(127 days)
The Uroview FD 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 treatment, planning and diagnostic procedures including but not limited to: · Querying and retrieving patient information and /or images from other modalities. · X-ray examination of the urogenital area (e.g. cyctoscopy, kidney, bladder, ureter, urethra) including KUB, IVP, vasovesiculography, reflux-cystogram, cystourethrogram, and micturation 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, transurethral resection of prostate or bladder, alternative treatment of the BPH and brachytherapy). · Percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy). · Laparoscopy (e.g. cholecystectomy, lymph node dissection, abdominal testis detection/correction, varicocele). - · Application of fistula (kidney/bladder). - · Simple procedures (e.g. urethra, testis, phimonis). - · Introcorporeal shock wave lithotripsy. - Uroflow/urodynamics. - · Pediatric radiological and therapeutic applications.
The "Uroview FD" is a solid state detector fluoroscopic, X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimal invasive urology/surgery). The basic unit is a cantilevered, continuously adjustable, isocentric tilting patient table called the "Uroview FD Skeleton", which can be raised and tilted to provide convenient access for the patient as well as optimum and ergonomic operating conditions for the user. The Uroview FD X-ray system is a completely mounted system and is equipped with a digital imaging system with a dynamic flat detector, designed to replace traditional spot film devices using screen-film cassettes or "CR" plates and fluoroscopy with image intensifier CCD cameras. The system is also equipped with a generator and automatic, multilayer, square field collimation system intended for installation on stationary X-ray equipment. A rotating anode X-ray tube is mounted. The measuring chamber is placed between the patient and the detector in order to detect the actual dose value for the automatic exposure control (AEC), to provide consistent x-ray film appearance and to guarantee error-free images even at low kV values. Attenuation factor is low and X-ray scattering is reduced to minimum by using a moveable grid. The Uroview FD X-ray system includes the following major components: - . Uroview FD skeleton (urological table incl. tilting table) - . High Frequency RF X-ray generator - X-ray tube incl. housing - . Collimator - . Measuring chamber - . Grid - . Dynamic flat panel detector (Pixium RF4343 FL, originally cleared under K080859) - . Digital imaging workstation - Video monitors - . Accessories The Uroview FD X-ray System includes the following two software programs: HIRIS RF43 and Uroview FD software; these are explained briefly. The Hiris RF43 software controls the digital imaging system in fluoroscopy and radiography modes using the flat panel detector. The software is specifically designed for remote controlled fluoroscopy and radiography and emergency equipment and performs real-time X-ray diagnostics of the gastro-intestinal tract and the urogenital system. The Uroview FD software controls the patient table Uroview FD (Skeleton) and does not interact with the HIRIS RF43 software. It allows the user comprehensive control of the patient table via hand control and foot switch allowing operator to activate movement of the Uroview FD. The Uroview FD system is designed to meet the requirements in accordance with relevant sections of 21CFR 1020.30-1020.33.
It appears there's a misunderstanding in the prompt's request for acceptance criteria and study details for an AI/Software as a Medical Device (SaMD). The provided text is a 510(k) summary for a physical medical device, the Uroview FD, which is an X-ray fluoroscopic system.
This document does not describe an AI/SaMD product or a clinical study evaluating its performance with respect to specific acceptance criteria in the way typically required for AI/SaMD. Instead, it focuses on demonstrating substantial equivalence of the Uroview FD X-ray system to a predicate physical device (UROSKOP Omnia) based on technological characteristics and non-clinical performance data.
Therefore, most of the requested information regarding AI/SaMD acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance for an AI model cannot be extracted from this document, as it pertains to a different type of device and different regulatory pathway.
The document explicitly states:
- "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." (Section 10. Clinical Performance Data)
- The software mentioned (HIRIS RF43 and Uroview FD software) controls the digital imaging system and patient table, respectively, and is verified at a "Moderate Level of Concern" for functionality, compatibility, risk analysis, and user interface. This is standard software validation for a hardware device, not an AI algorithm performing diagnosis or detection.
Given this, I cannot provide the requested table and study details as they are framed for an AI/SaMD. I can, however, summarize the non-clinical performance acceptance criteria and proof of adherence as outlined in the document for the physical Uroview FD X-ray system:
Summary of Acceptance Criteria and Performance for the Uroview FD X-ray System (Non-AI/SaMD)
The Uroview FD is a physical X-ray fluoroscopic system, not an AI/SaMD. Its acceptance criteria and performance demonstration are based on non-clinical testing to prove substantial equivalence to a legally marketed predicate device (UROSKOP Omnia).
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Category | Acceptance Criterion (Standard or Internal Requirement) | Reported Device Performance (Proof of Adherence) |
|---|---|---|
| Biocompatibility | ISO 10993-1, 5, 10 (Cytotoxicity, Sensitization, Irritation reactivity) | PASSED all testing |
| Electrical Safety | IEC 60601-1, IEC 60601-2-2 | PASSED required testing |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | PASSED required testing |
| Electromagnetic Safety (Specific to X-ray) | IEC 60601-1-6, IEC 60601-2-28 (X-ray tube assemblies), IEC 60601-2-43 (Interventional procedures), IEC 60601-2-54 (Radioscopy) | PASSED required testing |
| Radiation Dose Documentation | IEC 61910-1 | PASSED required testing |
| Usability Engineering | IEC 62366 | PASSED required testing |
| Software Verification & Validation | IEC 62304 / FDA Guidance (for Moderate Level of Concern software, including system compatibility, risk analysis, user interface) | PASSED required testing |
| Shelf Life Testing | Internal requirement: 10 years based on 13,000 life cycles for unit components (tube arm support, cassette box, vertical system movement, table tilt, longitudinal movement, transversal table top movement) | PASSED all testing |
| Packaging and Transport Testing | Internal requirement for humidity, temperature, and vibration testing to maintain integrity through normal shipping and handling | PASSED all testing |
| Risk Management | ISO 14971 | All requirements met and risks reduced as far as possible |
| General Compliance | 21 CFR 1020.30-1020.33 | System designed to meet requirements |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of AI/SaMD performance evaluation. The data for these tests are derived from laboratory and engineering tests of the physical device and its components, not from patient data or clinical imaging test sets.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
Not applicable. Ground truth as typically understood for AI models (e.g., diagnostic labels on medical images) is not relevant here. The "ground truth" for these tests refers to the engineering specifications and performance standards.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication process involving multiple human reviewers for these non-clinical engineering and electrical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." This study type is for evaluating the impact of AI on human reader performance, which isn't relevant for this physical X-ray system.
6. If a Standalone (Algorithm Only) Performance was done
No, a standalone algorithm performance study was not done. The software components are for controlling the hardware and imaging process, not for performing diagnostic tasks independently.
7. The Type of Ground Truth Used
The ground truth for this device's performance demonstration is based on engineering specifications, recognized national and international standards (e.g., IEC, ISO), and validated internal test procedures. This is typical for a hardware medical device seeking substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no "training set" for an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI algorithm.
§ 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.