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510(k) Data Aggregation
(77 days)
EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.
Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 3D, and Real time (RT) 3D Mode (4D).
Clinical applications include: Fetal/Obstetrics; 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; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV); Intraoperative (vascular); Intra-Cardiac; Thoracic/Pleural and Intra-Luminal.
EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the GE Healthcare Vivid family of ultrasound systems, as well as DICOM images from other ultrasound systems. EchoPAC Software Only will be offered as SW only to be installed directly on customer PC hardware and EchoPAC Plug-in is intended to be hosted by a generalized PACS host workstation. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between systems, hard copy devices, file servers and other workstations.
The provided 510(k) clearance letter and summary discuss the EchoPAC Software Only / EchoPAC Plug-in, including a new "AI Cardiac Auto Doppler" feature. The acceptance criteria and the study proving the device meets these criteria are primarily detailed for this AI-driven feature.
Here's an organized breakdown of the information:
1. Acceptance Criteria and Reported Device Performance (AI Cardiac Auto Doppler)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Feasibility score of more than 95% | The verification requirement included a step to check for a feasibility score of more than 95%. (Implies this was met for the AI Cardiac Auto Doppler). |
| Expected accuracy threshold calculated as the mean absolute difference in percentage for each measured parameter. | The verification requirement included a step to check mean percent absolute error across all cardiac cycles against a threshold. All clinical parameters, as performed by AI Cardiac Auto Doppler without user edits, passed this check. These results indicate that observed accuracy of each of the individual clinical parameters met the acceptance criteria. |
| For Tissue Doppler performance metric: Threshold not explicitly stated, but comparative values for BMI groups are provided. | **BMI |
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(29 days)
ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound.
ViewPoint 6 provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store, and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes.
ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system. ViewPoint 6 is not intended to operate medical devices in surgery related procedures.
ViewPoint 6 is an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data. It provides different calculations and tools to allow for the assessment of the images and data.
ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It has an intuitive graphical user interface (GUI) and is based on Microsoft Windows® with defined hardware requirements for the user to install on their computer.
ViewPoint 6 provides exam type specific reporting forms for various medical care areas. Forms are composed of different sections with data entry fields. The documentation can include measurements, exam findings, images, and graphs. All data is saved in the ViewPoint 6 database and can be compiled to a professional report. Images and image sequences can be reviewed in the ViewPoint 6 display area based on user preference. ViewPoint 6 supports both a single workstation and a client - server setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read - only functionality
The document provided is a 510(k) Premarket Notification Submission for the GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC's ViewPoint 6 device (K203677). This submission primarily focuses on establishing substantial equivalence to a predicate device (ViewPoint 6, K192917) and a reference device (EchoPAC Software Only, K200852).
Based on the provided information, the 510(k) submission states that clinical studies were not required or performed to support the substantial equivalence of ViewPoint 6. Therefore, there is no detailed study data, acceptance criteria, or performance metrics within this document that would typically be associated with a clinical trial or performance evaluation study specifically proving the device meets certain acceptance criteria through direct testing.
The conclusion explicitly states:
"The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence."
"GE Healthcare considers the ViewPoint 6 to be as safe, as effective, and performance is substantially equivalent to the predicate device."
This means that the manufacturer is asserting the new ViewPoint 6 is functionally equivalent to the previously cleared ViewPoint 6 (K192917) and EchoPAC Software Only (K200852) based on its intended use, technological characteristics, and non-clinical performance (e.g., meeting voluntary standards, software development quality assurance measures).
Therefore, it is not possible to provide the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details from the provided text, as such a study was not conducted or reported in this submission.
The document highlights the device's adherence to voluntary standards and internal quality assurance measures in lieu of clinical performance testing for this specific 510(k) submission.
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