(128 days)
The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The FDR Visionary Suite enables radiographic or tomographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The FDR Visionary Suite uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals. The device is not intended for mammographic applications.
The FDR Visionary Suite is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The FDR Visionary Suite can be used in a wide range of applications from general radiography using X-ray film or Computed Radiography (CR) cassettes, to digital radiography. The FDR Visionary Suite consists of an Xray high voltage generator, X-ray tube support and collimator. The system can be configured with radiographic table, radiographic stand and digital radiography system as well. Optionally, the device is also used to perform tomosynthesis radiography by two different reconstruction modes. Filtered Back-Projection (FBP) mode is used to obtain a tomosynthesis image by performing back-projection after correcting the projection data. Shift Addition (SA) mode is used to obtain a tomosynthesis image at an arbitrary slice plane height by shifting each image according to projection angle of the tube based on the reconstruction height, and by applying image addition processing to them. FBP mode is generally recommended for all body parts. In case an artifact is observed at joints and other similar places, SA mode may remedy this artifact. In case metal artifact is obviously displayed.
The provided text does not contain acceptance criteria for device performance related to a specific diagnostic task (e.g., disease detection accuracy), nor does it describe a study proving the device meets such criteria.
The document is a 510(k) Premarket Notification from the FDA to Shimadzu Corporation for their FDR Visionary Suite. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K152294).
Here's a breakdown of what the document does provide in relation to your questions, and what it does not:
What the document does provide:
- Device Description: The FDR Visionary Suite is an X-ray radiography system for various body parts and ages, including pediatric patients. It can perform general radiography and tomosynthesis.
- Modifications from Predicate: The submission outlines changes from the previous version of the FDR Visionary Suite (K152294). These changes are primarily hardware upgrades (larger LCD displays, added camera, wireless controls, updated flat panel detectors) and infrastructure software changes (programming language, OS) while maintaining the same functionality.
- Performance Testing (Non-Clinical):
- User Manuals: Modified to reflect changes.
- Software Validation: Performed according to FDA guidance for basic documentation level, including cybersecurity considerations.
- EMC and Electrical Safety Testing: Performed according to IEC standards (EN 60601-1-2 and IEC 60601-2-54).
- Conclusion: Based on risk analysis, software verification/validation, and non-clinical testing, the new device is considered substantially equivalent to the predicate, with no impact on clinical safety or effectiveness due to the changes.
What the document does NOT provide (and why it's missing in this context):
The questions you've asked are typically relevant for devices that employ AI/ML algorithms where diagnostic performance (e.g., sensitivity, specificity, AUC) is a key aspect of their functionality and a basis for 510(k) clearance or de novo classification.
This document describes an X-ray system where the core imaging technology and its functional performance (image acquisition, processing, generation) are being compared to a predicate. The software changes mentioned are related to the infrastructure and user interface, not a new AI-powered diagnostic algorithm.
Therefore, the following information is not present for the reasons stated:
- A table of acceptance criteria and reported device performance (e.g., diagnostic accuracy metrics): Not provided because this is an updated X-ray system, not a new diagnostic AI. The performance criteria relate to hardware safety, electrical compatibility, and software validation of its infrastructure, not diagnostic output.
- Sample size used for the test set and data provenance: No clinical test set involving patient data for diagnostic performance evaluation is described. The tests were non-clinical (e.g., electrical safety, software validation).
- Number of experts used to establish ground truth & qualifications: N/A, as there's no diagnostic ground truth being established for an AI algorithm.
- Adjudication method for the test set: N/A.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not done. This is typical for AI-assisted diagnostic tools, not for a general X-ray system hardware/software update where the functionality remains unchanged. The statement "The software functionality remains unchanged" (page 5) reinforces this.
- Standalone (algorithm-only) performance: Not applicable, as there's no distinct diagnostic algorithm being evaluated independently.
- Type of ground truth used: N/A.
- Sample size for the training set: N/A, as this is not an AI algorithm being trained. The software changes are infrastructure updates, not machine learning model training.
- How ground truth for the training set was established: N/A.
In summary, the provided FDA document is for a conventional X-ray system seeking clearance for minor hardware and infrastructure software updates via the 510(k) substantial equivalence pathway. It relies on non-clinical testing (safety, EMC, software validation) to demonstrate that the updated device is as safe and effective as its predicate, rather than clinical performance studies of an AI diagnostic algorithm.
§ 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.