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510(k) Data Aggregation
(108 days)
V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System:
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac) 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 Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode.
V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System:
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac), Peripheral vessel and Dermatology. 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 Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode, MV-Flow Mode.
■ V8/cV8, V7/cV7, V6/cV6
The V8/cV8, V7/cV7, V6/cV6 Diagnostic Ultrasound Systems are general purpose, mobile, software controlled, diagnostic ultrasound systems. Its function is to acquire ultrasound data and to display the data as 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 Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode. The V8/cV8, V7/cV7, V6/cV6 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 V8/cV8, V7/cV7, V6/cV6 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
■ V5/cV5, V4/cV4
The V5/cV5, V4/cV4 Diagnostic Ultrasound Systems are general purpose, mobile, software controlled, diagnostic ultrasound systems. Its function is to acquire ultrasound data and to display the data as B-mode, 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 V5/cV5, V4/cV4 diagnostic ultrasound systems also give the operator the ability to measure anatomical structures and offer analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The V5/cV5, V4/cV4 diagnostic ultrasound systems have a real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The provided FDA 510(k) clearance letter describes the Samsung Medison Ultrasound Systems (V8/cV8, V7/cV7, V6/cV6, V5/cV5, V4/cV4) and their AI-powered features: BiometryAssist, ViewAssist, HeartAssist (fetus), and EzNerveMeasure of NerveTrack.
Below is a breakdown of the acceptance criteria and study details for each AI feature, based on the provided text.
BiometryAssist
1. Table of Acceptance Criteria and Reported Device Performance
| Feature Area | Acceptance Criteria (Threshold) | Reported Device Performance |
|---|---|---|
| Segmentation | Average Dice-score ≥ 0.8 | Average Dice-score = 0.869 |
| Size Measurement (Circumference) | Error Rate ≤ 8% | Error Rate = 8% or less |
| Size Measurement (Distance) | Error Rate ≤ 4% | Error Rate = 4% or less |
| Size Measurement (NT) | Error Rate ≤ 1mm | Error Rate = 1mm or less |
2. Sample Size for Test Set and Data Provenance
- Individual Patients: 52 (17 from South Korea, 35 from the US)
- Images: 320 static images
- Data Provenance: Mix of retrospective and prospective data collection from hospitals in South Korea and the United States.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: 3 (one obstetrician, two sonographers) + 1 senior obstetrician for supervision.
- Qualifications:
- One obstetrician with over 20 years of experience in fetal cardiology.
- Two sonographers, each with more than 10 years of experience.
- One senior obstetrician with over 25 years of clinical experience (supervised and corrected annotations).
4. Adjudication Method for Test Set
- Expert reviewers manually performed view classification and measurements following the same protocol as used during actual device operation. The entire process was supervised by a senior obstetrician who reviewed and corrected all annotations to ensure consistency and accuracy. This implies an expert consensus-based adjudication, likely 3+1 or similar, though not explicitly stated as a formal (X+Y) method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not explicitly mentioned. The study focuses on standalone algorithm performance against expert ground truth.
6. Standalone Performance (Algorithm Only)
- Yes, performance metrics (Dice-score, error rates) are reported for the algorithm's output compared to established ground truth.
7. Type of Ground Truth Used
- Expert Consensus: Ground truth was established by expert reviewers manually classifying views and performing measurements, supervised and corrected by a senior obstetrician. This closely reflects the clinical use environment.
8. Sample Size for Training Set
- Not specified. The document only states that data used for training, tuning, and validation were completely separated.
9. How Ground Truth for Training Set Was Established
- All images used for training and tuning were first classified into the correct ultrasound views by three participating experts. Following view classification, the corresponding anatomical structures were manually annotated for each image.
ViewAssist
1. Table of Acceptance Criteria and Reported Device Performance
| Feature Area | Acceptance Criteria (Threshold) | Reported Device Performance |
|---|---|---|
| View Recognition (Sensitivity) | Not explicitly stated (thresholds 75.9%, 88.2% defined) | Achieved sensitivity = 93.97% |
| View Recognition (Specificity) | Not explicitly stated (thresholds 75.9%, 88.2% defined) | Achieved specificity = 99.62% |
| Segmentation | Average Dice-score ≥ 0.8 | Average Dice-score = 0.863 |
2. Sample Size for Test Set and Data Provenance
- Individual Patients: 102 (42 from South Korea, 60 from the US)
- Images: 680 static images
- Data Provenance: Mix of retrospective and prospective data collection from hospitals in South Korea and the United States.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: 3 (one obstetrician, two sonographers) + 1 senior obstetrician for supervision.
- Qualifications:
- One obstetrician with over 20 years of experience in fetal cardiology.
- Two sonographers, each with more than 10 years of experience.
- One senior obstetrician with over 25 years of clinical experience (supervised and corrected annotations).
4. Adjudication Method for Test Set
- Expert reviewers manually performed view classification and measurements following the same protocol as used during actual device operation. The entire process was supervised by a senior obstetrician who reviewed and corrected all annotations to ensure consistency and accuracy. This implies an expert consensus-based adjudication, likely 3+1 or similar.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not explicitly mentioned. The study focuses on standalone algorithm performance against expert ground truth.
6. Standalone Performance (Algorithm Only)
- Yes, performance metrics (sensitivity, specificity, Dice-score) are reported for the algorithm's output compared to established ground truth.
