(42 days)
The Orthoralix 8500 Panoramic Dental X-ray System is to be used as an extraoral source of x-rays for imaging of the dento-maxillo-facial area.
The Orthoralix 8500 is a system for rotational panoramic radiography of the dentomaxillo-facial area. The system consists of:
- Column to be mounted to the wall .
- Motor-driven overhead assembly with controls for patient postioning, setting of . technique factors and radiographic projection geometry.
- Cassette drvie system with flat cassette for 15 x 30 cm film .
- X-ray tubehead, with DC power supply ●
- Remote control box and handswitch ●
During a panoramic exposure, the x-ray tubehead and cassette holder move around the patient's head. The beam from the x-fay tabe is commans locks the radiation scattered from the patient. Patient positioning is simple, accurate and consistent by means of three postioning lasers, a bite guide and head stabilizers. During the exposure, the patient postioning lasers, a bitc guite and nead backless. All movements for the panoramic remains still with e tholorized components retater traiser traotors, which are microprocessor controlled.
Along wit the Standard Panoramic mode, the Orthoralix 8500 provides a special child Along with the Bandard Fanolania me adiation dosage to the child, and confining the image to the dentition.
This is a 510(k) premarket notification for the Gendex Orthoralix 8500 Panoramic Dental X-ray System, which is a submission to the FDA demonstrating substantial equivalence to a predicate device. 510(k) submissions typically do not contain details of specific acceptance criteria and detailed study reports in the same way a PMA (Premarket Approval) submission would.
The document provides a general overview of the device and its intended use, focusing on demonstrating equivalence to predicate devices already on the market. Therefore, the specific information requested about acceptance criteria and detailed study methodology is largely not present within this 510(k) summary.
Here's an analysis based on the provided text, highlighting what is (and isn't) available:
1. Table of Acceptance Criteria and Reported Device Performance
- Not available in this 510(k) summary.
- 510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device. This often involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness, or that any differences do not raise new questions of safety and effectiveness and that the data submitted demonstrate the device is as safe and effective as the predicate device. Specific quantitative acceptance criteria for performance metrics (e.g., image resolution, dose levels) and detailed performance data against those criteria are not typically included or required in the public 510(k) summary document for this type of device.
2. Sample Size Used for the Test Set and Data Provenance
- Not available in this 510(k) summary.
- There is no mention of a dedicated "test set" in the context of clinical or performance evaluation data. The submission relies on the established safety and effectiveness of the predicate devices.
- Data provenance (e.g., country of origin, retrospective/prospective) is also not discussed, as there are no explicit studies being described in this summary to evaluate the device against specific performance metrics.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable/Not available.
- Since no specific study involving expert-derived ground truth (e.g., for diagnostic accuracy) is described, information on experts or their qualifications is not provided.
4. Adjudication Method
- Not applicable/Not available.
- As there's no diagnostic accuracy study described, an adjudication method is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study is not mentioned.
- This type of study is more common for evaluating AI-driven diagnostic tools where the goal is to quantify the improvement in human reader performance with AI assistance. The Orthoralix 8500 is an X-ray system, not an AI diagnostic algorithm, and its 510(k) submission does not include such a study.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone performance study is not applicable or mentioned.
- This device is an X-ray imaging system, not a standalone algorithm. Its performance is inherent in its imaging capabilities and technical specifications, which are established through engineering design and testing (not explicitly detailed in this summary) and benchmarked against predicate devices.
7. Type of Ground Truth Used
- Not applicable/Not available in this context.
- For an X-ray system, "ground truth" might refer to phantoms or calibrated targets used during technical performance testing (e.g., for resolution, dose, geometry). However, no specific studies using such ground truth are detailed in this 510(k) summary. The submission primarily relies on the equivalency to predicate devices.
8. Sample Size for the Training Set
- Not applicable/Not available.
- This device is an X-ray system, not a machine learning or AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not available.
- As there is no training set mentioned, this information is not relevant.
In summary, this 510(k) summary for the Gendex Orthoralix 8500 Panoramic Dental X-ray System is a regulatory document focused on demonstrating substantial equivalence to pre-existing predicate devices. It does not contain the detailed study information, acceptance criteria, or performance metrics typically found in more comprehensive clinical trial reports or new technology evaluations. The FDA's acceptance of this 510(k) primarily signifies that the device is deemed as safe and effective as the predicate devices, based on its similar intended use, materials, design, operational characteristics, and functional features.
§ 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.