(224 days)
The XVISION-525 diagnostic X-ray system is a stationary X-ray imaging system, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy. This device is not intended for mammography or bone density applications.
The XVISION-525 diagnostic X-Ray System (Models HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50) generates medical X-rays passing through the patient's body and a X-ray detector for producing radiographic images of the human anatomical structures. The XVISION-525 diagnostic X-ray system consists of a high voltage (HV) generator, a tube support unit, an X-ray beam limiting device, patient table, wall Bucky stand, and a x-ray tube, that operates on a high-frequency inverter method. The user can select or change x-ray parameters easily using the operator control console. The AEC (Automatic Exposure Control) is an optional function to give the user control of exposure factors which can be optimized for different types of detectors selected, film or digital. The XVISION-525 X-ray system does not include a detector.
The provided text describes a 510(k) submission for an X-ray system. However, it does not contain information about acceptance criteria or a study proving that an AI/algorithm-based device meets those criteria. The device described, XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50, is a stationary X-ray system that does not include image processing software and does not include a detector. It is merely a system for acquiring X-ray images.
Therefore, the following information cannot be extracted from the provided document:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document primarily focuses on demonstrating substantial equivalence to a predicate device (DRGEM Corporation's GXR-Series Diagnostic X-Ray System) based on technical specifications, intended use, and adherence to electrical safety and electromagnetic compatibility standards (IEC 60601 series). It also mentions performance testing for image quality and radiation dose according to IEC 60601-2-54:2018, which applies to X-ray equipment itself, not an AI or image processing software. The software mentioned is firmware for controlling the X-ray equipment for image acquisition, not for image analysis or processing.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.