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The HS70A 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-esoph. (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.

The HS70A is a general purpose, mobile, 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 Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS70A 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 HS70A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

This document is a 510(k) Premarket Notification for the SAMSUNG MEDISON Co., Ltd. HS70A Diagnostic Ultrasound System. It details the device's intended use, technology, and comparison to predicate devices, but does not include acceptance criteria or the results of a study proving the device meets acceptance criteria related to diagnostic performance.

The document refers to non-clinical tests for safety and compliance with various standards but explicitly states: "The subject of this premarket submission, HS70A, is not required clinical studies to support substantial equivalence." This means that no clinical performance study was conducted or reported in this submission to evaluate the diagnostic accuracy of the device.

Therefore, the requested information regarding acceptance criteria and the study proving device performance related to diagnostic accuracy cannot be extracted from the provided text.

Based on the provided text, here is what can be inferred about the criteria and tests performed for regulatory submission:

1. A table of acceptance criteria and the reported device performance:

Since no clinical studies proving diagnostic performance were conducted or reported, no such table can be provided. The document focuses on regulatory compliance and safety standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable as no clinical test set for diagnostic performance was used or reported in this submission. The tests performed were non-clinical for safety and electrical compatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable as no clinical ground truth was established or reported in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable as no clinical test set was used or reported in this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable as implied by the statement "The subject of this premarket submission, HS70A, is not required clinical studies to support substantial equivalence." The device is a diagnostic ultrasound system and not explicitly stated to include AI for diagnostic assistance. There is a mention of "E-Strain, S-Detect for Breast, and S-Detect for Thyroid" which are described as "same functionalities in the predicate RS80A," suggesting image processing features rather than a separate AI-driven diagnostic interpretation system that would typically warrant an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable as no diagnostic standalone algorithm performance study was reported.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. For the non-clinical tests conducted, the "ground truth" would be the specifications and requirements of the various safety and performance standards (e.g., IEC 60601-1, NEMA UD 2-2004).

8. The sample size for the training set:

Not applicable as no machine learning algorithm development training set is mentioned or implied for diagnostic performance.

9. How the ground truth for the training set was established:

Not applicable.

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