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The HYDROS Robotic System is indicated 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
   The HYDROS Robotic System, consists of the following nine components:

• HYDROS Tower
• Touchscreen Interfaces - Monitor that supports the Tower Monitor (Tmon) and Surgeon Monitor (Smon)
• HYDROS Software
• HYDROS Operating System
• Embedded Software
• Motorpack
• Handpiece Arm
• TRUS Probe Arm
• Foot Pedal

The HYDROS Robotic System is provided non-sterile, and no sterilization is required prior to each use. The Tower, Foot Pedal, Roll Stand, Articulating Arms, and Motorpack are reprocessed per instructions provided with the device after each use. The HYDROS Robotic System does not come in contact with the patients during the procedure.

2. HYDROS TRUS Probe
   The HYDROS TRUS Probe is a biplane transrectal ultrasound probe that is used in the conjunction with the HYDROS Robotic System and HYDROS Handpiece to provide ultrasound imaging to deliver the AQUABLATION procedure. The HYDROS TRUS Probe is re-usable and provided non-sterile. It is reprocessed prior to each use as per the instructions provided in the IFU.

3. HYDROS Handpiece
   The HYDROS Handpiece is the single-use sterile surgical device introduced to the surgical site within the prostate through the urethra to visualize, resect and remove prostatic tissue. The HYDROS Handpiece is integrated with a digital CMOS Scope and is terminally sterilized by EtO.

The provided document is a 510(k) Clearance Letter and 510(k) Summary for the HYDROS Robotic System. This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results and acceptance criteria for specific AI/ML components as one might find in a De Novo or PMA submission.

Therefore, the document does not contain all the requested information for the acceptance criteria and the study proving the device meets those criteria, particularly for the AI/ML aspects. It only states that the AI/ML component "Passes" FDA guidance.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in quantitative terms for the AI/ML features. Instead, it indicates that the AI/ML component passed relevant FDA guidance.

Limitations: The document does not provide specific performance metrics (e.g., accuracy, sensitivity, specificity, or localization error thresholds) as acceptance criteria for the FirstAssist AI™ feature, nor does it present quantitative results. The "Pass" indicates general compliance with regulatory expectations for a 510(k) AI/ML submission.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective) for the AI/ML components. It only mentions "non-clinical performance data" and "simulated use testing and cadaver testing" for overall system validation, but these don't specifically refer to the AI/ML test set.

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications for the AI/ML test set.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set, particularly for the AI/ML component.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. It also does not provide any effect size for human readers improving with AI assistance. The AI feature ("FirstAssist AI™") is described as "optional" assistance during the PLAN step for displaying nozzle position, prostate capsule boundary, and placing landmarks, implying it's a tool for surgeons rather than a primary diagnostic AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

The document implicitly suggests a standalone component analysis for the AI/ML feature by stating it "provides the handpiece nozzle position and the prostate capsule boundary" and "will place the 4 landmarks." However, detailed standalone performance metrics (e.g., how accurate the AI's landmark placement is without human correction, or the performance of the AI in identifying boundaries) are not provided. The description focuses on its function as an assistive tool, implying human review and adjustment.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the AI/ML component. Given the nature of prostate anatomy and procedural planning in a surgical context, it could involve expert anatomical annotation on imaging data, but this is not specified.

8. The Sample Size for the Training Set

The document does not provide the sample size used for the training set of the AI/ML model.

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

The document does not describe how the ground truth for the training set was established for the AI/ML model.

Summary of AI/ML Specifics from the Document:

• Feature Name: FirstAssist AI™ (previously Assisted Planning)
• Functionality:
  • Transverse view: Provides handpiece nozzle position and prostate capsule boundary.
  • Sagittal view: Places 4 landmarks (treatment start (TS), bladder neck (BN), mid-prostate (MP), and treatment end (TE)).
• User Interaction: The surgeon has the option to adjust the landmarks as needed.
• Change from Predicate: The subject device has an "updated AI model for the same functionality of landmark identification."
• Regulatory Status: "Passes" FDA Guidance for AI/ML.

In conclusion, while the document confirms the HYDROS Robotic System has an AI/ML component ("FirstAssist AI™") and was cleared based on non-clinical performance and equivalence to a predicate, it lacks the detailed quantitative acceptance criteria and study particulars for the AI/ML model itself that would typically be found in a more comprehensive clinical validation report. The "Pass" for AI/ML indicates compliance with the regulatory requirements pertinent to a 510(k) submission, which often rely on demonstration of similar performance to a predicate or adherence to recognized performance standards rather than extensive de novo clinical studies specifically for the AI component's accuracy.

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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 FDA 510(k) summary does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and the study proving the device meets them. This document primarily focuses on demonstrating substantial equivalence to a predicate device, particularly regarding a software change. It indicates that most performance data relies on previous testing of the predicate device.

