(14 days)
CANON DIGITAL RADIOGRAPHY CXDI-50G 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.
The Canon digital radiography CXDI-50G 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.
Here's an analysis of the provided text regarding the Canon CXDI-50G device, focusing on acceptance criteria and study details.
Based on the provided text, the Canon CXDI-50G is a digital radiography device intended to replace conventional film/screen radiographic systems. The submission is a 510(k) premarket notification to establish substantial equivalence to predicate devices (Canon CXDI-31 and CXDI-40G).
Critically, the provided document DOES NOT contain a study with specific acceptance criteria and performance metrics for the CXDI-50G itself, nor does it detail a standalone clinical performance study or a multi-reader multi-case (MRMC) comparative effectiveness study.
The submission primarily focuses on demonstrating substantial equivalence based on:
- Technical Specifications: Stating that the technical specifications, imaging principle, physical characteristics, and intended use are "the same as those of the CXDI-40G including pixel pitch," with modifications primarily in physical appearance, mechanical structure, and sensor size (from 43x43cm to 35x43cm).
- Software Changes: Highlighting that the control software V6.0 for CXDI-50G includes changes from V5.0 (used in CXDI-40G) to add control for the CXDI-50G sensor and some GUI changes.
- Design Control Activities: General reference to "results of our design control activities" to support equivalence.
Since there is no explicit performance study detailed for the CXDI-50G against defined acceptance criteria, I cannot fill in most of the requested information. However, I can infer what the "acceptance criteria" and "reported device performance" are being judged against: substantial equivalence to the predicate devices.
Summary of Information from the Provided Text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Technical Equivalence: | "The CXDI-50G's technical specifications, imaging principle, physical characteristics and intended use are the same as those of the CXDI-40G including pixel pitch." |
| - Imaging Principle | Same as CXDI-40G |
| - Pixel Pitch | Same as CXDI-40G |
| - Intended Use | "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." (Same as predicate) |
| Mechanical/Physical Equivalence: | Difference noted in mechanical structure, physical appearance, and imaging area (35x43cm vs 43x43cm for CXDI-40G). However, deemed not to affect substantial equivalence. |
| Software Equivalence: | V6.0 software introduced for CXDI-50G, building upon V5.0 (used in CXDI-40G), with main changes for CXDI-50G sensor control and GUI. Deemed not to affect substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not explicitly stated in the provided text. The document relies on similarity to predicate devices rather than a new standalone 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)
- Not applicable. No specific independent expert review for a test set is described. The assessment is based on the manufacturer's technical comparison to predicate devices, reviewed by the FDA.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No specific adjudication method for a test set is described.
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
- No, an MRMC comparative effectiveness study was not done or reported. This device primarily focuses on converting conventional X-ray images to digital, not on AI-assisted interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone performance study against specific clinical criteria was not explicitly detailed or reported in this document. The submission is for substantial equivalence to existing devices that are already cleared for standalone use in digital radiography.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated. The "ground truth" for the substantial equivalence claim is essentially the established performance and safety of the predicate devices (CXDI-31 and CXDI-40G).
8. The sample size for the training set
- Not applicable/Not stated. This document describes a hardware device (digital X-ray imager) and its controlling software, not a machine learning algorithm that would require a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable/Not stated. See point 8.
In conclusion: The provided 510(k) submission for the Canon CXDI-50G is a declaration of substantial equivalence to previously cleared predicate devices (CXDI-31 and CXDI-40G). It does not present a de novo clinical study with specific acceptance criteria, a test set, expert review, or detailed performance metrics for the CXDI-50G as a new device. The "acceptance criteria" are implicitly met by demonstrating that the device is technically and functionally equivalent to already cleared devices, suggesting that its performance would be similar and thus acceptable.
§ 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.