The Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System is to be used as an extraoral source of x-rays for imaging of the dentomaxilofacial area.

Device Description

The DENTSPLY International, Gendex Division Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System is an extraoral source of x-rays for imaging of the dentomaxilofacial area.

The DENTSPLY International, Gendex Division Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System is comprised of the following main components:

High frequency inverter which supplies a true DC output and accurate technique factors .
A microprocessor controlled user-friendly electronic control .
A motorized column to be fixed to the wall ●
Counter balanced overhead carriage with controls for patient positioning, setting and control . of technique factors and radiographic projection geometry
Cassette drive system with flat cassette for 15x30 cm film
X-ray tubehead, with DC power supply via electronic converter .
Remote control box and handswitch
. Optional cephalometric arm and head postioner
Optional utilities for transverse scanography of the jaw ("Transcan®") ●

During a panoramic exposure, the x-ray tube and cassette holder moves around the patient's head. The beam from the x-ray tube is collimated by a slit diaphragm. The flat film cassette passes behind a secondary collimator which blocks the radiation scattered from the patient. Patient positioning is by means of a bite guide and a headrest. During exposure, the patient, remains still while the motorized components rotate. All movements for the panoramic radiographic projection are performed by four independent motors, which are microprocessor controlled.

AI/ML Overview

This 510(k) submission (K032355) for the Gendex Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System provides limited detail regarding specific acceptance criteria and a dedicated study to prove it. The submission primarily relies on demonstrating substantial equivalence to predicate devices rather than directly proving performance against a set of predefined acceptance criteria through a specific study.

However, based on the provided text, we can infer some information about how Gendex approached safety and effectiveness, which implicitly addresses performance.

Here's a breakdown of the requested information, with acknowledgments of where details are not explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Inferred)	Reported Device Performance (Inferred from Submission)
Product Specifications	"Performance testing to meet product specifications" was conducted. (Specific metrics not provided).
Software Design/Performance	"Software testing to validate software design/performance" was conducted. (Specific metrics not provided).
Clinical Image Effectiveness	"Effective clinical image exposures" were achieved. (Specific metrics like image resolution, contrast, artifact levels, or diagnostic accuracy not provided).
Safety - Risk Analysis	Risk analysis including risk level and solution was performed. (Specific risk reduction metrics not provided).
Indications for Use (Equivalence)	Shares the same indications for use as predicate devices. (Implies performance is similar enough to serve the same purpose).
Materials and Design (Equivalence)	Similar materials, design, operational, and functional features as predicate devices. (Implies comparable performance based on design similarity).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated. The submission mentions "Performance testing" and "Effective clinical image exposures" but does not quantify the number of images, patients, or cases used for these assessments.
Data Provenance: Not explicitly stated. Given it's a 2003 submission, and the focus is on substantial equivalence rather than a large clinical trial, it's likely a mix of internal testing data and potentially a limited number of clinical cases. There's no mention of country of origin or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. The phrase "Effective clinical image exposures" suggests clinical evaluation, which would typically involve dental professionals, but no specific professional roles or experience levels are mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. Without details on expert involvement or a formal clinical study design, it's impossible to determine an adjudication method (like 2+1, 3+1, none).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

MRMC Study: No. This submission predates the widespread regulatory emphasis on AI/CAD devices and therefore does not include a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The device itself is an X-ray system, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance Study: Not applicable. This device is an X-ray imaging system, not an algorithm, so a "standalone" algorithmic performance study as understood for AI is not relevant. Its performance is inherent to the image acquisition capabilities.

7. The Type of Ground Truth Used

Ground Truth Type: Not explicitly detailed. For "Effective clinical image exposures," the ground truth would likely be based on expert visual assessment of image quality, diagnostic utility, and the ability to visualize relevant anatomical structures for dental imaging. This falls under "expert consensus" regarding image quality and clinical utility. There's no mention of pathology or outcomes data as a primary ground truth for an imaging system's performance.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable in the context of device performance in this submission. This is an X-ray system, not a machine learning algorithm that requires a training set. The "software testing" refers to validation of the software controlling the X-ray system, not training an AI model.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable, as there is no mention of a training set for an AI/ML model for this device. For the software validation that was done, the ground truth would typically be established based on functional requirements, design specifications, and expected outputs, verified through testing.

Summary of the Study and Evidence Presented:

The submission for the Gendex Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System does not describe a specific clinical study with rigorous acceptance criteria and quantitative results in the way modern device submissions often do for AI/CAD devices. Instead, it relies on a demonstration of substantial equivalence to existing predicate devices (Gendex Orthoralix 9200 and 9200 Plus, Instrumentarium Orthoceph® OC100 D, Planmeca DIMAX2, Sirona Orthophos Plus DS).