7. Type of Ground Truth Used
- Expert Consensus: Ground truth was established by expert reviewers manually classifying views and performing measurements, supervised and corrected by a senior obstetrician. This closely reflects the clinical use environment.
8. Sample Size for Training Set
- Not specified. The document only states that data used for training, tuning, and validation were completely separated.
9. How Ground Truth for Training Set Was Established
- All images used for training and tuning were first classified into the correct ultrasound views by three participating experts. Following view classification, the corresponding anatomical structures were manually annotated for each image.
HeartAssist (fetus)
1. Table of Acceptance Criteria and Reported Device Performance
| Feature Area | Acceptance Criteria (Threshold) | Reported Device Performance |
|---|---|---|
| View Recognition (Sensitivity) | Not explicitly stated (thresholds 75.9%, 88.2% defined) | Achieved sensitivity = 94.29% |
| View Recognition (Specificity) | Not explicitly stated (thresholds 75.9%, 88.2% defined) | Achieved specificity = 99.62% |
| Segmentation | Average Dice-score ≥ 0.8 | Average Dice-score = 0.865 |
| Size Measurement (Area) | Error Rate ≤ 8% | Error Rate = 8% or less |
| Size Measurement (Angle) | Error Rate ≤ 4% | Error Rate = 4% or less |
| Size Measurement (Circumference) | Error Rate ≤ 11% | Error Rate = 11% or less |
| Size Measurement (Diameter) | Error Rate ≤ 11% | Error Rate = 11% or less |
2. Sample Size for Test Set and Data Provenance
- Individual Patients: 70 (26 from South Korea, 44 from the US)
- Images: 280 static images
- Data Provenance: Mix of retrospective and prospective data collection from hospitals in South Korea and the United States.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: 3 (one obstetrician, two sonographers) + 1 senior obstetrician for supervision.
- Qualifications:
- One obstetrician with over 20 years of experience in fetal cardiology.
- Two sonographers, each with more than 10 years of experience.
- One senior obstetrician with over 25 years of clinical experience (supervised and corrected annotations).
4. Adjudication Method for Test Set
- Expert reviewers manually performed view classification and measurements following the same protocol as used during actual device operation. The entire process was supervised by a senior obstetrician who reviewed and corrected all annotations to ensure consistency and accuracy. This implies an expert consensus-based adjudication, likely 3+1 or similar.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not explicitly mentioned. The study focuses on standalone algorithm performance against expert ground truth.
6. Standalone Performance (Algorithm Only)
- Yes, performance metrics (sensitivity, specificity, Dice-score, error rates) are reported for the algorithm's output compared to established ground truth.
7. Type of Ground Truth Used
- Expert Consensus: Ground truth was established by expert reviewers manually classifying views and performing measurements, supervised and corrected by a senior obstetrician. This closely reflects the clinical use environment.
8. Sample Size for Training Set
- Not specified. The document only states that data used for training, tuning, and validation were completely separated.
9. How Ground Truth for Training Set Was Established
- All images used for training and tuning were first classified into the correct ultrasound views by three participating experts. Following view classification, the corresponding anatomical structures were manually annotated for each image.
EzNerveMeasure of NerveTrack
1. Table of Acceptance Criteria and Reported Device Performance
| Feature Area | Acceptance Criteria (Threshold) | Reported Device Performance |
|---|---|---|
| Flattening Ratio (FR) | Not explicitly stated | Average error rate = 8.05% (95% CI: [7.64, 8.46]), Std Dev = 0.87 |
| Cross-Sectional Area (CSA) | Not explicitly stated | Average error rate = 13.11% (95% CI: [11.83, 14.38]), Std Dev = 2.73 |
2. Sample Size for Test Set and Data Provenance
- Individual Patients: 20 (10 from South Korea, 10 from the US)
- Images: 200 static images (10 static images per patient from a 2D sequence)
- Data Provenance: Prospective data collected in clinical practice using Samsung ultrasound systems (RS80A and V8) from South Korea and the United States.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: 3 anesthesiologists + 1 senior anesthesiologist for resolution.
- Qualifications: All three anesthesiologists had over 10 years of experience. The senior anesthesiologist had over 10 years of extensive clinical experience in regional anesthesia and ultrasound-guided procedures.
4. Adjudication Method for Test Set
- The ground truth (GT) for median nerve locations was initially drawn by one anesthesiologist performing the ultrasound scans, then verified by the other two anesthesiologists. Disagreements were resolved by a senior anesthesiologist. This is a consensus-based adjudication process, effectively a 3+1 method for resolving disagreements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not explicitly mentioned. The study focuses on standalone algorithm performance against expert ground truth.
6. Standalone Performance (Algorithm Only)
- Yes, performance metrics (average error rate, confidence interval, standard deviation) are reported for the algorithm's output compared to established ground truth.
7. Type of Ground Truth Used
- Expert Consensus: Ground truth (median nerve locations, FR, CSA measurements) was established by three anesthesiologists, with disagreements resolved by a senior anesthesiologist. A clinical evaluation was also conducted by experienced doctors to assess clinical significance.
8. Sample Size for Training Set
- Not specified. The document only states that data used for training, tuning, and validation were completely separated.
9. How Ground Truth for Training Set Was Established
- Not explicitly detailed for the training set itself, but it implies a similar expert annotation process as described for validation, with clear separation between data sets.
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