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The Exablate Prostate System is indicated for endorectal MR-Guided Focused Ultrasound (MRgFUS) ablation of Prostatic Tissue.

The Exablate 2100 / 2100V1 Type 3.0 Prostate System (Trademark Name: Exablate Prostate System) is a high intensity Magnetic Resonance ("MR") image- guided focused ultrasound (MRgFUS) system intended for endorectal use that delivers focused ultrasound energy into the prostate in a minimally invasive manner by utilizing an endorectal probe transducer.

The Exablate Prostate System combines a multiple-channel phased-array Focused Ultrasound (FUS) transducer probe and magnetic resonance imaging ("MRI") in a closed- loop treatment for the thermal procedure of Prostatic Tissue while monitoring the procedure in real time.

The Exablate Prostate System is designed to work in conjunction with FDA cleared 1.5T and 3.0T MRI scanners with phased array torso cardiac coils that is used for guidance and procedure monitoring and control feedback. The Exablate Prostate System is fully integrated with the MRI scanner used to provide MR images of the patient's anatomy and prepare an appropriate procedure plan. Measured tissue temperature changes provide feedback on the procedure dose in the targeted area and its surroundings, allowing real- time monitoring to achieve safe and effective outcomes.

The intended users for the Exablate Prostate System are trained and certified physicians and/or technicians (clinicians) who are seeking to offer patients an incisionless, focal, and MR guided and controlled prostate tissue ablation and have successfully completed the Insightec Exablate training to operate the device.

The Exablate Prostate System platform is intended to ablate prostatic tissue with focused ultrasound and operates in conjunction with FDA cleared compatible MRI scanners for the purposes of real time procedure planning, MR based guidance of the focused ultrasound energy to the target region, MR thermal imaging and ablation monitoring. The procedure effect of the Exablate Prostate System is achieved by accurately guiding the focus of the ultrasound energy to the target region. The energy is then repeatedly transmitted to the target until the desired outcome is achieved. The targeted area is defined based on MR images taken during the procedure, while patient is in procedure position.

The procedure is constantly monitored in a real-time closed-loop MR thermal feedback. Once the targeting is complete, the outcome is confirmed with adequate post-procedure MR imaging sequences.

This document appears to be a 510(k) summary for the Insightec Exablate Prostate System. It does not describe a clinical study for software performance and instead focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Therefore, many of the requested items related to a clinical study on device performance, particularly for AI/algorithm performance, are not applicable or cannot be found in this document.

Here's a breakdown based on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific performance acceptance criteria for an AI or algorithm, nor does it list reported device performance in those terms. Instead, it states that non-clinical studies demonstrated the device "meets the acceptance criteria and is adequate for its intended use" for various engineering and safety aspects.

2. Sample size used for the test set and the data provenance

Not applicable. The document does not describe a test set or data provenance for an AI/algorithm performance study. The studies mentioned are non-clinical (e.g., system level testing, usability testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no mention of a test set with ground truth established by experts as this is not a study evaluating human or AI performance.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "The Exablate Prostate System did not require clinical study because substantial equivalence to the currently marketed predicate device was demonstrated with the following attributes: Indication for use; Technological characteristics; Non-clinical performance testing."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The document describes the Exablate Prostate System as a high-intensity MR-guided focused ultrasound (MRgFUS) system for prostate tissue ablation, not a standalone AI algorithm. It mentions "Software verification and validation testing were performed", but this is software engineering testing, not standalone AI performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no algorithm performance study with ground truth is described. For the non-clinical studies (e.g., system level, electrical safety, EMC), the "ground truth" would be the engineering and safety standards themselves.

8. The sample size for the training set

Not applicable, as no AI model training is described.

9. How the ground truth for the training set was established

Not applicable.

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The Exablate Prostate System is indicated for endorectal MR-Guided Focused Ultrasound (MRgFUS) ablation of Prostatic Tissue.

The proposed Exablate 2100 / 2100V1 Type 3 Prostate System (Trademark Name: Exablate Prostate System) is a high intensity Magnetic Resonance ("MR") image- guided focused ultrasound (MRgFUS) system intended for endorectal use that delivers focused ultrasound energy into the prostate in a minimally invasive manner by utilizing anendorectal probe transducer.

