(71 days)
UROlogic is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to urologic and endoscopic applications The system may be used for other imaging applications at physician's discretion.
UROlogic is a universal fluoroscopic x-ray diagnostic system intended for use in providing x-ray imaging of patient with an undertable image intensifier. The system consists of a floor mounted tilting patient support table, x-ray generator, xsystem or a sembly, image intensifer and the tv system. The system is operated via tableside control panel, foot/handswitches and x-ray control panel. The system comes with a tripple mode image intensifier, a CCD camera with one frame memory, x-ray tube with housing and an image monitor. The tabletop can be moved motorized in longitudinal and lateral directions. The table can be tilted -15 to +87 degrees. Cranial movement of connected x-ray tube and image intensifer assembly gives the operator the advantage of scanning without moving patient. System has a stationary grid and casette holder for wallow mo films. Patient positioning and other accessories are also provided.
This 510(k) submission pertains to the UROlogic Urological Table, an image-intensified fluoroscopic x-ray system. The document provided does not contain specific acceptance criteria, device performance data, details of a clinical study, or information about AI integration.
The submission focuses entirely on demonstrating substantial equivalence to predicate devices (OEC Uroview 2600 and Liebel-Flarsheim Hydradjust IV) based on technological characteristics and intended use. The FDA letter confirms this substantial equivalence.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or AI-related metrics as these are not present in the provided text.
Based on the provided text, here's what can be stated:
1. A table of acceptance criteria and the reported device performance:
- This information is not provided in the given 510(k) summary. The submission focuses on substantial equivalence based on the device's technical specifications and intended use, rather than specific performance metrics against pre-defined acceptance criteria.
2. Sample size used for the test set and the data provenance:
- This information is not provided. No clinical study data is presented in the 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. No clinical study data is presented, and therefore no ground truth establishment for a test set is discussed.
4. Adjudication method for the test set:
- This information is not provided. No clinical study data is presented.
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 information is not provided. The device described is an X-ray table, and the submission makes no mention of AI or software for image interpretation, or human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not provided. No AI algorithm is mentioned or evaluated.
7. The type of ground truth used:
- This information is not provided. No clinical study data is presented requiring ground truth.
8. The sample size for the training set:
- This information is not provided. No AI training is mentioned.
9. How the ground truth for the training set was established:
- This information is not provided. No AI training is mentioned.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.