(42 days)
The GE EchoPAC workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Coded Pulse, Harmonic and Realtime 3D. Clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
The device may include EchoPilot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.
GE EchoPAC provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval of ultrasound images that are acquired via GE Vivid family of ultrasound scanners, primarily for cardiology ultrasound applications but also for general imaging. The EchoPAC software is an integral component of each Vivid system, providing the postacquisition image management and reporting functions of the scanner. EchoPAC will be offered as SW-only to be installed directly on customer PC hardware, or as an accessory to selected 3rd party image management workstations. EchoPAC is DICOM compliant, transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations. The modified or added software features for GE EchoPAC are substantially equivalent to the predicate devices.
This GE EchoPAC Review station K123894 510(k) summary states that no clinical studies were required to support substantial equivalence, thus no specific acceptance criteria or performance studies as typically described for a new diagnostic device are provided. The submission focuses on non-clinical tests and conformance to design specifications and industry standards.
Therefore, many of the requested fields cannot be filled as they pertain to clinical performance studies that were not conducted.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Conformance to design specifications | The device has been evaluated for conformance to its design specifications. |
| Conformance with applicable industry standards for software development | The device has been evaluated for conformance to applicable industry standards for software development. |
| System compatibility with communicating devices | The device is verified for system compatibility with the devices with which it communicates. |
| Conformance to DICOM standard | The device complies with DICOM standard (PS 3.2). |
| Compliance with IEC 60601-1-4 (Programmable electrical medical systems) | The device complies with IEC 60601-1-4. |
| Compliance with IEC 60601-1-6 (Usability) | The device complies with IEC 60601-1-6. |
| Compliance with IEC 62304 (Medical device software life cycle process) | The device complies with IEC 62304. |
| Compliance with ISO 14971 (Risk management) | The device complies with ISO 14971. |
| Substantially equivalent to predicate devices (K120221, K121063) in safety and effectiveness | GE Healthcare considers the EchoPAC to be as safe, as effective, and performance is substantially equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance
Not applicable. No clinical test set or patient data was used as part of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set requiring expert ground truth was used.
4. Adjudication method for the test set
Not applicable. No clinical test set requiring adjudication was used.
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
Not applicable. No MRMC comparative effectiveness study was done. The device (EchoPAC) is a workstation software for image review, analysis, and reporting, and the submission does not describe it as an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is software for a workstation, intended for human review and analysis of ultrasound images. It is not a standalone algorithm performing automated diagnoses without human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No clinical ground truth was established as no clinical studies were performed.
8. The sample size for the training set
Not applicable. No clinical training set was described or used for this submission.
9. How the ground truth for the training set was established
Not applicable. No clinical training set was described or used, and therefore no ground truth for a training set was established.
§ 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).