(8 days)
DIGITAL RADIOGRAPHY CXDI-40EG is used to directly capture and convert conventional projection X-ray images to digital images. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
The Canon digital radiography CXDI-40EG 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 Canon digital radiography CXDI-40EG is different from CXDI-40G in the following respect:
- The CXDI-40EG itself is a component without a control PC. Using a general . purpose computer with appropriate specifications and the designated system software installed in it, as a control PC, the CXDI-40G achieves performance stated herein (such as image capturing, DICOM transfer and etc.) predicate devices.
The CXDI-40EG can be characterized as almost an equivalent model to the CXDI-40G with a new software version and with a different interface of control PC. The sensor element of the The images taken with the CXDI-40EG has identical characteristics to the CXDI-40G. CXDI-40EG will be equivalent to the CXDI-40G.
This 510(k) summary for the CXDI-40EG device does not contain the detailed information requested regarding acceptance criteria, study performance, sample sizes, ground truth establishment, or expert involvement.
The provided document is a 510(k) summary seeking substantial equivalence to a predicate device (Canon CXDI-40G), primarily focusing on:
- Description of Device: Explaining the CXDI-40EG as a digital radiography system.
- Comparison to Predicate: Stating that the CXDI-40EG is "almost an equivalent model" to the CXDI-40G, with a new software version (V6.3) and a different interface for the control PC. It explicitly states, "The sensor element of the The images taken with the CXDI-40EG has identical characteristics to the CXDI-40G. CXDI-40EG will be equivalent to the CXDI-40G."
- Intended Use: "Digital radiography CXDI-40EG 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."
- Substantial Equivalence Claim: Concluding that based on the information, the CXDI-40EG is substantially equivalent to the predicate device.
Key Missing Information:
- Acceptance Criteria and Reported Device Performance: This document does not specify any quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, image quality metrics) or report the CXDI-40EG's performance against such criteria. The claim is based on equivalence to the predicate device, not on specific performance metrics.
- Study Details (Sample Size, Data Provenance, Ground Truth, Adjudication, MRMC, Standalone): None of this information is present. The submission focuses on the device's technical specifications and how it relates to the predicate, not on a new clinical or technical performance study demonstrating its capabilities.
- Training Set Details: As no new performance study is detailed, there's no mention of a training set, its size, or how its ground truth was established.
Conclusion:
The provided 510(k) summary is a declaration of substantial equivalence based on the technical similarity of the CXDI-40EG to its predicate device, the CXDI-40G. It asserts that the new device's images will be equivalent to the predicate's because the sensor is identical and the software changes are described as minor (GUI and control of the new sensor). This type of submission relies on the predicate device's existing clearance and does not typically include a new, independent performance study with its own acceptance criteria and detailed study methodology as you've requested.
Therefore, I cannot populate the table or answer the specific questions because the foundational information (acceptance criteria, study design, performance results, ground truth methodology, etc.) is not present in the provided text.
§ 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.