(170 days)
The device is a general purpose diagnostic ultrasound system intended for use by appropriately trained healthcare professionals in a hospital setting. The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid.
This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology;Transvaginal; Urology(including prostate); Transrectal; Cardiac(adult and pediatric); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle, Musculo-skeletal Conventional and Superficial); Pediatrics(including neonatal cephalic); and Adult Cephalic diagnostic Ultrasound applications.
The operating modes supported by the device are B mode, Harmonic mode, M mode, Color Flow mode, Power-Doppler mode, Pulsed Wave Doppler mode, Continuous Wave Doppler, 3D mode, 4D mode, Spatio Temporal Image Correlation mode, Tissue Doppler mode, Tissue Velocity Imaging mode, Elastography mode and Contrast Agent Imaging mode.
The VINNO G50、VINNO G55、VINNO M50、VINNO E30、VINNO X5、VINNO X6、VINNO X7、VINNO M55、VINNO E35、VINNO X65、VINNO X55、VINNO X35、VINNO G55E、 VINNO G55P、VINNO M55E、VINNO M55P、VINNO E35E、VINNO E35P ultrasound devices are professional digital color ultrasonic diagnostic apparatus. It transmits ultrasound waves into the body tissues and displays the echo images of the tissues and blood flow accordingly.
The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets them in the context of AI performance or clinical efficacy. Instead, it describes a 510(k) premarket notification for a general-purpose diagnostic ultrasound system (VINNO G50, etc.) and focuses on demonstrating substantial equivalence to a predicate device (HS40 Diagnostic Ultrasound System).
The "Performance Data" section (VIII) refers to non-clinical testing to support the substantial equivalence determination, rather than clinical performance or AI-specific criteria.
Therefore, I cannot provide the requested information from the given text regarding:
- A table of acceptance criteria and reported device performance (for clinical/AI performance)
- Sample size and provenance for a test set
- Number and qualifications of experts for ground truth
- Adjudication method for the test set
- MRMC comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used (for clinical/AI performance)
- Sample size for the training set
- How ground truth for the training set was established
The document primarily addresses electrical safety, EMC, software verification/validation (general to medical device software, not AI-specific), biocompatibility, and acoustic output, comparing these aspects to the predicate device and relevant standards. It concludes that the device is substantially equivalent, implying it is "as safe, as effective and performs as well as the legally marketed device" based on these non-clinical comparisons.
§ 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.