(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.
§ 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.