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The AQUABEAM® 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 AQUABEAM® Robotic System is intended for use in patients suffering from lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia (BPH). The AQUABEAM Robotic System is designed for resecting of prostate tissue during minimally invasive surgical procedures. The AQUABEAM Handpiece and AQUABEAM Scope are inserted via transurethral approach and advanced into the prostatic urethra.

The AQUABEAM Robotic System is designed to utilize a high-velocity sterile saline waterjet as the cutting medium which is projected through a nozzle positioned within the prostatic urethra. The nozzle assembly motion is driven by a motor system, controlled by the user. The pressure is generated by a highpressure pump system controlled by the AQUABEAM Console. The user is allowed to adjust the desired flow rates manually. All functions are displayed on the AQUABEAM Conformal Planning Unit. Precondition parameters are set on the AQUABEAM Conformal Planning Unit before operation.

The AQUABEAM Robotic System, consists of the following nine components:

• . AQUABEAM Console
• . AQUABEAM Motorpack
• AQUABEAM Foot pedal .
• . AQUABEAM Conformal Planning Unit
• AQUABEAM Roll Stand
• . AQUABEAM Handpiece Articulating Arm
• AQUABEAM TRUS Articulating Arm
• AQUABEAM Handpiece •
• . AQUABEAM Scope

Based on the provided text, the device in question is the PROCEPT BioRobotics AQUABEAM® Robotic System.

It's important to note that this document is a 510(k) summary for a Special 510(k), which means the device is being cleared as substantially equivalent to a previously cleared predicate device (AQUABEAM Robotic System 510(k) Number: K202961). The changes described are minor modifications related to sterility and the use life of a component. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily focused on demonstrating that these minor changes do not compromise the safety and effectiveness established in the predicate device's clearance.

The document does not provide details of acceptance criteria or a study that proves the device meets initial acceptance criteria in the way one might expect for a de novo device or a PMA application. Instead, it relies on substantial equivalence to a predicate device and non-clinical testing to confirm that the changes made do not negatively impact performance.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and performance data for this Special 510(k) relate specifically to the changes made to the predicate device, primarily the sterilization method for the AQUABEAM Scope and its updated use life. The document asserts that the fundamental performance characteristics (e.g., maximum angle rotation, maximum depth of penetration) remain the same as the predicate.

Important Note: The original 510(k) for the predicate device (K202961) would contain the clinical trial data and design verification/validation testing that established the primary safety and effectiveness of the system for prostate tissue removal. This Special 510(k) is a supplement for minor changes.

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

• For the non-clinical testing described in this Special 510(k) (sterilization, biocompatibility, reliability of the scope): The document does not specify the sample sizes used for these specific tests (e.g., how many scopes were tested for sterility or reliability).
• For any pre-existing "Clinical Trial data" referenced from the predicate device: The specific sample sizes and data provenance for the clinical studies supporting the predicate device's original clearance are not provided in this document. The document simply states "Clinical Trial data" was performed on the predicate device and is still applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This document pertains to a device (AQUABEAM Robotic System) for prostate tissue removal, not an AI/imaging diagnostic device. Ground truth, in the context of this device, would typically refer to the clinical outcomes and validation of its physical performance during surgery, rather than a diagnostic AI's performance against expert-labeled images.

Therefore, the concepts of "number of experts used to establish ground truth for the test set" and "qualifications of those experts" are not applicable in the context of this device's regulatory submission as described here. The "experts" involved would be the clinical investigators and surgeons who participated in the clinical trials supporting the predicate device's clearance.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

As this is not an AI/imaging diagnostic device requiring expert adjudication of image interpretations, an adjudication method for a test set is not applicable in the context of this device's regulatory review as described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

This is not applicable as the AQUABEAM Robotic System is a surgical device, not an AI or imaging diagnostic device where MRMC studies are typically performed.

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

This is not applicable for the same reasons as above. The device is a robotic surgical system, not an AI algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the overall performance of the AQUABEAM Robotic System (as established by the predicate device's original clearance and affirmed by this Special 510(k)), the "ground truth" would be clinical outcomes data related to prostate tissue removal and improvement in LUTS due to BPH, potentially supported by pathology of removed tissue and confirmed through clinical follow-up.

For the specific non-clinical tests in this Special 510(k) (sterilization, biocompatibility, scope reliability), the "ground truth" is adherence to established engineering and biological standards (e.g., SAL of 10^-6 for sterility, passing cytotoxicity tests, meeting internal design specifications for cycles).

8. The Sample Size for the Training Set

This is not applicable. The AQUABEAM Robotic System is a hardware-based medical device for surgery. It is not an AI/machine learning model that requires a training set.

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

This is not applicable for the same reasons as #8.

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