(447 days)
The TULSA-PRO® is indicated for transurethral ultrasound ablation (TULSA) of prostate tissue.
The TULSA-PRO system combines real-time Magnetic Resonance (MR) imaging and MR thermometry with transurethral directional ultrasound and closed-loop process control software to deliver precise thermal ablation of physician prescribed prostate tissue. The system consists of both hardware and software components. The transurethral ultrasound ablation (TULSA) treatment is delivered completely within the MR bore. A real-time MRI interface is used by closed-loop features of the TULSA-PRO system: real-time MRI prostate temperature measurements are processed by TULSA-PRO software which communicates with TULSA-PRO hardware, thereby controlling frequency, power and rotation rate of ultrasound to ablate physician prescribed prostate tissue with a high degree of precision. The physician inserts two catheters, one transurethral and another transrectal, into the patient before he is moved into the MR bore. The transurethral catheter consists of an Ultrasound Applicator (UA) which delivers energy from within the prostate tissue, heating it to thermal coagulation. The transrectal catheter is an Endorectal Cooling Device (ECD) which does not emit any energy and cools the rectal wall adjacent to the prostate. The modified ECD component provides users with a rectal bubble removing feature, and is manufactured using a 3-D printed technology. Both catheters have fluid flowing inside throughout the treatment to thermally protect the urethra and rectum, in order to minimize the potential of any thermal damage to either the urinary or rectal pathways. The physician uses the TULSA-PRO console that was cleared under K191200 to robotically position the Ultrasound Applicator in the prostate and plan the treatment by contouring the prescribed tissue on real-time high-resolution crosssectional MR images of the prostate. These cleared features provide the physician with the ability and the control to customize the treatment plan to minimize thermal impact to critical structures surrounding the prostate including the external urethral sphincter, rectum and neurovascular bundles. The treatment begins based upon the physician's instructions by enabling the software to initiate thermal ablation. The TULSA-PRO closed-loop process control software reads real-time MR thermometry measurements and adjusts automatically and dynamically the frequency, power and rotation rate of ultrasound provided by each UA transducer, to deliver precise ablation of the prescribed prostate tissue. The software controls automated. continuous and robotic rotation of the transurethral UA by 360 degrees in sync with the process-controlled delivery of thermal heating to all the required regions of the prostate. Following completion of the ablation process, the two catheters are removed from the natural orifices of the patients.
The provided text is an FDA 510(k) summary for the TULSA-PRO® System, which is a medical device for prostate tissue ablation. The document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing the detailed acceptance criteria and study results typically found for a novel AI/ML-based medical device.
Therefore, many of the requested details regarding acceptance criteria, study design for proving performance (especially for AI/ML models), expert ground truth establishment, MRMC studies, and sample sizes for training/test sets are not present in the provided document, as this submission is for a modification to an existing device.
The submission states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." This explicitly indicates that no clinical study (which would typically involve test sets, ground truth establishment, expert readers, etc.) was performed for this specific submission to prove device performance in a clinical setting. The "performance" being assessed here is the equivalence of the modified (and slightly different manufacturing process for the ECD component) to the previously cleared version.
However, based on the information available in the document, here's what can be inferred or stated:
1. A table of acceptance criteria and the reported device performance:
Since no clinical study data is presented, acceptance criteria for performance metrics (like sensitivity, specificity, accuracy for an AI model) are not relevant or provided. The "performance" here is demonstrating that the modified device is as safe and effective as the predicate device through bench testing.
