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TE7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, intra-operative(abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-esoph. (Cardiac), trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), urology, peripheral vessel, adult and pediatric cardiac exams.

TE7 is a software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, CW-Mode, CW-mode, Color-Mode, Power/Dirpower Mode, THI, LVO 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 3.0 MHz to 10.0 MHz.

I am unable to provide a description of acceptance criteria and a study proving device performance based on the provided text. The document is a 510(k) premarket notification for a diagnostic ultrasound system (TE7 Diagnostic Ultrasound System) and primarily outlines its intended use, comparison with predicate devices, and non-clinical tests conducted for safety and effectiveness.

Here's why I cannot fulfill your request for that specific information:

• No Acceptance Criteria or Performance Study Details: The provided text does not contain specific acceptance criteria (e.g., target percentages for accuracy, sensitivity, or specificity) or details of a study designed to prove the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to already cleared predicate devices through comparisons of technological characteristics, intended uses, and compliance with general safety and performance standards.
• "Not applicable. The subject of this submission. TE7 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.": This explicit statement in section 7, "Clinical Studies," confirms that a clinical study to directly prove performance against acceptance criteria was not conducted or required for this 510(k) submission.

Therefore, since the document does not include the requested information about acceptance criteria or a study proving the device meets them, I cannot extract or generate a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or expert adjudication.

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