SIDEXIS 4 is software that offers functions for the acquisition, administration, analysis, diagnosis, presentation and transfer of digital or digitized image data, e.g. X-ray images or video recordings, for medical use, predominantly in dentistry.

Device Description

SIDEXIS 4 combines the two Sirona products GALAXIS and SIDEXIS XG and now integrates 2D and 3D functions. New functions have been implemented (e.g. comparison of two volumes, comparison of two 2D projections).

AI/ML Overview

The provided documentation for Sirona Dental Systems SIDEXIS 4 does not contain information on acceptance criteria or a study proving that the device meets specific performance criteria.

Here's a breakdown of why this information is missing based on the provided text:

Section 7. PHYSICAL AND PERFORMANCE CHARACTERISTICS: States "Not applicable." This indicates that no specific performance characteristics or acceptance criteria were defined or tested in the context of a 510(k) submission that typically focuses on substantial equivalence.
Section 10. Clinical Testing: States "Clinical tests have not been performed." This explicitly indicates that no clinical studies were conducted to assess the device's performance against clinical endpoints or acceptance criteria.
Section 9. Non-clinical Testing: Mentions that "The SIDEXIS 4 system functions have been tested" and "Additional tests with technicians and physicians have been performed to compare images from SIDEXIS XG/GALAXIS with SIDEXIS 4." While this indicates some testing, it doesn't describe quantitative acceptance criteria or a formal study to prove performance. The nature of these tests appears to be focused on functional equivalence and user perception rather than quantifiable performance metrics.
Section 11. Conclusion: States that the device is deemed "safe and effective to perform its intended use and is substantially equivalent to the predicate devices" based on a comparison of intended use, indications, principle of operation, features, and technical data. This reinforces that the submission relies on substantial equivalence rather than meeting specific performance criteria.

Therefore, since the device's approval seems to be based on substantial equivalence to predicate devices (SIDEXIS XG, GALAXIS, Cybermed OnDemand3D) rather than meeting predefined performance criteria through a specific study, the requested information cannot be extracted from this document.

Summary of missing information:

Table of acceptance criteria and reported device performance: Not provided.
Sample size for the test set and data provenance: Not applicable as a formal performance test set and study were not conducted.
Number of experts used to establish ground truth and their qualifications: Not applicable.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted.
Standalone (algorithm only) performance study: Not conducted, as the device is a PACS system with image viewing capabilities, not an AI algorithm with standalone performance metrics.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable (this is an imaging system, not an AI model that undergoes training).
How ground truth for the training set was established: Not applicable.

Summary

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510(k) Summary for Sirona Dental Systems SIDEXIS 4

1. SPONSOR

Sirona Dental Systems GmbH
Fabrikstrasse 31
D-64625 Bensheim
Germany
Contact Person:	Fritz Kolle
Telephone:	+49 6251 16 3294
Date Prepared:	August 30, 2013

2. DEVICE NAME

Proprietary Name:	SIDEXIS 4
Common/Usual Name:	Picture archiving and communications system
Classification Name:	System, Image Processing, Radiological

3. Predicate Devices

SIDEXIS XG (K013659) .
GALAXIS cleared with (GALILEOS family K0123070) .
. Cybermed OnDemand3D (K113543)

4. Intended Use

Sirona Dental Systems 510(k) SIDEXIS 4

APPENDIX G

Page 1

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5. Device Description and Function

6. SCIENTIFIC CONCEPT

Not applicable

7. PHYSICAL AND PERFORMANCE CHARACTERISTICS

Not applicable

8. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS

SIDEXIS 4 offers similar functions and views as the predicate device Cybermed OnDemand3D (K113543). It offers similar functions to the predicate software parts of SIDEXIS XG and GALAXIS together.

All systems (SIDEXIS XG and GALAXIS are always taken into account together) are typical PACS systems with 3D and 2D image-viewing capabilities for dental imaging devices. They have lots of common options to change the display of the images. With adjustment of brightness, contrast and special filters for SIDEXIS 4, the physician can adjust the display to the preferred style.

9. Non-clinical Testing

The SIDEXIS 4 system functions have been tested.

Additional tests with technicians and physicians have been performed to compare images from SIDEXIS XG/GALAXIS with SIDEXIS 4.

Sirona Dental Systems 510(k) SIDEXIS 4

APPENDIX G

Page 2

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10. Clinical Testing

Clinical tests have not been performed.

11. Conclusion

ﺮ ﺳﻌﺪ ﺍﻟﻤﻌﺎﺭﺿﺎ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺘﻮﻗﻌﺔ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘ

Based on a comparison of intended use, indications, principle of operation, features and technical data, the SIDEXIS 4 is safe and effective to perform its intended use and is substantially equivalent to the predicate devices.

Sirona Dental Systems 510(k) SIDEXIS 4

APPENDIX G

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned above the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-0 Silver Spring, MD 20993-0002

December 11, 2013

Sirona Dental Systems GmbH % Mr. Fritz Kolle Fabrikstrasse 31 Bensheim. D-64625 GERMANY

Re: K132773

Trade/Device Name: Sidexis 4 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 19, 2013 Received: September 23, 2013

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, 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

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Page 2- Mr. Kolle

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/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.lda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132773

Device Name

..............................................................................................................................................................................

SIDEXIS 4

Indications for Use (Describe)

SIDEXIS 4 is software that offers function, administration, analysis, diagnosis, presentation and transfer of digital or digitized image data, e.g. X-ray images or video recordings, for medical use, predominantly in dentistry.

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sm.h.7)

FORM FDA 3881 (9/13)

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).