The "study" that proves the device meets the (inferred) acceptance criteria is embedded within the "Safety and Effectiveness Information" section, which states:

"Performance testing to meet product specifications"
"Software testing to validate software design/performance"
"Effective clinical image exposures"
"Risk analysis including risk level and solution"
"Same indications for use as predicate devices"

These points collectively form the basis of their claim for safety and effectiveness and, by extension, that the device performs acceptably. The ultimate conclusion is that the device "was found to be substantially equivalent" to predicate devices, sharing "the same indications for use, similar materials, design, operational, and functional features." This implies that its performance is presumed adequate because of its similarity to already cleared devices.

Summary

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K032355

SEP 2 5 2003

Image /page/0/Picture/2 description: The image shows the logos for Dentsply and Gendex. The Dentsply logo is in a bold, sans-serif font, with the letters closely spaced together. Below Dentsply is the Gendex logo, which is in a thinner, sans-serif font. Both logos are in black and are stacked vertically.

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DENTSPLY International Gendex Division 901 West Oakton Street Des Plaines, IL 60018-1884 Phone (847) 640-4800 Fax (847) 640-4970

510(k) Summary Statement for the Gendex Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System

I. General Information

Submitter:	DENTSPLY InternationalGendex Division901 West Oakton St.Des Plaines, IL 60018
Telephone:	(847) 640-4800 - Company Number(847) 640-4924 - Contact Person
Fax:	(847) 640-4970
Contact Person:	John R. MillerDirector, Quality Assurance and Regulatory Affairs
Summary Preparation Date:	June 30, 2003

II. Names

Device Name:	Orthoralix 9200 DDE Digital Panoramic and CephalometricDental X-Ray System
Primary Classification Name:	76EHD – Unit, X-Ray, Extraoral with Timer

III. Predicate Devices

Gendex Orthoralix 9200 and 9200 Plus
Instrumentarium Orthoceph® OC100 D Direct Digital Cephalometric Imaging System ●
Planmeca DIMAX2 Direct Digital Imaging System
. Sirona Orthophos Plus DS

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Orthoralix 9200 DDE Summary Statement Page 2 of 3

IV. Product Description

The DENTSPLY International, Gendex Division Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System is an extraoral source of x-rays for imaging of the dentomaxilofacial area.

The DENTSPLY International, Gendex Division Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System is comprised of the following main components:

High frequency inverter which supplies a true DC output and accurate technique factors .
A microprocessor controlled user-friendly electronic control .
A motorized column to be fixed to the wall ●
Counter balanced overhead carriage with controls for patient positioning, setting and control . of technique factors and radiographic projection geometry
Cassette drive system with flat cassette for 15x30 cm film
X-ray tubehead, with DC power supply via electronic converter .
Remote control box and handswitch
. Optional cephalometric arm and head postioner
Optional utilities for transverse scanography of the jaw ("Transcan®") ●

V. Indications for Use/Rationale for Substantial Equivalence

The Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System is to be used as an extraoral source of x-rays for imaging of the dento-maxilofacial area.

It shares the same indications for use, similar materials, design, operations, and functional features and therefore is substantially equivalent to the predicate devices listed in Section III of this summary.

VI. Safety and Effectiveness Information

Safety and Effectiveness is demonstrated by:

Performance testing to meet product specifications -
-Software testing to validate software design/performance
Effective clinical image exposures -
Risk analysis including risk level and solution -
Same indications for use as predicate devices. ..

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Orthoralix 9200 DDE Summary Statement Page 3 of 3

All the above steps and evaluations combine to demonstrate that the Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System is safe and effective when the device is used as labeled

VII. Conclusion

The DENTSPLY International, Gendex Division Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System was found to be substantially equivalent to the predicate devices, the Gendex Orthoralix 9200 and 9200 Plus, the Instrumentarium Orthoceph® OC100 D Direct Digital Cephalometric Imaging System, the Planmeca DIMAX2 Direct Digital Imaging System, and the Sirona Orthophos Plus DS. The DENTSPLY International, Gendex Division Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System shares the same indications for use, similar materials, design, operational, and functional features as the current marketed predicate devices. It has been shown to be safe and effective when used as labeled.

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Image /page/3/Picture/1 description: The image shows a black and white logo. The logo is circular in shape and features a stylized image of an eagle in flight. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 2003

Mr. John R. Miller Director DENTSPLY International Gendex Division 901 West Oakton Street DES PLAINES IL 60018-1884 Re: K032355

Trade/Device Name: Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 EHD Dated: July 21, 2003 Received: July 30, 2003

Dear Mr. Miller:

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. Brygdon

Nancy C. B rogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K032355

510(k) Number (if known): Not Assigned

Orthoralix 9200 DDE Digital Panoramic and Cephalometric Device Name: Dental X-Ray System

Indications for Use:

The Orthoralix 9200 DDE Digital Panoramic and Cephalometric Dental X-Ray System is to be used as an extraoral source of x-rays for imaging of the dentomaxilofacial area.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. deymm

(Division Sign-Off Division of Reproductive, Abdominal and Radiological Device 510(k) Number

Prescription Use
(Per 21CFR 801.109)

Over-The-Counter Use __

(Optional Format 1-2-96)

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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.