(27 days)
The DIGITAL RADIOGRAPHY CXDI-710C Wireless and CXDI-810C Wireless provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
The two models of detectors included in this submission are solid state x-ray imagers. Model CXDI-710C Wireless has an approximate imaging area of 35.0 x 42.6 cm, while model CXDI-810C Wireless has an approximate imaging area of 35.0 x 27.4 cm. For both models, the detector intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-detectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values and the images will be displayed on monitors. The digital value can be communicated to the operator console via wiring connection or wireless. For the proposed models, temporary image storage is now possible and the detector weight has been reduced from that of the predicates. The proposed models have increased protection against ingress, continue to include the Non-Generator Connection Mode (detection of x-ray irradiation without direct electrical connection to the x-ray generator) and are compatible with the Scatter Correction feature.
This document is a 510(k) summary for the Canon Digital Radiography CXDI-710C Wireless and CXDI-810C Wireless devices. It describes their equivalence to predicate devices rather than proving a new or unique performance based on specific clinical acceptance criteria in the way a novel AI algorithm might. Therefore, the information typically found for AI/ML device approval concerning acceptance criteria, ground truth establishment, and clinical study details (like MRMC studies) is not present.
However, based on the provided text, we can infer some aspects and extract relevant information about the non-clinical testing performed to demonstrate substantial equivalence.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) for a digital radiography detector aiming for substantial equivalence to a predicate device, the "acceptance criteria" are primarily related to meeting performance specifications comparable to the predicate and complying with relevant standards, rather than clinical efficacy metrics for a new diagnostic claim.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate | "The proposed devices are functionally identical to the predicate devices." (Page 4) "The evaluations of the CXDI-710C / 810C Wireless compared to the CXDI-701C / 801C Wireless, show the CXDI-710C / 810C Wireless to be equivalent to the CXDI-701C / 801C Wireless." (Page 5) "Canon, Inc. – Medical Equipment Group considers the DIGITAL RADIOGRAPHY CXDI-710C Wireless and DIGITAL RADIOGRAPHY CXDI-810C Wireless devices to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use." (Page 5) |
| Safety and Effectiveness Demonstration | "Tests were performed on the models which demonstrated that the device is safe and effective..." (Page 5) "...raises no new questions regarding either safety or effectiveness when compared to the predicate device(s)." (Page 5) |
| Image Quality (Implied comparability to predicate) | "non-clinical image comparisons involving flat panel display images taken with the new device and the predicate device(s)." (Page 5) |
| Compliance with FDA Guidance for Software in Medical Devices | "Documentation was provided demonstrating compliance... to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices for a moderate LOC, including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards." (Page 5) |
| Compliance with FDA Guidance for Solid State X-ray Devices | "Documentation was provided demonstrating that the CXDI-710C / 810C Wireless complies with the FDA requirements stated in Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices." (Page 5) |
| Compliance with Radiographic Equipment Standards | "Testing confirmed that the CXDI-710C Wireless and CXDI-810C Wireless complies with the U.S. Performance Standard for radiographic equipment and with relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing, specifically IEC standards 60601-1, 60601-1-6, and 60601-2-54." (Page 5) |
| Physical Characteristics (Comparable or Improved) | Weight: New: 710C: 2.3 kg, 810C: 1.8 kg vs. Predicate: 701C: 3.3 kg, 801C: 2.3 kg (Improved/Reduced Weight) (Page 4) External Dimensions, Scintillator, Pixel Pitch, Pixels, Spatial Resolution: (Functionally Equivalent/The Same) (Page 4) |
2. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: The document does not specify a "test set" in terms of patient images for clinical evaluation in the way an AI algorithm study would. The testing appears to be primarily non-clinical, involving functional specifications, image comparisons (presumably phantom or test patterns given the context of a DR detector), and compliance testing. No specific number of images or cases for clinical validation is mentioned.
- Data Provenance: Not applicable as no specific clinical patient data set or clinical study is described. The tests are non-clinical (e.g., "non-clinical image comparisons," "verification/validation testing to internal functional specifications").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this is a 510(k) for a digital radiography panel showing substantial equivalence to a predicate, and not a novel diagnostic AI algorithm, there is no mention of human expert readers establishing ground truth on a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set with human readers requiring adjudication 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 MRMC study was done. This 510(k) is for a digital X-ray detector, not an AI-assisted diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is a standalone imaging device (digital radiography detector). Its performance is evaluated intrinsically through physical and image quality metrics and comparison to a predicate, not as an algorithm performing a diagnostic task. The "Standalone function" mentioned under "Control SW" and "Device FW" (Page 4) refers to the detector's ability to save captured images internally without immediate connection to an external device, which is a technical feature, not a diagnostic performance claim.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of diagnostic ground truth from patient data. The "ground truth" for this device's evaluation is primarily its adherence to engineering specifications, image quality standards (e.g., MTF), and compliance with regulatory standards, as demonstrated through non-clinical testing. Comparison is made against a predicate device.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML algorithm that requires a training set or ground truth establishment for training.
§ 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.