However, based on the information available, here's what can be extracted:

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

The document does not explicitly present a table of acceptance criteria with corresponding reported device performance for the new software version. Instead, it discusses the purpose of the software change and states that testing was performed to ensure it works as intended and does not impact safety and effectiveness.

The key change described in the software is:

• Previous Software (SW0021-281): User had the option to exceed the depth for bladder neck, mid-prostate, and median lobe. Purple lines on the GUI blinked when depth was exceeded. Maximum depth constraint could not let the user place markers beyond 24.3 mm.
• New Software (SW0021-282): Limits the user from planning a cut in profile path beyond the depth of the cut defined in the angle step for mid prostate and bladder neck. The purple line indicator flashing is removed as the user is now limited. The median lobe depth of cut is not limited. The maximum depth constraint is removed from the Profile Landmark step, allowing the user to place 4 landmark points beyond 24.3 mm depth, though the maximum planned depth remains 24.3 mm.

Implied Acceptance Criteria (based on the software change description):

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

The document states "The new software and operating system verification and validation testing to ensure that the software and the operating system changes do not impact the safety and effectiveness of the subject device and the subject device software and OS works as intended."

However, no specific sample size or details about data provenance (e.g., country of origin, retrospective/prospective) are provided for this software verification and validation testing. The document largely relies on the past performance data of the predicate device.

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. The document refers to "verification and validation testing" for the software without detailing who performed or reviewed these tests, or how ground truth was established within this context.

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 provided in the document. The device in question is a robotic system for prostate tissue removal, not an AI-assisted diagnostic imaging system that would typically involve human readers.

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

This information is not directly applicable or provided for this type of robotic surgical device. The software changes described are related to planning and constraints within the user interface of the robotic system, which inherently involves a human operator (surgeon). The verification and validation testing would assess the software's behavior in this human-in-the-loop context.

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

For the software changes, the "ground truth" would likely be the expected and specified behavior of the software as defined by the developers and engineers, validated through testing scenarios. It is not equivalent to clinical 'ground truth' from pathology or outcomes data in the usual sense for diagnostic devices. However, the document does mention "Clinical Trial Data" as pre-existing non-clinical data relied upon, implying that the overall safety and effectiveness of the system (of which the software is a component) has been supported by clinical outcomes in the past. Details of this clinical trial ground truth are not provided for this specific submission.

8. The sample size for the training set

This information is not provided in the document. While the software was verified and validated, there is no indication that it employs machine learning or AI that would require a "training set" in the typical sense. It appears to be a rule-based or algorithmic software update.

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

As there is no mention of a "training set" in the context of machine learning, this information is not provided and likely not applicable.

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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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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 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 is a 510(k) summary for the AQUABEAM® Robotic System, which is intended for the resection and removal of prostate tissue. However, this document does not contain acceptance criteria or study data demonstrating the device meets specific performance criteria in the way that would typically be presented for an AI/ML medical device submission.

Instead, this 510(k) submission primarily focuses on:

• Device Description: What the AQUABEAM Robotic System is and how it works.
• Indications for Use: The medical conditions it is intended to treat.
• Technological Characteristics: Stating that these are unchanged from the predicate device.
• Device Comparison: Detailing changes only to the device labeling (specifically, to the contraindications section).
• Performance Data: Listing pre-existing non-clinical data (biocompatibility, sterilization, software/firmware verification, electrical safety, usability, system design validation, reliability testing) relied upon. This section does not outline new performance criteria or data related to the device's efficacy for tissue removal.
• Clinical Data Summary: Discussing a sub-group analysis from the WATER study (NCT02505919) and a study on circulating tumor cells (CTCs) in the context of the labeling change for contraindications, specifically regarding patients with diagnosed or suspected prostate cancer. This is to justify removing a contraindication, not to establish new performance metrics for the device's primary function of tissue removal.

Therefore, I cannot extract the requested information regarding acceptance criteria and study data proving the device meets those criteria, as it is not present in the provided text. The document states that "The device's technological characteristics are unchanged, therefore no further non-clinical performance test data is required to support the subject device." and relies on prior non-clinical data and clinical data to support a change in contraindications.

The provided text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set proving performance for tissue removal.
3. Number of experts or their qualifications for establishing ground truth for a test set.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results or effect size for AI assistance.
6. Standalone performance results.
7. Type of ground truth used for performance validation.
8. Sample size for a training set.
9. How ground truth for a training set was established.

Ask a specific question about this device

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.

Ask a specific question about this device

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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The AOUABEAM 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 System is a personalized image-guided prostate tissue removal system that uses a high-velocity water jet to resect and remove a predetermined volume of tissue. The AQUABEAM System is comprised of nine main components along with accessories: AQUABEAM Conformal Planning Unit, AQUABEAM Console, AQUABEAM Motorpack, AQUABEAM Roll Stand, AQUABEAM Foot Pedal, AQUABEAM Handpiece Articulating Arm, AQUABEAM TRUS Articulating Arm, AQUABEAM Handpiece, and AQUABEAM Scope.

