(75 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, Intraoperative. Pediatric, Small Organ, Neonatal Cephalic, Trans-rectal, Trans-rectal, 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/cV8, V7/cV7, V6/cV6 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/cV8, V7/cV7, V6/cV6 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/cV8, V7/cV7, V6/cV6 have a 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 the acceptance criteria and study proving the device meets those criteria, specifically for the 'EzNerveMeasure' functionality of the V8/cV8, V7/cV7, V6/cV6 Diagnostic Ultrasound System.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Flattening Ratio (FR) Error Rate | Not explicitly stated an acceptance criterion, but implicitly that the performance is acceptable for clinical use. | Average: 8.31% (95% CI: [7.29, 9.34]) |
| Standard Deviation: 5.22 | ||
| Cross-Sectional Area (CSA) Error Rate | Not explicitly stated an acceptance criterion, but implicitly that the performance is acceptable for clinical use. | Average: 13.12% (95% CI: [10.90, 15.34]) |
| Standard Deviation: 11.33 |
Note: The document states, "We tested on the flattening ratio (FR) and cross-sectional area (CSA) of NerveTrack EzNerveMeasure." and then presents the average error rates. While explicit acceptance criteria values are not given (e.g., "FR error
§ 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.