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510(k) Data Aggregation
(108 days)
V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7
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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(75 days)
V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intraoperative. Pediatric, Small Organ, Neonatal Cephalic, Trans-rectal, 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.
The V8/cV8, V7/cV7, V6/cV6 are a general purpose, mobile, software controlled, diagnostic ultrasound system. Their 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 offer 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 a real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The provided text describes the acceptance criteria and study proving the device meets those criteria, specifically for the 'EzNerveMeasure' functionality of the V8/cV8, V7/cV7, V6/cV6 Diagnostic Ultrasound System.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Flattening Ratio (FR) Error Rate | Not explicitly stated an acceptance criterion, but implicitly that the performance is acceptable for clinical use. | Average: 8.31% (95% CI: [7.29, 9.34]) |
| Standard Deviation: 5.22 | ||
| Cross-Sectional Area (CSA) Error Rate | Not explicitly stated an acceptance criterion, but implicitly that the performance is acceptable for clinical use. | Average: 13.12% (95% CI: [10.90, 15.34]) |
| Standard Deviation: 11.33 |
Note: The document states, "We tested on the flattening ratio (FR) and cross-sectional area (CSA) of NerveTrack EzNerveMeasure." and then presents the average error rates. While explicit acceptance criteria values are not given (e.g., "FR error
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(98 days)
V8 Diagnostic Ultrasound System, V7 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, Small Organ, Neonatal Cephalic, Adult Cephalic, 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
The V8 / V7 are a general purpose, mobile, software controlled, diagnostic ultrasound system. Their 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 / V7 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 V8 / V7 have a real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The document describes the acceptance criteria and study results for several AI-based features integrated into the Samsung V8/V7 Diagnostic Ultrasound System, specifically: NerveTrack, BiometryAssist, ViewAssist, and HeartAssist.
Here's a breakdown of the requested information for each feature:
1. NerveTrack Feature
1.1. Table of Acceptance Criteria and Reported Device Performance
| Validation Type | Definition | Acceptance Criteria | Reported Average | Standard Deviation | 95% Confidence Interval |
|---|---|---|---|---|---|
| Accuracy (%) | Number of correctly detected frames / Total frames with nerve * 100 | ≥ 80% | 90.3 | 4.8 | 88.6 to 92.0 |
| Speed (FPS) | 1000 / Average latency time of each frame (msec) | ≥ 2 FPS | 3.54 | 0.13 | 3.47 to 3.61 |
1.2. Sample Size and Data Provenance for Test Set
- Number of Subjects: 18 (13 Females, 5 Males)
- Number of Images: 2,146
- Data Provenance: All Koreans. Retrospective and Prospective data collection on Samsung ultrasound devices (including V8).
1.3. Number and Qualifications of Experts for Ground Truth (Test Set)
- Number of Experts: 10 anesthesiologists and 5 sonographers.
- Qualifications: All experts had more than 10 years of experience.
1.4. Adjudication Method for Test Set
- One anesthesiologist scanned the ultrasound and drew the initial ground truth.
- Two or more other anesthesiologists and sonographers reviewed and confirmed the ground truth.
- If any mistake was identified during review, it was revised. (This suggests a consensus/adjudication process, effectively 2+1 or more experts for verification after initial labeling).
1.5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done?
- No, an MRMC study comparing human readers with and without AI assistance was not reported for NerveTrack. This study focused on the standalone performance of the AI algorithm.
1.6. If a Standalone (algorithm only) performance was done?
- Yes, the performance data provided (Accuracy and Speed) are for the standalone (algorithm only) performance of the NerveTrack feature.
1.7. Type of Ground Truth Used
- Expert consensus (manual delineation/labeling of nerve locations by multiple experienced anesthesiologists and sonographers).
1.8. Sample Size for Training Set
- Not specified. The document only states that the training data is independent of the test data.
1.9. How the Ground Truth for the Training Set was Established
- Not specified, but it's implied that a similar expert-based process was used, as it states "The training data used for the training of the NerveTrack algorithm are independent of the data used to test the NerveTrack algorithm."
2. BiometryAssist Feature
2.1. Table of Acceptance Criteria and Reported Device Performance
| Validation Type | Definition | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Segmentation | Dice-score | 0.8 (threshold) | Average Dice-score 0.928 |
| Size Measurement | Circumference Error | ≤ 8% | 8% or less |
| Size Measurement | Distance Error | ≤ 4% | 4% or less |
| Size Measurement | NT Error | ≤ 1mm | 1mm or less |
2.2. Sample Size and Data Provenance for Test Set
- Number of Images: 320 fetal biometry images.
- Data Provenance: Collected at two hospitals. Ethnicity/Country: Americans and Koreans.
- Retrospective/Prospective: Mix of retrospective and prospective data collection. Only V8 images were used for the performance test.
2.3. Number and Qualifications of Experts for Ground Truth (Test Set)
- Number of Experts: Three participating experts (obstetricians) and two sonographers. The entire process was supervised by another obstetrician.
