(310 days)
The Orthopantomograph® OP300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device must only be operated and used by dentists and other legally qualified professionals.
Orthopantomograph® OP300 is an extraoral source dental x-ray device, which produces conventional digital 2D panoramic, cephalometric and TMJ x-ray images as well as digital x-ray projection images taken during cone beam rotations around a patient's head. The projection images are reconstructed to be viewed in 3D by a 3D viewing software. The name Orthopantomograph® OP300 is used when the device can produce panoramic, TMJ and optionally 3D images. The name Orthoceph® OC300 is used when the cephalometric option for cephalometric x-ray images is added to the device. Furthermore, the device can be equipped with the Volumetric Tomography device (K063773).
The provided text is a 510(k) summary for the Orthopantomograph® OP300, a dental X-ray device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity or specificity.
Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, and adjudication methods for a specific study proving device performance against acceptance criteria is not present in the provided text. The document primarily identifies the device, its intended use, technological characteristics, and claims substantial equivalence to predicate devices.
Here's a breakdown of why each specific piece of information cannot be extracted:
- 1. A table of acceptance criteria and the reported device performance: The document does not define specific performance acceptance criteria for the new device (e.g., minimum diagnostic accuracy, image quality scores). It doesn't report any direct performance metrics for the Orthopantomograph® OP300 in a study.
- 2. Sample size used for the test set and the data provenance: There is no mention of a test set, studies, or clinical data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no test set or study is described, this information is not available.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set or study is described.
- 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: This document is for an X-ray device, not an AI-powered diagnostic tool, and no MRMC studies or AI involvement are mentioned.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is mentioned as no study is described.
- 8. The sample size for the training set: Not applicable as this is not an AI algorithm or a study involving a training set.
- 9. How the ground truth for the training set was established: Not applicable for the same reasons as above.
In summary, the provided 510(k) summary (K093683) for the Orthopantomograph® OP300 is a regulatory document focused on establishing substantial equivalence based on intended use and technological characteristics rather than providing detailed clinical study results with performance metrics and acceptance criteria.
§ 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.