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The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

The HERA 110 is general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler. Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes. The HERA I10 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 HERA I10 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The provided text is a 510(k) Summary for the Samsung Medison HERA I10 Diagnostic Ultrasound System. This type of FDA submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical trials. Therefore, the document explicitly states:

"The subject of this premarket submission, HERA I10, did not require clinical studies to support substantial equivalence." (Page 24)

This means that the information you've requested regarding acceptance criteria and a study proving device performance in the context of AI/human reader studies, ground truth establishment, expert adjudication, and large-scale sample sizes for training and testing is not present in this document. The submission focuses on demonstrating that the HERA I10 has equivalent technological characteristics, intended uses, and safety standards as its predicate device (HERA W10, K182595).

The "studies" mentioned are non-clinical and primarily cover:

• Acoustic output
• Biocompatibility
• Cleaning and disinfection effectiveness
• Thermal, electrical, electromagnetic, and mechanical safety
• Software/firmware functionality (evaluated against the predicate's test criteria to ensure image quality was not compromised)

The acceptance criteria for this submission revolve around confirming compliance with relevant industry standards (e.g., IEC 60601-1, ISO 14971, ISO 10993-1, NEMA UD 2 & 3) and demonstrating that the device functions as intended without introducing new safety or effectiveness concerns compared to the predicate.

In summary, based solely on the provided text, the document does not contain the specific information requested in points 1-9 as it explicitly states that clinical studies were not required.

If you are looking for information on acceptance criteria and performance studies for an AI-powered medical device, you would typically need to consult a different type of FDA submission (e.g., De Novo, PMA, or an AI/ML-specific 510(k) where clinical performance data is required). This document is for a general diagnostic ultrasound system and its equivalence to a previous version.

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The ultrasound diagnostic system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.

The HERA W10 is general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound dasta and to display the data as B-mode. M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes. The HERA W10 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 HERA W10 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

I am sorry, but the provided text does not contain sufficient information to answer your request. The document is a 510(k) summary for the HERA W10 Diagnostic Ultrasound System, which primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's intended uses and compliance with safety standards.

Specifically, the text does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes used for test sets, data provenance, number or qualifications of experts for ground truth, or adjudication methods for test sets.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Information about a standalone (algorithm only) performance study.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set or how its ground truth was established.

In fact, section 11 explicitly states: "The subject of this premarket submission, HERA W10, did not require clinical studies to support substantial equivalence." This indicates that detailed performance studies as you've requested were not part of this specific FDA submission.

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