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The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications: Fetal: Abdominal (renal & GYN/pelvic); Pediatric, Small Organ (breast, testes, thyroid); Adult Cephalic; Trans-rectal, Trans-vaginal, Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult& pediatric); Peripheral Vascular (PV): and Urology (including prostate).

E-CUBE 15 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 18.5" (or 19.5") wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
Modes of operation:

1. Signal Mode:
   B(2D) mode, M mode, Color Flow(CF) mode, Power Doppler(PD) mode, Pulsed Wave Doppler(PWD) mode, Tissue Harmonic Imaging (THI)
2. Combination Mode:
   B/M, B/CF, B/PD, B/PWD, B/CF/PWD, B/PD/PWD, B/CF/M
   Acoustic output track: Track 3

The provided text describes the "E-CUBE 15 Diagnostic Ultrasound System" and its various transducers but does not contain information about specific acceptance criteria, studies proving performance, sample sizes, data provenance, expert ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies related to any AI components. The document is a 510(k) premarket notification to the FDA, focusing on establishing substantial equivalence to previously cleared predicate devices for various clinical applications and operating modes.

The document lists the intended uses and technical specifications of the E-CUBE 15 system and its transducers, comparing it to predicate devices (E-CUBE 9 and iU22). The "Summary of Non-Clinical Tests" mentions evaluation for biocompatibility, acoustic output, and thermal, electrical, electromagnetic, and mechanical safety, conforming to applicable medical device safety standards. It also lists quality management system measures applied during development.

Crucially, the "Summary of Clinical Tests" section explicitly states:
"The subject of this premarket submission, E-CUBE 15, did not require clinical studies to support substantial equivalence."

This means that for the purposes of this 510(k) submission, the device's substantial equivalence was established through non-clinical testing and comparison to predicate devices, rather than through clinical trials with defined acceptance criteria for AI performance, independent test sets, expert ground truth, or MRMC studies.

Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes, data provenance, expert adjudication, MRMC studies, or standalone algorithm performance for AI components cannot be extracted from this document, as it appears the submission did not rely on such data for device clearance. The document focuses on hardware aspects and basic functional modes, not advanced AI features requiring such rigorous evaluation.

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