(107 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, Pediatric, 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/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 diagnostic ultrasound system 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/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 diagnostic ultrasound system 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/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 diagnostic ultrasound system 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 a breakdown of the acceptance criteria and study details for the AI-based NerveTrack feature, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance (NerveTrack - Detection)
| Validation Type | Definition | Acceptance Criteria | Reported Average Performance | Standard Deviation | 95% Confidence Interval |
|---|---|---|---|---|---|
| Accuracy (%) | $\frac{\text{Number of correctly detected frames}}{\text{Total number of frames with nerve}} \times 100$ | ≥ 80% | 90.3 | 4.88 | 87.28 to 93.33 |
| Speed (FPS) | $\frac{1000}{\text{Average latency time of each frame (msec)}}$ | ≥ 2 FPS | 3.66 | 0.25 | 3.51 to 3.82 |
1. Table of Acceptance Criteria and Reported Device Performance (NerveTrack - Segmentation)
| Validation Type | Definition | Acceptance Criteria | Reported Average Performance | Standard Deviation | 95% Confidence Interval |
|---|---|---|---|---|---|
| Accuracy (%) | $\frac{\text{Number of correctly segmented frames}}{\text{Total number of frames with nerve}} \times 100$ | ≥ 80% | 98.42 | 3.99 | 97.13 to 99.71 |
| Speed (FPS) | $\frac{1000}{\text{Average latency time of each frame (msec)}}$ | ≥ 2 FPS | 3.64 | 0.40 | 3.48 to 3.80 |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the numerical sample size for the test set (number of frames or cases). It only mentions that the "test images" were used and that evaluation included "BMI subgroups" (underweight, healthy weight, overweight, and obesity) to assess generalizability.
- Sample Size: Not explicitly quantified.
- Data Provenance:
- Country of Origin: Not explicitly stated, though Samsung Medison Co., Ltd. is based in the Republic of Korea. The document mentions "All the nerve data were acquired on Samsung ultrasound devices including V8."
- Retrospective or Prospective: Not explicitly stated, however, the description of "collecting scan data" and the involvement of experts in "establishing the ground truth" suggests these were real-world scans that were then annotated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: 12 anesthesiologists and 5 sonographers (total of 17 experts).
- Qualifications: Over ten years' experience.
4. Adjudication Method for the Test Set:
- Adjudication Method: For each dataset, the doctors who performed the ultrasound scans directly drew the ground truth (GT) of the nerve locations. These were then reviewed and verified as accurate by at least two additional anesthesiologists and sonographers. Any errors or discrepancies were corrected until satisfactory results were achieved. This effectively describes a form of expert consensus and review process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not reported. The study focused on the standalone performance of the AI algorithm.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Yes, a standalone performance study was done. The reported accuracy and speed metrics are for the NerveTrack algorithm itself, without human intervention or assistance during the test. The document states, "The standalone performance of NerveTrack was evaluated..."
7. Type of Ground Truth Used:
- Type of Ground Truth: Expert consensus. Specifically, "The ground truth made by anesthesiologists" and established by the manual drawing/delineation of nerve locations by doctors who performed the scans, followed by review and verification by at least two additional experts.
8. Sample Size for the Training Set:
- Sample Size: Not explicitly stated. The document only mentions "The training data used for the training of the NerveTrack algorithm are independent of the data used to test the NerveTrack algorithm."
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: The document does not explicitly describe how the ground truth for the training set was established. It only states that the training data and test data are independent. However, given the robust process described for the test set's ground truth (expert drawing and multi-expert review/verification), it is highly probable that a similar, if not identical, expert-driven ground truth establishment method was used for the training data as well.
§ 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.