(86 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, 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.
§ 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.