(42 days)
Intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well of capabilities and function of the device provides radiographic, multiradiographic and fluoroscopic imaging and is used for guidance and visualization during diagnostic radiographic, surgery, and interventional procedures. The device is to be used in healthcare facilities both inside of hospital, in a variety of procedures of the skull, spinal column, extremities, and at the discretion of the medical professional the device may be used for other imaging applications on all pediatric patients (birth to 21 years) within the limits of the device. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications
The Virtual C DRF-NEO system is a mobile imaging system that acquire, process and display both static radiographic images and dynamic radiographic images such as photo-spot and fluoroscopy. Dynamic image acquisition is performed without the limitation of a mechanical linkage between the x-ray source and the x-ray detector. The mechanical linkage typical in existing dynamic imaging systems is either a c-arm or u-arm that ensures the alignment of the imaging components during image acquisition. The Virtual C DRF-NEO System features a novel collimator with built-in x-ray source to detector alignment software (Machine-Vision Collimator (MVC), combine they provide the technology for a "virtual c-arm" system. The novel MVC utilized four independent shutter to automatically position the radiation beam, so the area of exposure always remains within the confines of the active area of the detector. In addition, the angle and inclination of x-ray source is displayed to the operator. A visual display provides real time video images of the patient and a shaded area within the video images represent the location and size of the radiation beam with respect to the patient.
The provided text describes a 510(k) premarket notification for the "Virtual C DRF-NEO Digital Imaging System." This document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technical specifications and summaries of non-clinical testing. It explicitly states that "No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification."
Therefore, based on the provided text, there is no study that proves the device meets specific acceptance criteria related to its performance in a clinical or standalone setting. The submission relies on establishing substantial equivalence to a predicate device, and thus, does not include information on acceptance criteria based on clinical performance metrics or studies involving human readers or ground truth.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document does not define specific clinical acceptance criteria for the "Virtual C DRF-NEO Digital Imaging System" or present a study comparing its performance against such criteria. The submission focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not defined in the document for clinical or standalone performance. | Not applicable as no such study was presented. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No clinical test set was used, as "No clinical data is necessary to evaluate safety or effectiveness." The assessment was based on non-clinical bench testing and comparison to technical specifications of a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No clinical test set was used, and therefore, no experts were involved in establishing ground truth for clinical performance.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance
Not applicable. No MRMC comparative effectiveness study was conducted. The device is a digital imaging system, not an AI-assisted diagnostic tool that would typically involve a multi-reader study to evaluate improvement with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. No standalone performance study was conducted. The assessment was based on demonstrating substantial equivalence to a predicate device.
7. The Type of Ground Truth Used
Not applicable. For the purpose of this 510(k) submission, the ground truth was effectively the technical specifications and validated performance of the predicate device and the digital panel component (DRTECH EVS 2430W with K171137 clearance), against which the proposed device's characteristics were compared for substantial equivalence. No clinical ground truth (e.g., pathology, outcomes data) was used for evaluating the new device's performance in a clinical context.
8. The Sample Size for the Training Set
Not applicable. No training set was involved, as this submission is not for an AI/ML algorithm requiring a training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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.