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The diagnostic ultrasound system (U60) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.

The U60 is a portable Diagnostic Ultrasound System, which applies advanced technologies. Various image parameter adjustments, 15.0 inch LCD and diverse probes are configured to provide clear and stable images.

The provided text is a 510(k) premarket notification for the Edan Instruments U60 Diagnostic Ultrasound System. This type of FDA submission aims to demonstrate "substantial equivalence" to a predicate device, rather than proving safety and effectiveness from scratch through extensive clinical trials for a new, revolutionary device.

Therefore, the document does not contain detailed information about acceptance criteria and studies demonstrating that the device meets those acceptance criteria in the way one might expect for a novel AI/ML device or a device with new clinical indications. Instead, it focuses on demonstrating that the U60 is substantially equivalent to a predicate device (the U50 Diagnostic Ultrasound System) by showing similar design, intended use, indications for use, fundamental scientific technology, and performance, while complying with relevant safety standards.

Here's a breakdown of what can and cannot be extracted from the document based on your request:

Information Present in the Document:

• 1. Table of Acceptance Criteria and Reported Device Performance:
  • The document presents a comparison table (within "9. Predicate Device Comparison") between the U60 (subject device) and the U50 (predicate device) across various parameters. This table effectively serves as the "acceptance criteria" for demonstrating substantial equivalence, where the acceptance criteria is generally "same" or "similar" to the predicate.
  • Table of Performance (Comparison to Predicate):

• 2. Sample sized used for the test set and the data provenance:

  • The document explicitly states: "Clinical testing is not required." and "Verification and validation testing has been conducted on the U60 Ultrasound Imaging System."
  • This indicates that no patient data (test set) was used in a clinical study to evaluate the device's performance against clinical endpoints. The acceptance criteria and performance data are based on bench testing and engineering verification, which demonstrate that the device performs within established technical specifications comparable to the predicate. Therefore, information about sample size or data provenance (country, retrospective/prospective) for a clinical test set is not applicable here.

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

  • This is not an AI/ML device. It's a diagnostic ultrasound system. Its "performance" refers to its imaging capabilities and measurement accuracy, which are evaluated intrinsically through non-clinical (bench) testing, not through standalone algorithm performance.

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

  • For the non-clinical tests (e.g., B-Mode Measurement Accuracy, M-mode Measurement Accuracy), the "ground truth" would be established by known physical standards or phantoms with precisely measured characteristics (e.g., a known distance in a test object for distance accuracy). This is standard for ultrasound system performance verification.

Information NOT Present / Not Applicable based on the Document:

• 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 test set requiring expert ground truth was performed for this 510(k) submission.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, for the reason above.
• 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 this is a diagnostic ultrasound system, not an AI-assisted device.
• 8. The sample size for the training set: Not applicable, as this is not an AI/ML device with a training set.
• 9. How the ground truth for the training set was established: Not applicable, for the reason above.

In summary:

This 510(k) submission for the Edan Instruments U60 Diagnostic Ultrasound System demonstrates substantial equivalence to a predicate (U50) primarily through non-clinical bench testing and adherence to recognized performance and safety standards. It is not an AI/ML device, nor does it present clinical study data with human-in-the-loop performance or expert-established ground truth, as is often seen with AI-based medical devices. The "acceptance criteria" discussed are a comparison of technical specifications and performance metrics to an already cleared device, asserting that the new device is "same" or "similar" and therefore equally safe and effective.

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