The Dentsply/Gendex Orthoralix E/GX-9000™ is a high frequency panoramic x-ray system for radiographic diagnostic extraoral dental images. It is available in two models: standard pan and pan/ceph. The Dentsply/Gendex Orthoralix E/GX-9000™ Panoramic 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 unit which is cofigurable in six different languages; A cloumn to be fixed to the wall; Counter balanced overhead carriage with controls for patient positioning, setting of technique factors and radiographic projection geometry; Cassette drive system with flat cassette for 15 x 30 cm film; X-ray tubehead, with DC power supply via electronic converter; Remote control box and handswitch; Optional cephalometric arm and head positioner. During a panoramic exposure, the x-ray tube and cassette holder move 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 two independent motors which are microprocessor controlled.

AI/ML Overview

The provided text is a 510(k) summary for a dental x-ray system and does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and the study that proves the device meets those criteria.

Specifically, the document mentions "performance testing to meet product specifications" and "effective clinical image exposures" as demonstrations of safety and effectiveness, but it does not provide any specific acceptance criteria or the reported device performance against those criteria. It also does not delve into the specifics of any clinical studies that would align with your questions about sample size, ground truth establishment, or expert involvement.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be provided. The document states "performance testing to meet product specifications" was conducted but does not list any specific specifications, acceptance criteria, or the numerical results of such testing.

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

Cannot be provided. The document mentions "effective clinical image exposures" as part of demonstrating safety and effectiveness, but it provides no details about the sample size, the type of test set (e.g., patient images), or the data's provenance.

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)

Cannot be provided. The document does not describe a process for establishing ground truth using experts, nor does it mention the number or qualifications of any experts involved in evaluating clinical images.

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

Cannot be provided. There is no information about any adjudication methods used for a test set.

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

Cannot be provided. This device is a panoramic X-ray system, not an AI-powered diagnostic assist tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be applicable or expected for this type of device.

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

Not applicable / Cannot be provided. As a physical X-ray imaging device, it does not have an "algorithm only" performance separate from its function as an imaging tool. The device is the standalone output.

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

Cannot be provided. The document mentions "effective clinical image exposures" but does not specify how the effectiveness (i.e., accuracy against a ground truth) of these exposures was determined.

8. The sample size for the training set

Not applicable / Cannot be provided. This device is a traditional X-ray system and does not involve machine learning or a "training set" in the context of AI models.

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

Not applicable / Cannot be provided. As above, there is no training set for this type of device.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and broadly stating that safety and effectiveness were shown through performance testing, software testing, and clinical image evaluations. It does not offer the granular detail about specific performance metrics, study designs, or ground truth methodologies that your questions require.

Summary

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K 964659
PI93

DEC 2 3 1996

Tab 23

510(k) Summary Statement for the Gendex Orthoralix E/GX-9000™ Panoramic Dental System

I. General Information

Submitter: Gendex Dental X-Ray Division Dentsply International, Inc. 901 West Oakton St. Des Plaines, IL 60018

Telephone: 847-640-4800 (company number) 847-640-4908 (contact person)

FAX: 847-640-4970

Contact Person: Daniel P. Murphy (Director Engineering, Quality Assurance, & Regulatory Affairs)

Summary Prenaration Date: November 13, 1996

II. Names

Device Name: Orthoralix E/GX-9000™ Panoramic Dental System

Primary Classification Name: Extraoral Source X-Ray System (76 EHD)

III. Predicate Devices

· Model PC-1000 marketed by Panoramic Corporation of America
· Versa View marketed by J. Morita, USA Inc.
· Cranex 2.5 + marketed by Sorodex/Orion Corp.
· GX-Pan marketed by Gendex Dental X-Ray Div./Dentsply Int'l, Inc.
· Orthoralix SD2/S marketed by Gendex Dental X-Ray Div. Dentsply Int'l, Inc.

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1.964659 P293

IV. Product Description

The Dentsply/Gendex Orthoralix E/GX-9000™ is a high frequency panoramic x-ray system for radiographic diagnostic extraoral dental images. It is available in two models: standard pan and pan/ceph.

The Dentsply/Gendex Orthoralix E/GX-9000™ Panoramic 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 unit which is cofigurable in six different languages
· A cloumn to be fixed to the wall
· Counter balanced overhead carriage with controls for patient positioning, setting of technique factors and radiographic projection geometry
· Cassette drive system with flat cassette for 15 x 30 cm film
· X-ray tubehead, with DC power supply via electronic converter
· Remote control box and handswitch
· Optional cephalometric arm and head positioner

During a panoramic exposure, the x-ray tube and cassette holder move 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 two independent motors which are microprocessor controlled.

V.A. Indications For Use/Rationale for Substantial Equivalence

The Orthoralix E/GX-9000™ Panoramic Dental X-Ray System is used as an extraoral source of x-rays in dental radiography.

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

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K964659
p3093

V. 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
hazard analysis including risk level and solutions
same indications for use as predicate devices

All the above steps and evaluations combine to demonstrate that the Orthoralix E/GX-9000™ is safe and effective when the device is used as labeled.

VI. Conclusion

The Orthoralix E/GX-9000™ Panoramic Dental X-Ray System was found to be substantially equivalent to the current marketed predicate devices: PC-1000; Versa View; Cranex 2.5 +; GX-Pan; and the Orthoralix SD2/S. The Orthoralix E/GX-9000™ share 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 the device is used as labeled.

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.