(30 days)
eSie Apps Suite software is a software-only product to be run on a user's PACS (Picture Archiving and Communication System) workstation. It is intended to launch Siemens CAPs (clinical application packages) for image processing, including the acceptance, transfer, display and digital processing of ultrasound images. Digital processing includes image manipulation and quantification on a workstation. Use of a clinical application package by a qualified clinician can add information to the study to be used for a clinical diagnosis.
The software supports the following clinical application packages:
- eSie Volume Viewer .
- eSie LVA .
- eSie PISA
eSie Apps Suite is intended to be the CAP host for 2D and volume imaging applications on a PACS workstation. It is intended to maximize the reuse of the SC2000 renderer for volume display and manipulation. Additionally, the imaging applications from the SC2000 will be redeployed on a PACS workstation for the 2D and volume imaging analysis.
eSie Apps Suite is intended to have a simple basic configuration as a PACS plug-in by utilizing the third party launching capability of the host PACS. On the customer's workstation a command line will launch the eSie Apps Suite application - patient context will be shared between the PACS and eSie Apps Suite. Results created by the respective CAPs will be sent back to the PACS for appending to the patient study.
The software level of concern for the eSie Apps Suite is considered moderate.
The provided document is a 510(k) summary for the eSie Apps Suite, an image processing system for ultrasound images. However, it does not contain any information regarding acceptance criteria, device performance, validation studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.
The document primarily focuses on:
- Device Identification: Name, common name, classification, and sponsor.
- Predicate Devices: Listing previously cleared devices to which the eSie Apps Suite is substantially equivalent.
- Device Description: Explaining its function as a PACS host for 2D and volume imaging applications, maximizing reuse of the SC2000 renderer, and running clinical application packages (CAPs).
- Indications for Use: Stating its purpose for image processing, manipulation, and quantification of ultrasound images on a PACS workstation, to add information for clinical diagnosis.
- Regulatory Information: FDA clearance letter, regulation number, product code, and general controls provisions.
Therefore, based solely on the provided text, I cannot provide the requested information regarding acceptance criteria and performance studies. The document does not describe such studies or their results.
§ 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).