(89 days)
The Vivid iq is high-performance compact diagnostic ultrasound system designed for cardiovascular and shared services. It is intended for use by Healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid iq clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Urology (Including prostate), Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy), Thoracic/Pleural, Intraoperative(Vascular), Intracardiac and Intraluminal. Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power/PWD. The device is intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities.
The proposed Vivid ig system is a general-purpose, Track 3, diagnostic ultrasound device, primarily intended for cardiovascular diagnostic use and shared service imaging. It is an ultrasound imaging & analysis system, consisting of a compact console with control panel including a track pad, color LCD Touch Panel that includes an on-screen alfa-numeric keyboard. The system also has an optional height-adjustable cart for comfortable standing and sitting positions. An extended battery is integrated within the Vivid ig cart and provides additional power for longer scanning time.
There are options for image storage, USB wireless connectivity, cardiac signal input for cardiac gating and output capabilities to printing devices. Vivid ig utilizes 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 transducer. The system can also be used with compatible ICE transducers.
The system includes electronics for transmit and receive of 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.
Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The document describes the performance of the AI algorithms, "Easy Auto EF" and "Easy AFI LV," which are components of the Vivid iq system. The primary acceptance criterion appears to be the accuracy of the AI algorithm in terms of its Dice score.
| Acceptance Criterion | Reported Device Performance (Dice Score) |
|---|---|
| Accuracy on different countries | >= 92% |
| Accuracy on different scan views | >= 91% |
| Accuracy on different LV volumes | >= 92% |
Note: The document only provides performance metrics for the AI algorithms specifically, not for the entire Vivid iq system's overall clinical performance beyond safety and equivalence to predicates for its general ultrasound functions.
Study Details for AI Algorithms (Easy Auto EF and Easy AFI LV)
2. Sample size used for the test set and the data provenance:
- Number of images: 135 images.
- Number of exams: 45 exams.
- Assumed number of patients: 45 patients (exact number unknown due to anonymization).
- Provenance: Retrospective data collected from different countries, including Europe, Asia, and the US. The document states that the testing dataset came from different clinical sites than the training data to ensure independence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Initial Experts: Two certified cardiologists.
- Adjudication Panel: An unspecified "panel of experienced experts" for cases where the initial two cardiologists did not agree. Specific qualifications for the panel are not provided beyond "experienced experts."
4. Adjudication method for the test set:
- Primary Method: Consensus reading between two certified cardiologists. They performed manual delineation and then reviewed each other's annotations. They discussed and agreed upon annotations.
- Secondary Method: For annotations where the two cardiologists could not agree, a "panel of experienced experts" further reviewed and established a consensus ground truth. This suggests a 2+1 (or 2+N) approach for disagreements.
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 involving human readers with and without AI assistance is described in the provided text. The evaluation focuses solely on the standalone performance of the AI algorithm against expert-established ground truth.
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. The reported Dice scores (91-92% or higher) reflect the algorithm's accuracy in autonomously delineating structures.
7. The type of ground truth used:
- Expert consensus was used as the ground truth. This was derived from manual delineations by two certified cardiologists, with a panel of experienced experts resolving disagreements.
8. The sample size for the training set:
- The sample size for the training set is not specified in the provided document. It only mentions that datasets from different clinical sites were used for training compared to the test set.
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. However, given the description for the test set, it is highly probable that a similar expert-driven delineation and consensus process was used.
§ 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.