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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.

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.

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

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.

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