Search Results
Found 1 results
510(k) Data Aggregation
(86 days)
Vivid Pioneer 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 or sonographer for ultrasound imaging, measurement, display and analysis of the human body and fluid.
Vivid Pioneer 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, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transesophageal, Transvaginal, Transrectal, Intra-cardiac, Intra-luminal and Interventional Guidance (including Biopsy, Vascular Access), Thoracic/Pleural and Intraoperative (vascular).
Modes of operation include: 3D, Real time (RT) 3D Mode (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.
The proposed Vivid Pioneer is a general purpose, Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It provides digital acquisition, processing, display and analysis capabilities. It consists of a mobile console with a height-adjustable control panel, color LCD touch panel, and a display monitor.
Vivid Pioneer 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 transducer. The proposed Vivid Pioneer can be used with the stated compatible OEM ICE transducers. The system includes capability to output data to other devices like printing devices.
The user-interface includes an operator control panel, a 23.8" High-Definition Ultrasound LCD type of display monitor (mounted on an arm for rotation and / or adjustment of height), a layout of pre-defined user controls (hard-keys) and a 15.6-inch multi-touch LCD panel with mode-and operation dependent soft-keys.
The operator panel also includes two loudspeakers for audio, shelves for convenient placement of papers or accessories, and 6 holders with cable management for the connected transducers.
The lower console is mounted on 4 rotational wheels with brakes, for ergonomic transport and safe parking. The lower console also includes all 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.
This document describes the acceptance criteria and study proving the device meets the criteria for two AI features of the Vivid Pioneer Ultrasound System: AI Cardiac Auto Doppler and AI FlexiViews LAA.
1. Table of Acceptance Criteria and Reported Device Performance
AI Cardiac Auto Doppler
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Feasibility score of > 95% | All clinical parameters, as performed by AI Cardiac Auto Doppler without user edits, passed the check for mean percent absolute error across all cardiac cycles against a threshold. This implies the accuracy threshold was met, which indirectly suggests successful feasibility to achieve this accuracy. |
| Expected accuracy threshold calculated as the mean absolute difference in percentage for each measured parameter. | All clinical parameters, as performed by AI Cardiac Auto Doppler without user edits, passed this check. |
| Mean percent absolute error across all cardiac cycles against a threshold. | All clinical parameters, as performed by AI Cardiac Auto Doppler without user edits, passed this check. |
| Consistent model performance across BMI groups (<25 and $\ge$ 25) with predefined metric quantifying agreement between manual and AI-derived peak velocities. | Tissue Doppler: Mean performance metric = -0.002 (SD = 0.077) for BMI < 25; -0.006 (SD = 0.081) for BMI $\ge$ 25.Flow Doppler: Mean performance metric = 0.021 (SD = 0.073) for BMI < 25; 0.003 (SD = 0.057) for BMI $\ge$ 25. |
AI FlexiViews LAA
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Greater than 80% success rate of LAA region localization and landmark extraction | The model achieved a verification success rate of 85%, with a sensitivity of 84.91% and a specificity of 91.82%. Consistent model performance observed across TEE angles (0 to 100 degrees) with a success rate of 80% or higher. Strong model performance for individuals with a BMI above 25 (over 85% accuracy). |
2. Sample Size Used for the Test Set and Data Provenance
AI Cardiac Auto Doppler:
- Tissue Doppler test set: 4106 recordings from 805 individuals.
- Doppler Trace test set: 3390 recordings from 1369 individuals.
- Data Provenance: Retrospective, collected from USA (several locations), Australia, France, Spain, Norway, Italy, Germany, Thailand, Philippines.
AI FlexiViews LAA:
- Test set: 342 recordings from 84 individuals.
- Data Provenance: Retrospective, collected from USA, Norway, Italy, France, Philippines.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
AI Cardiac Auto Doppler:
- Experts for annotations: Two cardiologists.
- Review panel for consensus: Five clinical experts.
- Qualifications: The document specifies "cardiologists" and "clinical experts" but does not explicitly state years of experience or board certification details.
AI FlexiViews LAA:
- Experts for annotations: Two cardiologists.
- Supervision for annotations: Two US certified clinicians.
- Review panel for consensus: Three clinical experts.
- Qualifications: The document specifies "cardiologists" and "US certified clinicians" and "clinical experts" but does not explicitly state years of experience or board certification details.
4. Adjudication Method for the Test Set
AI Cardiac Auto Doppler:
- Annotations were performed by two cardiologists.
- A review panel of five clinical experts provided feedback.
- Annotations were corrected (as needed) until a consensus agreement was achieved between the annotators and reviewers. This suggests an adjudication method aimed at reaching a single agreed-upon ground truth.
AI FlexiViews LAA:
- Annotations were performed by two cardiologists, supervised by two US certified clinicians.
- A review panel of three clinical experts provided feedback.
- Annotations were corrected (as needed) until a consensus agreement was achieved between the annotators and reviewers. Similar to Auto Doppler, this indicates a consensus-based adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study to assess how much human readers improve with AI vs. without AI assistance for either AI Cardiac Auto Doppler or AI FlexiViews LAA. The evaluation focused on the standalone performance of the AI algorithms against expert-derived ground truth.
6. Standalone Performance (Algorithm Only)
Yes, standalone (algorithm only without human-in-the-loop performance) studies were done for both AI features.
- AI Cardiac Auto Doppler: Performance was evaluated based on the AI algorithm's measurements directly compared to expert-derived ground truth. The verification explicitly states "AI Cardiac Auto Doppler without user edits passed this check."
- AI FlexiViews LAA: The "model achieved a verification success rate of 85%" based on its localization and landmark extraction, directly reflecting standalone performance.
7. Type of Ground Truth Used
Expert Consensus.
For both AI Cardiac Auto Doppler and AI FlexiViews LAA, the ground truth was established through:
- Manual measurements/annotations performed by cardiologists.
- Assessment of Doppler/ECG signal quality.
- Supervision by US certified clinicians (for LAA).
- Review and consensus agreement among a panel of clinical experts.
8. Sample Size for the Training Set
AI Cardiac Auto Doppler:
- Tissue Doppler development dataset: 1482 recordings from 4 unique clinical sites.
- Doppler Trace development dataset: 2070 recordings from 4 unique clinical sites.
AI FlexiViews LAA:
- Total development dataset: 612 recordings from 5 unique clinical sites.
9. How the Ground Truth for the Training Set Was Established
The ground truth for the development (training/validation) datasets was established in the same manner as the ground truth for the test sets:
- For both AI Cardiac Auto Doppler and AI FlexiViews LAA:
- Annotators (cardiologists, supervised by US certified clinicians for LAA) performed manual measurements/annotations after assessing image quality (Doppler signal quality and ECG signal quality for Auto Doppler, LAA contour and specific points for FlexiViews LAA).
- Annotations followed US ASE (American Society of Echocardiography) based annotation guidelines.
- A review panel of clinical experts (five for Auto Doppler, three for FlexiViews LAA) provided feedback.
- Annotations were corrected (as needed) until a consensus agreement was achieved between the annotators and reviewers.
Ask a specific question about this device
Page 1 of 1