(100 days)
The Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.
Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan+TM Mode, Combined modes, Multi-Image modes (Dual, Quad), 3D/4D modes.
The HERA W9/ HERA W10 are general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as Bmode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S- Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes.
The HERA W9/HERA W10 also give the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HERA W9/HERA W10 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Here's an analysis of the acceptance criteria and study details for the BiometryAssist and ViewAssist features of the HERA W9/HERA W10 Diagnostic Ultrasound System, based on the provided document:
BiometryAssist
1. Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria | Reported Performance |
|---|---|---|
| Segmentation Test | Average Dice-score ≥ 0.8 | 0.91 (threshold 0.8) |
| Size Measurement | Circumference error rate ≤ 8% | 8% or less |
| Distance measured value error rate ≤ 4% | 4% or less | |
| NT measured value error rate ≤ 1mm | 1mm or less |
2. Sample Size and Data Provenance
- Test Set Sample Size: 320 fetal biometry images.
- Data Provenance: Images collected retrospectively and prospectively at two hospitals in South Korea and the United States.
3. Number of Experts and Qualifications
- Experts for Test Set Ground Truth: Three participating experts and one supervising obstetrician.
- Qualifications:
- One obstetrician with more than 20 years of experience (supervisor).
- Two sonographers with more than 10 years of experience, all specializing in fetal cardiology.
- One obstetrician with more than 25 years of experience (supervisor).
4. Adjudication Method
- The document implies a consensus-based approach among the three experts for classifying images and manually drawing anatomy areas, supervised by a fourth obstetrician. No specific "2+1" or "3+1" adjudication method is explicitly stated, but the process involves multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not explicitly mentioned or described for comparing human readers with and without AI assistance. The study focuses on the standalone performance of the AI algorithm.
6. Standalone Performance
- Yes, the study describes the standalone performance of the algorithm for segmentation and size measurement without human intervention after the initial image acquisition and ground truthing.
7. Type of Ground Truth Used
- Expert consensus. All acquired images for training, tuning, and validation were classified into correct views by experts, and corresponding anatomy areas were manually drawn by them.
8. Training Set Sample Size
- Not explicitly stated, but the document mentions that a dataset was acquired for training, tuning, and validation.
9. How Ground Truth for Training Set Was Established
- All acquired images for training, tuning, and validation were first classified into the correct views by three participating experts. Afterwards, corresponding anatomy areas were manually drawn for each image. The participating experts were composed of an obstetrician with more than 20 years of experience and two sonographers with more than 10 years of experience, all in fetal cardiology, and the entire process was supervised by another obstetrician with more than 25 years of experience.
ViewAssist
1. Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria | Reported Performance |
|---|---|---|
| View Recognition Test | Average recognition accuracy ≥ 89% | 94.70% (threshold 89%) |
| Anatomy Annotation (Segmentation) Test | Average Dice-score ≥ 0.8 | 0.875 (threshold 0.8) |
2. Sample Size and Data Provenance
- Test Set Sample Size: 1,320 fetal heart and fetal biometry images.
- Data Provenance: Images collected retrospectively and prospectively at two hospitals in South Korea and the United States.
3. Number of Experts and Qualifications
- Experts for Test Set Ground Truth: Three participating experts and one supervising obstetrician.
- Qualifications:
- One obstetrician with more than 20 years of experience (supervisor).
- Two sonographers with more than 10 years of experience, all specializing in fetal cardiology.
- One obstetrician with more than 25 years of experience (supervisor).
4. Adjudication Method
- Similar to BiometryAssist, the document implies a consensus-based approach among the three experts for classifying images and manually drawing anatomy areas, supervised by a fourth obstetrician. No specific "2+1" or "3+1" adjudication method is explicitly stated, but the process involves multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not explicitly mentioned or described for comparing human readers with and without AI assistance. The study focuses on the standalone performance of the AI algorithm.
6. Standalone Performance
- Yes, the study describes the standalone performance of the algorithm for view recognition and anatomy annotation (segmentation) without human intervention after the initial image acquisition and ground truthing.
7. Type of Ground Truth Used
- Expert consensus. All acquired images for training, tuning, and validation were classified into correct views by experts, and corresponding anatomy areas were manually drawn by them.
8. Training Set Sample Size
- Not explicitly stated, but the document mentions that a dataset was acquired for training, tuning, and validation.
9. How Ground Truth for Training Set Was Established
- All acquired images for training, tuning, and validation were first classified into the correct views by three participating experts. Afterwards, corresponding anatomy areas were manually drawn for each image. The participating experts were composed of an obstetrician with more than 20 years of experience and two sonographers with more than 10 years of experience, all in fetal cardiology, and the entire process was supervised by another obstetrician with more than 25 years of experience.
§ 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.