(9 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 document is a 510(k) Premarket Notification Submission for the GE Vivid E80, Vivid E90, and Vivid E95 diagnostic ultrasound systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results and acceptance criteria in the manner one might find in a full clinical trial report for novel technologies.
Based on the provided text, the device itself is a diagnostic ultrasound system (Vivid E80, Vivid E90, Vivid E95) and the acceptance criteria and study information are presented in the context of demonstrating substantial equivalence to a predicate device (Vivid E80, Vivid E90, Vivid E95 (K170823)).
Here's the breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) and corresponding reported performance values from a dedicated clinical study for the entire device. Instead, it states that the device complies with voluntary standards for safety and performance (summarized below). The "performance" reported is primarily in terms of equivalency to the predicate device and the added capabilities.
| Acceptance Criterion (Implied/Standard) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Substantially equivalent to the predicate device(s). |
| Acoustic Output | Evaluated and complies with applicable medical device safety standards. |
| Biocompatibility | Evaluated and complies with applicable medical device safety standards. Transducer materials and other patient contact materials are biocompatible. |
| Cleaning and Disinfection Effectiveness | Evaluated and complies with applicable medical device safety standards. |
| Thermal Safety | Evaluated and complies with applicable medical device safety standards. |
| Electrical Safety | Evaluated and complies with applicable medical device safety standards. |
| Electromagnetic Safety | Evaluated and complies with applicable medical device safety standards (IEC60601-1-2). |
| Mechanical Safety | Evaluated and complies with applicable medical device safety standards. |
| Compliance with Voluntary Standards | ANSI / AAMI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, IEC62359, ISO14971, NEMA DICOM Set. |
| Functional Equivalence (with predicate) | Same fundamental scientific technology, intended use, imaging capabilities, technological characteristics. |
| New Transducer Features | 4Vc-D: Reduced physical dimensions and weight compared to predicate 4V-D, identical indications for use. |
| 10T-D: Same indications for use as predicate 9T transducer. | |
| New Option Feature | Vmax: Higher processing speed (GPU) enabling higher 4D volume-rates in imaging. |
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 explicitly states: "The subject of this premarket submission, Vivid E80 / Vivid E90 / Vivid E95, did not require clinical studies to support substantial equivalence." This means no clinical "test set" in the traditional sense of patient data was used for this 510(k) submission. The evaluation was based on non-clinical tests (bench testing, engineering verification).
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)
Since no clinical studies were required, there were no "experts" establishing ground truth in the context of a clinical test set. The substantial equivalence argument relies on the established safety and effectiveness of the predicate device and the demonstration that the modified device (including new transducers and GPU option) does not raise new questions of safety or effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring ground truth 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
Not applicable. This device is an ultrasound system (hardware and software), not an AI-assisted diagnostic tool in the sense of providing interpretations that would be evaluated in an MRMC study for reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As above, this is a diagnostic ultrasound imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies were required and the submission relies on non-clinical testing and substantial equivalence to a predicate device. The "ground truth" here is compliance with recognized safety and performance standards for ultrasound equipment.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device that undergoes training on a dataset. The device is a diagnostic ultrasound system.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device that undergoes training on a dataset.
§ 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.