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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.

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:

2. 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.
3. 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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic device submission requiring such a study.
6. 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.
7. 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.
8. 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.
9. 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.

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