(119 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 and trained physician 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 EP lab or in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (including renal, GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transvaginal, Transvaginal, Transrectal, Intra-cardiac and Intra-luminal Guidance (including Biopsy, Vascular Access), ThoracicPleural and Intraoperative (vascular). Modes of operation include: 3D, Real time (RT) 3D (4D), B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
Vivid™ E80 / Vivid E90 / Vivid E95 is a Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals, 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 capabilities.
The Vivid E80 / Vivid E90 / Vivid E95 consists of a mobile console with a height-adjustable control panel, color LCD touch panel, and display monitor. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array or dual array format, including dedicated CW transducers and real time 3D transducers. System can also be used with compatible ICE transducer.
The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection. The system includes capability to output data to other devices like printing devices.
The device in question is the Vivid E80/Vivid E90/Vivid E95 ultrasound system, which includes Artificial Intelligence (AI) features named Easy Auto EF and Easy AFI LV.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (for AI algorithm accuracy) | Reported Device Performance (Average Dice Score) |
|---|---|
| 92% or higher for datasets from different countries | 92% or higher |
| 91% or higher for datasets from different scanning views | 91% or higher |
| 92% or higher for datasets from different left ventricle volumes | 92% or higher |
2. Sample Size Used for the Test Set and Data Provenance:
- Number of individual patients' images: 45 exams from assumed 45 patients (exact number of patients unknown due to anonymization).
- Number of samples (images): 135 images extracted from the 45 exams.
- Data Provenance: Retrospective, collected from different countries across Europe, Asia, and the US. The dataset included adult patients; specific age and gender were unknown due to anonymization.
- Clinical Subgroups and Confounders: The test dataset included images from different countries, different scanning views, and a range of different Left Ventricle (LV) volumes.
- Equipment and Protocols: Mixed data from 5 different probes and 4 different Console variants. Data collection protocol was standardized across all sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Initial Ground Truthing: Two certified cardiologists.
- Adjudication/Consensus: A panel of experienced experts further reviewed annotations that the two cardiologists could not agree on.
- Qualifications: "Certified cardiologists" for initial delineation and "experienced experts" for the panel. Specific experience levels (e.g., years of experience) are not provided.
4. Adjudication Method for the Test Set:
- Method: A 2+1 (or 2+panel) adjudication method was used.
- First, two certified cardiologists performed manual delineation and reviewed each other's annotations.
- A consensus reading was performed where the two cardiologists discussed disagreements.
- If they could not agree, a panel of experienced experts reviewed the annotations to reach a final consensus.
- Ground Truth Definition: The ground truth used was the annotations that the initial two cardiologists agreed upon, and the consensus annotations achieved by the expert panel for disagreed cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No MRMC comparative effectiveness study involving human readers with and without AI assistance was mentioned in the provided text. The evaluation 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 (Easy Auto EF and Easy AFI LV) was conducted. The accuracy was measured using the average Dice score based on the ground truth established by expert consensus.
7. The Type of Ground Truth Used:
- Expert Consensus: The ground truth for the test set was established through a multi-stage process involving manual delineation by two certified cardiologists, their peer review, and a final consensus by a panel of experienced experts.
8. The Sample Size for the Training Set:
- The document states that to ensure independence, "we used datasets from different clinical sites for testing as compared to the clinical sites for training." However, the specific sample size of the training set is not provided in the given text.
9. How the Ground Truth for the Training Set Was Established:
- The document implies that training data existed ("datasets from different clinical sites for training"), but it does not explicitly describe how the ground truth for the training set was established.
§ 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.