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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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The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Intraoperative Abdominal, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications.

The Acuson SC2000™ has been designed to meet the following product safety standards: UL 60601-1, Safety Requirements for Medical Equipment; IEC 60601-2-37 Diagnostic Ultrasound Safety Standards; CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment; AIUM/NEMA UD-3. Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment; AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound; Safety and EMC Requirements for Medical Equipment; IEC 60601-1; IEC 60601-1-1; IEC 60601-1-2; IEC 1157 Declaration of Acoustic Power; ISO 10993-1 Biocompatibility.

This 510(k) summary for the ACUSON SC2000 Diagnostic Ultrasound System is a Special 510(k), indicating a minor change to a previously cleared device. Therefore, a comprehensive de novo clinical study demonstrating performance against acceptance criteria for a novel device is not part of this submission. Instead, the performance data section explicitly states: "No performance data required to support this modification, as there is no change to any hardware or software, or method of use."

The submission focuses on demonstrating substantial equivalence to a previously cleared device (K123622) by only renaming three transducers. As such, the typical elements of a study proving a device meets acceptance criteria (like a test set, ground truth, experts, and statistical results) are not provided in this document.

However, I can extract the acceptance criteria implied by this type of submission, which is the determination of substantial equivalence to the predicate device for the specified indications for use.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied for a Special 510(k) for Renaming Transducers): The modified device, specifically the renamed transducers, must demonstrate substantial equivalence to the previously cleared predicate device concerning intended use and technological characteristics, with no changes to hardware, software, or method of use.

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

• Sample Size for Test Set: Not applicable. No new performance testing with a specific test set was conducted for this Special 510(k) given the nature of the modification (renaming transducers).
• Data Provenance: Not applicable. No new data was generated or analyzed for this submission. The basis for substantial equivalence relies on the established performance of the predicate device and the claim that the changes are confined to nomenclature.

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

• Number of Experts: Not applicable. No new ground truth establishment was required as no new performance data was generated.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. This submission does not describe an MRMC comparative effectiveness study.
• Effect Size of Human Readers Improvement: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This device is an ultrasound imaging system, not an AI algorithm requiring standalone performance evaluation in the context of this submission.
• The document states there is "no change to any hardware or software," implying no new algorithms or software features are being introduced that would require such testing.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable for new performance evaluation. The "ground truth" for this Special 510(k) is implicitly the established safety and effectiveness of the predicate device (K123622), to which the modified device (with renamed transducers) is claimed to be substantially equivalent without any functional changes.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document does not describe the development or training of any new algorithms or software components.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth Establishment for Training Set: Not applicable.

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