(12 days)
Uses for SuniRay in the dental industry are as follows:
- Organize and archive radiographs and patient related files
- Facilitate sharing and transmission of information between doctors, other applications and other computers
- Place markers and annotations on radiographs for diagnostic purposes
- Allows users to dimension radiographs based on dimensions of X-ray sensors or reference objects.
- Provides image-processing tools such as sharpening, colorizing, resizing, etc. (none of which physically alter images).
- Permits sending of data by email.
The target group for using SuniRay for diagnostic purposes will be the doctor/dentist population. This software is primarily used to store a patient's imaging data (i.e. radiographs) in a form compatible with today's networked online medical practice management software may also be used to transmit radiographs to specialists who will be treating the patient or the insurance company for approval of procedure and etc.
SuniRay is a software package designed to work with Standard PC compatible computers capable of running a Microsoft Windows operating system. The software is designed to be a fully functional digital radiograph scanning, archiving, electronic transmission and diagnostic review system. SuniRay permits the acquisition of images directly from commercially available scanners, digital cameras, intra-oral X-ray sensors, panoramic X-ray machines, etc.
Once an image has been converted into digital format, SuniRay permits the user to easily organize and archive digital radiographs, images, and other patient related files.
SuniRay provides tools that permit the user to enhance images and place markers as well as annotations on radiographs to aid in the diagnostic process. The image enhancements provided by this software package utilize industry standard algorithms that do not result in the alteration of an image's or a radiograph's content. Once imported into SuniRay, the original image content is never chancements are stored separately from the original image.
Unlike a direct digital system, SuniRay does not control the X-ray taking system and does not generate radiographs directly from the physical world (SuniRay processes images and radiographs produced from other devices and physical media). Sun!Ray only permits enhancing radiographs for diagnostic purposes and does not allow the introduction of false data or the modification of the original images and radiographs in any way.
To facilitate enhanced correlation of information with images, SuniRay permits direct association of customized information with an image. Using those associations the user is able to relate doctor information, patient's information, applied procedures, etc. with an image.
The provided 510(k) summary for the SuniRay device does not contain specific acceptance criteria or a dedicated study section demonstrating the device meets such criteria.
Instead of explicit acceptance criteria and performance data, the submission focuses on establishing substantial equivalence to a predicate device (XRAY VISION) by comparing technological characteristics and intended use. The core argument is that SuniRay's functionalities are similar or marginally different (with justifications for those differences) to the predicate, and that these differences do not raise new safety or effectiveness concerns.
Therefore, I cannot populate the requested table or answer most of the questions directly. However, I can infer the general "acceptance criteria" through the comparison to the predicate, and I can address what information is missing from the submission.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The submission lacks a table outlining specific performance metrics (e.g., accuracy, precision, speed for image processing, transmission success rates, etc.) and their target values, along with the results from a study demonstrating the device meets these targets.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided. There is no mention of a dedicated test set of images or patient data used for performance evaluation.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
This information is not provided. Since no specific performance study is detailed, there's no mention of experts establishing ground truth for a test set.
4. Adjudication Method:
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not provided. There is no mention of a study involving human readers with and without AI assistance to assess improved effectiveness. SuniRay is a software package with image processing and archiving tools, not an AI diagnostic tool in the sense of directly assisting human interpretation with AI-generated findings.
6. Standalone Performance Study:
This information is not provided. There is no section detailing a standalone performance study of the algorithm's capabilities. The document describes the features of the software (e.g., image processing algorithms, transmission capabilities) but not how their performance was quantitatively measured against predefined criteria.
7. Type of Ground Truth Used:
This information is not provided.
8. Sample Size for the Training Set:
This information is not provided. As SuniRay is described as utilizing "industry standard algorithms" for image enhancements and "standard image file formats," it is likely that these are well-established, pre-existing algorithms that do not require proprietary training data in the context of this submission. The software itself is not an AI algorithm that learns from a training set in the typical machine learning sense described in the prompt.
9. How the Ground Truth for the Training Set was Established:
This information is not provided. (See point 8).
Summary of the Study (as described in the 510(k) submission):
The "study" presented in this 510(k) is a substantial equivalence comparison to a legally marketed predicate device (XRAY VISION, K983111). The manufacturer argues that SuniRay is substantially equivalent based on:
- Device Description: SuniRay is a software package for digital radiograph scanning, archiving, electronic transmission, and diagnostic review. It acquires images from various sources, organizes and archives them, provides image enhancement tools, and allows for annotations. Crucially, it does not control X-ray systems or generate radiographs, nor does it alter original image content.
- Intended Use Comparison: SuniRay's intended uses in the dental industry (organize/archive, share info, mark/annotate, dimension radiographs, image-process, email data) are compared to XRAY VISION's. Minor differences in specific transmission methods (e.g., SuniRay relies on standard Windows functions for file transfer rather than explicit phone/FTP/client-server) are noted but deemed non-critical.
- Technological Characteristics Comparison: A direct table comparison is provided between SuniRay and XRAY VISION for several characteristics:
- TWAIN interface utilization: Both use TWAIN for image acquisition.
- Standard image processing algorithms: Both utilize standard algorithms for contrast, sharpness, and quality improvement.
- Electronic transmission media: XRAY VISION lists phone, FTP, client/server, email, and disk. SuniRay lists email and disk, relying on standard OS functionality for other transfers. This difference is discussed as not raising new concerns.
- Archiving: XRAY VISION uses a knowledge base for file location; SuniRay keeps patient files in its own data store for improved safety.
- Markers and annotations: Both use standard markers and annotations.
- Encryption algorithms: XRAY VISION uses industry-standard encryption; SuniRay does not provide cryptographic functionality directly, stating data integrity is within the scope of system administration and email encryption depends on user choice of third-party tools. This is justified as not raising new safety concerns.
- Duplication of physical X-rays: XRAY VISION mentions physical X-ray duplication; SuniRay printouts are for patient information only, not diagnostic purposes, with digital copies being more reliable for diagnosis.
Conclusion of the Submission:
The manufacturer concludes that SuniRay is substantially equivalent to the predicate device because the potential hazards have been studied and controlled through a risk analysis, test, and design considerations, and planned verification and validation testing processes (though details of these tests are not provided in this summary). The noted differences are not considered to raise new issues of safety or effectiveness.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).