(46 days)
The GE EchoPAC is indicated for diagnostic review and analysis of ultrasound images acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic and Real time 3D. Clinical applications include: Fetal; Abdominal (including renal and GYN) ; Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Transvaginal (TV); and Intraoperative (abdominal, thoracic and vascular).
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 post-acquisition 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 device and functionality cleared on GE EchoPAC K131685
The provided document is a 510(k) premarket notification for the GE EchoPAC, a software-only device for diagnostic review and analysis of ultrasound images. Based on the document, here's a breakdown of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the format of a table with numerical targets, nor does it present specific "reported device performance" metrics for individual features. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if the device performs as safely and effectively as the predicate and exhibits similar technological characteristics.
The comparison table provided in the document focuses on features and capabilities rather than quantifiable performance metrics.
| Feature / Criterion | Proposed Device (GE EchoPAC) | Predicate Device (GE EchoPAC K131685) | Predicate Device (Vivid S60/S70 K142323) | Acceptance (vs. Predicate) |
|---|---|---|---|---|
| Indications and Clinical Applications: | ||||
| Fetal | ✓ | ✓ | N/A | Equivalent |
| Abdominal (Including Renal & Gyn) | ✓ | ✓ | N/A | Equivalent |
| Urology (including prostate) | ✓ | ✓ | N/A | Equivalent |
| Pediatric | ✓ | ✓ | N/A | Equivalent |
| Small Organ (breast, testes, thyroid) | ✓ | ✓ | N/A | Equivalent |
| Neonatal and Adult Cephalic | ✓ | ✓ | N/A | Equivalent |
| Cardiac (adult and pediatrics) | ✓ | ✓ | N/A | Equivalent |
| Peripheral Vascular | ✓ | ✓ | N/A | Equivalent |
| Transesophageal (TEE) | ✓ | ✓ | N/A | Equivalent |
| Musculo-skeletal Conventional | ✓ | ✓ | N/A | Equivalent |
| Transrectal (TR) | ✓ | ✓ | N/A | Equivalent |
| Transvaginal (TV) | ✓ | ✓ | N/A | Equivalent |
| Intraoperative (abdominal, thoracic, & vascular) | ✓ | ✓ | N/A | Equivalent |
| Image modes: | ||||
| B (2D), M, Color M modes, Color, Power, Pulsed and CW | ✓ | ✓ | N/A | Equivalent |
| Doppler modes, Coded Pulse, Harmonic and Real time 3D | ✓ | ✓ | N/A | Equivalent |
| Processing & Display features: | ||||
| Image mapping, Time/spatial filtering and enhancement, | ✓ | ✓ | N/A | Equivalent |
| TGC, TVI, SI/SRI, TSI, Harmonic Imaging, Pulsatile-Flow, | ||||
| B-Flow, Extended FOV, Tissue Tracking, Realtime 3D and | ||||
| Multi-plane processing, 2D Stress and Multiplane Stress, | ||||
| 4D Stress, TSI w/ surface rendering, Blood Flow Imaging | ||||
| (BFI), Spatial Compounding / Speckle Reduction imaging, | ||||
| LCD display, Realtime 3D Color Flow, Automated | ||||
| Functional Imaging (AFI), Triplane AFI, Auto EF (2D), | ||||
| Depth Color Rendering/map, Depth Illumination map, | ||||
| Stereo Vision, 2 Click Crop, FlexiSlice, LaserLines, | ||||
| Auto ROI | ||||
| HD live | ✓ | ✓ (Improvement to Depth Illumination Map) | N/A | Equivalent (with improvement noted) |
| AFI Stress | ✓ | N/A | ✓ (same features as on the predicate Vivid S60/S70 K142323) | Equivalent (to Vivid S60/S70) |
| Measurement & Analysis: | ||||
| Length, Area, Time, Circumference, Volume, Heart rate, | ✓ | ✓ | N/A | Equivalent |
| Slope, Velocity, Angle, Thickness Measurement Tool | ||||
| (IMT), OB Tables, Vascular and Cardiac calcs. including | ||||
| Strain (2D and 4D) and Strain rate, 4D LV Function by | ||||
| TomTec, 4D RV Function by TomTec, 4D LV Mass, Mitral | ||||
| Valve (MV) Quantification tool by TomTec, Z-score, LA | ||||
| Volume by Biplane Simpson, 4D Auto LVQ, Multilayered 2D | ||||
| Strain , ROI width adjustment, Time Caliper, Export of | ||||
| 4D Strain trace and mesh data | ||||
| 4D Auto AVQ | ✓ | ✓ (modification of area measurements used in predicate EchoPAC) | N/A | Equivalent (with modification noted) |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The subject of this premarket submission. GE EchoPAC, did not require clinical studies to support substantial equivalence."
Therefore, there is no information provided regarding a "test set" in the context of clinical performance evaluation (i.e., patient data, images, etc.). The "testing" referred to in the "Summary of Non-Clinical Tests" section pertains to software development and validation processes, not clinical outcome testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As clinical studies were not required, there is no mention of experts establishing ground truth for a clinical test set.
4. Adjudication Method for the Test Set
Not applicable, as 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
No MRMC comparative effectiveness study was conducted or reported in this submission for the GE EchoPAC. The device is for "diagnostic review and analysis" of ultrasound images, and the submission focuses on software functionality and equivalence to predicates, not AI-assisted reader performance improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document does not describe standalone algorithm performance without human-in-the-loop. The device, EchoPAC workstation software, is inherently designed to be used by human operators for review and analysis. The "performance testing" described in the non-clinical tests refers to software verification and validation, not clinical standalone performance.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Given the lack of clinical studies, there is no information about the type of clinical ground truth used for performance evaluation. The "ground truth" for the software's functionality would have been defined by the software requirements and design specifications, verified through internal testing against those specifications.
8. The Sample Size for the Training Set
No training set information is provided, as clinical studies involving machine learning or AI model training are not discussed in this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set information is provided.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" presented here is a non-clinical software verification and validation effort to demonstrate the device's adherence to voluntary standards and internal quality assurance measures, as well as a comparison to legally marketed predicate devices to establish substantial equivalence.
The proof the device meets acceptance criteria (which are largely defined by demonstrating substantial equivalence and compliance with engineering standards) comes from:
- Non-Clinical Tests:
- Compliance with voluntary standards: IEC 62366 (usability), IEC 62304 (software life cycle), NEMA PS 3.1 3.20 (DICOM), ISO 14971 (risk management).
- Internal quality assurance measures: Risk analysis, requirements reviews, design reviews, unit testing, integration testing, final acceptance testing (validation), performance testing (verification), and safety testing (verification).
- Substantial Equivalence Argument: The core of the submission is the detailed comparison of the proposed GE EchoPAC's indications for use, imaging capabilities, technological characteristics, and safety and effectiveness to those of the predicate devices (K131685 GE EchoPAC and K142323 Vivid S60/S70). The document concludes that the proposed device employs the "same fundamental scientific technology" and is "substantially equivalent" to the predicates.
In essence, for this 510(k), the "acceptance criteria" are implicitly met by demonstrating that the new GE EchoPAC, with its modified/added software features, is as safe, as effective, and performs substantially equivalently to the previously cleared predicate devices, supported by robust software development and testing processes, rather than new clinical performance data.
§ 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).