The AQUABEAM System is a fluid jet system for prostate tissue removal intended for the resection and removal of prostatic tissue for the treatment of benign prostatic hyperplasia (BPH). The device cuts tissue using a pressurized fluid jet and can image the treatment area or pairs with an imaging modality to monitor treatment progress.
The provided text details the acceptance criteria and the study that proves the device meets these criteria. The study, named WATER, was a prospective, multicenter, international double-blinded randomized clinical trial comparing the AQUABEAM System (Aquablation) to transurethral resection of the prostate (TURP).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the "Special Controls" section, which outlines the performance data required to establish safety and effectiveness. The reported device performance is extracted from the "Safety Results" and "Efficacy Results" sections of the WATER clinical study.

Study Details for Clinical Performance Testing (WATER Study)

The clinical performance testing (WATER study) is paramount for demonstrating the device meets the acceptance criteria related to LUTS improvement and adverse events.

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

• Test Set Sample Size:
  • 181 subjects were enrolled, randomized, and treated.
  • Aquablation arm: 116 subjects
  • TURP arm: 65 subjects
  • At 6-month follow-up (primary efficacy endpoint): 114/116 (98.3%) Aquablation subjects and 62/65 (95.4%) TURP subjects were available.
• Data Provenance:
  • Country of Origin: International (multicenter study). Specific countries are not listed, but it implies a diverse geographic origin.
  • Retrospective or Prospective: Prospective. The study was "designed and executed WATER, a prospective, multicenter, international double-blinded randomized clinical trial."

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

The term "ground truth" generally refers to a definitive diagnosis or outcome used to evaluate the performance of a device or algorithm. In this context, it's about the clinical outcomes of patients.

• Number of Experts: An "independent clinical events committee (CEC)" was used for adjudication related to the primary safety endpoint. The exact number of experts on the CEC is not specified.
• Qualifications of Experts: Not explicitly stated, but as a "clinical events committee," it is expected that the members are qualified medical professionals, likely urologists or others with expertise in BPH treatment and adverse event assessment.

4. Adjudication Method for the Test Set

• Adjudication Method: "The primary safety endpoint was adjudicated by an independent clinical events committee (CEC). The CEC classified (assigned relatedness) to the adverse events based on severity and association to the procedure or other attribution."
  • This implies a process where the CEC reviews reported adverse events and makes a consensus decision on their classification and relatedness to the procedure, rather than a 2+1 or 3+1 system typically used for image interpretation in AI studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, a true MRMC study was not described. The WATER study was a randomized controlled trial comparing two surgical interventions (Aquablation vs. TURP) with human surgeons performing the procedures and patient outcomes being measured. This is different from an MRMC study where human readers interpret medical images with or without AI assistance to assess AI's impact on diagnostic accuracy.
• Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable, as this was not an AI assistance study. The AQUABEAM System is a surgical device, not a diagnostic AI tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• Was standalone performance done? Not applicable in the traditional sense of an "algorithm only" study for a diagnostic AI. The AQUABEAM System is a surgical device that requires continuous human operation and decision-making (e.g., planning the resection, monitoring the procedure). While it has software components that control the device's mechanics ("Console FPGA firmware," "Motorpack FPGA firmware," and "CPU Software"), its overall "performance" is inherently linked to its use by a qualified physician. The pre-clinical bench and animal studies serve as "standalone" performance verification of the device's technical capabilities as a surgical tool.

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

• Clinical Efficacy Ground Truth: Patient-reported outcomes (International Prostate Symptom Score - IPSS, IPSS Quality of Life - QOL), objective physiological measurements (Qmax, Post Void Residual - PVR), and expert assessment of adverse events. These are forms of outcomes data and expert consensus/adjudication (for adverse events).
• Safety Ground Truth: Clavien-Dindo classification of adverse events, adjudicated by an independent CEC, which represents an expert consensus on event severity and relatedness.
• Animal Studies Ground Truth: Histopathological analysis of ablated tissue and surrounding areas to verify controlled tissue resection and lack of injury to non-target tissue. This is pathology-based ground truth.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not explicitly stated for the device's underlying "algorithm" or software, as this refers to a traditional machine learning model's training data. For a hardware device with embedded software, the "training" involves extensive R&D, iterative design, and validation against design specifications rather than labeling a dataset. The software itself underwent "Verification and validation testing" (Table 6), implying rigorous internal testing, but not in the context of a "training set" for a learning algorithm.

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

• Ground Truth for Training Set: Not applicable in the context of a machine learning training dataset. For the AQUABEAM System, the "ground truth" for its development would be based on engineering specifications, physiological principles of fluid dynamics and tissue ablation, and clinical requirements for safe and effective prostate tissue removal. These "truths" were established through engineering design, scientific literature, anatomical knowledge, and preclinical and clinical expertise guiding the device's functionality and software logic. User input via the Conformal Planning Unit defines the "ground truth" for each specific patient's treatment plan.

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