The Exablate Prostate System combines a multiple-channel phased-array Focused Ultrasound (FUS) transducer probe and magnetic resonance imaging (“MRI”) in a closed-loop treatment for the thermal procedure of Prostatic Tissue while monitoring the procedure in real time.

The Exablate Prostate System is designed to work in conjunction with FDA cleared 1.5Tand 3.0T MRI scanners with phased array torso cardiac coils that is used for guidance andprocedure monitoring and control feedback. The Exablate Prostate System is fully integrated with the MRI scanner used to provide MR images of the patient's anatomy and prepare an appropriate procedure plan. Measured tissue temperature changes provide feedback on the procedure dose in the targeted area and its surroundings, allowing real-time monitoring to achieve safe and effective outcomes.

The intended users for the Exablate Prostate System are trained and certified physicians and/or technicians (clinicians) who are seeking to offer patients an incisionless, focal, and MR guided and controlled prostate tissue ablation and have successfully completed the Insightec Exablate training to operate the device.

The Exablate Prostate System platform is intended to ablate prostatic tissue with focused ultrasound and operates in conjunction with FDA cleared compatible MRI scanners for the purposes of real time procedure planning, MR based guidance of the focused ultrasound energy to the target region, MR thermal imaging and ablation monitoring. The procedure effect of the Exablate Prostate System is achieved by accurately guiding the focus of the ultrasound energy to the target region. The energy is then repeatedly transmitted to the target until the desired outcome is achieved. The targeted area is defined based on MR images taken during the procedure, while patient is in procedure position. The procedure is constantly monitored in a real-time closed-loop MR thermal feedback. Once the targeting is complete, the outcome is confirmed with adequate post-procedure MR imaging sequences.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 101 male subjects.
• Data Provenance:
  • Country of Origin: United States.
  • Retrospective or Prospective: Prospective, single-arm clinical study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not explicitly state the number of experts used to establish the ground truth for the test set or their specific qualifications. However, it indicates:

• "MRI-visible, hemilateral lesion of biopsy proven Gleason Grade Group 2 (3+4) or 3 (4+3) adenocarcinoma" – This implies that a pathologist (expert) would have reviewed the biopsies to determine the Gleason Grade Group, which serves as a form of ground truth for disease presence and severity.
• "physician targeted prostate tissue" and "clinical study was conducted in accordance with Good Clinical Practice, Insightec Standard Operating Procedures and FDA 21 CFR 50, 54, 56 and 812" – This suggests that medical professionals (likely including radiologists for MRI interpretation and urologists for treatment planning and clinical assessment) were involved in defining the target area and evaluating outcomes.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1, 3+1). The "biopsy proven" and "physician targeted" phrases suggest that standard clinical practice and expert interpretation were used, but no specific adjudication process for controversial cases is detailed.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study solely evaluated the performance of the Exablate Prostate System without comparing it to human readers with or without AI assistance. The study is an evaluation of the device's clinical performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The Exablate Prostate System is a High Intensity Focused Ultrasound (HIFU) system that requires human operators (trained and certified physicians and/or technicians). It is not an "algorithm only" device. The system aids human operators by providing "real time-controlled ablation of prostate tissue" and "MR based guidance of the focused ultrasound energy to the target region, MR thermal imaging and ablation monitoring." Therefore, a standalone (algorithm only) performance evaluation would not be applicable, as human interaction is integral to its intended use.

7. The Type of Ground Truth Used

The ground truth used for the effectiveness endpoints was:

• Pathology/Histology: For the "biopsy results," the presence or absence of Gleason Grade Group tissue was determined via biopsy, which is a pathology-based ground truth.
• Clinical/Biomarker Data: For "reduction in PSA value," blood test results (PSA levels) served as the ground truth.
• Imaging-based Assessment: "Non-Perfused Volume (NPV) covering physician targeted prostate tissue at treatment" was likely assessed using post-treatment MR imaging, interpreted by medical professionals.

8. The Sample Size for the Training Set

The document does not provide information regarding a separate training set or its sample size. The study described is a prospective clinical trial for evaluating the device's safety and effectiveness in a clinical population. If the device incorporates AI/ML components that require training, that information is not detailed in this summary.

9. How the Ground Truth for the Training Set Was Established

Since information about a training set is not provided, the method for establishing ground truth for a training set is also not described in this document.

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