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The Speq ultrasound system is for non-invasive imaging of the human body and is intended for the following applications: Fetal, Abdominal, Pediatric, Musculo-skeletal, Cardiac and Peripheral Vessel. Users must have ultrasound training before using the device. See the attached Indications for Use form for specific imaging modes and applications.

The Signostics Pty Ltd Speq ultrasound system is a hand-held, diagnostic ultrasound system with an on-screen display. Its purpose is to acquire ultrasound echo data and display it in B-Mode or M-Mode on an LCD display.

The provided text is a 510(k) Summary for the Signostics Pty Ltd Speq Ultrasound System. It describes the device, its classification, and comparison to predicate devices, along with its indications for use. However, it does not contain any information regarding acceptance criteria, studies proving device performance against such criteria, sample sizes for test or training sets, expert qualifications, ground truth establishment methods, or comparative effectiveness studies.

The document states that the Speq ultrasound system is "substantially equivalent to the predicate devices listed above. All systems transmit ultrasonic energy into patients, then process received echoes to produce on-screen images of anatomic structures within the body. All systems allow for measurements of structures to aid in diagnosis." This statement of substantial equivalence is the basis for regulatory clearance, rather than a detailed performance study against specific acceptance criteria.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and performance studies based on the provided text. The document focuses on regulatory clearance through substantial equivalence, not detailed efficacy or performance studies with specific metrics.

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