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The Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculoskeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel, and urology exam.

The Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode , Power/Dirpower Mode, 4D, Smart3D,TDI, Color M, Elastography, Biopsy Guidance, Contrast imaging (Contrast agent for Liver) or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include Linear array, Convex array probe.

The provided text is a 510(k) Pre-market Notification from the FDA, and it does not contain information about a study that proves the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML-driven device would. This document pertains to traditional diagnostic ultrasound systems.

Specifically, it states multiple times:

• "Not applicable. The subject of this submission, Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." (Page 26, Section 8. Clinical Studies)
• "The Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System has the same technological characteristics, is comparable in key safety and effectiveness features, and has the same intended uses and basic operating modes as the predicate devices." (Page 25, Section 6. Comparison with Predicate Devices)

Therefore, based on the provided document, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets those criteria, as an AI/ML performance study was not conducted or required for this conventional diagnostic ultrasound system.

The document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, primarily the Mindray Z6 (K182603) and DC-40 (K183377), by showing:

• Same intended uses: The document lists "fetal, abdominal, intra-operative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams." (Page 24)
• Similar technological characteristics and operating modes: B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, 4D, Smart3D, TDI, Color M, Elastography, Biopsy Guidance, Contrast imaging (for liver). (Page 23)
• Compliance with recognized safety standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, IEC 62366, IEC 60601-1-6, ISO 14971, ISO 10993-1. (Page 25-26)
• Acoustic power levels below FDA limits. (Page 25)

The concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" as it relates to AI/ML performance (e.g., specific sensitivity, specificity, or AUC targets, or human-in-the-loop improvement metrics) is not relevant to this type of traditional device submission. The "acceptance criteria" here are implicitly meeting the performance characteristics and safety standards of the predicate devices.

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