(137 days)
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
| Acceptance Criteria (Endpoint) | Reported Device Performance (Exablate Prostate System) |
|---|---|
| Safety Endpoints (Primary) | |
| No Serious Adverse Events (SAEs) | No SAEs reported |
| No Life-threatening Adverse Events (AEs) | No Life-threatening AEs reported |
| Majority of AEs Mild or Moderate | 99.5% of AEs Mild (86.5%) or Moderate (13%) |
| Most events resolved within 90 days or less | 63.5% resolved within 90 days |
| Number of device-related AEs unresolved at 12 months | 32 (16%) |
| Effectiveness Endpoints (Primary) | |
| Negative biopsy within area of treatment at 6 months | 91.1% negative biopsies (n=92/101) |
| Reduction in PSA value at 6 months | 91.1% of subjects showed a decrease in PSA (n=92/101) |
| Non-Perfused Volume (NPV) covered targeted Gleason Grade Group (GGG) tissue at treatment | 87.1% of subjects showed NPV covered targeted GGG tissue (n=88/101) |
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.
§ 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.