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The DEI System ultrasound imaging system is intended for the following uses: Small Parts, Pediatrics, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The DEI System is a general purpose, software-controlled, diagnostic ultrasound system that complies with pre-amendment application-specific output levels (track 1). Its function is to acquire ultrasound data in acoustical holography mode and display it on an LCD monitor.

The provided text is a 510(k) summary for the Altair Model DEI System, an acoustical holography imaging system. It describes the device, its intended use, and its technological comparison to a predicate device. However, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, as typically found in performance testing sections of a 510(k) submission.

The document primarily focuses on regulatory compliance (safety standards, substantial equivalence to a predicate device) and a general description of the device's technology and intended uses.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving their fulfillment based on the provided text. The requested information (points 1-9) is not present in this document.

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