The X-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistry, including pediatric dentistry, for hard-tissue diagnostics within ENT medicine, and for carpus exposures.

Device Description

The device comprises image receptors for cephalometric exposures, 2D panoramic radiographs and 3D volume exposures. The combination of sensors in the device varies depending on the installed options and the regions of interest can be altered. The technology behind this is collimation and different start- and end angles of exposure. These allow for a reduced dosage depending on the program selected. This function is available with some volume, cephalometric and panoramic programs.

Class I laser beam light localizers aid in the positioning of a patient's head which may be fixed through the use of bite blocks and adjustable forehead and temple supports.

From the obtained exposures, reconstructed images can be viewed. The reconstructed 3D volumes, simulated projection exposures and panoramic/cephalometric data can be conveyed to SIDEXIS (an FDA approved Sirona software for acquisition, administration, analysis, diagnosis, presentation and transfer of image data for medical/dental use) and stored in the SIDEXIS database.

An operator control panel allows for height adjustment, selection of mode and program, and indication of machine states. A separate handheld push-button serves for exposure release and an optional remote control is available.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "ORTHOPHOS SL" dental X-ray system. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets them in the context of an AI/algorithm-driven device.

Therefore, many of the requested items (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not present in this type of regulatory submission for a conventional medical imaging device without explicit AI involvement.

Based on the provided text, here's the information that can be extracted:

1. A table of acceptance criteria and the reported device performance

Not applicable for an AI device. This document is for a traditional X-ray system. The "acceptance criteria" discussed are largely related to meeting established X-ray performance standards and demonstrating substantial equivalence to predicate devices. Specific quantitative performance metrics for diagnostic accuracy (e.g., sensitivity, specificity, AUC) against a defined ground truth, as would be expected for an AI device, are not detailed.
The study focuses on demonstrating that the device's technical specifications and image quality are comparable to predicate devices and comply with relevant international standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: "test phantoms" were used for evaluating exposure programs. "Sample clinical images" were provided. No specific numerical sample size for either is given.
Data Provenance: Not specified beyond "test phantoms" and "sample clinical images." It does not mention country of origin or whether clinical data was retrospective or prospective.

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)

"Oral Surgeon reports" were provided with the sample clinical images, "asserting the general diagnostic quality of the images."
Number of Experts: Not specified.
Qualifications: "Oral Surgeon" is mentioned as the expert type, but no specific experience level is provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

None explicitly mentioned. The "Oral Surgeon reports" seem to imply a singular assessment rather than an adjudicated consensus process.

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, an MRMC comparative effectiveness study was not done. This document is for a conventional X-ray system, not an AI-assisted diagnostic tool, so improvement of human readers with AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware X-ray device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For technical testing, "test phantoms" were used.
For clinical images, "Oral Surgeon reports asserting the general diagnostic quality" served as a form of expert assessment of image quality, not necessarily a definitive "ground truth" for specific disease presence/absence.

8. The sample size for the training set

Not applicable; no training set mentioned. This is a conventional X-ray system, not an AI model that undergoes training.

9. How the ground truth for the training set was established

Not applicable; no training set mentioned.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 8, 2015

Sirona Dental Systems GmbH % Mr. Kofi Aninakwa Legal Services Engineer Sirona Dental Systems, Inc. 30-30 47th Avenue, Suite 500 LONG ISLAND NY 11101

Re: K150217

Trade/Device Name: ORTHOPHOS SL Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: April 13, 2015 Received: April 17, 2015

Dear Mr. Aninakwa:

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.

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.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 yours,

Robert A Ochs

Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K150217

Device Name ORTHOPHOS SL

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

For

Sirona Dental Systems

ORTHOPHOS SL

1 SPONSOR

Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim Germany

Contact Person: Kofi Aninakwa Telephone: 718-482-2248 Date Prepared: January 19 2015

DEVICE NAME 2

ORTHOPHOS SL Proprietary Name: Common/Usual Name: X-Ray, Tomography, Computed, Dental Classification Name: Computed Tomography X-ray system Classification Number: 21 CFR 892.1750 - Computed Tomography X-ray system OAS - X-ray, Tomography, Computed, Dental Product Code:

3 PREDICATE DEVICES

Sirona ORTHOPHOS XG 3D / Ceph (K103711) Classification Number: 21 CFR 892.1750 - Computed Tomography X-ray system Product Code : OAS
Sirona GALILEOS Comfort Plus (GALILEOS Family K123070) ● Classification Number: 21 CFR 892.1750 - Computed Tomography X-ray system Product Code : OAS

The primary predicate device is ORTHOPHOS XG 3D / Ceph. This is because ORTHOPHOS SL is a further development of ORTHOPHOS XG3D and as such both have very similar functionality. The PC software of ORTHOPHOS SL has similar functions and operations as that of GALILEOS Comfort Plus.

{4}------------------------------------------------

4 INTENDED USE

5 DEVICE DESCRIPTION AND FUNCTION

Class I laser beam light localizers aid in the positioning of a patient's head which may be fixed through the use of bite blocks and adjustable forehead and temple supports.