- Qualifications: Obstetricians with more than 20 years of experience, sonographers with more than 10 years of experience, and a supervising obstetrician with more than 25 years of experience; all in fetal cardiology (though the feature is biometry, experts are stated as "in fetal cardiology").
2.4. Adjudication Method for Test Set
- All acquired images were first classified into correct views by three participating experts.
- Corresponding anatomy areas were manually drawn for each image.
- The entire process was supervised (implying a form of consensus/adjudication).
2.5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done?
- No, an MRMC study was not reported. This study assessed the standalone algorithm's performance against expert ground truth.
2.6. If a Standalone (algorithm only) performance was done?
- Yes, the validation was for the deep learning based segmentation algorithm and its measurement capabilities.
2.7. Type of Ground Truth Used
- Expert consensus (manual drawing/delineation of anatomy areas by multiple experienced obstetricians and sonographers).
2.8. Sample Size for Training Set
- Not specified. The data used for training, tuning, and validation are completely separated.
2.9. How the Ground Truth for the Training Set was Established
- Implied to be similar to the test set ground truth establishment: "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 of the images."
3. ViewAssist Feature
3.1. Table of Acceptance Criteria and Reported Device Performance
| Validation Type | Definition | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| View Recognition | Recognition Accuracy (%) | 89% (threshold) | Average 94.56% |
| Anatomy Annotation (Segmentation) | Dice-score | 0.8 (threshold) | Average Dice-score 0.898 |
3.2. Sample Size and Data Provenance for Test Set
- Number of Images: 680 fetal heart and fetal biometry images.
- Data Provenance: Collected at two hospitals. Ethnicity/Country: Americans and Koreans.
- Retrospective/Prospective: Mix of retrospective and prospective data collection. Only V8 images were used for the performance test.
3.3. Number and Qualifications of Experts for Ground Truth (Test Set)
- Number of Experts: Three participating experts (obstetricians) and two sonographers. The entire process was supervised by another obstetrician.
- Qualifications: Obstetricians with more than 20 years of experience, sonographers with more than 10 years of experience, and a supervising obstetrician with more than 25 years of experience; all in fetal cardiology.
3.4. Adjudication Method for Test Set
- All acquired images were first classified into correct views by three participating experts.
- Corresponding anatomy areas were manually drawn for each image.
- The entire process was supervised (implying a form of consensus/adjudication).
3.5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done?
- No, an MRMC study was not reported. This study assessed the standalone algorithm's performance against expert ground truth.
3.6. If a Standalone (algorithm only) performance was done?
- Yes, the validation was for the deep learning based view recognition and anatomy annotation algorithms.
3.7. Type of Ground Truth Used
- Expert consensus (manual classification of views and delineation of anatomy areas by multiple experienced obstetricians and sonographers).
3.8. Sample Size for Training Set
- Not specified. The data used for training, tuning, and validation are completely separated.
3.9. How the Ground Truth for the Training Set was Established
- Implied to be similar to the test set ground truth establishment: "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 of the images."
4. HeartAssist Feature
4.1. Table of Acceptance Criteria and Reported Device Performance
| Validation Type | Definition | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| View Recognition (Fetus) | Recognition Accuracy (%) | 89% (threshold) | Average 93.21% |
| View Recognition (Adult) | Recognition Accuracy (%) | 84% (threshold) | Average 98.31% |
| Segmentation (Fetus) | Dice-score | 0.8 (threshold) | Average Dice-score 0.88 |
| Segmentation (Adult) | Dice-score | 0.9 (threshold) | Average Dice-score 0.93 |
| Size Measurement (Fetus) | Area Error | ≤ 8% | 8% or less |
| Size Measurement (Fetus) | Angle Error | ≤ 4% | 4% or less |
| Size Measurement (Fetus) | Circumference Error | ≤ 11% | 11% or less |
| Size Measurement (Fetus) | Diameter Error | ≤ 11% | 11% or less |
| Size Measurement (Adult, B-mode) | PCC value | ≥ 0.8 | Pass |
| Size Measurement (Adult, M-mode) | PCC value | ≥ 0.8 | Pass |
| Size Measurement (Adult, Doppler-mode) | PCC value | ≥ 0.8 | Pass |
4.2. Sample Size and Data Provenance for Test Set
- Number of Images: 888 fetal heart and adult heart images.
- Data Provenance: Collected at five hospitals. Ethnicity/Country: Americans and Koreans.
- Retrospective/Prospective: Mix of retrospective and prospective data collection. Only V8 images were used for the performance test.
4.3. Number and Qualifications of Experts for Ground Truth (Test Set)
- Fetus: Three participating experts (obstetricians) and two sonographers. The entire process was supervised by another obstetrician.
- Qualifications: Obstetrician with more than 20 years of experience, two sonographers with more than 10 years of experience, and a supervising obstetrician with more than 25 years of experience; all in fetal cardiology.
