(46 days)
The M7/M7T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial) exams.
M7/M7T Diagnostic Ultrasound System is a general purpose, portable/mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode 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 with a frequency range of approximately 2.5 MHz to 10.0 MHz.
The provided text [K103677](https://510k.innolitics.com/search/K103677) is a 510(k) Pre-Market Notification for the M7/M7T Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to existing predicate devices and ensuring the device meets various safety and electrical standards. It does not contain the specific types of performance studies or acceptance criteria that would typically be associated with AI/CADe devices.
In the context of the provided document, the "acceptance criteria" primarily refer to compliance with recognized medical device safety standards and demonstrating substantial equivalence to predicate devices, rather than performance metrics for an AI algorithm. Therefore, the information requested in the prompt, which is geared towards AI/CADe device evaluation, is largely absent from this 510(k) summary.
Here's a breakdown of why many sections of your request cannot be fulfilled based on the provided text:
- No AI/CADe Device: The M7/M7T Diagnostic Ultrasound System is described as a general-purpose diagnostic ultrasound system. There is no mention of any AI or CADe (Computer-Aided Detection/Diagnosis) functionality within the device. Thus, there is no AI algorithm to evaluate.
Given this, I cannot provide the requested information that pertains to AI/CADe device performance or clinical studies. The document only describes the device's technical characteristics, intended use, and conformance to general safety and electrical standards.
If you have a different document that describes an AI/CADe device, I would be happy to analyze it according to your criteria.
§ 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.