| Acceptance Criteria (Implied for Substantial Equivalence of Modified ECD) | Reported Device Performance (as stated in the document) |
|---|---|
| The modified TULSA-PRO system meets the requirements of the product design specification. | "Bench Performance testing was conducted to demonstrate that the TULSA-PRO system meets the requirements of the product design specification and performs in accordance with its intended use." |
| The modified ECD component (with bubble removal feature and 3D printing) performs safely and effectively. | "Bench testing was performed to verify and validate the ECD performance and safety and effectiveness of the TULSA PRO system." |
| Biocompatibility requirements. | "Biocompatibility testing was conducted in accordance with the 2020 FDA guidance document, 'Use of International Standard ISO 10993-1 [...]'" and modified materials meet "Biocompatibility criteria for the intended use of ECD." |
| Device is as safe, as effective, and performs as well as or better than the predicate device. | "The verification and validation tests demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device." |
| No new concerns on safety and effectiveness compared to the predicate. | "The modified features of the TULSA-PRO Endorectal Cooling Device (ECD) do not raise any new concerns or different questions of safety and effectiveness." |
Regarding points 2-9:
These points are primarily relevant for submissions involving new AI/ML device performance claims or significant changes requiring clinical validation/testing. As stated in the document, "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." Therefore, the following information is not applicable or not provided in this specific 510(k) summary:
- Sample sized used for the test set and the data provenance: Not applicable, as no clinical test set for AI performance was used. The testing was bench-based.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for image interpretation by experts is not described, as there was no clinical study.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is not an AI-assisted diagnostic device submission requiring such a study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a standalone AI diagnostic algorithm. The TULSA-PRO system has software with closed-loop process control, but this submission pertains to mechanical/material modifications to a component (ECD) and expanded MR scanner compatibility, not a new or significantly altered AI component requiring standalone validation.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as detailed clinical performance validation with ground truth is not the subject of this 510(k). The ground truth for their bench testing would be engineering measurements and material specifications.
- The sample size for the training set: Not applicable. This document does not describe the development or training of a new AI model. The software exists and controls the ablation process, but no new AI training is discussed.
- How the ground truth for the training set was established: Not applicable.
In summary: The provided document is a 510(k) submission for demonstrating substantial equivalence of a modified version of an already cleared device, primarily through non-clinical bench testing of hardware/material changes (specifically to the Endorectal Cooling Device and expanded MR compatibility). It does not contain the detailed clinical study data, AI model performance metrics, or ground truth establishment processes that would be typically found for a novel AI/ML device or a significant software upgrade requiring clinical validation. The "study" mentioned here refers to the bench testing conducted to ensure the modified device retains its safety and effectiveness compared to the predicate.
§ 876.4340 High intensity ultrasound system for prostate tissue ablation.
(a)
Identification. A high intensity ultrasound system for prostate tissue ablation is a prescription device that transmits high intensity therapeutic ultrasound energy into the prostate to thermally ablate a defined, targeted volume of tissue, performed under imaging guidance. This classification does not include devices that are intended for the treatment of any specific prostate disease and does not include devices that are intended to ablate non-prostatic tissues/organs.(b)
Classification. Class II (special controls). The special controls for this device are:(1) 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) Characterization of acoustic pressure and power output at clinically relevant levels;
(ii) Measurement of targeting accuracy and reproducibility of high intensity ultrasound output;
(iii) Ultrasound-induced heating verification testing at target and non-target tissues;
(iv) Electrical safety testing; and
(v) Electromagnetic compatibility testing.
(2) Software verification, validation, and hazard analysis must be performed.
(3) The elements of the device that may contact the patient's mucosal tissue must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the device components that contact the patient's mucosal tissue.
(5) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the identified shelf life.
(6) Performance data must support the instructions for reprocessing all reusable components.
(7)
In vivo testing must demonstrate that the device thermally ablates targeted tissue in a controlled manner without thermal injury to adjacent, non-target tissues.(8) Clinical testing must document the adverse event profile, provide evidence of prostatic ablation, and demonstrate that the device performs as intended under anticipated conditions of use.
(9) Training must be provided so that upon completion of the training program, the physician can:
(i) Use all safety features of the device;
(ii) Accurately target the high intensity ultrasound energy within the desired region of the prostate; and
(iii) Perform the ablation procedure in a manner that minimizes damage to non-target tissues.
(10) Labeling must include:
(i) A section that summarizes the clinical testing results, including the adverse event profile and evidence of prostate ablation achieved; and
(ii) An expiration date or shelf life for single use components.