(27 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 Valves
eSie Apps Suite is intended to be the Clinical Application Package (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.
This document is a 510(k) summary for the Siemens Medical Solutions USA, Inc. eSie Apps Suite. It outlines the device, its intended use, and its substantial equivalence to previously cleared predicate devices. However, it does not contain a study designed to prove the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or reader agreement.
The document focuses on demonstrating substantial equivalence based on technological characteristics and intended use, stating that "clinical data is not required" because the device uses the same technology and principles as existing devices. Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, and MRMC studies is not available within this document.
Here's a breakdown of the explicitly stated information from the document related to your request:
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A table of acceptance criteria and the reported device performance:
- Not provided. The document states that the device was subject to "extensive safety and performance testing" to ensure it "meets all of its specifications." However, it does not list specific acceptance criteria (e.g., minimum sensitivity, specificity, or agreement rates) or quantitative performance results against such criteria.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. No clinical performance test set or data provenance is mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Since no clinical performance study or test set is described, there's no mention of experts establishing ground truth for such a set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
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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:
- No MRMC study was done or reported. The document explicitly states, "clinical data is not required."
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No standalone performance study for the algorithm is reported. The validation mentioned focuses on DICOM compliance and software lifecycle processes, not clinical performance metrics. The software is described as being for "image manipulation and quantification on a workstation" with "use of a clinical application package by a qualified clinician."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided.
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The sample size for the training set:
- Not provided. As no machine learning or AI model with distinct training and test sets are described in terms of clinical performance, no training set size is mentioned.
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How the ground truth for the training set was established:
- Not applicable / Not provided.
Summary of Nonclinical Tests:
The document briefly mentions nonclinical tests:
- DICOM (Digital Imaging and Communications in Medicine) compliance.
- IEC 62304 Medical device software - Software Life Cycle Process compliance.
These tests ensure the software's technical functionality and adherence to medical device software standards, but they do not provide clinical performance data.
Conclusion from the document:
The conclusion is that the device is substantially equivalent to predicate devices based on intended use and technological characteristics, and that "testing indicates that no new issues of safety or effectiveness are raised." This statement refers to the nonclinical (technical) testing, not clinical performance studies comparing the device's output to a ground truth established by experts or pathology.
§ 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).