(26 days)
As a part of the CXDI series radiography system, the CXDI Control Software when used with a compatible CXDI detector is intended to provide digital image capture, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications.
The subject of this Special 510(k) submission is a change to the CXDI Control Software to incorporate the ability to capture an automatically stitched long length image in a single exposure. The addition of the One Shot Long Length to the cleared Scatter Correction of CXDI Series is the subject of this Special 510(k) Submission. The One Shot Long Length stitches long length images into a single image which is accomplished by using multiple detectors, a single exposure, and the automatic stitching software. The One Shot Long Length software feature along with the Scatter Correction cleared under K153312 make up the Enhanced Feature Software Pack for CXDI Series. The Scatter Correction clearance and compatible detectors are not impacted by this submission. This submission adds the One Shot Long Length feature to limited compatible FPDs. The One Shot Long Length feature included in the Enhanced Feature Software Pack for CXDI Series also includes features for manual stitching to allow for users to manually adjust and fine-tune the stitch positions after the automatic stitch operation. By incorporating the One Shot Long Length imaging into the CXDI Control Software, images up to 120cm in length can be acquired in one exposure. The firmware within the flat panel detectors did not require updating. The flat panel detectors that have been previously cleared by FDA and are compatible with the Enhanced Feature Software Pack for CXDI Series have not been physically modified and performance have not changed.
Here's a summary of the acceptance criteria and study information for the Enhanced Feature Software Pack for CXDI Series, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria and device performance metrics. However, the core change in the proposed device is the "One Shot Long Length Imaging" feature, which involves automatic stitching of images from multiple detectors with manual adjustment capabilities. The performance is largely implied by the claim of substantial equivalence and successful mitigation of risks.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Image Quality / Stitching Accuracy for One Shot Long Length | The "One Shot Long Length" feature allows obtaining images across multiple detectors, automatically stitched together, with the ability to make manual adjustments after the automatic stitching. It enables capturing images up to 120cm in length in one exposure. The text implies that the performance for this feature is adequate, and substantially equivalent to the predicate device for its intended use, as no specific performance deficiencies are noted. The study would have demonstrated that the automatically stitched images are clinically acceptable and that the manual adjustment feature provides sufficient control for fine-tuning. |
| Safety and Effectiveness | The hardware within the Canon Digital Radiography CXDI Series Detectors has not been modified, and the detectors retain the same performance, biocompatibility, effectiveness, and safety as the predicate device. A FMEA methodology was used to analyze risks and hazardous impacts of the device modification, and risk control and protective measures were reviewed and implemented. "The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted." The device complies with U.S. Performance Standard for radiographic equipment and relevant voluntary safety standards (IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-32), and FCC and ICES standards for wireless detectors. This indicates that the device's performance, post-modification, continues to meet established safety and effectiveness standards, especially given that the core imaging hardware remains unchanged. |
| Maintenance of Indication for Use | The intended use of the modified device, as described in the labeling, has not changed as a result of the modification(s). This is explicitly stated, suggesting the new feature does not alter the fundamental clinical applications for which the device is intended. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission refers to a "Special 510(k) Submission" for a software change, and typically such submissions might rely on internal validation and verification testing demonstrating that the new feature does not adversely affect the already cleared device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The submission focuses on the technical aspects of the software modification and its substantial equivalence. Clinical studies with expert-adjudicated ground truth are not explicitly mentioned in this summary.
4. Adjudication Method for the Test Set
This information is not provided in the 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
There is no mention of an MRMC comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The "Enhanced Feature Software Pack" introduces an "One Shot Long Length Imaging" feature that automatically stitches images, but it's not described as an AI-driven diagnostic aid that would typically involve an MRMC study for assessing reader performance. It's more of an image acquisition and processing enhancement.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The document does not explicitly state that a standalone performance study was done for the "One Shot Long Length Imaging" algorithm. However, given that it's an automated stitching process, internal verification and validation testing would have been conducted to ensure the accuracy and quality of the stitched images generated by the algorithm. This would be a form of standalone testing, but specific metrics and methodology are not detailed here.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used for any testing. For an image stitching feature, ground truth would likely involve measurements of anatomical alignment and continuity as determined by expert review or comparison to reference images, but this is not explicitly stated.
8. The Sample Size for the Training Set
This information is not provided in the document. The device primarily involves an automated image stitching algorithm, rather than a machine learning model that typically requires a large training set in the conventional sense.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the document. As mentioned above, it's unclear if a traditional "training set" with ground truth, as used for machine learning, was employed in the development of this image stitching feature.
§ 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.