(146 days)
The CRADLE HIPAX PACS device is intended for the manipulation, . management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards.
Typical users of this software system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
CRADLE HIPAX PACS consists of databank mainframe, file storage backup system, medical tomography interlink, job query, image diagnose and archive, and medical information integral linking modules and subsystems.
The provided document is a 510(k) summary for the CRADLE HIPAX PACS device, which is a Picture Archiving and Communications System. The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to present a study proving the device meets specific performance acceptance criteria for a clinical task.
Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria. Specifically:
- No acceptance criteria are mentioned. Acceptance criteria are typically quantitative thresholds for performance metrics (e.g., sensitivity, specificity, accuracy, processing time).
- No study proving specific performance metrics is presented. The document focuses on establishing substantial equivalence based on similar technology, design aspects, and clinical function to a predicate device (DVVNET Mdv-PACS, K031816). It states that the new device performs the same functions in the same way and raises no new safety or effectiveness hazards.
Without a detailed performance study, the following information cannot be extracted from the provided text:
- Table of acceptance criteria and reported device performance: Not available.
- Sample size used for the test set and data provenance: Not applicable as no performance study is described.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported.
- Standalone (algorithm only) performance study: Not conducted or reported. The device is a PACS system, which facilitates the management and display of images, rather than performing automated diagnostic analysis.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable as a training set for an AI/ML algorithm is not relevant to this type of device and submission.
- How the ground truth for the training set was established: Not applicable.
§ 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).