is Claimed (Predicate 4. Device)
5. Description of the Device
Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Bridge Restoration is a permanent abutment intended for placement on the
- Straumann Narrow Neck CrossFit (NNC) tissue level Implant with a diameter : of 3,3mm. The abutment is made of a non-oxiding gold alloy.
Intended Use of the Device 6.
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
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7. Technological Characteristics
The proposed device is substantially equivalent to the currently marketed device. They share the same indication for use, prosthetic platform, implant/abutment connection, and fundamental operating principles.
8. Performance Testing
Verification and validation testing were performed to ensure that the Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Bridge restoration functions as intended and that the modifications do not impact the performance of the device. Testing included:
-
- Performance Testing
- i. Fatigue Testing in accordance to FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."
9. Conclusion
The results from the testing conducted demonstrated that the Straumann Narrow Neck CrossFit (NNC) Gold Abutment for bridge restoration functions as intended and met the pre-determined acceptance criteria.
The Straumann Narrow Neck CrossFit (NNC) Gold Abutment for bridge restoration is a validated system. The results of the performance bench testing and risk analysis indicate that the Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Bridge is substantially equivalent to the Straumann Narrow Neck CrossFit (NNC) Gold Abutment for crown restoration.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular and features the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Ms. Elaine Alan Senior Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover, Massachusetts 01810
JAN 2 7 2012
Re: KI13606.
Trade/Device Name: Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Bridges
Regulation Number: 21 CFR 872.3630
Regulation Name: . Endosseous Dental Implant Abutments
Regulatory Class: NHA Product Code: II Dated: December 22, 2011 Received: December 28, 2011
Dear Ms. Alan:
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 - Ms. Desrochers
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 (rea neting of medical device-related adverse events) (21 CFR 803); good manufacturing (reporting of increats 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/ ucm115809.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,
for Anthony Dubtson
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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Indications for Use Statement
KI136606 510(k) Number (if known):
Device Name: Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Bridges
Indications for Use:
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruaser
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113606
Special 510(k) Submission: NNC Gold Abutment, Bridges December 5, 2011
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§ 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.)