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510(k) Data Aggregation
(85 days)
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.
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, Trans-esophageal (Cardiac), Peripheral vessel, Lung 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 (includes emergency room), 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 HM70 EVO 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. M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HM70 EVO 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 HM70 EVO has 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 two AI-based features of the HM70 EVO Diagnostic Ultrasound System: UterineAssist and NerveTrack. The acceptance criteria and performance studies for each are detailed below.
UterineAssist
1. Table of Acceptance Criteria and Reported Device Performance
For UterineAssist, the document details performance for three areas: image segmentation, feature points extraction, and size measurement. While explicit acceptance criteria values (like a minimum percentage or maximum error) are not stated in a direct acceptance criteria table, the reported device performance serves as the evidence of meeting internal acceptance.
| Feature Area | Reported Device Performance |
|---|---|
| Segmentation | |
| Average Dice-score (Uterus) | 96% |
| Average Dice-score (Endometrium) | 92% |
| Feature Points Extraction | |
| Errors of Uterus Feature Points | 5.8 mm or less |
| Errors of Endometrium Feature Points | 4.3 mm or less |
| Size Measurement | |
| Errors of Measurements Performance | 2.0 mm or less |
2. Sample Sizes Used for the Test Set and Data Provenance
-
Segmentation Test:
- Sample Size: 450 sagittal uterus images and 150 transverse uterus images (total 600 images).
- Data Provenance: Collected at three hospitals. Mix of retrospective and prospective data collection in clinical practice.
- Country of Origin: All Koreans (implies South Korea).
-
Feature Points Extraction Test & Size Measurement Test:
- Sample Size: 45 sagittal and 41 transverse plane images of uterus (total 86 images).
- Data Provenance: Collected at three hospitals. Mix of retrospective and prospective data collection in clinical practice.
- Country of Origin: All Koreans (implies South Korea).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Three participating OB/GYN experts.
- Qualifications: Each had more than 10 years' experience.
4. Adjudication Method for the Test Set
- Method: The set of images (uterus and endometrium) were divided into 3 subsets. Each of the three OB/GYN experts drew the ground truths for one of the subsets. The ground truths drawn by one expert were then cross-checked by the other two experts. Any images not meeting inclusion/exclusion criteria were excluded. This can be described as a 1+2 cross-check adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No MRMC comparative effectiveness study is reported for UterineAssist, as this section only describes the standalone performance metrics.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Yes, the reported performance metrics (Dice-score, error measurements) reflect the "standalone" performance of the algorithm.
7. The Type of Ground Truth Used
- The ground truth for both segmentation and feature points/size measurements was established by expert consensus/adjudication from three experienced OB/GYN experts.
8. The Sample Size for the Training Set
- The training data details (specific sample size) are not provided, but it is stated that it is independent of the test data.
9. How the Ground Truth for the Training Set was Established
- Not explicitly stated, but implicitly, similar expert labeling or other reliable methods would have been used, consistent with the independent test data approach. It is only mentioned that the training and test data sets are "completely separated" and there is "no overlap."
NerveTrack
1. Table of Acceptance Criteria and Reported Device Performance
| Validation Type | Acceptance Criteria | Reported Average | Standard Deviation | 95% CI |
|---|---|---|---|---|
| Accuracy (%) | ≥ 80% | 91.50 | 5.08 | 88.35 to 94.65 |
| Speed (FPS) | ≥ 2 FPS | 3.71 | 0.06 | 3.65 to 3.78 |
2. Sample Sizes Used for the Test Set and Data Provenance
- Number of Subjects: 18 (13 Females, 5 Males)
- Number of Images: 2,146
- Age Range: 22-68 years
- BMI Range: 16-31.5
- Data Provenance: Not explicitly stated as retrospective or prospective, but the description of gathering scan data and expert involvement suggests a prospective collection or a specifically designed retrospective collection process for validation.
- Country of Origin: All Koreans (implies South Korea).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Ten anesthesiologists and five sonographers (total 15 experts) for review and confirmation.
- Qualifications: All had more than 10 years of experience.
- Initial Ground Truth Drawing: One anesthesiologist who scanned the ultrasound directly drew the GT.
4. Adjudication Method for the Test Set
- Method: One anesthesiologist who directly scanned the ultrasound drew the initial ground truth (GT) for the nerve location. Then, "two or more other anesthesiologists and sonographers reviewed and confirmed that it was correct." If any mistake was identified during the review, it was revised. This indicates a 1 + (2 or more) consensus/adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, the document describes "standalone performance" validation of the NerveTrack algorithm, specifically focusing on accuracy and speed. It does not mention any MRMC study comparing human readers with and without AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Yes, the validation clearly states, "The standalone performance of NerveTrack was evaluated..." and provides performance metrics (accuracy and speed) for the algorithm itself.
7. The Type of Ground Truth Used
- The ground truth for the location of 10 different kinds of nerves was established by expert consensus/adjudication involving anesthesiologists and sonographers with significant experience.
8. The Sample Size for the Training Set
- The training data details (specific sample size) are not provided, but it is stated that it is independent of the test data.
