(19 days)
JLK-AILink is a software that receives digital images and data from various sources (i.e., CT scanners, MR scanners, ultrasound systems, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and analyzed data with optional modules can be stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals including but not limited to physicians and medical technicians. The device is not intended for mammography.
JLK-AILink is a software designed to streamline the management, visualization, and communication of medical imaging data within clinical workflows. It facilitates bidirection with hospital PACS systems or imaging equipment such as MR, CT, or X-ray scanners, enabling the communication of DICOM images. This functionality ensures seamless integration with existing hospital IT infrastructure while adhering to DICOM communication standards.
The software includes a DICOM viewer that offers tools for image manipulation and annotation, such as zoom, magnify, contrast adjustment, cobb angle measurement, and annotation tools, making it an efficient and userfriendly interface for medical professionals. The modular architecture allows healthcare institutions to integrate optional analysis solutions with DICOM communication to expand its image analysis capabilities as needed.
JLK-AlLink also supports mobile access, enabling clinicians to view images, interact with annotations, and receive critical alerts remotely. With a focus on interoperability, the software ensures compatibility not only with PACS systems but also with containerized environments, allowing for secure and data management.
This combination of DICOM functionalities, modular integration, and mobile accessibility makes ILK-AILink a clinical tool for enhancing clinical workflows and improving the efficiency of medical imaging data usage in diverse healthcare settings.
The provided FDA 510(k) clearance letter for JLK-AILink (K250348) primarily focuses on establishing substantial equivalence to a predicate device (STARPACS™ K031013) for a general medical image management and processing system. The documentation explicitly states that "JLK-AILink is a software that receives digital images and data from various sources... Images and analyzed data with optional modules can be stored, communicated, processed, and displayed..."
However, the provided text does not contain the detailed information required to describe the acceptance criteria and the specific study proving the device meets those criteria for any optional analysis modules. The clearance is for the base platform, which is a medical image management and processing system, not an AI-powered diagnostic or assistive tool with specific performance metrics.
The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section (Page 7-8) states:
"JLK-AILink was designed and developed according to the standards required for software development. For software evaluation, software functionality, risk management, cybersecurity, verification, validation, and requirements were addressed. The evaluation was tested according to the verification and validation processes and planning, and the test results support that all system requirements have met their acceptance criteria and are adequate for their intended use."
This statement confirms that the base system functionality (image reception, storage, communication, processing, display, and features like zoom, magnify, contrast adjustment, Cobb angle measurement, annotation tools) was verified and validated against its design requirements and acceptance criteria, but it does not specify what those criteria were in a quantitative sense, nor does it detail a performance study as one would expect for an AI/ML diagnostic or assistive device that provides analytical outputs (e.g., disease detection, segmentation, quantitative measurements relevant to a clinical endpoint).
Therefore, based solely on the provided text, the following information cannot be extracted:
- A table of acceptance criteria and reported device performance for an AI module: The document describes the system as a general image management and processing system. While it mentions "optional modules" that can expand its "image analysis capabilities," the clearance itself (K250348) pertains to the core platform, not specific AI analysis functionalities that would require detailed performance metrics.
- Sample size for the test set: Not mentioned.
- Data provenance for the test set: Not mentioned.
- Number of experts used to establish ground truth: Not mentioned, as ground truth for specific AI analysis outputs is not addressed.
- Qualifications of experts: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study: Not mentioned. The focus is on functionality and equivalence to a predicate PACS system, not comparative clinical performance for an AI-assisted workflow.
- Effect size of human reader improvement with AI assistance: Not applicable based on the scope of clearance described.
- Standalone (algorithm only) performance: Not mentioned, as no specific AI algorithm's performance is described.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How ground truth for the training set was established: Not mentioned.
In summary: The provided 510(k) clearance letter for JLK-AILink pertains to a general medical image management and processing system (PACS-like functionality), falling under Regulation Number 892.2050 and Product Code LLZ. This product code typically covers systems that handle, display, and process medical images, but does not inherently imply specific AI diagnostic or analytical capabilities that would necessitate the detailed performance study information requested. The "optional modules" are noted, but their specific functionalities and performance (if they are AI-powered analytics) are not covered in this general clearance document.
To answer your questions for an AI-enabled device with specific analytical functions, one would typically need a 510(k) summary that details the performance of those specific AI modules, rather than just the general image management system.
§ 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).