(127 days)
CAMLOG® Abutments PS are intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.
The CAMLOG Implant System CAMLOG Abutments PS (Platform Switching) allows the treatment option of using a smaller abutment interface diameter than the platform diameter of the implant. The system includes a series of permanent abutments, temporary abutments and healing caps.
The provided text is a 510(k) summary for the Altatec GmbH CAMLOG® Abutments PS, which is a dental implant abutment. This type of regulatory submission is focused on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or performance through clinical studies with acceptance criteria in the way a novel drug or high-risk medical device might.
Therefore, the document does not contain information regarding a study with specific acceptance criteria, sample sizes for test or training sets, expert ground truth establishment, or comparative effectiveness studies in the way you've outlined. The FDA 510(k) process for a device like this relies heavily on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through design, material, and manufacturing similarities, and often through bench testing rather than human-centric clinical trials.
The provided text only includes the following relevant information to your request:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the document. The 510(k) focuses on equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information on a test set sample size or data provenance is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
No information on experts establishing ground truth is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
No information on an adjudication method is provided.
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:
No MRMC study information is provided. This device is a physical dental abutment, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
No information on ground truth is provided.
8. The sample size for the training set:
No information on a training set sample size is provided.
9. How the ground truth for the training set was established:
No information on ground truth for a training set is provided.
Summary of available information:
- Intended Use: Used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.
- Device Description: The CAMLOG® Abutments PS (Platform Switching) allows the treatment option of using a smaller abutment interface diameter than the platform diameter of the implant. The system includes a series of permanent abutments, temporary abutments, and healing caps.
- Equivalence to Marketed Product: The submission demonstrates that the device is substantially equivalent to predicate devices based on:
- Same operating principle.
- Same basic design.
- Same materials.
- Same packaging and sterilization methods.
In conclusion, the 510(k) summary for Altatec GmbH CAMLOG® Abutments PS does not contain the type of detail you are requesting regarding acceptance criteria, study methodologies, and ground truth establishment because it's a submission focused on substantial equivalence for a physical medical device, not an AI/diagnostic tool.
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510(k) Summary
Altatec GmbH CAMLOG® Abutments PS
JUN 18 2009
ADMINISTRATIVE INFORMATION
Manufacturer-Name:
Official Contact:
Altatec GmbH Maybachstrasse 5 D-71299 Wimsheim, Germany Telephone: +49 7044 9445 0 Fax: +49 7044 9445 723
Tina Steffanie-Oak CAMLOG USA Telephone: +1 (717) 335-7230 Fax: +1 (717) 335-7240 Email: Tina.Steffanie-Oak@henryschein.com
Linda K. Schulz or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA USA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 Email: Ischulz@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Regulations:
Representative/Consultant:
Product Code: Classification Panel: Reviewing Branch:
CAMLOG® Abutments PS Dental implant abutments Endosseous dental implant abutment 21 CFR 872.3630, Class II NHA Dental Products Panel Dental Devices Branch
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510(k) Summary
INTENDED USE
CAMLOG® Abutments PS are intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.
DEVICE DESCRIPTION
The CAMLOG Implant System CAMLOG Abutments PS (Platform Switching) allows the treatment option of using a smaller abutment interface diameter than the platform diameter of the implant. The system includes a series of permanent abutments, temporary abutments and healing caps.
EQUIVALENCE TO MARKETED PRODUCT
Altatec GmbH demonstrated that, for the purposes of FDA's regulation of medical devices, CAMLOG Abutments PS are substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.
Overall, the CAMLOG Abutments PS have the following similarities to the predicate devices:
- I use the same operating principle,
- incorporate the same basic design,
- I incorporate the same materials, and
- 트 are packaged and sterilized using the same materials and processes.
In summary, CAMLOG Abutments PS described in this submission are, in our opinion, substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
JUN 18 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Altatec GmbH C/O Linda K. Schulz, RDH, BSDH Senior Regulatory Affairs Specialist PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K090347
Trade/Device Name: CAMLOG® Abutments PS Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 26, 2009 Received: May 27, 2009
Dear Ms. Schulz:
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- Ms. Schulz
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/Centers Offices/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Punner
Susan Runner, D.D.S., M.A. Acting Division 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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510(k) Summary
Indications for Use
510(k) Number (if known):
CAMLOG® Abutments PS Device Name:
Indications for Use:
CAMLOG® Abutments PS are intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
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| Infection Control, Dental Devices |
| 510(k) Number: | K090347 |
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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.)