(30 days)
The Uroview FD II 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 II 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 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 II 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 II 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
- Digital imaging workstation
- . Video monitors
- Accessories
The Uroview FD II is considered as an update to the model Uroview FD with some new components as part of the continuous X-ray system evolution. Major X-ray components are identical to the Uroview FD and new components use FDA-cleared or FDA-registered X-ray components. Therefore the Uroview FD II is considered similar by properties and technological characteristics.
The Uroview FD II system is designed to meet the requirements in accordance with relevant sections of 21 CFR 1020.30-1020.33.
The provided text is a 510(k) premarket notification for a medical device called Uroview FD II. It extensively details the device's characteristics and compares it to a predicate device, Uroview FD. However, it 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. These types of devices, including the predicate device, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device."
Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or human-in-the-loop performance with AI assistance. The focus is solely on non-clinical performance and demonstrating substantial equivalence to a predicate device through technical specifications and compliance with standards.
Here's a breakdown of what can be extracted based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance:
Since no clinical study based on explicit acceptance criteria for diagnostic performance is described, a table like this cannot be created from the provided text. The performance reported relates to compliance with engineering and safety standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable as no clinical test set was used for a clinical performance study. The "test set" here refers to the physical device and its components undergoing non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable as no human interpretation or "ground truth" establishment by experts was part of the non-clinical testing for performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as no human-based assessment requiring adjudication was conducted.
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:
No. The document explicitly states "There was no human clinical testing required." This device is an X-ray system, and the submission focuses on its hardware and software compliance, not on AI assistance to human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as the device is a fluoroscopic X-ray system, not an AI algorithm. Its performance is inherent to its physical operation and image quality, not an independent algorithmic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. For the non-clinical tests conducted, the "ground truth" was established by engineering specifications, validated test methods, and industry standards (e.g., whether the device passed a given electrical safety test).
8. The sample size for the training set:
Not applicable. The device is hardware and software for image acquisition and processing, not a machine learning model that requires a training set in the typical sense.
9. How the ground truth for the training set was established:
Not applicable as per point 8.
Summary of available information regarding compliance and "acceptance criteria" from the document:
The primary "acceptance criteria" for the Uroview FD II, as demonstrated in this 510(k) submission, revolve around its non-clinical performance and compliance with relevant national and international standards, and substantial equivalence to a legally marketed predicate device (Uroview FD).
Here's a table summarizing the reported device performance against these non-clinical acceptance criteria (which are essentially compliance with standards):
| Acceptance Criteria (Compliance with Standards/Requirements) | Reported Device Performance (as stated in Non-Clinical Performance Data) |
|---|---|
| Biocompatibility (ISO 10993-1, 5, 10) | PASSED all testing (cytotoxicity, sensitization, irritation reactivity) |
| Electrical safety (IEC 60601-1) | PASSED required testing |
| Electrical safety (IEC 60601-2-2) | PASSED required testing |
| Electromagnetic Compatibility (IEC 60601-1-2) | PASSED required testing |
| Electromagnetic Safety (IEC 60601-1-6) | PASSED required testing |
| Electromagnetic Safety (IEC 60601-2-28) | PASSED required testing |
| Electromagnetic Safety (IEC 60601-2-43) | PASSED required testing |
| Electromagnetic Safety (IEC 60601-2-54) | 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) | PASSED required testing (system compatibility, risk analysis, user interface) |
| Shelf Life Testing (10 years / 13000 life cycles for unit components) | PASSED all testing (tube arm support, cassette box, vertical system movement, table tilt, longitudinal movement, transversal table top movement) |
| Packaging and Transport Testing (humidity, temperature, vibration) | PASSED all testing (to maintain integrity through normal shipping and handling) |
| Risk Management (ISO 14971 and EN ISO 14971) | All requirements were met and risks reduced as far as possible. |
Study Proving Device Meets Acceptance Criteria:
The "study" proving the device meets these non-clinical acceptance criteria is the comprehensive non-clinical performance testing program conducted by Pausch Medical GmbH. This is detailed in Section 9 of the 510(k) submission, "Non-Clinical Performance Data."
- Sample size: Not applicable in the traditional sense for these engineering and safety tests. The "sample" is the manufactured device (Uroview FD II) and its components.
- Data provenance: Not specified in terms of country of origin for the test results, but the submission is from Pausch Medical GmbH in Germany. The tests are "non-clinical," meaning they were conducted in a lab environment or on the device itself, not on human subjects.
- Experts/Ground Truth/Adjudication: For these non-clinical tests, the "ground truth" is defined by the technical specifications outlined in the standards (e.g., maximum radiation leakage, acceptable temperature range, etc.). Expertise lies in the engineers performing the tests and interpreting the results against these established quantitative and qualitative criteria. There's no "adjudication" in the sense of reconciling human interpretations.
In essence, the device's acceptance is based on demonstrating that its technical specifications and physical performance meet established safety and performance standards for X-ray systems, and that any differences from its predicate device do not raise new safety or effectiveness concerns. No new clinical performance claims, particularly those involving AI or human reader improvement, are made or substantiated.
§ 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.