(20 days)
Sedecal Digital Radiographic Upgrade Model SDRU-T is intended for digital image capture use in general radiographic examinations, wherever conventional screenfilm systems may be used, excluding fluoroscopy, angiography and mammography. The kit allows imaging of the skull, chest, shoulders, spine. abdomen, pelvis. and extremities.
This Digital Radiographic Upgrade is intended for those radiographic examination rooms where the X-rav image receptors used are Cassette with Film or CR. This upgrade allows to acquire digital medical diagnostic X-ray images and transfer the images to hardcopy, softcopy, and archive devices on the same network. Some functions allowed with the Digital Radiography Operator Console (DROC) software: Add new patients to the system, enter information about the patient and physician that will be associated with the digital radiographic images. Edit existing patient information. Emergency registration and edit Emergency settings. Pick from a selection of procedures, which defines the series of images to be taken. Adjust technique settings before capturing the X-ray image. Preview the image, accept or reject the image entering comments or rejection reasons to the image. Accepted images will be sent to the selected output destinations. Save an incomplete procedure, for which the rest of the exposures will be made at a later time. Close a procedure when all images have been captured. Review History images. resend and reprint images. Re-exam a completed patient. Protect patient records from being deleted by the system. Delete an examined Study with all images being captured. Edit user accounts. Check statistical information. Image QC. Image stitching.
Here's an analysis of the provided text regarding the Sedecal Digital Radiographic Upgrade (SDRU-T) and its acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety | Electrical Safety (IEC 60601-1) | Device passed testing. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Device passed testing. | |
| Effectiveness/Performance | Software Validation | Device passed testing. |
| Diagnostic Image Quality (General Radiography) | Images were acquired, evaluated, and found to be of good diagnostic quality. | |
| Substantial Equivalence | Same technological characteristics (design, material, chemical composition, energy source) as predicate devices. | Stated to have the same technological characteristics, specifications are identical. |
| Safe, effective, and performs as well as or better than legally marketed devices. | Concluded to be safe and effective, performing as well as predicate devices. | |
| Materials and construction methods nearly identical to predicate. | Stated to be nearly identical. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the "test images" acquired. It only states that "Test images were acquired and evaluated."
- Data Provenance: The document does not explicitly state the country of origin of the data. It also does not specify if the images were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number of experts, their qualifications, or how they established ground truth for the test images. It only mentions that images were "evaluated."
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The submission focuses on demonstrating substantial equivalence to predicate devices rather than directly comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a form of standalone performance evaluation was conducted. The device (specifically the digital panel component) performance was evaluated based on "Test images... acquired and evaluated based on the FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices." The images "were evaluated and found to be of good diagnostic quality." This implies an evaluation of the device's output quality without direct human-in-the-loop intervention for the evaluation phase of those test images. However, the overall device is an "upgrade" that works with a human operator.
7. Type of Ground Truth Used
The type of ground truth used was primarily expert evaluation of "diagnostic quality." It is not stated to be pathology, outcomes data, or a formal expert consensus process as typically understood for algorithm validation. It appears to be an assessment of the visual quality and interpretability of the generated images by qualified individuals, likely radiologists or imaging specialists, who implicitly form a consensus on "good diagnostic quality."
8. Sample Size for the Training Set
The document does not mention or provide any information regarding a training set sample size. This is likely because the device is an "upgrade kit" combining well-established components (digital X-ray panels and imaging software) that would have been trained/validated independently by their respective manufacturers, or are based on traditional signal processing rather than deep learning models requiring a specific training set. The submission focuses on the integration and functionality of these already cleared components.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned for this specific device in the context of this 510(k) submission, there is no information on how its ground truth would have been established.
§ 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.