(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.
§ 876.4350 Fluid jet system for prostate tissue removal.
(a)
Identification. A fluid jet system for prostate tissue removal is a prescription device intended for the resection and removal of prostatic tissue for the treatment of benign prostatic hyperplasia. The device cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra. The device is able to image the treatment area, or pairs with an imaging modality, to monitor treatment progress.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must evaluate the following:
(i) All adverse events associated with the device, and
(ii) Improvement in lower urinary tract symptoms (LUTS).
(2) Physician training must be provided that includes:
(i) Information on key aspects and use of the device, and
(ii) Information on how to override or stop resection.
(3) Animal testing must demonstrate that the device resects targeted tissue in a controlled manner without injury to adjacent non-target tissues.
(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:
(i) Measurement of targeting accuracy and reproducibility of high velocity fluid jet, and
(ii) High pressure fluid jet verification testing at target and non-target tissues.
(5) Software verification, validation, and hazard analysis must be performed.
(6) The patient-contacting elements of the device must be demonstrated to be biocompatible.
(7) Performance data must demonstrate the electrical safety and electromagnetic compatibility of the device.
(8) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(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.
(10) Performance data must validate the instructions for reprocessing and reliability of reusable components.
(11) Labeling must include the following:
(i) A section that summarizes the clinical testing results, including the adverse event profile and improvement in LUTS;
(ii) A shelf life for single use components;
(iii) A use life for reusable components; and
(iv) Reprocessing instructions for reusable components.