- Adult: Four professionals: two cardiologists and two sonographers.
- Qualifications: Cardiologists with at least 10 years of experience, and sonographers with at least 10 years of experience.
4.4. Adjudication Method for Test Set
- Fetus: All acquired images were first classified into correct views by three participating experts. Corresponding anatomy areas were manually drawn. The entire process was supervised.
- Adult: Experts manually traced the contours of the heart and the signal outline on the images. (Implies consensus/adjudication or a single expert annotation considered ground truth, though multiple experts were involved in the process).
4.5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done?
- No, an MRMC study was not reported. This study assesses the standalone algorithm's performance against expert ground truth.
4.6. If a Standalone (algorithm only) performance was done?
- Yes, the validation was for the deep learning based view recognition, segmentation, and size measurement algorithms.
4.7. Type of Ground Truth Used
- Expert consensus (manual classification of views, delineation of anatomy areas, and measurement of values by multiple experienced obstetricians/cardiologists and sonographers). For adult measurements, the "cardiologist's measurements" were defined as ground truth.
4.8. Sample Size for Training Set
- Not specified. The data used for training, tuning, and validation are completely separated.
4.9. How the Ground Truth for the Training Set was Established
- Implied to be similar to the test set ground truth establishment:
- Fetus: "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 of the image."
- Adult: Similar process of experts manually tracing contours and signal outlines.
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(86 days)
V8 Diagnostic Ultrasound System, V7 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-raginal, 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
The V8 / V7 are a general purpose, mobile, software controlled, diagnostic ultrasound system. 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 / V7 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 / V7 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Validation Type | Definition | Acceptance Criteria | Reported Device Performance (Average) | Standard Deviation | 95% Confidence Interval |
|---|---|---|---|---|---|
| Accuracy (%) | (Number of correctly detected frames / Total frames with nerve) * 100 | ≥ 80% | 91.7% | 5.6 | 89.5 to 93.9% |
| Speed (FPS) | 1000 / Average latency time of each frame (msec) | ≥ 2 FPS | 7.93 FPS | 1.11 | 7.04 to 8.82 FPS |
Study Details
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Sample Size and Data Provenance for Test Set:
- Number of Subjects: 18 (13 females, 5 males)
- Number of Images: 2,146 (1,168 from females, 978 from males)
- Country of Origin: All Koreans
- Data Provenance: The text does not explicitly state if the data was retrospective or prospective, but it describes the process of "collecting scan data" and the involvement of experts in establishing ground truth, suggesting it was acquired for the purpose of this validation.
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Number of Experts and Qualifications for Ground Truth:
- Number of Experts: 15 experts (Ten anesthesiologists and five sonographers).
- Qualifications: All experts had "more than 10 years of experience."
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Adjudication Method for Test Set:
- One anesthesiologist who scanned the ultrasound directly drew the initial ground truth of the nerve location.
- "Two or more other anesthesiologists and sonographers reviewed and confirmed that it was correct."
- If there was any mistake during the review, "it was revised again." This indicates an iterative consensus-based adjudication.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- The provided document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study to assess how human readers improve with AI vs. without AI assistance. The study focuses solely on the performance of the AI algorithm (NerveTrack) itself.
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Standalone Performance (Algorithm Only):
- Yes, a standalone performance study was done. The "Acceptance Criteria" and "Summary Performance data" tables explicitly relate to the performance of the NerveTrack AI algorithm (Accuracy and Speed). The study evaluates the algorithm's ability to detect nerves independently.
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Type of Ground Truth Used:
- Expert Consensus: The ground truth was established by a panel of experienced anesthesiologists and sonographers who directly drew and reviewed the nerve locations.
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Sample Size for Training Set:
- The document states: "The training data used for the training of the NerveTrack algorithm is independent of the data used to test the NerveTrack algorithm." However, it does not specify the sample size of the training set.
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How Ground Truth for Training Set Was Established:
- The document explicitly states that the training data and test data are independent. However, it does not provide details on how the ground truth for the training set was established. It can be inferred that a similar expert-driven annotation process likely took place for the training data, but it is not explicitly stated in the provided text.
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(77 days)
V8 Diagnostic Ultrasound System
The V8 diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obsterics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-raginal, 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, 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
The V8 is a general purpose, mobile, software controlled, diagnostic ultrasound system. 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 also gives 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 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The provided document is a 510(k) Summary for the Samsung Medison V8 Diagnostic Ultrasound System. It details the device's intended use, technological comparison to predicate devices, and non-clinical testing. However, it explicitly states that no clinical studies were required to demonstrate substantial equivalence.
Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria from this document. The document primarily focuses on demonstrating substantial equivalence through non-clinical testing and comparison to existing predicate devices, rather than a clinical study with defined performance metrics and acceptance criteria.
The relevant section from the document is:
12. Summary of Clinical Tests
The proposed device V8 Ultrasound System did not require clinical studies to demonstrate substantial equivalence.
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