(83 days)
HCP DICOM Net® is a software device intended to acquire and store medical images studies from catheterization laboratories, Echo cardiograms, CT & MRI and other such modalities. In addition, HCP DICOM Net® provides image enhancement and filtering tools for viewing of selected images. It also imports image studies from DICOM CD's/DVD's, makes copies of image studies and converts and exports image studies into DICOM3 and other commercial file formats. HCP DICOM Net® also integrates industry standard third party approved software within its application to allow for analysis of the acquired image.
HCP DICOM Net® is a computerized system that acquires images which are captured by cardiac catherterization laboratories and other modalities like Echocardiograms. MRI & CT. These images are acquired through a video source or a DICOM3 interface of the modality. These images are then stored in DICOM3 format on Hard Disk Drives, Magnetic Tape. CD-R or DVD. If images are acquired through a video source, in a non-DICOM3 format then these images are converted into a DICOM3 format before they are stored. After storage these images are retrieved and displayed on workstations for convenient review and analysis. Analysis of images is provided via approved industry standard third party software. These workstations are also capable of reading DICOM3 images from CD and DVD media and uploading them to the image store for retrieval, viewing and analysis at a later time.
The provided text is a 510(k) summary for the HCP DICOM Net® device. It details the device's intended use, comparison to predicate devices, and concludes with a substantial equivalence statement. However, it explicitly states "Discussion of Clinical Tests Performed: - Not applicable." This means that no clinical efficacy study was conducted for this device beyond non-clinical tests like risk analysis and software validation.
Therefore, there is no information available in the provided text to fulfill the request for acceptance criteria and the study that proves the device meets those criteria.
Specifically, the following information cannot be extracted because no clinical study was performed:
- A table of acceptance criteria and the reported device performance: No acceptance criteria related to clinical performance are mentioned, and therefore no reported performance relative to such criteria.
- Sample size used for the test set and the data provenance: No clinical test set was used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set was used.
- Adjudication method for the test set: Not applicable as no clinical test set was used.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable as no clinical study was performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no clinical study was performed.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no clinical test involving ground truth was performed.
- The sample size for the training set: Not applicable as no clinical study involving a training set for an AI/algorithm was performed. The device is described as software that integrates "industry standard third party approved software within its application to allow for analysis of the acquired image," implying it's not a de novo AI algorithm from the submitter.
- How the ground truth for the training set was established: Not applicable as no clinical study involving a training set was performed by the submitter.
§ 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).