(11 days)
GALILEOS consists of an x-ray device that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support.
GALILEOS comprises a package of PC software modules to expand SIDEXIS capabilities to handling 3D data. This includes 3D reconstruction, storage, retrieval, viewing and processing of 3D-image data.
The GALILEOS comprises of the GALILEOS-device, the reconstruction server and the 2D and 3D viewing client SIDEXIS. The GALILEOS device generates a conical x-ray beam that rotates round the patient's head within a certain angle. From the obtained exposures a three dimensional image is reconstructed and can be viewed. The GALILEOS features the navigation within this displayed volume and special views may be selected, calculated and eventually displayed.
The provided documentation for K060892, Sirona Dental Systems GALILEOS, is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria or extensive performance study results. Therefore, much of the requested information regarding specific performance metrics, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.
Based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It broadly states that "Performance testing to validate the safety and effectiveness of the GALILEOS included electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions." This indicates that the device met internal performance standards for these general categories to be considered substantially equivalent.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The device is described as an x-ray system with 3D reconstruction and viewing software, not an AI-assisted diagnostic tool in the modern sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the GALILEOS as an "x-ray device that uses a cone beam... providing two-dimensional images and three-dimensional volume reconstructions... for use in planning and diagnostic support," and "comprises a package of PC software modules to expand SIDEXIS capabilities to handling 3D data." This implies a standalone performance of the imaging and reconstruction system itself, as the primary function is to generate and display images for human interpretation. However, specific standalone performance metrics (e.g., image quality, resolution, contrast-to-noise ratio) are not detailed beyond the general statement of "validation testing of both hardware and software functions."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. Given the nature of a 510(k) submission for an imaging device, ground truth for image quality might be assessed internally, but clinical ground truth (e.g., disease presence) would likely not be the primary focus of this type of submission unless a specific diagnostic claim was being made beyond "diagnostic support."
8. The sample size for the training set
This information is not provided in the document. The device is described as an imaging system and software, implying traditional engineering validation rather than machine learning training sets in the contemporary sense.
9. How the ground truth for the training set was established
This information is not provided in the document. Assuming a lack of machine learning, a "training set" and associated "ground truth" for training are not applicable in this context.
§ 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.