(141 days)
The CPI RAD VISION is a full featured Radiographic Flat Panel Digital Imaging System for X-ray Generator and Acquisition of digital radiography. The CPI RAD VISION is configurable to any high resolution (3K x 3K) Solid State X-Ray Imager (SSXI) presently in the market. It is intended to replace conventional film screen systems.
The CPI RAD VISION allows a qualified operator to perform digital radiographic examinations of various anatomic regions on both adult and pediatric patients. Anatomic regions of interest for diagnostic radiographic exposure include: skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle and extremities.
The CPI RAD VISION enables a qualified operator to acquire, process, and display images with for the benefit of obtaining an optimal diagnostic product. The CPI RAD VISION system enables the qualified operator to store, hardcopy images with a laser printer or send images over a network. This device is not intended for mammographic, fluoroscopic and or angiographic applications. The CPI RAD VISION will not include the X-Ray system itself.
The CPI RAD VISION is a component of a complete radiographic x-ray system. The CPI RAD VISION provides a single user interface for control of the x-ray generator and all digital imaging functions required by a radiographic acquisition modality (acquisition, processing, storage, display, and distribution of images).
The CPI RAD VISION consists of Flat Panel Detector, ISO-BOX (Medical Grade Isolation Transformer), LCD Monitor, and a workstation (computer) with x-ray generator interface, image receptor interface, and network port for communications with supported DICOM devices.
This document is a 510(k) summary for the CPI RAD VISION, a digital radiography system. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria based on performance metrics. Therefore, many of the requested details about a study and acceptance criteria are not present in the provided text.
Based on the provided text, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria. The "Conclusion drawn from comparison" section merely states that the CPI RAD VISION can be considered substantially equivalent to the CMT MEDICAL TECHNOLOGIES LTD. SMART RAD. There are no performance metrics or acceptance criteria reported.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. As explained above, the document does not detail a study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
There is no indication that an MRMC comparative effectiveness study was done. The device is described as a "Digital Radiography" system, primarily involving image acquisition, processing, storage, and display, and not an AI-assisted diagnostic tool that would typically involve human reader improvement metrics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device is an imaging system, not an algorithm being tested in isolation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided.
8. The sample size for the training set
This information is not provided.
9. How the ground truth for the training set was established
This information is not provided.
Summary of available information:
The document serves as a 510(k) premarket notification for the CPI RAD VISION, a digital radiography system. Its primary purpose is to establish substantial equivalence to a
predicate device (CMT MEDICAL TECHNOLOGIES LTD. SMART RAD 510(k) - K003438) based on its intended use and technological characteristics. The document does not contain specific acceptance criteria, detailed study designs, performance metrics, or information regarding ground truth establishment or expert involvement, as it is structured to fulfill the requirements of a 510(k) submission for substantial equivalence rather than a detailed clinical performance study.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.