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The device is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal , Abdominal, Pediatric, Small Organ (breast, thyroid,testes ), Neonatal Cephalic, Cardiac (adult , pediatric),Musculo-skeletal (Conventional , Superficial) ,Peripheral Vascular,Transesophageal,Transvaginal, Urology.

The EBit Series Diagnostic Ultrasound System is an integrated preprogrammed color doppler ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array. This system consists of a mobile console with keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and to display the image B-Mode (including Fusion Harmonic Imaging), M-Mode, Pulsed (PW) Doppler Mode. Continuous (CW) Doppler Mode, Color Doppler Mode, Power Doppler Mode, Directional Power Doppler Mode, TDI Mode or a combination of these modes, Elastography, 3D/4D.

I am sorry, but the provided text is a 510(k) Pre-Market Notification for a Diagnostic Ultrasound System and does not contain the specific details about acceptance criteria, device performance, study designs (sample sizes, provenance, ground truth, expert qualifications, adjudication methods), MRMC comparative effectiveness studies, or standalone algorithm performance that you requested.

The document primarily focuses on:

• Indications for Use: Listing the clinical applications for which the device is intended.
• Safety and Performance Standards: Stating that the device conforms to various IEC, NEMA, and ISO standards related to electrical, mechanical, thermal, electromagnetic compatibility, biocompatibility, and acoustic output.
• Comparison to Predicate Device: Highlighting similarities in features, operating controls, display modes, and safety compliance with a previously cleared device (Q Series Diagnostic Ultrasound System K153085).
• Conclusion: Asserting substantial equivalence to predicate devices based on safety and effectiveness.

It explicitly states: "No clinical testing was required." This means there wasn't a study of the type you are asking about, designed to assess the device's diagnostic performance against a ground truth or compared to human readers. The substantial equivalence was established based on engineering and safety testing, and comparison of technical specifications to a predicate device.

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