(12 days)
The APAX™ PACS is intended to be used by authorized staff to perform medical image management, communications, storage, archiving and review. Images and data can be stored, transmitted (communicated), processed at the workstation, physician's desktop or other clinical application and distributed across networks or the world wide web. Typical users are trained professionals, including not limited to physicians, nurses, and technicians.
The APAX™ PACS system is a general purpose software designed for acquisition/ capture/ view/ archival and transmission of medical images. This device allows easy capturing, selection, review, processing and filming of multi-modality DICOM images from a variety of diagnosis imaging systems such as MRI, CT, CR, etc., and of non-DICOM images from Ultrasound (by capturing) and X-ray Film (by scanning). When interpreted by a trained physician, filmed images may be used as a basis for a diagnosis. The PACS system
The provided 510(k) summary for the APAX™ PACS System (K032760) is primarily focused on demonstrating substantial equivalence to a predicate device based on its intended use and general performance characteristics. It does not present specific acceptance criteria in the form of performance metrics nor does it detail a study proving the device meets such criteria.
The submission is for a Picture Archiving and Communication System (PACS), which is a general-purpose medical image management, communication, storage, archiving, and review system. For such devices, the FDA typically assesses functionality, data integrity, compatibility with DICOM standards, and overall safety and effectiveness for its intended use, rather than specific diagnostic accuracy metrics.
Here's an breakdown of the requested information based on the provided text, highlighting what is not available:
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Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the submission. The submission describes the general functions of the APAX™ PACS, such as acquisition, capture, view, archival, and transmission of medical images, and its ability to handle multi-modality DICOM and non-DICOM images. It states, "When interpreted by a trained physician, filmed images may be used as a basis for a diagnosis." However, no specific performance metrics (e.g., image loading speed, archival success rate, accuracy of image processing algorithms if any were specifically highlighted for diagnostic impact) are mentioned as acceptance criteria or reported as device performance.
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Sample Size Used for the Test Set and Data Provenance: This information is not provided. As no specific performance study is detailed, there's no mention of a test set, its size, or the origin of any data that might have been used for testing.
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Number of Experts Used to Establish Ground Truth and Qualifications: This information is not provided. Since there's no diagnostic accuracy study, there's no mention of experts establishing ground truth.
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Adjudication Method for the Test Set: This information is not provided.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study was not mentioned or conducted. The submission does not discuss AI assistance or human-in-the-loop performance. The device is described as a system for managing and reviewing images, with diagnosis being performed by a trained physician.
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Standalone Performance Study (Algorithm only without human-in-the-loop performance): This information is not provided. The device is a PACS, not an AI or algorithm-based diagnostic tool that would typically have standalone performance metrics. Its function is to facilitate image review by human professionals.
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Type of Ground Truth Used: This information is not provided.
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Sample Size for the Training Set: This information is not provided. As no specific AI or machine learning algorithm requiring a training set is highlighted or evaluated, this information is not relevant to the submission's content.
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How the Ground Truth for the Training Set was Established: This information is not provided.
Summary of Device Capabilities (from text):
- Functions: Acquisition/capture/view/archival and transmission of medical images.
- Image Modalities: Multi-modality DICOM images (MRI, CT, CR, etc.) and non-DICOM images (Ultrasound by capturing, X-ray Film by scanning).
- Users: Authorized staff, including physicians, nurses, and technicians.
- Purpose: Medical image management, communications, storage, archiving, and review.
- Diagnosis: Filmed images, when interpreted by a trained physician, may be used as a basis for a diagnosis.
Conclusion based on the provided text:
The 510(k) submission for the APAX™ PACS System focuses on demonstrating substantial equivalence to a predicate device (Mediface Co., Ltd. Mediface PACS™ System K010259) primarily based on its intended use and functional capabilities as a general-purpose medical image management system. It does not contain information about specific performance acceptance criteria or a study detailing the device reaching those criteria, as typically seen for devices with explicit diagnostic claims or AI components. The FDA's letter confirms that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."
§ 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).