K Number
K223917
Date Cleared
2023-06-17

(170 days)

Product Code
Regulation Number
892.1550
Panel
RA
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid.

The operating modes supported by the device are B, M.PWD CWD, Tissue Doppler, Color Doppler, Power Doppler, Tissue Velocity Imaging, Harmonic Imaging, 3D/4D, Combine modes.

This device is indicated for Abdominal; Fetal; Obstetrics; gynecology;Trans-vagmal; Urology(including prostate); Transrectal; Cardiac(adult and pediatic); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle); Musculoskeletal(Conventional and Superficial); Pediatrics(including neonatal cephalic diagnostic Ultrasound applications.

This device is intended to use by, or by the order of, and under the supervision of an appropriately-trained healtheare professional qualified to direct the use of the device in hospitals or clinics.

Device Description

VINNO E20, VINNO E10, VINNO E10E, VINNO X1, VINNOX1E, VINNOX1E, VINNO X2, VINNO X2E, VINNO X2E ultrasound devices are professional digital color ultrasonic apparatus. It transmits ultrasound waves into the body tissues and displays the echo images of the tissues and blood flow accordingly.

AI/ML Overview

This document is a 510(k) Premarket Notification summary for VINNO E20, VINNO E10, VINNO E10P, VINNO E10E, VINNO X1, VINNO X1E, VINNO X1P, VINNO X2, VINNO X2E, VINNO X2P ultrasound devices. It establishes substantial equivalence to an existing predicate device rather than presenting comprehensive clinical study data with detailed acceptance criteria for an AI-powered device.

Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving an AI device meets those criteria. The document focuses on showing the VINNO ultrasound systems are similar to a previously cleared ultrasound system, referencing general performance data for basic functions such as biocompatibility, electrical safety, software verification, and acoustic output.

It does not describe a clinical study for an AI algorithm, nor does it provide details such as:

  • A table of acceptance criteria and reported device performance for an AI feature.
  • Sample sizes for AI test sets.
  • Number of experts, their qualifications, or adjudication methods for establishing ground truth for AI.
  • MRMC comparative effectiveness studies for AI assistance.
  • Standalone performance data for an AI algorithm.
  • Specific types of ground truth (e.g., pathology, outcomes data) for AI.
  • Training set sample sizes or how ground truth was established for an AI training set.

The document generally states that the device "performs as well as the legally marketed device" based on non-clinical testing, which is the standard for a 510(k) submission seeking substantial equivalence for a medical device that doesn't contain a novel AI component requiring extensive clinical validation.

§ 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.