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510(k) Data Aggregation
(141 days)
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:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set proving performance for tissue removal.
- Number of experts or their qualifications for establishing ground truth for a test set.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results or effect size for AI assistance.
- Standalone performance results.
- Type of ground truth used for performance validation.
- Sample size for a training set.
- How ground truth for a training set was established.
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(29 days)
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.
| Acceptance Criteria (for the changes) | Reported Device Performance (as demonstrated by testing within this 510(k)) |
|---|---|
| Scope Sterilization Efficacy: AQUABEAM Scope must be effectively sterilized by the new STERRAD 100NX Express cycle, meeting a Sterility Assurance Level (SAL) of 10^-6. | Sterilization Validation Testing (EN ISO 14937: 2009) was performed and found to conform to the standard, indicating effective sterilization. |
| Scope Biocompatibility: The scope, after reprocessing with the new cycle, must maintain biocompatibility. | Biological Evaluation (ISO 10993-5 and ISO 10993-12) was performed and found to conform for in vitro cytotoxicity, suggesting maintenance of biocompatibility. |
| Scope Use Life: The AQUABEAM Scope must maintain its functional integrity and sterility capabilities for "at least 10 use cycles." | AQUABEAM Scope Reliability testing was performed (though the specific results or methodology aren't detailed in this summary, the updated use life is stated as "at least 10 cycles," implying this was met). |
| Overall Safety and Effectiveness: The minor changes (IFU update and scope use life) must not compromise the overall safety and effectiveness of the device. | The conclusion states: "The overall performance data in this submission supports that the AQUABEAM Robotic System is safe, effective, and substantially equivalent to the predicate device when utilized for its intended use." This is an overarching claim based on the non-clinical testing performed and the reliance on the predicate device's existing clearance. |
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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(162 days)
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:
| Non-Clinical Testing Category | Implicit Acceptance Criterion (as per conclusion) | Reported Device Performance/Conclusion |
|---|---|---|
| Software and Firmware Verification | Performance as intended, meeting all acceptance criteria. | Verification testing performed on CPU software, operating system, MCU firmware, and updates to Console FPGA and Motorpack FPGA. "The software and firmware performed as intended and all acceptance criteria were met demonstrating substantial equivalence." |
| Hardware Verification | Performance as intended, meeting all acceptance criteria. | Verification testing conducted on Console, Motorpack, and System. "The Console, Motorpack and System performed as intended and all acceptance criteria were met demonstrating substantial equivalence." |
| Electrical Safety and Electromagnetic Compatibility | Compliance with relevant standards. | "All testing passed EMC per IEC 60601-1-2 4th edition requirements. All testing passed electrical safety per the standards listed." |
| System Design Verification | Functional and simulated use performance, meeting all acceptance criteria. | Verification testing performed on the AQUABEAM Robotic System to test functional and simulated use. "All acceptance criteria were met demonstrating substantial equivalence to the predicate device." |
| System Design Validation | Performance in a cadaver study, meeting all acceptance criteria. | A design validation was conducted via a cadaver study. "All acceptance criteria were met demonstrating substantial equivalence to the predicate device." |
| Packaging Validation | Compliance with ASTM standards for packaging and transportation. | Validation performed on components with design changes (Console, Motorpack). "The components with design change passed all testing conducted." |
| Reliability Testing | Reliability equivalent to predicate device, documented use life. | Evaluated the reliability of components with design changes. "The results are equivalent to the predicate device. The use life is documented in the table above and in the product labeling." |
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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(248 days)
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.
| 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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