Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, transvaginal, musculo-skeletal(conventional, superficial), cardiac(adult, pediatric) , peripheral vessel and urology exams.
DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, Color-mode, Power/Dirpower mode, THI mode, 3D/4D mode, iScape mode, Biopsy Guidance, Elastography, Contrast imaging (Contrast agent for Liver) or the combined mode (i.e. B/M-Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array.
The provided text is a 510(k) summary for the Shenzhen Mindray Bio-Medical Electronics Co., Ltd. DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System. It details the device's intended use, classification, comparison to predicate devices, and non-clinical tests conducted. The document explicitly states "Not applicable" for clinical studies, meaning no patient data or expert evaluations were used to establish acceptance criteria or prove device performance through a clinical study as would be typical for an AI/ML powered device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set sizes cannot be extracted from this document. This document pertains to a traditional medical device (ultrasound system) that relies on engineering verification and validation against recognized standards and comparison to predicate devices for substantial equivalence, rather than clinical performance metrics in the way AI/ML devices often do.
Based on the provided text, the device relies on substantial equivalence to predicate devices and adherence to recognized safety standards, not on clinical performance studies with acceptance criteria in the typical sense for AI/ML algorithms.
Here's a breakdown of why the requested information is absent:
- No AI/ML Component: The submission describes an ultrasound system, not an AI/ML-powered device. Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to AI performance (e.g., sensitivity, specificity, AUC) is not relevant here.
- Substantial Equivalence: The primary method for gaining clearance is demonstrating "substantial equivalence" to legally marketed predicate devices. This involves showing similar intended use, technology, safety, and effectiveness.
- Non-Clinical Tests: The "Non-clinical Tests" section lists compliance with various electrical, mechanical, acoustic, and biocompatibility standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 14971). These are engineering and safety standards, not performance metrics derived from clinical data in the context of an AI algorithm.
- Clinical Studies Not Applicable: The document explicitly states: "Not applicable. The subject of this submission, DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." This directly confirms the absence of the type of study you are asking about.
Therefore, I cannot provide the requested table or bullet points as the information does not exist within the provided text for this specific device clearance. The regulatory pathway for this ultrasound system did not require the demonstration of performance metrics against clinical ground truth in the way your questions imply.
§ 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.