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The device is intended for use by a qualified physician for ultrasound evaluation of adult abdomen, adult cardiology, pediatric abdomen, pediatric cardiology, fetal cardiology, gynecology, obstetrics (first trimester, second and third trimester), kidney, prostate, thyroid, breast, and other small parts, and peripheral vascular (peripheral artery and peripheral vein), and carotid scanning.

The DC-6 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound mages in B-Mode, M-Mode, Color mode, PW mode, Power/DirPower mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.5 MHz to 12 MHz.

The provided text is a 510(k) summary for the DC-6 Diagnostic Ultrasound System. This document does not describe acceptance criteria for specific performance metrics of the device or a study designed to prove the device meets such criteria in terms of diagnostic accuracy or effectiveness.

Instead, the document focuses on:

• Substantial Equivalence: It asserts that the DC-6 Diagnostic Ultrasound System is "substantially equivalent" to several legally marketed predicate devices. This is the primary regulatory pathway for this type of device, meaning it doesn't need to prove entirely new safety and effectiveness but rather equivalence to existing cleared devices.
• Safety Considerations: It states that the device has been tested as a "Track 3 Device" per FDA guidance, acoustic output has been measured and calculated per NEMA UD standards, and the device conforms to applicable medical device safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1). These are safety criteria and standards for the device itself, not performance metrics related to diagnostic accuracy.
• Intended Use and Modes of Operation: The attached forms (pages 5-9) specify the clinical applications and modes of operation (B, M, PWD, Color Doppler, etc.) for which the system and its transducers are intended. This defines the scope of its use, but not specific performance targets (e.g., sensitivity, specificity for a particular condition).

Therefore, based on the provided text, I cannot extract the requested information about acceptance criteria for device performance (e.g., diagnostic accuracy) and a study proving the device meets those criteria because such details are not present.

The document implies that the device's safety and effectiveness are established through adherence to standards and comparison to predicate devices, rather than a specific clinical performance study with predefined acceptance criteria for diagnostic output.

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