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The Avenda Health AI Prostate Cancer Planning Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health AI Prostate Cancer Planning Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate. The Avenda Health Al Prostate Cancer Planning Software's lesion characterization functions are intended for use on patients with a pathology-confirmed Gleason Grade Group (GGG) ≥ 2 lesion and for whom corresponding biopsy coordinate information have been uploaded. These functions are indicated for the extent of known disease. Extent of known disease refers to the boundary of a pathology confirmed lesion of GGG ≥ 2 for a particular patient. Specifically, using prostate MR images, biopsy, pathology, and clinical data, the device creates and displays a cancer map that assigns a probability to each voxel within the prostate, indicating its probability for containing clinically significant prostate cancer (csPCa, defined as GGG ≥ 2 ). A user selects a threshold for the cancer map to create a boundary of the lesion. The lesion boundary is assigned an Encapsulation Confidence Score indicating the confidence that all csPCa is encapsulated within the boundary. The Encapsulation Confidence Score is from a lookup table generated by a database of cases with known ground-truth. When interpreted by a trained physician, this information may be useful in supporting lesion characterization and subsequent patient management. The Avenda Health Al Prostate Planning Software may also be used as a medical image application, for the viewing. manipulation, 3D-visualization, and comparison of MR prostate images can be viewed in a number of output formats including volume rendering. It enables visualization of information that would otherwise have to be visually compared disjointedly.

The Avenda Health AI Prostate Cancer Planning Software ("AI Prostate Cancer Planning Software" or "Software") is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic resonance (MR) prostate images and biopsy findings in the prostate oncological workflow. The Avenda Health AI Prostate Cancer Planning Software is designed to support the prostate oncological workflow by helping the user with the segmentation of MR image features, including the prostate; in the evaluation, quantification, and documentation of lesions; and in pre-planning for diagnostic and interventional procedures such as biopsy and/or soft tissue ablation. The device is intended to be used by physicians trained in the oncological workflow in a clinical setting for planning and guidance for clinical, interventional, diagnostic, and/or treatment procedures of the prostate. The software has three main features: - 1. Artificial Intelligence (AI) Powered Prostate MRI Segmentation Tool, - 2. AI Powered Lesion Contour Tool, and - 3. Simulated Interventional Tool Placement. The user can choose which subset of features of the Software to employ based on the specific oncological workflow. Not all features are required to be used for every workflow. Once the user has completed planning and has reviewed and verified the information, it can be exported into a supported file format such that it can be imported into a compatible interventional system or biopsy system.

The Avenda Health Treatment System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, orthopedics, pulmonology, radiology, adiology, and urology, at a wavelength of 980nm.

The Avenda Health Treatment System ("Treatment System") is a thermal laser ablation system that causes coagulation necrosis of soft tissue. The Treatment System consists of the capital system Workstation and the single use Laser Applicator Kit. The Workstation contains core system hardware and software, provides the System's touchscreen user interface (UI), and serves as a "hub" to facilitate the connectivity of other System components. The Laser Applicator Kit consists of two patient-contacting disposable components, the Laser Catheter, and the Thermal-Optical Probe ("TOP"), which facilitate delivery of laser energy and monitoring of temperature, respectively. The Treatment Monitoring Software, which operates on the Workstation, provides the UI for controlling the device, displays previously generated patient and treatment plan information for the procedure, and actively monitors the treatment progress during a procedure by displaying output from the TOP. The Treatment System is additionally used with an off-the-shelf accessory, the Tubing Set, which transports saline in a closed-loop system between the Workstation and Laser Catheter to provide cooling of the Laser Catheter. The Treatment System further includes an optional patient-contacting disposable accessory, the Multi-Channel Needle Guide ("MCG"), which may be used to attach an ultrasound probe to the Laser Catheter and TOP for enhanced visualization tracking, if desired.