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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:

1. 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.

2. 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.

3. 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.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable / Not provided.

5. 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."

6. 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."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable / Not provided.

8. 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.

9. 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.

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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.

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eSie Apps Suite software is intended for use as a PACS plug in utilizing the third party application launching feature of the PACS workstation. eSie Apps Suite software will provide the ability to launch Siemens CAPs (Clinical Application Packages) for image processing. Use of a CAP by a qualified clinician can add information to the study to be used for a clinical diagnosis. This initial release employs one CAP, the eSie Volume Viewer, which provides offline viewing and manipulation of the Acuson SC2000 system volume datasets.

The typical ultrasound user must be knowledgeable in the use of the ultrasound system in order to properly optimize and utilize the software. The eSie Apps Suite software is intended for use on a PACS workstation that must meet minimum system requirements to run optimally and also supports launching of third party applications.

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. Other CAPs will be integrated as the market demands.

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 Siemens eSie Apps Suite, as described in K132062, is a PACS plug-in designed to launch Siemens Clinical Application Packages (CAPs) for image processing. The initial release included the eSie Volume Viewer for offline viewing and manipulation of Acuson SC2000 system volume datasets.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the final testing performed on the eSie Apps Suite. It broadly mentions "various safety and performance testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used to establish ground truth or their qualifications for the testing of the eSie Apps Suite. Given the nature of the device (a PACS plug-in for viewing and manipulation), the "ground truth" might pertain more to software functionality and rendering accuracy rather than diagnostic accuracy that would typically require expert consensus on clinical findings.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for a test set. This type of method (e.g., 2+1, 3+1) is typically employed in studies assessing diagnostic accuracy where multiple readers interpret cases and disagreements are resolved. As the device is primarily a viewing and manipulation tool, such an adjudication method might not be directly applicable or explicitly detailed in this type of submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not specifically mentioned or detailed in the provided submission. The submission focuses on the device's technical performance and equivalence to predicate devices, rather than an assessment of human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study

The submission does not explicitly describe a standalone (algorithm only) performance study in terms of diagnostic accuracy or clinical decision-making. The device is presented as a tool within a PACS workstation to launch clinical applications, implying human interaction. The "performance testing" referenced is more related to software functionality and standards compliance.

7. Type of Ground Truth Used

Based on the information provided, the "ground truth" for the testing appears to be related to technical specifications, functional requirements, and compliance with industry standards (DICOM, IEC 62304). This implies that the device was evaluated against predefined technical correctness (e.g., proper image rendering, accurate manipulation, data transfer) rather than a clinical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set

The document does not specify the sample size for a training set. This is likely because the eSie Apps Suite, particularly the eSie Volume Viewer, is described as a tool for viewing and manipulation, not as a device utilizing machine learning that typically requires a large training dataset for model development. The focus is on re-deploying existing rendering software and applications.

9. How Ground Truth for the Training Set Was Established

Since a training set and a machine learning model are not explicitly described, the document does not provide information on how ground truth for a training set was established.

Summary of Study that Proves Acceptance Criteria:

The provided 510(k) summary states that the eSie Apps Suite was "designed, verified, and validated according to the company's design control process" and subjected to "extensive safety and performance testing before release." This testing included ensuring the device meets its specifications and complies with DICOM standards and IEC 62304 for medical device software.

The specific details of these tests (e.g., number of test cases, specific metrics measured beyond general compliance, data used, human expert involvement) are not provided in this excerpt. The submission relies on demonstrating substantial equivalence to predicate devices (Siemens fourSight ViewTool, K052895, and the rendering software on the Acuson SC2000, K123622) in terms of intended use and technological characteristics, as outlined in the comparison table. This suggests that the primary "proof" of meeting acceptance criteria is through adherence to internal design controls and demonstrating that its functionality and performance are comparable to already-cleared devices within established standards.

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