Search Results

CPI RAD VISION is a digital imaging system intended for the capture and display of radiographic images of human anatomy, as part of a diagnostic x-ray system. It is intended for use in general radiographic examinations and applications. The device is not intended for mammographic, fluoroscopic or angiographic applications.

The CPI RAD VISION product will provide a user interface to control the digital imaging functions of a radiographic acquisition modality (acquisition, processing, storage, display, and distribution of images from a Solid State X-ray Imager (SSXI)).

The CPI RAD VISION product will also provide either an option on the user interface to control the x-ray generator functions required by a radiographic acquisition modality or an optional hardware interface to allow the x-ray generator functions to be controlled by an independent third-party operator console while maintaining synchronization with the digital imaging functions of the product.

CPI RAD VISION is a component of a complete radiographic x-ray system.

The provided text is a 510(k) summary for the CPI RAD VISION device, a digital imaging system for radiography. The text states that the device's performance testing demonstrated its safety and effectiveness, and its equivalence to predicate devices, through "Electrical safety (IEC60601-1:2005) and Electromagnetic compatibility (IEC60601-1-2, Edition 3:2007-03), Software verification (IEC60601-1-4:2000), other performance testing and the acquisition of sample clinical images." However, the document does not include specific acceptance criteria, detailed device performance metrics, or the study specifics (like sample size, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone studies, or details on ground truth for training/test sets) requested in the prompt.

Therefore, most of the requested information cannot be extracted from this document.

1. A table of acceptance criteria and the reported device performance
The document does not specify acceptance criteria or quantitative device performance metrics. It generally states that the device "demonstrated that CPI RAD VISION is safe and effective, and is equivalent to the aforementioned predicates devices" based on compliance with electrical safety, EMC, and software verification standards, and the acquisition of "sample clinical images."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document. The document only mentions "acquisition of sample clinical images" without any details on sample size or data provenance.

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)
Not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided in the document.

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
Not provided in the document. The device is described as a "digital imaging system," not explicitly an AI-assisted device for human reader improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not explicitly stated or detailed in the document. The device is a system for image capture and display, implying human interaction for diagnosis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not provided in the document. The document mentions "acquisition of sample clinical images" but does not detail how ground truth was established for these images for evaluation purposes.

8. The sample size for the training set
Not provided in the document.

9. How the ground truth for the training set was established
Not provided in the document.

Ask a specific question about this device

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.

Ask a specific question about this device