5.1 Scientific concept

The underlying scientific concept of the 3D volumes, is the cone-beam x-ray technology. New direct conversion sensors are used to reduce the loss of information along with an autofocus feature that eliminates the need to preselect exact jaw shapes for panoramic exposures. The panoramic and cephalometric exposures are obtained by the standard technology that have been used in dental medicine for a very long time.

5.2 Physical and Performance Characteristics

5.2.1 Design

The ORTHOPHOS SL comprises a support stand to which a height adjustable sled is attached. The sled carries the patient fixation, the operator control panel (easy pad) and

{5}------------------------------------------------

the motor driven rotatable ring. The X-ray source and image receptor are fixed to the ring. During a scan the device generates an x-ray beam that rotates around the patient´s head at varying angles.

The exposure area is defined by the geometry of the ORTHOPHOS SL. 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.

The PC software reconstructs the three-dimensional image as well as processes 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 database.

New features include a Direct Conversion Sensor and an autofocus feature that eliminates the need to preselect exact jaw shapes for panoramic exposures. These have been tested in a system test. An Oral Surgeon report provided also covers these features.

5.2.2 Materials Used

Materials that come into patient 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.

5.3 Software Level of Concern

The ORTHOPHOS SL software was determined to be of a MODERATE level of concern.

The software of the OTHOPHOS SL has been modified to support the new hardware. Software adaptations have been made to include the new autofocus for panoramic X-ray images, the Acquisition server and the new choice of x-ray programs.

6 SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The ORTHOPHOS SL is a further development of the ORTHOPHOS XG3D (USA 510(k)-K103711).

The ORTHOPHOS SL has a different source to skin distance than the ORTHOPHOS XG3D and the amount of images during an exposure has been increased.

{6}------------------------------------------------

The ORTHOPHOS SL is capable of a range of x-ray parameters. The tube voltage can vary between 60kV and 90kV. The tube current can vary between 6mA and 12mA with an addition current of 16mA at 66kV. The maximum is 90kV and 12 mA.

A new sensor type is integrated in the ORTHOPHOS SL. It is a direct conversion sensor.

The PC software performs identical functions and algorithms as the GALILEOS. The software has been adapted to the higher number of images.

The ORTHOPHOS SL offers a calculated panoramic view in combination with slices orthogonal to the panoramic curve ('transversal slices') as the predicate GALILEOS for volumes. The GALILEOS family offers nearly the same functionality in viewing slices, projections and volume views for volume exposures.

ORTHOPHOS SL looks similar to the predicate ORTHOPHOS XG 3D, but the color of the operator panel differs. The panel is new, but the main difference is a color change. The offered functions for the operator are nearly the same.

In comparison to ORTHOPHOS XG 3D, ORTHOPHOS SL has an additional class I laser light beam localizer that helps the user identify volume size. The principles of the patient fixation for both devices are the same.

ORTHOPHOS SL has more volume sizes, volume positions and collimations than the predicate devices. This results in more possibilities to get an exposure of relevant dentomaxillofacial areas.

The ORTHOPHOS SL has a higher dose area product than ORTHOPHOS XG 3D due to demand from medical professionals to use with patients with dense bone, patients who are overweight and also due to the larger size of the detector.

7 NONCLINICAL TESTING

The ORTHOPHOS SL system functions have been tested in a system test (covers the requirements from the function specification, the risk/hazard analysis and the functionality of the equipment from the user's perspective).

The exposure programs have been tested utilizing test phantoms. The tests evaluate the equality of exposures of proposed ORTHOPHOS SL and predicate device ORTHOPHOS XG 3D.

Additional tests have 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" adapted for image intensifier products. In particular, DQE and MTF data in 3D mode for the Hamamatsu detector mode have been provided to demonstrate substantial equivalence.

{7}------------------------------------------------

Finally, The ORTHOPHOS SL Device complies with the applicable requirements of the following international and national standards:

. IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: electromagnetic compatibility - Requirements and Tests
EN 60601-1:2006 + Corr.:2010 + A1:2013 (IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012) - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Edition 3.1)
IEC/EN 60601-1-3:2008 Medical electrical equipment Part 1-3: General . requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
. IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability, (with third edition of 60601-1)
IEC 60601-2-63:2012 Medical electrical equipment - Part 2-63: Particular Requirements For The Basic Safety And Essential Performance Of Dental Extra-Oral X-Ray Equipment
IEC 62304: 2006 Medical Devices Software life cycle processes ●
IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
. IEC 60336:2005 Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots.
. IEC 60825-1:2007 Safety of laser products - Part 1: Equipment classification, requirements and requirements
IEC 62471:2006, Photobiological safety of lamps and lamp systems ●
ISO 14971:2007 Medical devices Application of risk management to medical ● devices
ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation ● and testing within a risk management system

CLINICAL TESTING 8

Sample clinical images have been provided. These were accompanied with Oral Surgeon reports asserting the general diagnostic quality of the images.

9 CONCLUSION

Based on the comparison of intended use, construction, and technical features, Sirona Dental Systems believes that the ORTHOPHOS SL is substantially equivalent to the Sirona ORTHOPHOS XG 3D/CEPH (K103711) and the Sirona GALILEOS (K123070).

Regulation Number and Section

§ 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.