(84 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, OLED 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.
The provided text describes a 510(k) premarket notification for the GE Vivid E80, E90, and E95 ultrasound systems. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies to prove effectiveness. Therefore, the document explicitly states that "The subject of this premarket submission, Vivid E80 / Vivid E90 / Vivid E95, did not require clinical studies to support substantial equivalence."
Because no new clinical study was required or performed for this specific submission, detailed information regarding acceptance criteria, device performance from such a study, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not available within this document. The device's acceptance is based on its similarity to existing, cleared devices and its compliance with non-clinical performance and safety standards.
Here's a breakdown of the information that is available based on your request, understanding that a new clinical study to "prove acceptance" was not conducted:
1. A table of acceptance criteria and the reported device performance
Since no new clinical study was presented for this submission, there are no specific performance metrics to report from such a study that demonstrate the device meets acceptance criteria. The acceptance is based on:
| Acceptance Criteria Category | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Intended Use Equivalence | The Vivid E80 / Vivid E90 / Vivid E95 is equivalent to its predicate devices for the specified clinical applications (Fetal/Obstetrics, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology, Transesophageal, Transrectal, Transvaginal, Intraoperative, Tissue Biopsy, Vascular Access) and corresponding modes of operation. New indications (Musculo-skeletal Superficial) and transducer expansions are within the scope of previously cleared applications or are minor enhancements not changing body surface type or patient contact time. |
| Technological Equivalence | Employs the same fundamental scientific technology as its predicate devices. |
| Safety and Effectiveness | Complies with applicable medical device safety standards including acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety. Compliance with voluntary standards: ANSI / AAMI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, IEC62359, ISO14971, NEMA DICOM Set. |
| Quality Assurance | Applied measures including Risk Analysis, Usability Analysis, Requirements Reviews, Design Reviews, unit-level testing (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), Simulated use testing (Validation). Transducer materials and other patient contact materials are biocompatible. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no new clinical study was conducted for this 510(k) submission. Acceptance is based on non-clinical testing and comparison to predicate devices.
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)
Not applicable, as no new clinical study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical study was conducted.
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, as no new clinical study was conducted for this 510(k) submission. The document mentions new features like "Myocardial Work" (builds on existing functionality), "4D Auto RVQ" and "4D Auto MVQ" (alternative implementations of existing functionality), "Cardiac AutoDoppler", "FlexiViews", and "QuickApps" (workflow improvements). "Blood Speckle Imaging" (BSI) is a new tool described as displaying graphical presentations of blood flow trajectories, but its performance is not assessed in a comparative effectiveness study within this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as no new clinical study was conducted. The document broadly covers "Diagnostic Ultrasound System" and its various transducers; it is not a submission for a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new clinical study was conducted.
8. The sample size for the training set
Not applicable, as no new clinical study or AI algorithm training data details are provided in this regulatory submission.
9. How the ground truth for the training set was established
Not applicable, as no new clinical study or AI algorithm training data details are provided in this regulatory submission.
§ 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.