(92 days)
The ORTHOPHOS XG 3D/ Ceph is intended to produce two dimensional images and three dimensional volume reconstructions, including partial volumes and selected projections of the dentomaxillofacial areas, for use in planning and diagnostic support. Image acquisition, modes include panoramic X-ray, cephalometric X-ray, specialized tomographic X-ray, and cone beam tomography X-ray. The system can also acquire carpal exposures. The system includes an X-ray source, flat panel X-ray detector, positioning devices, as well as interactive 3D reconstruction, processing, and archiving software.
The ORTHOPHOS XG 3D/ Ceph is a dental computed tomography system intended to produce X-rays for obtaining two dimensional images (panoramic and cephalometric) and three dimensional volume reconstructions of the teeth, jaw, and the head area, which includes dentomaxillofacial areas, for use in planning and diagnostic support. In 3D mode the OP XG 3D device generates a conical x-ray beam that rotates round the patient´s head within a certain angle.
The device comprises a combi sensor with 2D panoramic and cephalometric sensors and a flat panel sensor for 3D volume exposure. Five volume regions are defined by the geometry of the ORTHOPHOS XG 3D/ Ceph. Four class I laser beam light localizers serve for postioning the patient's head that may be fixed through bite block and adjustable forehead and temple supports.
From the obtained exposures in the 3D mode a three dimensional image is reconstructed and can be viewed as well as panoramic/cephalometric images. The constructed 3D volume and simulated projection exposures as well as panoramic/cephalometric data are conveyed to SIDEXIS and stored in the SIDEXIS data base.
An operator control panel allows height adjustment, selection of mode and program and indicates machine states.
A separate handhold push-button serves for exposure release.
An optional remote control is available.
The provided text describes a 510(k) summary for the Sirona Dental Systems ORTHOPHOS XG 3D/Ceph, which is an X-ray imaging device. The document does not contain information about acceptance criteria, detailed device performance metrics, or a study that proves the device meets specific acceptance criteria in terms of diagnostic effectiveness or accuracy.
Instead, this 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, which is a regulatory pathway for medical devices. The "study" mentioned here refers to nonclinical testing for technical equivalence, not a clinical study to establish diagnostic performance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not available in the provided document. The 510(k) summary for this device focuses on demonstrating substantial equivalence to predicate devices (Sirona GALILEOS and Sirona ORTHOPHOS XGDS) rather than presenting specific quantitative acceptance criteria for diagnostic performance and corresponding study results.
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided document. The nonclinical testing mentioned was performed using "test phantoms" (see Section 7), not human subjects or a defined dataset with provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not available in the provided document. As clinical testing was not performed and phantoms were used, there was no need for experts to establish ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not available in the provided document. No clinical test set requiring adjudication was used.
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 in the document. This device is an X-ray imaging system, and there is no indication of AI assistance being evaluated in this context.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device described is an X-ray imaging system, not an AI algorithm. Its performance is tied to image acquisition and reconstruction, not an automated diagnostic algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the nonclinical testing, the "ground truth" was implicitly the known physical properties and characteristics of the test phantoms used to evaluate exposure equality and conformance with FDA guidance (see Section 7). No expert consensus, pathology, or outcomes data were used as "ground truth" for diagnostic performance.
8. The Sample Size for the Training Set
This information is not available in the provided document. The document describes a medical device, not a machine learning algorithm that requires a training set. The "PC software" mentioned (Section 5.2.1) performs reconstruction and processing but is not described as involving a learnable model with a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not available and not applicable as there is no mention of a training set for a machine learning algorithm.
Summary of the "Study" Mentioned in the Document:
The "study" referenced in the 510(k) summary is "NONCLINICAL TESTING" (Section 7).
- Type of Study: System testing using test phantoms.
- Purpose: To evaluate the "equality of exposures" of the proposed ORTHOPHOS XG 3D/Ceph device against its predicate devices (ORTHOPHOS XGDS/Ceph and GALILEOS) in both 2D and 3D modes. For 3D mode, additional tests were performed in accordance with FDA Guidance for Solid State X-ray Imaging Devices.
- Methodology: Exposures were performed using "test phantoms." The specific types of phantoms or the quantitative metrics measured are not detailed beyond "equality of exposures."
- Conclusion: Based on this nonclinical testing, along with comparison of intended use, indications, construction materials, principles of operation, features, and technical data, the device was deemed "substantially equivalent" to the predicate devices and "safe and effective to perform its intended use."
