(49 days)
The Siremobil C02 is a mobile x-ray system intended for use in operating room, traumatology, endoscopy, intensive care station, pediatrics, ambulatory patient care and in veterinary medicine. The Siremobil C02 can operate in six different modes: Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, and Roadmapping, which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of intra-medullary nail implant in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
The Siremobil C02 is a mobile x-ray C-ram which consists of a high frequency generator, X-ray tube assembly, image intensifier, TV camera, film cassette attachment, Laser light localizers, electronics cabinet and a trolley which consists of the image memory device, image monitor(s), and user interface. The Siremobil C02 is designed to meet the monitor(s), and user interface. The Siremobil Councilled onvironments identified below.
This document is a 510(k) Summary for the Siemens Siremobil C02 Mobile X-ray System. It describes the device, its intended use, and technological characteristics. Crucially, it is a submission for regulatory clearance and focuses on establishing substantial equivalence to a predicate device, not on presenting a study to prove acceptance criteria through performance metrics. As such, the information you've requested about specific performance criteria, study design, sample sizes, ground truth establishment, expert adjudication, or MRMC studies is not present in this type of document.
Here's an explanation of why the requested information isn't available in this document and how a 510(k) works:
- 510(k) Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This means it has the same intended use and the same technological characteristics, or, if there are different technological characteristics, that these do not raise new questions of safety and effectiveness.
- Performance Data in a 510(k): While a 510(k) may include performance data, it's typically to support the claim of substantial equivalence (e.g., showing that the new device performs at least as well as the predicate device in relevant aspects). It's not usually a comprehensive study designed to meet pre-defined acceptance criteria as one might see for a novel device or a PMA (Pre-Market Approval) study.
- "Acceptance Criteria" for a 510(k): The "acceptance criteria" for a 510(k) are largely regulatory: satisfying the FDA that the device is safe and effective and substantially equivalent to a predicate device. It's not about quantitative performance metrics in the same way your request implies.
Given the nature of the provided document, I cannot fulfill your request for the specific details outlined (Table of acceptance criteria and performance, sample sizes, ground truth, expert qualifications, adjudication, MRMC or standalone studies, training set details). The document simply doesn't contain that level of detail about a performance study.
The document does provide the following:
- Device Name: Siremobil C02 (Mobile X-ray System)
- Manufacturer: Siemens Medical Systems, Inc.
- Intended Use: Mobile x-ray system for use in operating rooms, traumatology, endoscopy, intensive care, pediatrics, ambulatory patient care, and veterinary medicine. It supports various modes like Digital Radiography, Fluoroscopy, Pulsed Fluoroscopy, Cassette Exposures, Digital Subtraction, and Roadmapping for procedures such as bile duct display, intra-medullary nail implant display, low dose fluoroscopy in pediatrics, pain therapy techniques, and catheter/probe positioning.
- Technological Characteristics:
- Isocentric C-arm
- Expanded orbital angle of 190°
- Increased distance between X-ray tube and image intensifier (SID)
- Electromagnetic brakes (instead of manual)
- Concealed, integrated cable routing
- Optimized for use with other medical systems.
To reiterate, the requested information elements related to a study proving acceptance criteria are not present in this 510(k) summary.
§ 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.