9. How the Ground Truth for the Training Set was Established
- Not explicitly stated, but it is mentioned that the "training data used for the training of the NerveTrack algorithm are independent of the data used to test the NerveTrack algorithm." This implies a separate, established ground truth for the training set, likely using similar expert labeling methods.
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(81 days)
The HS40 diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.
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 Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode.
The HS40 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, M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS40 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 HS40 has 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 two AI-based features of the HS40 Diagnostic Ultrasound System: NerveTrack and UterineAssist. Here's a breakdown of their acceptance criteria and supporting studies:
1. Acceptance Criteria and Device Performance
NerveTrack
| Validation Type | Definition | Acceptance Criteria | Reported Device Performance (Average) | 95% CI |
|---|---|---|---|---|
| Accuracy (%) | Number of correctly detected frames / Total number of frames with nerve x 100 | ≥ 80% | 91.7% | 89.5% to 93.9% |
| Speed (FPS) | 1000 / Average latency time of each frame (msec) | ≥ 2 FPS | 7.93 FPS | 7.04 to 8.82 |
UterineAssist
| Validation Type | Acceptance Criteria / Description | Reported Device Performance (Average / Max Error) |
|---|---|---|
| Image Segmentation (Uterus Dice-score) | N/A (implicit high score) | 96% |
| Image Segmentation (Endometrium Dice-score) | N/A (implicit high score) | 92% |
| Feature Points Extraction (Uterus Error) | N/A (implicit low error) | 5.8 mm or less |
| Feature Points Extraction (Endometrium Error) | N/A (implicit low error) | 4.3 mm or less |
| Size Measurement (Measurement Error) | N/A (implicit low error) | 2.0 mm or less |
2. Sample Sizes and Data Provenance
NerveTrack
- Test Set Sample Size:
- Number of Subjects: 18 (13 females, 5 males)
- Number of Images: 2,146 (1,168 from females, 978 from males)
- Data Provenance: All data were collected from Koreans. The study does not specify if the data was retrospective or prospective, but mentions "When collecting scan data, the speed of the probe varies..." which suggests prospective collection or at least data collected under specific scanning conditions.
UterineAssist
- Test Set Sample Size:
- Segmentation Test: 450 sagittal uterus images and 150 transverse uterus images (total 600 images).
- Feature Points Extraction & Size Measurement Tests: 45 sagittal and 41 transverse plane images of uterus (total 86 images).
- Data Provenance: Data collected at three hospitals. The ethnicity/country is All Koreans. It involved a mix of retrospective and prospective data collection in clinical practice.
3. Number and Qualifications of Experts for Test Set Ground Truth
NerveTrack
- Number of Experts: 10 anesthesiologists and 5 sonographers (total 15 experts).
- Qualifications: All experts had more than 10 years of experience.
UterineAssist
- Number of Experts: 3 OB/GYN experts.
- Qualifications: All experts had more than 10 years' experience.
4. Adjudication Method for the Test Set
NerveTrack
- Adjudication Method: "One anesthesiologist who scanned the ultrasound directly drew the GT of nerve location, and 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 initial drawing by one expert with confirmation/review by at least two (or more) others, followed by revision if errors were found. This is a form of expert consensus with review and revision.
UterineAssist
- Adjudication Method: "The set of images (uterus and endometrium) were divided into 3 subsets and the three participating OB/GYN experts each drew the ground truths for one of the subsets. The ground truths drawn by an expert were cross-checked by the other two experts. Any images that do not meet the inclusion/exclusion criteria were excluded from the set of images." This is a cross-checking method where each expert's ground truth was reviewed by the other two, with exclusion of non-conforming images.
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 the improvement of human readers with AI assistance versus without. The studies described focus on the standalone performance of the AI algorithms.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
- Yes, standalone performance was done for both algorithms.
- NerveTrack: The acceptance criteria and reported performance (Accuracy, Speed) directly measure the algorithm's ability to detect nerves and its processing speed, without human intervention in the detection process.
- UterineAssist: The segmentation accuracy (Dice-score) and error in feature point extraction and size measurement refer to the algorithm's direct output.
7. Type of Ground Truth Used
NerveTrack
- Type of Ground Truth: Expert Consensus. The ground truth for the location of 8 different kinds of nerves was established by a group of anesthesiologists and sonographers through a process of drawing, review, and confirmation.
UterineAssist
- Type of Ground Truth: Expert Consensus (Segmentation by experts). "Segmentation of the ground truth was generated by three participating OB/GYN experts with more than 10 years' experience."
8. Sample Size for the Training Set
NerveTrack
- The document states, "The training data used for the training of the NerveTrack algorithm are independent of the data used to test the NerveTrack algorithm," but it does not specify the sample size for the training set.
UterineAssist
- The document states, "Data used for test/training validation purpose are completely separated from the ones during training process and there is no overlap between the two," but it does not specify the sample size for the training set.
9. How the Ground Truth for the Training Set was Established
NerveTrack
- The document mentions that training data is independent of test data but does not describe how the ground truth for the training set was established.
UterineAssist
- The document implies that the ground truth for the training set would have been established similarly to the test set (i.e., by experts), as it only specifies the independence of the datasets. However, it does not explicitly describe the ground truth establishment method for the training set.
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