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DC-60/DC-60S/DC-60 Exp/DC-55 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, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exam.

DC-60/DC-60S/DC-60 EXP/DC-55 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include linear array and convex array with a frequency range of approximately 2.0 MHz to 10.0 MHz.

I'm sorry, but this document does not contain the detailed information necessary to answer your request.

Here's why:

• No Acceptance Criteria or Performance Data: The document is a 510(k) premarket notification for an ultrasound system. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing specific acceptance criteria and performance data for a new AI/ML device. The tables provided list intended uses and modes of operation, not performance metrics.
• No Mention of AI/ML Study: There is no indication that this device incorporates AI or machine learning. The focus is on the hardware and software capabilities of a diagnostic ultrasound system, and its conformance to established safety and performance standards relevant to ultrasound technology, not AI algorithms.
• Focus on Substantial Equivalence: The primary goal of a 510(k) summary is to show that a new device is "substantially equivalent" to existing, legally marketed predicate devices. This typically involves comparing intended use, technological characteristics, and safety and effectiveness, often through non-clinical bench testing and compliance with recognized standards. It does not typically include detailed studies on AI performance as you've requested.
• No Clinical Study Details: The document explicitly states "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." Therefore, it would not contain information about sample sizes, data provenance, ground truth establishment, or expert adjudication for clinical studies, which are crucial for AI/ML performance evaluation.

To answer your request, I would need a document specifically detailing the development and validation of an AI/ML component of a medical device, including its predefined acceptance criteria and the results of a robust clinical or technical study.

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