(89 days)
The Vivid T8/Vivid T9 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by qualified and trained Healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab, and in private medical offices. The systems support the following clinical applications: Fetal/ Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Ceplalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculosketal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transesophageal, Transrectal, Transvaginal, Interventional guidance (including Biopsy, Fluid Drainage), Thoracic/Pleural, Intraoperative(Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color M, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD, B/Color/PWD, B/Power/PWD.
Vivid T9/Vivid T8 is a Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability.
The Vivid T9/Vivid T8 consists of a mobile console with control panel color LCD touch panel, LCD display monitor and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, and dual array including dedicated CW transducers.
The user-interface includes an operator control panel, a 21.5-inch-wide screen LCD monitor (mounted on an arm for rotation and/or adjustment of height), a 10.1-inch touch panel with multi-touch capabilities and alpha-numeric keyboard.
The smart standby battery is an option to allow the system to not have to be powered down when moving from room to room. Imaging is not allowed when it is not plugged in.
The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.
Vivid T8 and Vivid T9 are based on the same SW platform and similar HW design. Each system may have different configurations available. The configurations may differ by available SW-options and transducers provided commercially. Vivid T9 has height-adjustable control panel, while Vivid T8's control panel can't be adjustable. Vivid T9 has monitor flexible arm, while Vivid T8 has a monitor fixed arm and monitor flexible arm as an option.
The product named Vivid T9 represents the system that has the full functionality and is offered with full support for transducers.
The GE Vivid T8/Vivid T9 ultrasound system includes AI algorithms named Easy Auto EF and Easy AFI LV. The acceptance criteria and the study proving the device meets these criteria are described below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Metric) | Reported Device Performance (Easy Auto EF and Easy AFI LV) |
|---|---|
| Average Dice Score (overall) | 92% or higher |
| Average Dice Score (different scanning views) | 91% or higher |
| Average Dice Score (different left ventricle volumes) | 92% or higher |
2. Sample Size Used for the Test Set and Data Provenance
- Number of Individual Patients' Images: 135 images
- Number of Exams: 45 exams (assumed 45 patients, exact number of patients unknown due to anonymization)
- Data Provenance:
- Country of Origin: Europe, Asia, US
- Retrospective/Prospective: Not explicitly stated, but implies retrospective collection from various clinical sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Initial Ground Truth Establishment: Two certified cardiologists.
- Adjudication Panel: A panel of experienced experts. Specific number and years of experience not provided, beyond "experienced experts."
4. Adjudication Method for the Test Set
The adjudication method appears to be a 2 + 1 method (or similar consensus-based approach):
- Two certified cardiologists performed manual delineation and reviewed each other's annotations.
- A consensus reading was conducted where the two cardiologists discussed their agreement.
- For annotations where the two cardiologists could not agree, a panel of experienced experts further reviewed and established the consensus.
- The final ground truth comprised annotations agreed upon by the two cardiologists, and the consensus annotations from the expert panel review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not conducted. The document focuses on the standalone performance of the AI algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation of the AI algorithm was conducted, specifically measuring the accuracy (Dice score) of the AI algorithm(s) against an established ground truth.
7. The Type of Ground Truth Used
The ground truth used was expert consensus. It was established through a multi-step process involving initial independent delineation by two certified cardiologists, their consensus discussions, and further review by a panel of experienced experts for disagreements.
8. The Sample Size for the Training Set
The document does not provide the sample size for the training set. It only states that the testing dataset was independent of the training data.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly describe how the ground truth for the training set was established. It only mentions that the testing dataset was ensured to be independent from the training data by using datasets from "different clinical sites for testing as compared to the clinical sites for training."
§ 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.