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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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Special Controls)	Reported Device Performance and How It Meets the Criteria
1. Clinical performance testing must evaluate:	WATER Clinical Study Results:
a. All adverse events associated with the device;	- Primary Safety Endpoint: Occurrence of Clavien-Dindo persistent grade 1 or grade 2 or higher perioperative complications at 3 months. - Aquablation (25.0%) vs. TURP (40.0%). - Rate difference: -15.0% (95% CI: -29.2 to -1.0%). - UCL (-1.0%) < 10% non-inferiority delta, demonstrating non-inferiority. - UCL < 0, demonstrating statistical superiority of Aquablation vs. TURP. - Key finding: Lower incidence of retrograde ejaculation in Aquablation (11.3%) vs. TURP (36.4%). - Comprehensive listing of Clavien-Dindo graded events by type and percentage for both groups at 3 months (Table 3), covering various adverse events (bladder spasm, bleeding, dysuria, pain, urethral damage, UTI, urinary retention, stricture, arrhhythmia, etc.).
b. Improvement in Lower Urinary Tract Symptoms (LUTS).	- Primary Efficacy Endpoint: Change in International Prostate Symptom Score (IPSS) at 6 months compared to baseline. - Mean IPSS scores decreased from 22.9 to 5.9 (Aquablation) and 22.2 to 6.8 (TURP). - IPSS change score at month 6 (Aquablation vs. TURP): 1.8 points larger (95% CI: -0.4 to 4.0). - Lower confidence limit (-0.4) was above the non-inferiority margin of -4.7, substantiating statistical and clinical non-inferiority of effectiveness. - All Aquablation subjects with baseline and 6-month data showed IPSS improvements. - Additional endpoints: Improvement in IPSS QOL, Qmax, and Post Void Residual (PVR) were seen in both groups and compared for non-inferiority/superiority (Table 6).
2. Physician training must be provided that includes:	- Training Program: Mandated and detailed (System and procedure review, hands-on lab with didactic review, treatment planning simulator, cadaveric/similar model lab, and case support from a qualified proctor). Goals include: understanding key aspects, resection contour planning, imaging methods, and how to override/stop resection.
3. Animal testing must demonstrate that the device resects targeted tissue in a controlled manner without injury to adjacent non-target tissues.	- Animal Performance Testing: 8 non-castrated male beagles treated with AQUABEAM System. - Demonstrated ablation of targeted tissue without damage to adjacent tissues. - Results showed intact capsular architecture and normal cellular architecture beyond the resected zone. - Widely patent prostatic urethral lumen observed in survived animals.
4. Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:	- Bench Studies (Table 1): Comprehensive successful testing of various device functions, including: a. Measurement of targeting accuracy and reproducibility of high velocity fluid jet: Verified accuracy of longitudinal stroke, longitudinal velocity, sweep angle, and probe centering (e.g., "Probe Longitudinal Stroke Verification," "Simulated-Use, AQUABEAM Sweep Angle Verification and Probe Centering Verification Testing"). b. High pressure fluid jet verification testing at target and non-target tissues: Verified pump performance, aspiration flow rate, irrigation flow rate, and simulated-use cutting on potato analogue ("Simulated-Use, Pump Power/Flow Testing," "Simulated-Use, Aspiration Flow Rate Testing," "Simulated Use Testing (Potato Cutting)").
5. Software verification, validation, and hazard analysis must be performed.	- Software Documentation: Developed in accordance with FDA guidance and IEC 62304. - Major Level of Concern (LOC) software. - Documentation provided and adequate: software description, device hazard analysis, requirements, architecture, design, traceability, development, V&V testing, revision history, unresolved anomalies, run-time error detection. - Console FPGA firmware, Motorpack FPGA firmware, and CPU Software components verified.
6. The patient-contacting elements of the device must be demonstrated to be biocompatible.	- Biocompatibility Testing: AQUABEAM Handpiece and AQUABEAM Scope (direct/indirect patient contact components) tested successfully using ISO 10993 tests for external communicating devices with limited exposure (<24 hours) against: Cytotoxicity, Sensitization, Irritation/intracutaneous reactivity, Acute systemic toxicity, Material-mediated pyrogenicity, Hemolysis. All tests passed.
7. Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of the device.	- Electrical Safety & EMC: Evaluated and confirmed conformance to IEC 60601-1 (general requirements) and IEC 60601-1-2 (EMC), and IEC 60601-2-37 (specific to ultrasonic diagnostic and monitoring equipment).
8. Performance data must demonstrate the sterility of the patient-contacting components of the device.	- Sterility: AQUABEAM Handpiece is provided sterile. - Sterilized using 100% Ethylene Oxide (EO) gas to a Sterility Assurance Level (SAL) of 10-6. - Packaging integrity and design verification testing performed after double sterilization and accelerated aging.
9. Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.	- Shelf Life Testing: AQUABEAM Handpiece shelf-life tested using 2-year accelerated aging (ASTM F1980). - Packaging integrity and design verification testing performed; all test samples sterilized twice prior to accelerated aging.
10. Performance data must validate the instructions for reprocessing and reliability of reusable components.	- Reprocessing Validation: Reusable components (AQUABEAM Scope) validated in accordance with AAMI TIR30, FDA guidance "Reprocessing Medical Devices in Health Care Settings," and ISO 17664. - Detailed reprocessing steps for the Scope are provided (disassembly, pre-cleaning, manual cleaning, rinsing, EO sterilization, inspection/function testing). - Scope has a use life of eight months; other reusable components have a 3-year use life. - Reliability: "Scope Re-Use testing" demonstrated performance after repeated sterilization and cleaning cycles (Table 8).
11. Labeling must include the following:	- Labeling Documentation: Complies with 21 CFR 801.109 for prescription devices. - Includes: a. A section summarizing clinical testing results (adverse event profile and LUTS improvement): Covered in "Safety Results" and "Efficacy Results" and summarized in "Benefit-Risk Determination." b. A shelf life for single use components: Explicitly stated that Handpiece shelf life supported by testing. c. A use life for reusable components: Stated (e.g., Scope 8 months, other components 3 years). d. Reprocessing instructions for reusable components: Referenced in "Reprocessing" section and "Instructions for Use."
Additionally, the following risks were mitigated through appropriate measures: (from "Risks to Health" table) - Injury from device operation (bleeding, pain, sexual dysfunction, urethral damage, etc.) - Adverse tissue reaction - Infection - Failure to remove target tissue or removal of non-target tissue - Electrical shock or electromagnetic interference	- Injury from device operation: Mitigated by Clinical performance testing (WATER study results), Animal testing, Labeling warnings/precautions, and Training requirements. - Adverse tissue reaction: Mitigated by Biocompatibility evaluation. - Infection: Mitigated by Sterilization validation, Reprocessing validation, Shelf life testing, and Labeling. - Failure to remove target tissue or removal of non-target tissue: Mitigated by Clinical performance testing (WATER study efficacy), Animal testing, Software verification/validation/hazard analysis, Non-clinical performance testing (bench studies on accuracy/cutting), Labeling, and Training. - Electrical shock or electromagnetic interference: Mitigated by Electrical safety testing, Electromagnetic compatibility testing, and Labeling (MR unsafe warning).

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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