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510(k) Data Aggregation
(27 days)
syngo Ultrasound Apps Suite (sUSAS)
The syngo® Ultrasound Apps Suite is a software-only product to be run on a user's PACS (Picture Archiving and Communications System) workstation. It is intended to launch Siemens' CAPs (Clinical Applications Packages) for image processing, including the acceptance, display and digital processing of ultrasound images. Digital processing includes image manipulation and quantification. 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
syngo® Ultrasound Apps Suite™ (sUSAS) is a dedicated software application for use activated on a workstation connected to a cardiology PACS that includes a third-party application launcher. It is a graphical launch pad designed to provide viewing, manipulation and quantification functionality for ACUSON SC2000™ Ultrasound System image data sets using Clinical Application Packages (CAPS).
The analysis packages included in this release of the syngo® Ultrasound Apps Suite (formerly eSie Apps Suite) software are essentially the same as those available in the software on the ACUSON SC2000™ Ultrasound System. Features on sUSAS are limited to the eSie Volume Viewer (for 2D image and 3D volume image display), eSie LVA, eSie PISA, and eSie Valves clinical application software.
The syngo® Ultrasound Apps Suite™ (sUSAS) is a software-only product intended for image processing, manipulation, and quantification of ultrasound images from the ACUSON SC2000™ Ultrasound System on a PACS workstation. It supports several clinical application packages (CAPS): eSie Volume Viewer, eSie LVA, eSie PISA, and eSie Valves.
The device's acceptance criteria and proven performance are primarily established through a demonstration of substantial equivalence to a predicate device (eSie Apps Suite, K143254) and a secondary predicate (ACUSON SC2000 Diagnostic Ultrasound System v6.0, K200585), rather than through a standalone clinical study with specific performance metrics against an independent ground truth. The submission emphasizes that the subject device utilizes the same fundamental scientific technology and intended use/indications for use as the predicate device. Non-clinical testing for verification and validation was performed.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria with corresponding performance results for human readers or algorithm-only performance. Instead, substantial equivalence is claimed based on functional and technological characteristics matching or improving upon the predicate devices. The "performance" is demonstrated through alignment with the predicate's capabilities and additional updated features.
| Feature / Characteristic | Predicate Device (eSie Apps Suite K143254) | Reported Device Performance (syngo® Ultrasound Apps Suite™ (sUSAS)) | Acceptance Criterion (Implicit) |
|---|---|---|---|
| Intended Use/Indications for Use | To launch Siemens CAPs for image processing, display, manipulation, quantification for clinical diagnosis. Supports eSie Volume Viewer, eSie LVA, eSie PISA, eSie Valves. | SAME AS PREDICATE | The indications for use must be substantially equivalent to the primary predicate device. |
| Clinical Application Packages (CAPS) | eSie Volume Viewer, eSie LVA, eSie PISA, eSie Valves. | SAME as predicate (K143254) and secondary predicate (K200585) | The device must include the same clinical application packages with equivalent functionality as the primary predicate and align with the version on the secondary predicate (SC2000 v6.0) for consistent performance. |
| Left Ventricle volume quantitative analyses (eSie LVA) | Supports Single + Multibeat (up to 3 beats implied from predicate date) | YES (eSie LVA) + 5 beats; SAME As SC2000 6.0 | Must perform 3D Left Ventricle volume quantitative analyses. Improvement from 3 to 5 cardiac cycles is an accepted update aligned with SC2000 6.0. |
| Quantification of proximal isovelocity surface area (eSie PISA) | 2D data acquired with TTE probe | YES (eSie PISA); 2D and 3D volume data acquired with TTE, and TEE probes. Color Doppler only. | Must perform quantification of proximal isovelocity surface area. Expanded support for 3D volume data and TEE probes from SC2000 6.0, and Color Doppler only, is acceptable. |
| Volume Load Performance (Volume review) | 80 secs | 40 secs; SAME AS VA16A | Volume loading time in volume review should be 80 seconds or less. An improvement to 40 seconds is acceptable. |
| Windows 10 Support | No | YES (New) for VA17A; SAME as SC2000 6.0 | The updated device must support current operating systems (Windows 10) in alignment with related devices (SC2000 6.0). |
| Display Improvements (e.g., VR Measurement Tools, Reference Lines) | No | YES; aligns with SC2000 6.0 | Display improvements like VR Measurement Tools, Reference Lines, One-click MPR alignment, Volume Reference Line Projections, Trace erase, and consolidated windows should align with SC2000 v6.0 capabilities, indicating enhanced user experience without altering fundamental technology or intended use. |
| Software Verification & Validation | N/A (Previous clearance) | Conforms to IEC 62304, IEC 62366-1, NEMA PS 3.1-3.20 (DICOM), ISO 14971. | The software must undergo verification and validation according to design control requirements and relevant international standards (IEC 62304, IEC 62366-1, NEMA PS 3.1-3.20 (DICOM), ISO 14971), and cybersecurity considerations must be addressed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of clinical performance evaluation with human readers or an algorithm-only study. The submission relies on non-clinical verification and validation testing of the software to ensure it meets specifications and claims of functioning identically or with minor beneficial updates compared to the predicate device. Therefore, information on sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not provided as it would typically be for a clinical performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
As no specific clinical test set and human performance comparison is detailed, information regarding the number of experts or their qualifications for establishing ground truth is not applicable or provided in this submission for determining substantial equivalence based on clinical outcomes. Ground truth for non-clinical software testing would be based on design specifications and expected behavior.
4. Adjudication Method for the Test Set
Since no clinical test set requiring expert adjudication for ground truth establishing is described, information on the adjudication method (e.g., 2+1, 3+1, none) is not applicable or provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission states, "clinical studies were not required to support substantial equivalence" because the device uses the "same technology and operating principles as the predicate device." Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document does not describe a standalone (algorithm only) performance study against a specific ground truth. The device is software that launches clinical application packages. Its effectiveness is tied to its functional equivalence to existing validated software on predicate devices. The "performance" is therefore inherent in the established and proven functionality of the CAPS, not a new standalone AI algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the claims of substantial equivalence and based on the non-clinical verification and validation, the ground truth is implicitly the established and validated functionality and performance of the predicate device (eSie Apps Suite) and the ACUSON SC2000 Diagnostic Ultrasound System v6.0. This refers to adherence to specifications, expected software behavior, and the established clinical utility of the underlying CAPS, rather than a clinical ground truth derived from pathology or outcomes data specifically for this submission.
8. The Sample Size for the Training Set
The document does not describe a training set for a machine learning or AI algorithm. The device is primarily an application suite with image processing and quantification tools, not a newly developed AI algorithm requiring a dedicated training set as described in clinical AI/ML regulatory submissions.
9. How the Ground Truth for the Training Set Was Established
Since no training set is described, information on how its ground truth was established is not applicable.
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