- No Clinical Testing: Section 8 explicitly states, "Clinical tests have not been performed."
In essence, the document confirms that the device's technical specifications and image acquisition capabilities were tested against established standards and predicate devices using phantoms, rather than through a clinical study demonstrating diagnostic performance against specific acceptance criteria.
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510(k) Summary for Sirona Dental Systems ORTHOPHOS XG 3D/ Ceph
MAR 2 2 2011
ー SPONSOR
Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim Germany Contact Person: Fritz Kolle 49 6251 16 32 94 Telephone: Date Prepared: December 14, 2010
રપ DEVICE NAME
| Proprietary Name: | ORTHOPHOS XG 3D / Ceph |
|---|---|
| Common/Usual Name: | x-ray, tomography, computed, dental |
| Classification Name: | Computed tomography x-ray system |
3 PREDICATE DEVICES
Sirona GALILEOS (K060892) and Sirona ORTHOPHOS XG"]48 DS (K033073)
INTENDED USE ব
The ORTHOPHOS XG 3D/ Ceph is intended to produce two dimensional images and three dimensional volume reconstructions, including partial volumes and selected projections of the dentomaxillofacial areas, for use in planning and diagnostic support. Image acquisition, modes include panoramic X-ray, cephalometric X-ray, specialized tomographic X-ray, and cone beam tomography X-ray. The system can also acquire carpal exposures. The system includes an X-ray source, flat panel X-ray detector, positioning devices, as well as interactive 3D reconstruction, processing, and archiving software.
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ട് Device Description and Function
The ORTHOPHOS XG 3D/ Ceph is a dental computed tomography system intended to produce X-rays for obtaining two dimensional images (panoramic and cephalometric) and three dimensional volume reconstructions of the teeth, jaw, and the head area, which includes dentomaxillofacial areas, for use in planning and diagnostic support. In 3D mode the OP XG 3D device generates a conical x-ray beam that rotates round the patient´s head within a certain angle.
The device comprises a combi sensor with 2D panoramic and cephalometric sensors and a flat panel sensor for 3D volume exposure. Five volume regions are defined by the geometry of the ORTHOPHOS XG 3D/ Ceph. Four class I laser beam light localizers serve for postioning the patient's head that may be fixed through bite block and adjustable forehead and temple supports.
From the obtained exposures in the 3D mode a three dimensional image is reconstructed and can be viewed as well as panoramic/cephalometric images. The constructed 3D volume and simulated projection exposures as well as panoramic/cephalometric data are conveyed to SIDEXIS and stored in the SIDEXIS data base.
An operator control panel allows height adjustment, selection of mode and program and indicates machine states.
A separate handhold push-button serves for exposure release.
An optional remote control is available.
Sirona Dental Systems 510(k) ORTHOPHOS XG 3D/ Ceph
Page 2 of 6
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5.1 Scientific Concept
The underlying scientific concept is combining two exposure technologies, panoramic including cephalometric, (2D), and volumetric (3D), in one device. Volumetric exposures are obtained by cone-beam technology.
5.2 Physical and Performance Characteristics
5.2.1 Design
The ORTHOPHOS XG 3D/ Ceph comprises of a support stand to which a height adjustable sled is attached. The sled carries the patient fixation, the operator control panel (easy pad) and the motor driven rotatable ring. The X-ray source and a combi sensor are fixed to the ring. The combi sensor houses a panoramic and cephalometric line sensor (2D) and a flat panel sensor for volumetric exposures (3D). In 3D mode the OP XG 3D device generates a conical x-ray beam that rotates round the patient's head within a certain angle.
Four class 1 laser beam light localizers serve for positioning the patient's head that may be fixed through bite block and adjustable forehead and temple supports.
The exposure area is defined by the geometry of the ORTHOPHOS XG 3D/ Ceph. A control panel allows the user to select the exposure modes and the exposure factors, view the machine status information, control the height adjustment and turn on the laser indicator.
An optional remote control is available.
The PC software reconstructs the three dimensional image as well as processing panoramic/ cephalometric images. The constructed 3D volume and simulated projection exposures as well as panoramic/ cephalometric data are conveyed to SIDEXIS and stored in the SIDEXIS data base.
