(163 days)
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.
§ 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.