(22 days)
DIGITAL RADIOGRAPHY CXDI-80C Wireless and CXDI-80G Wireless provide digital image capture for conventional film/screen radiographic examinations. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. These devices are not intended for mammography applications.
The DIGITAL RADIOGRAPHY CXDI-80C Wireless and CXD1-80G Wireless are solid state x-ray imagers which have 27x35cm imaging area. The DIGITAL RADIOGRAPHY CXDI-80C/80G Wireless intercept x-ray photons and the scintillator of the CXDI-80C/80G Wireless emit visible spectrum phonomy photons and the array of photo-detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors. The digital value can be communicated to the operator conselver wia wiring connection or wireless.
The provided FDA 510(k) summary for the Canon DIGITAL RADIOGRAPHY CXDI-80C Wireless and CXDI-80G Wireless devices does not include specific acceptance criteria or a detailed study proving the device meets said criteria in the way typically expected for AI/CADe devices.
Instead, this submission focuses on demonstrating substantial equivalence to predicate devices (Canon DIGITAL RADIOGRAPHY CXDI-70C Wireless and CXDI-401G) based on established performance parameters for X-ray imagers and established safety and effectiveness.
Here's an analysis based on the provided text, addressing the points you requested, with the caveat that many aspects relevant to AI/CADe performance studies are not applicable to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety & Effectiveness | Device is safe and effective as a digital radiography imager. | Performance testing for Electrical safety, Electromagnetic compatibility, and other performance tests demonstrated the devices are safe and effective. |
| Equivalence to Predicate | Devices are substantially equivalent to predicate devices (CXDI-70C Wireless and CXDI-401G). This implies equivalent imaging principle, intended use, and amorphous silicon array specifications. | The amorphous silicon array specifications, imaging principle, and intended use are stated to be the same as the predicate devices. Performance data is stated to demonstrate equivalence. |
| Intended Use | Digital image capture for conventional film/screen radiographic examinations; replace film/screen systems in all general purpose diagnostic procedures; not for mammography. | The device's intended use is precisely stated as these criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable / Not specified. The submission refers to "performance testing" generally. This is not a clinical study involving a "test set" of patient data in the context of diagnostic accuracy for AI/CADe. It's focused on engineering performance, safety, and regulatory compliance of an imaging hardware device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No expert ground truth establishment for a diagnostic test set is described.
4. Adjudication Method for the Test Set
- Not applicable. No diagnostic test set or adjudication method 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. This is a submission for an X-ray imager (hardware device), not an AI/CADe software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is hardware; there is no standalone algorithm being evaluated.
7. The Type of Ground Truth Used
- Not applicable. For this hardware device, "ground truth" would refer to engineering specifications and measurements (e.g., image quality metrics, electrical safety standards) rather than clinical diagnostic ground truth like pathology or expert consensus. The document states "performance testing" was done, implying these types of engineering and regulatory tests.
8. The Sample Size for the Training Set
- Not applicable. This device is hardware; there is no training set mentioned or implied.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an algorithm, there is no ground truth establishment for it.
Summary of the Study (as described in this document):
The "study" presented here is a pre-market notification (510(k)) for substantial equivalence of a new digital radiography imager (CXDI-80C Wireless and CXDI-80G Wireless) to existing legally marketed predicate devices (CXDI-70C Wireless and CXDI-401G).
The "proof" that the device meets "acceptance criteria" (which are fundamentally regulatory requirements for safety, effectiveness, and equivalence) is based on:
- Performance testing: This broadly covers "Electrical safety, Electromagnetic compatibility and other performance testings." The document states these tests demonstrated the devices are "safe and effective."
- Comparison to predicate devices: The submission explicitly states that the amorphous silicon array specifications, imaging principle, and intended use of the new devices are "the same as those of the predicate devices."
- Design Control activities and non-clinical testing: These are general regulatory requirements for medical device development, and the conclusion mentions that the results of these activities support the substantial equivalence.
In essence, the "study" for this type of hardware device demonstrates that it functions as intended, meets safety standards, and is fundamentally similar in design and performance to devices already cleared by the FDA, rather than conducting a clinical trial with patient data or comparing diagnostic accuracy as would be done for an AI/CADe medical device.
§ 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.