(81 days)
The IMPERIUM 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 digital subtraction angiography (DSA), orthopedic, neurologic, abdominal, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at physician's discretion.
The IMPERIUM is a mobile c-arm x-ray imaging equipment consisting of a carm stand and a monitor trolley. The c-arm stand holds the high-frequency x-ray generator, x-ray tube assembly, x-ray controls, image intensifier and TV camera. Monitor trolley supports the image display monitors, image processing and recording devices.
The IMPERIUM is designed to provide the user with smooth lincar and rotational movements around patient without need of further reorientations. The C-arm movements are fully motorized for ease of operation.
The IMPERIUM is designed according to such principles as lower dosage, better image quality and manipulation, workflow enhancement, operator and patient comfort and versatility. The IMPERIUM can be operated at Fluoroscopy, Pulsed Fluoroscopy, Digital Radiography, Cassette Radiography, Digital Subtraction Angiography (DSA) and Roadman modes. Image processing and storage capabilities such as last image hold, recursive filtering, real time edge enhancement, real time zooming, image reversal, continuous image rotation, radiation-free collimation and contrast/brightness adjustment are possible under user control.
The provided text is a 510(k) summary for the IMPERIUM Mobile C-arm X-Ray Equipment. This document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to safety standards. It does not describe a study that establishes acceptance criteria for device performance based on clinical metrics, nor does it report on the device's performance against such criteria.
Therefore, I cannot fulfill most of your request as the information is not present in the provided text. Specifically:
- 1. A table of acceptance criteria and the reported device performance: Not available. The document discusses technical specifications and compliance with safety standards, but not clinical performance metrics or their acceptance criteria.
- 2. Sample sized used for the test set and the data provenance: Not available. No clinical test set or data provenance is mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. No clinical evaluation with ground truth establishment is described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
- 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: Not available. This device is a C-arm X-ray system, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available. This is a hardware device, not an algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available.
- 8. The sample size for the training set: Not available. No training set is mentioned for this hardware device.
- 9. How the ground truth for the training set was established: Not available.
What the document does provide regarding performance and acceptance:
The document states that the device was designed according to principles of:
- lower dosage
- better image quality and manipulation
- workflow enhancement
- operator and patient comfort
- versatility
It also mentions that the "Results of performance and compliance testing conducted at manufacturing facility and independent test organizations on IMPERIUM system, indicates conformance to all applicable performance standards promulgated by FDA for these systems." These performance standards would be related to electrical safety, radiation safety, and general medical device standards, as listed in Table-1 (21 CFR 1020.30-32, ANSI/NFPA 70&99, UL 2601, CSA-C22.2 No. 601.1-M90, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32).
The core of this 510(k) is a demonstration of substantial equivalence to existing predicate devices (GE OEC 9800 PLUS and SIEMENS MEDICAL SIREMOBIL ISO-C) based on shared technological characteristics and intended use, rather than a clinical performance study with acceptance criteria.
§ 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.