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The HD80 Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment.

The systems support the following clinical applications:

The HD80 series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac (adult, pediatric), peripheral vessel, and urology exams.

Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

The HD80 Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor and optional image storage and printing device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, and real time 3D transducer. HD80 series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage, hard copy printing, and network access to the facility through LAN or Wireless with WIFI adapter module.

The provided text is a 510(k) summary for the Hisense HD80 Series Ultrasound Diagnostic System. It aims to demonstrate substantial equivalence to a predicate device, the Hisense HD60 Series Ultrasound Diagnostic System (K213862), rather than providing detailed acceptance criteria and proof of their meeting by a specific study in the context of an AI/human-in-the-loop diagnostic device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, performance studies with sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a diagnostic AI device.

The document primarily focuses on:

• Device Description and Intended Use: General purpose ultrasound system for various clinical applications.
• Comparison to Predicate Device: Highlighting similarities in intended use, physical characteristics, modes of operation, and basic functions.
• Differences and Justification: Discussing minor differences (e.g., new functions like Ribbon flow imaging, 3D PW, SCV, and the addition of WIFI and battery) and explaining why these do not affect substantial equivalence or raise new safety/effectiveness concerns.
• Non-clinical Testing: Listing various safety and performance standards the device complies with (e.g., electrical safety, EMC, biocompatibility, usability, software life cycle).
• Absence of Clinical Studies: Explicitly stating that clinical studies were not required for this 510(k) submission.

**In summary, there is no information in the provided text to fulfill your request for: **

1. A table of acceptance criteria and reported device performance: This document does not present such a table because it's a 510(k) summary for an ultrasound system, not an AI diagnostic device with specific performance metrics like sensitivity or specificity.
2. Sample sizes used for the test set and data provenance: No test set data or provenance is mentioned.
3. Number of experts used to establish ground truth and their qualifications: Not applicable as no diagnostic AI performance study is described.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study and effect size: Not applicable.
6. Standalone performance study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The document states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence." This means the submission relies on demonstrating that the HD80 Series is similar enough to a previously cleared device (HD60 Series) that no new safety or effectiveness questions are raised, and therefore, specific performance studies (like those for an AI diagnostic algorithm) were not necessary for its clearance.

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