(11 days)
GALILEOS consists of an x-ray device that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support.
GALILEOS comprises a package of PC software modules to expand SIDEXIS capabilities to handling 3D data. This includes 3D reconstruction, storage, retrieval, viewing and processing of 3D-image data.
The GALILEOS comprises of the GALILEOS-device, the reconstruction server and the 2D and 3D viewing client SIDEXIS. The GALILEOS device generates a conical x-ray beam that rotates round the patient's head within a certain angle. From the obtained exposures a three dimensional image is reconstructed and can be viewed. The GALILEOS features the navigation within this displayed volume and special views may be selected, calculated and eventually displayed.
The provided documentation for K060892, Sirona Dental Systems GALILEOS, is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria or extensive performance study results. Therefore, much of the requested information regarding specific performance metrics, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.
Based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It broadly states that "Performance testing to validate the safety and effectiveness of the GALILEOS included electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions." This indicates that the device met internal performance standards for these general categories to be considered substantially equivalent.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The device is described as an x-ray system with 3D reconstruction and viewing software, not an AI-assisted diagnostic tool in the modern sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the GALILEOS as an "x-ray device that uses a cone beam... providing two-dimensional images and three-dimensional volume reconstructions... for use in planning and diagnostic support," and "comprises a package of PC software modules to expand SIDEXIS capabilities to handling 3D data." This implies a standalone performance of the imaging and reconstruction system itself, as the primary function is to generate and display images for human interpretation. However, specific standalone performance metrics (e.g., image quality, resolution, contrast-to-noise ratio) are not detailed beyond the general statement of "validation testing of both hardware and software functions."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. Given the nature of a 510(k) submission for an imaging device, ground truth for image quality might be assessed internally, but clinical ground truth (e.g., disease presence) would likely not be the primary focus of this type of submission unless a specific diagnostic claim was being made beyond "diagnostic support."
8. The sample size for the training set
This information is not provided in the document. The device is described as an imaging system and software, implying traditional engineering validation rather than machine learning training sets in the contemporary sense.
9. How the ground truth for the training set was established
This information is not provided in the document. Assuming a lack of machine learning, a "training set" and associated "ground truth" for training are not applicable in this context.
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APR 1 4 2006
510(k) Summary for Sirona Dental Systems GALILEOS
1. SPONSOR
Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim Germany
Contact Person: Fritz Kolle 49 6251 16 32 94 Telephone:
Date Prepared: March 17, 2005
2. DEVICE NAME
| Proprietary Name: | GALILEOS |
|---|---|
| Common/Usual Name: | System, X-Ray, Extraoral, Digital |
| Classification Names: | Extraoral source x-ray system |
PREDICATE DEVICE 3.
Hitachi CB Mercuray Dental Cone Beam X-Ray System (K033248)
4. INTENDED USE
GALILEOS consists of an x-ray device that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volumereconstructions of the head area, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support.
GALILEOS comprises a package of PC software modules to expand SIDEXIS capabilities to handling 3D data. This includes 3D reconstruction, storage, retrieval, viewing and processing of 3D-image data.
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నే. DEVICE DESCRIPTION
The GALILEOS comprises of the GALILEOS-device, the reconstruction server and the 2D and 3D viewing client SIDEXIS. The GALILEOS device generates a conical x-ray beam that rotates round the patient's head within a certain angle. From the obtained exposures a three dimensional image is reconstructed and can be viewed. The GALILEOS features the navigation within this displayed volume and special views may be selected, calculated and eventually displayed.
6. BASIS FOR SUBSTANTIAL EQUIVALENCE
The GALILEOS is substantially equivalent to the Hitachi CB Mercuray Dental Cone Beam X-Ray System (K033248) based on the equivalence of the intended use, similar features and technical characteristics. Performance testing to validate the safety and effectiveness of the GALILEOS included electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions.
APPENDIX G • Page 2 of 2
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
APR 1 4 200G
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Sirona Dental Systems GmbH % Mr. Stefan Preiss Responsible Third Party Official TÜV America, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891
Re: K060892
Trade/Device Name: GALILEOS Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: March 31, 2006 Received: April 3, 2006
Dear Mr. Preiss:
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image is a circular logo with the text "FDA Centennial" in the center. Above the text is "1906-2006". The logo is surrounded by a circular border with text that is difficult to read due to the image quality. The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration (FDA).
Protecting and Promoting Public Health
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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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Kobod92
Device Name: _____________ GALILEOS
Indications for Use:
GALILEOS consists of an x-ray device that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support.
GALILEOS comprises a package of PC software modules to expand SIDEXIS capabilities to handling 3D data. This includes 3D reconstruction, storage, retrieval, viewing and processing of 3D-image data.
Prescription Use (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David M. Seymour
Sirona Dental Systems 510(k) GALILEOS
March 17, 2006
Page viii
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.