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The HYDROS™ Robotic System is intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia.

The HYDROS™ Robotic System has three components - the HYDROS Robotic System, HYDROS TRUS Probe, and HYDROS Handpiece.

1. HYDROS Robotic System: consists of the HYDROS Tower, Touchscreen Interfaces Monitor, HYDROS Software, HYDROS Operating System, Embedded Software, Motorpack, Handpiece Arm, TRUS Probe Arm, and Foot Pedal. It is provided non-sterile and reprocessed per instructions. It does not contact patients during the procedure.
2. HYDROS TRUS Probe: a biplane transrectal ultrasound probe used with the HYDROS Robotic System and HYDROS Handpiece to provide ultrasound imaging for the AQUABLATION procedure. It is re-usable, provided non-sterile, and reprocessed prior to each use.
3. HYDROS Handpiece: a single-use sterile surgical device introduced through the urethra to visualize, resect and remove prostatic tissue. It is integrated with a digital CMOS Scope and terminally sterilized by EtO.

Here's a summary of the acceptance criteria and study information for the HYDROS™ Robotic System, HYDROS™ Handpiece, and HYDROS™ TRUS Probe, based on the provided text:

Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not contain information about a clinical study or performance metrics specifically for AI functionality, as the AI feature seems to be an optional "FirstAssist AI™" feature that aids in planning rather than directly dictating treatment. Therefore, many of the requested clinical study-related details are not available in this document.

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily reports "Pass" for all non-clinical bench tests, indicating that the device met the requirements of the specified standards and guidance documents. Specific quantitative acceptance criteria or performance metrics beyond a "Pass" result are not provided in this summary.

Non-Clinical Testing Details:

• Study Type: Design validation included simulated use testing and cadaver testing. The summary primarily lists compliance with various national and international standards and FDA guidance documents.
• Sample Size (Test Set): Not explicitly stated in the provided text for each specific test. The "Pass" results suggest that the tests were conducted with sufficient samples to meet the requirements of the standards.
• Data Provenance: Not specified, but implied to be from laboratory and cadaver testing within the manufacturer's control, as it's non-clinical performance data.
• Number of Experts for Ground Truth & Qualifications: Not applicable for non-clinical bench testing.
• Adjudication Method: Not applicable for non-clinical bench testing.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned in this non-clinical summary. The AI feature ("FirstAssist AI™") is described as "optional" and assists in planning by providing handpiece nozzle position and prostate capsule boundary, and placing profile landmarks for adjustment by the surgeon. This suggests it's a decision-support tool rather than an autonomous diagnostic or treatment device requiring MRMC studies for performance comparison against human readers.
• Standalone (Algorithm Only) Performance: The AI/ML entry indicates compliance with FDA guidance documents for CADe devices and good machine learning practice. This suggests standalone performance testing for the AI component was likely conducted to meet these guidelines, but specific metrics are not detailed in this summary. The AI assists in planning rather than directly performing the procedure.
• Type of Ground Truth (for AI): The AI feature provides "handpiece nozzle position and the prostate capsule boundary" and places "4 landmarks - treatment start (TS), bladder neck (BN), mid-prostate (MP) and treatment end (TE)." The implication is that these are derived from anatomical structures visible on TRUS imaging, and the ground truth for these would typically be established by expert review/annotations of such images.
• Sample Size for Training Set (for AI): Not specified in the provided text.
• How Ground Truth for Training Set was Established (for AI): Not explicitly stated. For AI in medical imaging, ground truth is typically established by expert annotation (e.g., urologists or radiologists marking anatomical structures or disease boundaries on medical images).

Conclusion from the document:
"The overall performance data in this submission supports that the HYDROS Robotic System and its components are substantially equivalent to the predicate device when utilized for its intended use." This statement confirms that all acceptance criteria relevant to demonstrating substantial equivalence through non-clinical means were met.

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