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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 wateriet 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 high-pressure 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. Pre-condition 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

The provided text describes the AQUABEAM® Robotic System and its substantial equivalence to a predicate device (DEN170024). It details various non-clinical tests performed to demonstrate this equivalence, but does not include information about acceptance criteria or a specific study proving the device meets those criteria in a quantitative manner (e.g., using specific metrics like sensitivity, specificity, accuracy with established thresholds).

The document focuses on verification testing to show that changes to the device (e.g., software, hardware) perform as intended and that the system remains substantially equivalent to the previously cleared predicate device.

Here's a breakdown of the information that is available, and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance

The document provides a table of "Non-Clinical Testing" and "Conclusion" which states that "all acceptance criteria were met" for various categories. However, it does not explicitly define those acceptance criteria (e.g., "Software performed as intended" is a conclusion, not a measurable criterion with a numerical target). Therefore, a detailed table as requested cannot be constructed from the provided text.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text mentions "cadaver study" for design validation, but doesn't specify sample size, origin, or retrospective/prospective nature.

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)

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

This information is not applicable/not provided. The device is a robotic system for surgical resection, not an AI diagnostic or assistance tool for human readers in the context of image interpretation.

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

This information is not applicable/not provided. The device is a physical robotic system, not an algorithm in the typical sense of standalone AI performance.

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

For the system design validation, the document mentions a "cadaver study." While it doesn't explicitly state the "ground truth" for this cadaver study, it implies that the performance of the system in resecting prostate tissue on cadavers served as a proxy for validating its functionality. The nature of the ground truth (e.g., precise tissue removal confirmed by dissection or imaging) is not detailed.

8. The sample size for the training set

This information is not applicable/not provided. The device is a robotic system, not a machine learning model that undergoes a "training set."

9. How the ground truth for the training set was established

This information is not applicable/not provided for the same reason as point 8.

Summary of available information related to acceptance criteria and performance:

The document states that a variety of non-clinical tests were performed on the AQUABEAM Robotic System to demonstrate substantial equivalence to its predicate device. For each category of testing, the conclusion is that "all acceptance criteria were met." However, the specific metrics and thresholds for these "acceptance criteria" are not detailed.

Here's what the document indicates regarding testing and conclusions:

Table of Acceptance "Criteria" (Implicit) and Reported Device Performance:

Additional relevant points from the text:

• Clinical Trial Data: "Existing clinical trial data is sufficient to establish the safety and effectiveness of the subject device, AQUABEAM Robotic System with the changes in design subject of this traditional 510(k) do not change the mode of operation/mechanism of action of the device." This indicates that previous clinical data for the predicate device, which shares the same indications for use and mechanism of action, is being leveraged, eliminating the need for new clinical trials for this specific 510(k) submission.
• The 510(k) submission is for changes to an existing, already cleared device, demonstrating substantial equivalence to its predicate (DEN170024). The focus is on showing that the changes do not negatively impact safety or effectiveness.

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