(29 days)
The UROSKOP Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimal invasive urology/surgery). The system, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including:
- Querying and retrieving patient history information and/or previous diagnosis and images from other modalities.
- X-ray examinations of the urogenital and area (e.g. cystoscopy, kidney, bladder, ureter, urethra) including KUB, IVP, vasovesiculography, reflux-cystogram, cystourethrogram, and michuration cystourethrogram combined with uroflow measurements.
- Ultrasound examinations (in conjunction with a stand-alone ultrasound system) of the kidney, bladder, prostate, scrotum.
- endourological interventions (e.g. of the urethra, prostate, bladder, sphincter, ostium, kidney and ureter, catheter placement, penile implant placement, transvirethral resection of prostate or bladder, alternative treatment of the BPH, brachytherapy, as well as gynecological pacedures requiring radiological support).
- percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy)
- laparoscopy (e.g. cholecystectomy, nephrectomy, lymph node dissection, abdominal testis. detection/correction, varicocele).
- application of fistula (kidney/bladder)
- simple procedures (e.g. urethra, testis, phimosis)
- intracorporeal shock wave lithotripsy
- uroflow/urodynamics
- pediatric radiological and therapeutic applications.
UROSKOP Omnia is a radiographic and fluoroscopy examination table with the X-ray tube over the table and the detector underneath the patient table. The table top can be moved longitudinally and laterally as well as vertically. This system is a modified version of the UROSKOP U04 (marketed as UROSKOP Access). The modification features a solid state image detector with the Fluoros of Compact in place of the Image Intensifier and CCD camera for image recording and processing. The table design remains unchanged while the new imaging chain is based on the AXIOM Luminos dRF described in premarket notification K. 062623 which received FDA Cleanance on August 22. 2007.
This 510(k) summary for the UROSKOP Omnia does not include specific acceptance criteria or a detailed study proving the device meets those criteria. The submission focuses on demonstrating substantial equivalence to predicate devices (UROSKOP U04 and AXIOM Luminos dRF) by highlighting similarities in intended use, design, and components, particularly the imaging chain modification from an image intensifier to a flat panel detector.
Therefore, many of the requested details about acceptance criteria, performance metrics, sample sizes, expert qualifications, and ground truth establishment are not provided in the given document.
Here's an attempt to answer the questions based on the available information:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., resolution, contrast, dose). The acceptance is implicitly based on meeting the same performance and safety standards as the predicate devices, particularly the AXIOM Luminos dRF regarding its imaging chain.
- Reported Device Performance: Not quantified. The submission states that the UROSKOP Omnia uses the same flat detector (Pixium 5100) and digital imaging system (Fluorospot Compact) as the AXIOM Luminos dRF, implying that its imaging performance should be comparable to the cleared predicate device.
Acceptance Criteria (Implicit) Reported Device Performance (Implicit) Comparable imaging quality and safety to predicate devices (UROSKOP U04 and AXIOM Luminos dRF). Uses identical flat detector (Pixium 5100) and digital imaging system (Fluorospot Compact) as the AXIOM Luminos dRF, which was previously cleared (K062623). Compliance with general safety and effectiveness concerns, including appropriate warnings, error handling, and adherence to industry practices. Instructions for use provided, visual/audible warnings incorporated, continuous system monitoring with error blocking, operators are healthcare professionals, adherence to recognized industry practices, and final performance testing. -
Sample size used for the test set and the data provenance
- No specific test set or data from a clinical or phantom study is described in this 510(k) summary to establish direct performance for the UROSKOP Omnia itself. The assessment relies on substantial equivalence to predicate devices. Therefore, sample size and data provenance are not applicable in the context of a new performance study for this specific device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No new test set requiring expert ground truth establishment for this device is mentioned.
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Adjudication method for the test set
- Not applicable.
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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
- Not applicable. This device is an X-ray system, not an AI-powered diagnostic tool, and no MRMC study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI algorithm.
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The type of ground truth used
- Not applicable, as no new performance study generating ground truth is described. The "ground truth" for the device's clearance is its demonstrated equivalence to legally marketed predicate devices, which would have undergone their own testing and validation procedures.
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The sample size for the training set
- Not applicable. This device is not an AI algorithm requiring a training set.
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How the ground truth for the training set was established
- Not applicable.
§ 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.