(171 days)
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.
§ 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.