(43 days)
The CPIVision Digital Imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications when general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.
The CPIVision Digital Imaging system allows the operator to view and enhance digital fluoroscopic images. High resolution digital spot images may be acquired at single or rapid acquisition rates. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques.
The CPIVision Digital Imaging system enables the operator to hardcopy image with a laser printer or send images over a network. The major system includes: a fluoroscopic CCD camera/lens, monitors, and an image processor.
The CPIVision Digital Imaging system allows the use of digital imaging to be applied to conventional X-ray system used in general fluoroscopy, interventional fluoroscopy, angiography and cardiac imaging areas. The system works by installing a CCD camera/lens on the output port of the image intensifier and digitizing the video output on the image intensifier. The digital image can be displayed on the monitor; it can be stored to the hard drive, or sent to an external device such as a laser imager or Network Storage Provider. The image can also be computer processed, including brightness and contrast, edge enhancement, zoom, and subtraction.
The CPIVision Digital Imaging enables the operator to hardcopy image with a laser printer or send images over a network. The major system components are: a fluoroscopic CCD camera/lens, monitors, and an image processor.
This document describes the CPIVision Digital Imaging System, a digital radiography device. However, this document does not contain explicit acceptance criteria or a study dedicated to proving the device meets specific performance metrics.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (INFIMED INC. ORION FLUOROSCOPIC IMAGING SYSTEM 510(k) – K012490) based on its device description and intended use. This is a common regulatory pathway for medical devices that are similar in technology and purpose to devices already on the market.
Therefore, many of your specific questions cannot be answered from the provided text, as the focus is not on a direct performance study against a predefined set of acceptance criteria.
Here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated. The document implies that the "acceptance criteria" for regulatory approval were met by demonstrating substantial equivalence to the predicate device. This means its performance is considered acceptable if it performs comparably to the predicate for its intended use.
- Reported Device Performance: Not directly reported in quantitative terms. The document describes the system's capabilities (e.g., high resolution, digital videography, image enhancement, rapid acquisition rates, hardcopying, networking) but does not provide specific performance metrics (e.g., spatial resolution in lp/mm, signal-to-noise ratio, frame rates under specific conditions, diagnostic accuracy for particular findings).
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not provided. The document does not describe a performance study with a test set of images or patient data. The basis for comparison is the functional and intended use equivalence to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable / Not provided. No specific test set or ground truth establishment process is described.
4. Adjudication Method for the Test Set:
- Not applicable / Not provided. No test set or adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document does not describe an MRMC study. It focuses on the device's capabilities and its equivalence to an existing device, not on comparing human reader performance with and without the device.
6. Standalone Performance Study:
- No. The document does not describe a standalone (algorithm-only) performance study. The system described is hardware and software designed to process and display fluoroscopic images for human interpretation, not an AI algorithm making diagnoses independently.
7. Type of Ground Truth Used:
- Not applicable / Not provided. No specific ground truth is referenced as no performance study is described. The "ground truth" for regulatory approval in this context is that the device functions as intended and is as safe and effective as the predicate device.
8. Sample Size for the Training Set:
- Not applicable / Not provided. The CPIVision Digital Imaging system as described is not an AI/ML algorithm that requires a "training set" in the conventional sense. It's a digital imaging system replacing analog film techniques.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable / Not provided. As it's not an AI/ML algorithm requiring a training set, this question is not relevant to the provided text.
Summary based on the provided text:
The CPIVision Digital Imaging system sought 510(k) clearance by demonstrating substantial equivalence to the INFIMED INC. ORION FLUOROSCOPIC IMAGING SYSTEM (K012490). The acceptance criteria were implicitly met by showing the new device shares the same intended use and fundamentally similar technological characteristics to the predicate, ensuring it is as safe and effective. No specific performance study with a defined test set, ground truth, or statistical analysis against pre-specified acceptance metrics is described in this document.
§ 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.