(17 days)
DIGITAL RADIOGRAPHY CXDI-50C provides digital Image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
The Canon digital radiography CXI)1-50C is used to directly capture and convert conventional projection X ray images to digital images. A sub-sampled image can be displayed on a preview monitor for viewing. The diagnostic image can be transmitted through a DICOM compatible digital network for printing. The device provides digital image capture for conventional film/screen radiographic examinations.
The provided text is a 510(k) summary for the Canon CXDI-50C digital radiography device. It describes the device, its differences from predicate devices, and the FDA's substantial equivalence determination. However, it does not contain any information regarding specific acceptance criteria, study methodologies, or performance metrics that would directly answer most of the questions posed.
Based on the information provided, here's what can be extracted and what remains unknown:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific reported device performance metrics. It generally states that the CXDI-50C "achieves performance stated herein (such as image capturing, DICOM transfer and etc.)" but does not detail these performance metrics or how they were measured against specific criteria. It only highlights that the CXDI-50C's DQE approximately doubles compared to the CXDI-50G due to the use of CsI. This is a characteristic of the device, not a performance metric against a set of acceptance criteria.
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 present in the provided document.
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 present in the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided 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
This document describes a digital radiography capture device, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable or described here. No such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document describes hardware (a digital radiography imager) and its ability to capture and convert X-ray images. It is not an algorithm evaluated for standalone performance. Therefore, this question is not applicable, and no such study is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present in the provided document.
8. The sample size for the training set
This information is not present in the provided document.
9. How the ground truth for the training set was established
This information is not present in the provided document.
Summary of available relevant information from the text:
- Device: Canon CXDI-50C Digital Radiography Imager
- Purpose: Directly capture and convert conventional projection X-ray images to digital images, replacing film/screen systems in general purpose diagnostic procedures (not mammography).
- Key improvement over predicate (CXDI-50G): Uses CsI (Cesium Iodide) for the fluorescent screen instead of GOS (Gadolinium Oxy-Sulfide). This results in higher X-ray absorption, requiring less X-ray dosage, and the CXDI-50C's DQE (Detective Quantum Efficiency) approximately doubles compared to CXDI-50G.
- Comparison to CXDI-40C: Similar principle, modifications in housing size and shape. The sensor has the same characteristics, but the imaging area changed from 43x43cm to 35x43cm.
- Performance Claim: The device "achieves performance stated herein" for image capturing, DICOM transfer, etc., when used with a general-purpose computer and designated system software. However, specific metrics and acceptance criteria for these performances are not detailed.
§ 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.