(155 days)
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; Transvagmal; Urology(including prostate); Trans rectal; Cardiac(adult and child); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle), Musculoskeletal(Conventional and Superficial); Pediatrics(including neonatal cephalic); interventional(nerve block and vascular access); Intraoperative (abdominal, brain) and Adult 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.
VINNO G86,VINNO G86E, VINNO M86E, VINNO G65, VINNO G65, VINNO G65E, VINNO G65D, VINNO G65D, VINNO G90, VINNO G90E 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.
The provided document is a 510(k) summary for an ultrasound system, not a document detailing the performance study of an AI/ML-based medical device. Therefore, it does not contain the specific information requested regarding acceptance criteria and performance study details for an AI-powered device.
The document discusses the substantial equivalence of the VINNO G86, G86E, M86, M86E, G65, G65P, G65E, G65D, G90, and G90E ultrasound devices to a predicate device (Resona 7 series). It focuses on safety and performance characteristics of generalized ultrasound systems, not a specific AI/ML diagnostic or assistive tool.
Key sections that would typically contain the requested information for an AI/ML device are missing or not applicable in this document:
- Acceptance Criteria for an AI device: This document lists technical and safety standards (e.g., IEC 60601-1, NEMA UD 2) rather than diagnostic performance metrics (sensitivity, specificity, AUROC) for an AI output.
- Study Proving Acceptance Criteria: The performance data section mentions biocompatibility, electrical safety, EMC, software V&V, and acoustic output testing, which are standard for all medical devices. It does not describe a clinical performance study for an AI algorithm's diagnostic accuracy.
- Sample size for test set and data provenance: Not mentioned as there's no AI performance study described.
- Number of experts and qualifications for ground truth: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance: Not mentioned.
- Type of ground truth: Not mentioned.
- Training set sample size and ground truth establishment: Not mentioned.
In summary, based on the provided text, it is not possible to answer the questions about acceptance criteria and the study proving the device meets them for an AI/ML powered medical device. The document describes a standard ultrasound system clearance, not one with an integral AI diagnostic or assistive component that would require such performance evaluations.
§ 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.