(109 days)
The diagnostic ultrasound system and transducers 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 / V6 / H8 / H7 / H6 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 / V6 / H8 / H7 / H6 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 / V6 / H8 / H7 / H6 have a 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 the study proving the device meets those criteria, based on the provided document:
Device: Samsung Medison V8/H8, V7/H7, V6/H6 Diagnostic Ultrasound System with NerveTrack AI
1. Table of Acceptance Criteria and Reported Device Performance
| Validation Type | Definition | Acceptance Criteria | Reported Device Performance (Average) | Standard Deviation | 95% CI |
|---|---|---|---|---|---|
| Nerve Detection | |||||
| Accuracy (%) | Number of correctly detected frames / Total number of 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 | 3.61 | 0.25 | 3.43 to 3.78 |
| Nerve Segmentation | |||||
| Accuracy (%) | Number of correctly segmented frames / Total number of frames with nerve × 100 | ≥ 80% | 98.69% | 0.64 | 96.31 to 100 |
| Speed (FPS) | 1000 / Average latency time of each frame (msec) | ≥ 2 FPS | 3.62 | 0.36 | 3.49 to 3.75 |
2. Sample Size Used for the Test Set and Data Provenance
-
Nerve Detection Test Set:
- Number of Subjects: 18 (13 females, 5 males)
- Number of Images/Frames: 2,146
- Data Provenance: All Koreans. The document does not explicitly state if the data was retrospective or prospective. However, the description of data collection (sliding transducer at specific speeds) suggests it was collected for the purpose of this study, indicating a prospective component or at least an intentionally collected dataset.
-
Nerve Segmentation Test Set:
- Number of Subjects: 11 (8 females, 3 males)
- Number of Images/Frames: 3,836
- Data Provenance: All Koreans. Similar to the detection dataset, the provenance is Korean, and the collection method description points towards intentionally collected data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: 15 experts were involved (10 anesthesiologists and 5 sonographers).
- Qualifications of Experts: All experts had "more than 10 years of experience."
4. Adjudication Method for the Test Set
The ground truth establishment method was as follows:
- One anesthesiologist who scanned the ultrasound directly drew the initial ground truth (GT) 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 describes a form of consensus-based adjudication with an initial ground truth creator and subsequent confirmation/revision by multiple independent experts. It's not a strict N+M or sequential read, but rather a collaborative review and refinement process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to compare human readers with vs. without AI assistance. The study focuses solely on the standalone performance of the AI algorithm (NerveTrack).
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Yes, the document explicitly states: "The standalone performance of NerveTrack was evaluated..." The "Summary Performance data" tables provided are for the algorithm's performance without a human in the loop.
7. The Type of Ground Truth Used
The ground truth used was expert consensus. It was established by a team of experienced anesthesiologists and sonographers who reviewed and confirmed the actual nerve locations in the ultrasound images.
8. The Sample Size for the Training Set
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." However, the exact sample size for the training set is not provided in the given text.
9. How the Ground Truth for the Training Set was Established
The document mentions that the training data is independent of the test data. While it does not explicitly detail the ground truth establishment method for the training set, it is highly probable that a similar expert-based annotation process (as described for the test set) was used to establish the ground truth for the training data. This is a common practice in AI development to ensure consistency in data labeling.
§ 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.