(29 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, Code Pulse, Harmonic and Realtime 3D. Specific clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional; Peripheral Vascular; Transesophageal (TEE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
The GE EchoPAC is an Ultrasound image Analysis and Review Workstation optimized for ultrasound images that are acquired primarily via the GE Vivid family of diagnostic ultrasound systems. It is sold either with computer hardware only with hardware specifications.
This document, K072952, describes the GE EchoPAC Ultrasound Workstation, a medical image management device. It's important to note that this is a Special 510(k) Premarket Notification, meaning it leverages a previously cleared device (K060542) and likely involves minor changes. Therefore, the depth of performance data might differ from a standard 510(k).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to design specifications | "The device has been evaluated for conformance to its design specifications..." |
| Conformance to applicable industry standards for software development | "...and applicable industry standards for software development." |
| System compatibility with communicating devices | "It is further verified for system compatibility with the devices with which it communicates." |
| Computer hardware certified to applicable safety standards | "Computer hardware is certified to applicable safety standards." |
| Reliability within the intended network environment | "evaluation in a clinical setting is performed to help assure reliability within the intended network environment." |
| Consistency with traditional clinical practice, FDA guidelines, and established methods for handling patient examination images and data | "Intended uses and other key features of the device are consistent with traditional clinical practice. FDA quidelines and established methods of handling patient examination images and data." |
| Conformance to 21 CFR 820, ISO 9001:2000, and ISO 13485:2000 quality systems | "The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485:2000 quality systems." |
| Conformance to applicable medical device safety standards | "The device conforms to applicable medical device safety standards..." |
| Compliance verified through internal and independent quality system audit | "...and compliance is verified through internal and independent quality system audit." |
| Substantial equivalence to predicate device (K060542) | "it is the opinion of GE Healthcare that the GE EchoPAC™ is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document refers to "evaluation in a clinical setting" but does not provide details on the number of cases or patients used for this evaluation.
- Data Provenance: Not explicitly stated. The "clinical setting" implies real-world data, but the country of origin and whether it was retrospective or prospective data are not mentioned. Given the nature of a Special 510(k) for an updated workstation for existing ultrasound systems, it's possible this involved internal testing or smaller-scale evaluations rather than a large clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not specified. The document does not describe the methodology for establishing ground truth for any test set or the involvement of experts for this purpose.
4. Adjudication Method for the Test Set:
- Not specified. No information about expert adjudication or consensus is provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Tests: None required to confirm safety and effectiveness." The evaluation mentioned is for "reliability within the intended network environment," which is not an MRMC study.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- No standalone study was conducted or described in the provided text. The device is an "Image Analysis and Review Workstation," implying interaction with a human user. The performance claims focus on its design, software, compatibility, and safety standards, rather than the standalone diagnostic accuracy of an algorithm.
7. Type of Ground Truth Used:
- Not specified. Since no clinical tests for confirming safety and effectiveness were "required" and no details of an evaluation test set (beyond "reliability within the intended network environment") are provided, the type of ground truth used is not described.
8. Sample Size for the Training Set:
- Not applicable/Not specified. The GE EchoPAC is described as an "Ultrasound image Analysis and Review Workstation." It does not appear to employ AI in the sense of a machine learning algorithm that requires a "training set" to learn to perform a diagnostic task. Its function is image management, processing, and review, not automated diagnosis. Therefore, there's no mention of a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not specified, as there is no mention of a training set for an AI algorithm.
§ 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).