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The eHertz Functional Series Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), trans-rectal, trans-vaginal, musculoskeletal(conventional, superficial), adult and pediatric cardiac, peripheral vessel and urology exams. This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic. Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Panoramic Imaging, TDI, Color M, Elastography.

The proposed eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) are portable, laptop-style ultrasound imaging system used to perform diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, convex, and phased array transducers to produce images, which are displayed on a LED monitor. The eHertz Functional 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. The eHertz Functional Series Diagnostic Ultrasound System's software features include mFlow, eSRI, eTuner, eTissue , Steer angle, and 2B/4B, etc.

The provided 510(k) clearance letter and summary do not include specific acceptance criteria or details of a study that proves the device meets those criteria.

The document indicates that non-clinical tests were performed to ensure the device complies with safety standards, and performance tests were conducted to demonstrate substantial equivalence to the predicate device. However, it does not explicitly state quantitative acceptance criteria for device performance or the results of those performance tests in a comparative manner that would fit the requested table.

Here's a breakdown of the information that is available from the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The 510(k) summary only states that "All data fell within pre-determined product specifications and external standard requirements" and "For testing, all pre-determined acceptance criteria were met." It does not provide the specific acceptance criteria or the measured performance values.

2. Sample Size Used for the Test Set and Data Provenance

Not available in the provided document. The document states that "The eHertz Functional Series Ultrasound Diagnostic System were evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as performance tests, thermal, electrical, electromagnetic, and mechanical safety," but it does not specify any sample sizes for these tests or the provenance of any data. Since no clinical studies were conducted, there is no patient-specific data provenance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable/Not available. As no clinical studies were conducted, and the evaluation focused on non-clinical performance and safety standards, there was no need for experts to establish ground truth in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable/Not available. No clinical test set requiring adjudication was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC study was not done. The document explicitly states: "Not Applicable. The subject of this premarket submission, did not require clinical studies to support substantial equivalence."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is a diagnostic ultrasound system, not an AI algorithm that would typically have standalone performance metrics. The non-clinical tests evaluated the system's compliance with various electrical, mechanical, and safety standards, as well as its acoustic output and biocompatibility.

7. The Type of Ground Truth Used

Compliance with Voluntary Standards. For non-clinical tests, the "ground truth" was compliance with recognized national and international voluntary standards (e.g., ANSI/AAMI, IEC, ISO, NEMA). For performance demonstration, the ground truth was the performance of the predicate device (M9 Premium Diagnostic Ultrasound System (K230768)) and meeting internal product specifications.

8. The Sample Size for the Training Set

Not applicable/Not available. Since this is a diagnostic ultrasound system and not an AI/ML algorithm that requires training data in the typical sense for image interpretation, there is no mention of a "training set." The system's software features (e.g., mFlow, eSRI, eTuner) are described as specific imaging techniques or image optimization processes, which are likely based on fixed algorithms or calibrated parameters rather than being trained on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not available. See point 8.

Summary of what is available regarding "acceptance criteria" and "study":

The "acceptance criteria" for this clearance process were primarily compliance with various recognized safety and performance standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993 series, NEMA PS 3.1-3.20 DICOM set, etc.), and demonstrating substantial equivalence to the predicate device in terms of intended use, technological characteristics, and modes of operation.

The "study" or "tests" performed were non-clinical tests that evaluated the device's acoustic output, biocompatibility, cleaning and disinfection effectiveness, performance attributes, and electrical, thermal, electromagnetic, and mechanical safety. These tests confirmed that the device met these voluntary standards and performed according to its stated intended use. No clinical studies were deemed necessary to support substantial equivalence for this device.

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