The Orthophos XGPMS DS/Ceph Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

Device Description

The Orthophos XGPMS DS/Ceph is the neXt Generation in the Orthophos family of digital dental X-ray Systems. Similar to the prior Orthophos PLUS DS/PLUS DS Ceph device, the Orthophos XG "105 DS/Ceph offers digital imaging with or without the optional cephalometric attachment. Both the new and predicate digital imaging systems offer substantially the same panoramic and optional cephalometric imaging programs with the same exposure levels (kV/mA). Modifications resulting in the new device include a new control panel consisting of an EasyPad with a touchscreen graphical user interface and associated buttons, a new sized CCD sensor, artifact reduction on selected programs, additional options for refining image quality, an electromechanical diaphragm controlled by stepper motors with an adjustable filter system, Class I laser light system for head positioning (replaces halogen light source), and a modified scanning technique for the cephalometric imaging.

AI/ML Overview

The provided text is a 510(k) summary for the Orthophos XGPlus DS/Ceph Dental X-Ray System. It does not describe an acceptance criteria or a study that proves the device meets the acceptance criteria in the format requested.

This document is a regulatory submission for premarket notification (510(k)) to the FDA, asserting substantial equivalence to a predicate device. It primarily focuses on comparing the new device to existing technology and highlighting improvements, rather than presenting a detailed performance study with explicit acceptance criteria and results.

Specifically, the document states:

Basis for Substantial Equivalence: "The modified device has the same intended use and principles of operation as the prior Orthophos devices, as well as substantially equivalent technical specifications. The modifications were implemented to improve ease of use and image quality, and do not change the intended use or fundamental scientific technology of the device. A hazard analysis, validation testing, and Declaration of Conformity to Design Controls were submitted to support the substantial equivalence of the modified Orthophos system."

This indicates that Sirona Dental Systems performed validation testing and a hazard analysis to support substantial equivalence, but the details of these tests, including specific acceptance criteria and detailed performance metrics, are not provided in this 510(k) summary.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text. The document focuses on regulatory approval based on equivalence rather than a detailed performance study.

Summary

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K033073

OCT 1 0 2003

510(k) Summary for Orthophos XGPlus DS/Ceph Dental X-Ray System

1. SPONSOR

Sirona Dental Systems GmbH Fabrikstraße 31 D-64625 Bensheim Germany

Contact Person: Fritz Kolle Telephone: 49 6251 16 3294

Date Prepared: September 26, 2003

2. DEVICE NAME

Proprietary Name:	Orthophos XGPlus DS/Ceph
Common/Usual Name:	Dental panoramic and cephalometric X-ray system
Classification Name:	Extraoral source dental X-ray system

3. PREDICATE DEVICE

Orthophos PLUS DS / PLUS DS Ceph: K013650

4. INTENDED USE

DEVICE DESCRIPTION ട്.

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the optional cephalometric attachment. Both the new and predicate digital imaging systems offer substantially the same panoramic and optional cephalometric imaging programs with the same exposure levels (kV/mA). Modifications resulting in the new device include a new control panel consisting of an EasyPad with a touchscreen graphical user interface and associated buttons, a new sized CCD sensor, artifact reduction on selected programs, additional options for refining image quality, an electromechanical diaphragm controlled by stepper motors with an adjustable filter system, Class I laser light system for head positioning (replaces halogen light source), and a modified scanning technique for the cephalometric imaging.

6. BASIS FOR SUBSTANTIAL EQUIVALENCE

The modified device has the same intended use and principles of operation as the prior Orthophos devices, as well as substantially equivalent technical specifications. The modifications were implemented to improve ease of use and image quality, and do not change the intended use or fundamental scientific technology of the device. A hazard analysis, validation testing, and Declaration of Conformity to Design Controls were submitted to support the substantial equivalence of the modified Orthophos system.

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Image /page/2/Picture/1 description: The image shows a black and white logo of the Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2003

Sirona Dental Systems GmbH % Sheila M. Hemeon-Heyer, JD, RAC Senior Staff Consultant Medical Devices Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

Re: K033073

Trade/Device Name: Orthophos XGPlus DS/Ceph Dental X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 76 EHD Dated: September 26, 2003

Received: September 29, 2003

Dear Ms. Hemeon-Heyer:

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.

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.

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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 the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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):

033073

Device Name: Orthophos XGPlus DS/Ceph Dental X-Ray System

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number KO 33073

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Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-Counter Use -------

Page vii

Regulation Number and Section

§ 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.