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The DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), pediatric cardiac, adult cardiac(only for DP-7), peripheral vessel and urology exams.

The DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging System are general purpose, mobile, software controlled, ultrasonic diagnostic systems. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, or their combined mode B+M Mode. The systems are Track 3 device that employs an array of transducers including linear array, convex array and phase array with a frequency range of approximately 2.0 MHz to 14.0 MHz.

The provided text does not contain information about acceptance criteria or specific studies detailing device performance against such criteria. The document is a 510(k) premarket notification summary for the Mindray DP-5 and DP-7 Digital Ultrasonic Diagnostic Imaging Systems, focusing on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance metrics or clinical study results.

The document primarily covers:

• Device Description: General features and modes of operation (B-Mode, M-Mode, combined).
• Intended Use: Broad clinical applications for various patient populations and anatomical regions.
• Comparison with Predicate Devices: Lists several Mindray systems as predicates, stating "They have the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate device."
• Non-clinical Tests: Mentions evaluations for acoustic output, biocompatibility, cleaning/disinfection, and safety standards conformance (ISO 14971, IEC standards, UL 60601-1, etc.).
• Conclusion: Asserts substantial equivalence based on intended uses, traditional clinical practices, FDA guidelines, manufacturing quality processes, and conformity to safety standards.
• Transducer Information: Detailed tables indicating the clinical applications and modes of operation ("P" for previously cleared or "N" for new indication) for each specific transducer model associated with the DP-5 and DP-7 systems. These tables also note additional features like Tissue Harmonic Imaging and Biopsy Guidance.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not present in the provided text. The 510(k) summary format does not typically include this level of detail about specific performance studies for devices demonstrating substantial equivalence to existing cleared devices.

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