(38 days)
The RadPro ION Mobile Fluoroscopy Systems are designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, critical care and emergency room procedures The system may be used for other imaging applications at the physician's discretion
The RadPro ION Mobile Fluoroscopy Systems (Multiple Models) are mobile x-ray units which employ unage intensifier units and have various options for image display and storage The units are used to equip a radiological room of general surgery, orthopedic, traumatology and cardiology The CCD camera is characterized by high contrast and sensitivity and no persistence of image The camera head include a mage rotation and image reversal system The automatic dose control, which acts either on KV and mA values, allows the user to reduce step by step the x-ray radiation to the minimum value, in accordance with the thickness and the density of the screened part All the configurations can accept connection to a digital memory, which allows to store and display in real time the ımage on the monitor only with a very little x-ray dose The new control panel with an alphanumerical display permits a fast and easy use by a rational and simple symbology, this console by an extension cable, could be located on the patient support to enable the c-arm control by the operator itself The system employs a Dose Area Product (DAP) meter for compliance with the US performance standard requirements
The provided text is a 510(k) summary for the RadPro ION Mobile Fluoroscopy Systems. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving performance against specific acceptance criteria.
The acceptance criteria discussed are primarily related to general device characteristics and compliance with regulatory standards, which are met by comparing the new device to a legally marketed predicate device.
Here's an analysis of the provided information in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" in this document is effectively the characteristics of the predicate device, which the new device aims to match or demonstrate equivalence to. "Reported device performance" refers to how the RadPro ION Mobile Fluoroscopy Systems compare to these characteristics.
| Acceptance Criteria (Predicate Device K073543 OEC 9900 Elite) | Reported Device Performance (RadPro ION Mobile Fluoroscopy Systems) |
|---|---|
| Intended Use: Designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures (e.g., cholangiography, endoscopy, urologic, orthopedic, neurologic, critical care, emergency room procedures). System may be used for other imaging applications at the physician's discretion. | SAME |
| Configuration: Mobile C-Arm | SAME |
| Performance Standard: 21 CFR 1020.30 | SAME |
| Generator: 15 kW | 18 kW (Higher, but acceptable in the context of substantial equivalence) |
| Power Source: 120 VAC 1 phase 20 amp | SAME |
| Image Intensifiers: 9" or 12" | 9" or 13" (Slight difference in maximum size, deemed acceptable) |
| Electrical safety: Electrical Safety per IEC-60601 UL listed | SAME |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a specific "test set" in the way one would for an AI algorithm or a clinical trial with patient data. The evaluation is based on "bench and test laboratory testing" and "clinical images."
- Sample Size: Not specified for "clinical images." No specific number of cases or patients is mentioned.
- Data Provenance: Not specified. It's unclear if "clinical images" refer to retrospective data, prospective data, or from which country they originated.
- Retrospective/Prospective: Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The document states "clinical images" were analyzed but does not specify how "ground truth" was established for these images or if experts were involved in establishing it for the context of this 510(k). The evaluation leans heavily on engineering and regulatory compliance rather than expert image interpretation in a comparative setting.
4. Adjudication Method for the Test Set
Not applicable/Not specified. There is no mention of an adjudication process for clinical images or expert consensus within this 510(k) summary. The "Conclusion" indicates that Virtual Imaging, Inc. concluded the device's safety and effectiveness.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. The document describes a comparison to a predicate device for substantial equivalence, focusing on technical characteristics and intended use, not on the improvement of human readers with or without AI assistance.
- Effect size: Not applicable, as no such study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device is a mobile fluoroscopy system, which is a hardware device that produces images, not an AI algorithm that operates standalone or assists in image interpretation without human intervention. Its performance is inherent in the image quality and system functionality for human use.
7. Type of Ground Truth Used
The concept of "ground truth" for image interpretation, as would be used for evaluating diagnostic accuracy, is not explicitly defined or used in this 510(k) summary. The evaluation relies on:
- Comparison of technical specifications (e.g., generator power, image intensifier size).
- Compliance with performance standards (21 CFR 1020.30).
- Results from "bench and test laboratory testing."
- Review of "clinical images" to support safety and effectiveness, likely focusing on image quality and proper function, but without defining a specific "ground truth" against which diagnostic accuracy was measured.
8. Sample Size for the Training Set
Not applicable. This device is a hardware system, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a hardware fluoroscopy system.
§ 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.