(121 days)
Vivid E80 / Vivid E90 / Vivid E95 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrios; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate), Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
Vivid E80 / Vivid E90 / Vivid E95 systems are Track 3 diagnostic ultrasound systems primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E80 / Vivid E90 / Vivid E95 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers. Vivid E80 will support 2D imaging, while Vivid E90 and Vivid E95 will support real time 3D imaging in addition to 2D, and incorporate several real-time 3D transducers. Vivid E80 / Vivid E90 / Vivid 95 consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, an OLED or LCD color video display, DVI connector for optional external video display, and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.
This document is a 510(k) Premarket Notification submission for the GE Vivid E80, Vivid E90, and Vivid E95 diagnostic ultrasound systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices and does not describe a study to establish new acceptance criteria or performance metrics for the core ultrasound imaging functionalities.
Instead, the submission highlights updates and new features compared to the predicate devices and confirms adherence to established safety and performance standards. Therefore, the device doesn't "meet acceptance criteria" in the sense of a novel clinical efficacy study, but rather demonstrates that changes and new features do not negatively impact safety or effectiveness, and that the device continues to conform to existing regulatory and voluntary standards.
Here's a breakdown of the information requested, based on the provided text:
1. Table of acceptance criteria and the reported device performance:
Since this is a submission for substantial equivalence based on updates to a previously cleared device (K173341) and new features, the "acceptance criteria" discussed are primarily compliance with general safety and performance standards and demonstrating that the new features do not compromise this. There are no specific numerical performance metrics for clinical efficacy presented for the overall device in this document, as the core diagnostic ultrasound functionality has been cleared previously.
The document lists compliance with several voluntary standards:
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance |
|---|---|
| ANSI / AAMI ES60601-1 (Medical Electrical Equipment Safety) | Complied |
| IEC60601-1-2 (Electromagnetic Compatibility) | Complied |
| IEC60601-2-37 (Ultrasonic Medical Diagnostic Equipment Safety) | Complied |
| ISO10993-1 (Biological Evaluation of Medical Devices) | Complied (Biocompatibility of materials) |
| IEC62359 (Thermal and Mechanical Indices of Ultrasonic Fields) | Complied |
| ISO14971 (Application of risk management) | Complied |
| NEMA (Digital Imaging and Communications in Medicine - DICOM Set) | Complied (DICOM capability in device description) |
For the new features, the "acceptance criteria" are implied to be that they perform as intended and are substantially equivalent to existing functionalities or enhance workflow without impacting safety or effectiveness. The document asserts this by stating:
- CT Fusion: "substantially equivalent to the V Nav feature with Fusion on LOGIQ E9 (K082185)."
- 4D Marker: "an extension of existing image annotation capabilities on the predicate Vivid E90 / Vivid E95 (K173341)."
- 4D Auto LAO: "substantially equivalent to the 4D Auto RVQ already present on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K173341)."
- AutoEF 2.0 & AFI 2.0: "workflow improvement of functionality already available on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K173341)." and "expanded ... for pediatric use."
- Automatic View Recognition: "workflow improvement to AFI 2.0 and Auto EF 2.0 and provides an automated alternative to manual image selection already available on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K173341)."
- "Whitelisting", "Texture", "Hybrid Filter", 24" LCD monitor, reduced weight: Explicitly state "no impact on the safety or effectiveness of the clinical functionality" or device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail specific sample sizes or data provenance for a test set in the context of a clinical study for performance evaluation. The submission relies on non-clinical tests and demonstrations of substantial equivalence for feature updates rather than a new clinical performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
No information provided. Clinical studies with expert ground truth establishment are not described for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No information provided, as clinical studies with adjudication methods are not described.
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 is mentioned in this document. The "Automatic View Recognition" feature uses a deep neural network, but its performance is described as an "automated alternative to manual image selection" and a "workflow improvement" to existing functionalities, rather than a comparative effectiveness study showing human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document mentions "Automatic View Recognition" which is "new functionality based on deep neural network embedded into the software." While this suggests a standalone algorithm, no standalone performance metrics (e.g., sensitivity, specificity) are provided for this feature. Its role is described as a "workflow improvement" and "automated alternative" to manual processes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the new AI/software features, the "ground truth" seems to be implicitly the functionality of the predicate device or a clinical outcome (e.g., left atrium volumes as measured by the device for "4D Auto LAO"). However, the explicit method of establishing this ground truth (e.g., expert consensus on specific cases for validation) is not detailed in this summary.
8. The sample size for the training set
The document states that "Automatic View Recognition" is "new functionality based on deep neural network." However, it does not provide any information regarding the sample size of the training set used for this deep neural network.
9. How the ground truth for the training set was established
The document does not provide any information regarding how the ground truth for the training set was established for the deep neural network used in "Automatic View Recognition."
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.