(89 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 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):
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from software change) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Software Functionality | 1. Limit user from planning beyond defined depth for mid prostate and bladder neck. | Testing performed to ensure "software and OS works as intended" and "changes do not impact the safety and effectiveness." |
| 2. Remove purple line indicator flashing for mid prostate and bladder neck when depth is exceeded (since it's now limited). | Implied: The flashing (if applicable under old conditions) is now absent as the planning limitation prevents exceeding depth in these areas. | |
| 3. Allow flexible planning for median lobe depth of cut (no limitation). | Testing performed to ensure "software and OS works as intended." | |
| 4. Enable user to place 4 landmark points beyond 24.3 mm depth in the Profile Landmark step, while keeping maximum planned depth at 24.3 mm. | Testing performed to ensure "software and OS works as intended." | |
| Safety and Effectiveness | No adverse impact on safety and effectiveness compared to the predicate device. | "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..." |
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.
§ 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.