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5.2.2 Material Used
Materials that come into patent contact intentionally are biocompatible and evaluated according to ISO 10993-1: 2003, "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process".
5.2.3 Physical Properties
Not applicable.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS ರಿ
The ORTHOPHOS XG 3D/Ceph is a further development of the ORTHOPHOS XGPlus DS / Ceph (K033073) 1 and expands the device capabilities with the 3D function of GALILEOS (K060892).
In 2D mode the ORTHOPHOS XG 3D /Ceph provides the same 2D operating principles and programs as the predicate device ORTHOPHOS XGRUS DS/Ceph.
In 3D mode the ORTHOPHOS XG 3D /Ceph provides an adapted program-subset of the GALILEOS and the same 3D operating principles as the predicate device GALILEOS.
The modified operator panel of the ORTHOPHOS XGP™s DS/Ceph now incorporates the 3D functionality in addition.
In the ORTHOPHOS XG 3D/Ceph a solid state flat panel image receptor replaces the image intensifier of the GALILEOS and is combined in a common housing with image receptors of the ORTHOPHOS XG°l45 DS / Ceph. The appropriate sensors are moved in the correct positions automatically according to mode and program selected.
ORTHOPHOS XG 3D/Ceph provides the selection of five volume regions whereas the GALILEOS provides these regions together in one volume.
1 It includes the ORTHOPHOS XG 5DS / Ceph which provides a subset of programs.
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The X-ray generator of the ORTHOPHOS XGP™ DS / Ceph has been adapted in order to be capable of 3D scans and to have similar technical characteristics as the GALILEOS generator.
ORTHOPHOS XG 3D/Ceph has a smaller collimator opening in 3D mode compared with GALILEOS (smaller field of view and five volume regions).
An additional class I laser light beam localizer has been added to ORTHOPHOS XGPUS DS / Ceph that in conjunction with another one marks the Field of View in 3D mode.
The PC software performs same functions and algorithms as with the ORTHOPHOS XG 105 DS / Ceph in the 2D mode and GALILEOS in 3D mode. For the 3D mode the software has been adapted to the smaller field of view and the selection for five volume regions.
ORTHOPHOS XG 3D/Ceph offers a calculated panoramic view in combination with slices orthogonal to the panoramic curve ('transversal slices') as predicate GALILEOS.
ORTHOPHOS XG 3D/Ceph offers same functionality in viewing slices, projections and volume views.
7 NONCLINICAL TESTING
The ORTHOPHOS XG 3D/ Ceph system functions have been tested in a system test.
For both modes, 2D and 3D, exposures have been tested utilizing test phantoms. The tests evaluate the equality of exposures of proposed ORTHOPHOS XG 3D/ Ceph and predicate devices ORTHOPHOS XG" " DS/Ceph and GALILEOS.
For 3D mode additional tests has been performed taking into account FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, Document issued on: August 6, 1999"
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8 CLINICAL TESTING
Clinical tests have not been performed.
த CONCLUSION
Based on a comparison of intended use, indications, construction materials, principal of operations, features and technical data, the Sirona Dental ORTHOPHOS XG 3D /Ceph is safe and effective to perform its intended use as well as substantially equivalent to the Predicate Devices.
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Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Fritz Kolle Primary Contact Sirona Dental System GmbH Fabrikstrasse 3, D-64625 Bensheim GERMANY
MAR 2 2 2011
Re: K103711
Trade/Device Name: Orthophos XG 3D/ Ceph Regulation Number: 21 CFR 872.1800 · Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: December 14, 2010 Received: December 20, 2010
Dear Mr. Kolle:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely Yours,
Mary S Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
K.103711
ORTHOPHOS XG 3D/ Ceph Device Name:
Indications for Use:
The ORTHOPHOS XG 3D/ Ceph is intended to produce two dimensional images and three dimensional volume reconstructions, including partial volumes and selected projections of the dentomaxillofacial areas, for use in planning and diagnostic support. Image acquisition, modes include panoramic X-ray, cephalometric X-ray, specialized tomographic X-ray, and cone beam tomography X-ray. The system can also acquire carpal exposures. The system includes an X-ray source, flat panel X-ray detector, positioning devices, as well as interactive 3D reconstruction, processing, and archiving software.
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)
Mary Scott
Vivision Sign-On)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K103711
Sirona Dental Systems 510(k) ORTHOPHOS XG 3D/ Ceph
November 10, 2010
Page viii
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.