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The HM70A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-esophageal (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Peripheral vessel.

The HM70A is a general purpose, hand-held, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging(including Directional Power Doppler mode; S-Flow), PW/CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HM70A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HM70A has real time acoustic output display with two basic indices, a mechanical index, which are both automatically displayed.

The provided text is a 510(k) Summary for the Samsung Medison HM70A Diagnostic Ultrasound System. It details the device's intended use, technological characteristics, and compliance with safety standards, asserting substantial equivalence to predicate devices. However, this document does not contain acceptance criteria, device performance metrics, or information about specific studies, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set parameters.

Therefore, I cannot extract the requested information from the provided text. The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission, HM70A, did not require clinical studies to support substantial equivalence." This means that no clinical studies (which would typically involve test sets, ground truth, expert review, etc.) were conducted or submitted for this particular 510(k) clearance based on this document.

The document focuses on establishing substantial equivalence through a comparison of technological characteristics and compliance with recognized safety standards, rather than through performance metrics derived from clinical trials or test sets.

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