Who is the manufacturer of Avenda Health AI Prostate Cancer Planning Software?

Avenda Health, Inc. filed the 510(k) submission for Avenda Health AI Prostate Cancer Planning Software (K221624).

What is the FDA product code for Avenda Health AI Prostate Cancer Planning Software?

POK. It is classified under 21 CFR 892.2060 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Avenda Health AI Prostate Cancer Planning Software?

510(k) clearance (submission type: Traditional).

Does Avenda Health AI Prostate Cancer Planning Software use AI or machine learning?

Yes. Avenda Health AI Prostate Cancer Planning Software (K221624) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Avenda Health AI Prostate Cancer Planning Software?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Avenda Health AI Prostate Cancer Planning Software get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Avenda Health AI Prostate Cancer Planning Software

Q: What are the predicate devices for Avenda Health AI Prostate Cancer Planning Software?

Quantitative Insights, Inc. QuantX (DEN170022).

K221624 · Avenda Health, Inc. · POK · Nov 22, 2022 · Radiology

Device Facts

Record ID	K221624
Device Name	Avenda Health AI Prostate Cancer Planning Software
Applicant	Avenda Health, Inc.
Product Code	POK · Radiology
Decision Date	Nov 22, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2060
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

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 AI 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 AI 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.

Device Story

Software processes MR prostate images, biopsy, pathology, and clinical data to support oncological workflows. Features include AI-powered prostate segmentation, lesion contouring, and simulated interventional tool placement. Device generates a cancer probability map (voxel-level) and assigns an Encapsulation Confidence Score to user-defined lesion boundaries. Used in clinical settings by physicians to assist in diagnostic and interventional planning (e.g., biopsy, soft tissue ablation). Physicians review outputs to refine lesion characterization and guide clinical management. Benefits include improved accuracy in lesion contouring, better encapsulation of clinically significant prostate cancer (csPCa), and reduced unnecessary encapsulation of benign tissue compared to standard-of-care manual methods.

Clinical Evidence

Multi-reader, multi-case (MRMC) study with 10 readers (urologists/radiologists) evaluating 3D whole-mount pathology-registered T2-weighted MRI cases. Results: Device-assisted contours showed superior sensitivity (97.4% vs 38.2%, p<0.0001) and specificity (72.1% vs hemi-gland, p<0.0001). Balanced accuracy was 84.7% (vs 67.2% SOC, 75.9% hemi-gland). Complete csPCa encapsulation rate was 72.8% with device vs 1.6% SOC (p<0.0001). Bench testing validated prostate segmentation (137 patients) and lesion contouring (50 patients).

Technological Characteristics

Cloud-based software application. Inputs: DICOM-compatible MR images, biopsy, pathology, and clinical data. Features: AI-driven prostate segmentation, lesion contouring, and interventional tool overlay. Outputs: Cancer probability map, lesion boundary, Encapsulation Confidence Score. Connectivity: Web-based, DICOM-compatible. Software: Machine learning-based algorithm utilizing morphological, intensity, and geometric characteristics.

Indications for Use

Indicated for patients with pathology-confirmed Gleason Grade Group (GGG) ≥ 2 prostate lesions. Used by physicians (radiologists/urologists) as an adjunct to MR image and biopsy review for segmentation, lesion evaluation, and pre-planning of diagnostic/interventional procedures (biopsy/ablation).

Regulatory Classification

Identification

A radiological computer-assisted diagnostic software for lesions suspicious of cancer is an image processing prescription device intended to aid in the characterization of lesions as suspicious for cancer identified on acquired medical images such as magnetic resonance, mammography, radiography, or computed tomography. The device characterizes lesions based on features or information extracted from the images and provides information about the lesion(s) to the user. Diagnostic and patient management decisions are made by the clinical user.

Special Controls

A radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer must comply with the following special controls: 1. Design verification and validation must include: i. A detailed description of the image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, and algorithm limitations. ii. A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will improve reader performance as intended. iii. Results from performance testing protocols that demonstrate that the device improves reader performance in the intended use population when used in accordance with the instructions for use. The performance assessment must be based on appropriate diagnostic accuracy measures (e.g., receiver operator characteristic plot, sensitivity, specificity, predictive value, and diagnostic likelihood ratio). The test dataset must contain sufficient numbers of cases from important cohorts (e.g., subsets defined by clinically relevant confounders, effect modifiers, concomitant diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals of the device for these individual subsets can be characterized for the intended use population and imaging equipment. iv. Standalone performance testing protocols and results of the device. v. Appropriate software documentation (e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, results, and cybersecurity). 2. Labeling must include: i. A detailed description of the patient population for which the device is indicated for use. ii. A detailed description of the intended reading protocol. iii. A detailed description of the intended user and recommended user training. iv. A detailed description of the device inputs and outputs. v. A detailed description of compatible imaging hardware and imaging protocols. vi. Warnings, precautions, and limitations, including situations in which the device may fail or may not operate at its expected performance level (e.g., poor image quality or for certain subpopulations), as applicable. vii. Detailed instructions for use. viii. A detailed summary of the performance testing, including: test methods, dataset characteristics, results, and a summary of sub-analyses on case distributions stratified by relevant confounders (e.g., lesion and organ characteristics, disease stages, and imaging equipment).

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include: (i) A detailed description of the image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, and algorithm limitations. (ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will improve reader performance as intended. (iii) Results from performance testing protocols that demonstrate that the device improves reader performance in the intended use population when used in accordance with the instructions for use. The performance assessment must be based on appropriate diagnostic accuracy measures ( *e.g.,* receiver operator characteristic plot, sensitivity, specificity, predictive value, and diagnostic likelihood ratio). The test dataset must contain sufficient numbers of cases from important cohorts (*e.g.,* subsets defined by clinically relevant confounders, effect modifiers, concomitant diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals of the device for these individual subsets can be characterized for the intended use population and imaging equipment.(iv) Standalone performance testing protocols and results of the device. (v) Appropriate software documentation ( *e.g.,* device hazard analysis; software requirements specification document; software design specification document; traceability analysis; and description of verification and validation activities including system level test protocol, pass/fail criteria, results, and cybersecurity).(2) Labeling must include: (i) A detailed description of the patient population for which the device is indicated for use. (ii) A detailed description of the intended reading protocol. (iii) A detailed description of the intended user and recommended user training. (iv) A detailed description of the device inputs and outputs. (v) A detailed description of compatible imaging hardware and imaging protocols. (vi) Warnings, precautions, and limitations, including situations in which the device may fail or may not operate at its expected performance level ( *e.g.,* poor image quality or for certain subpopulations), as applicable.(vii) Detailed instructions for use. (viii) A detailed summary of the performance testing, including: Test methods, dataset characteristics, results, and a summary of sub-analyses on case distributions stratified by relevant confounders ( *e.g.,* lesion and organ characteristics, disease stages, and imaging equipment).

Predicate Devices

Quantitative Insights, Inc. QuantX (DEN170022)

Reference Devices

DynaCAD

Related Devices

K193283 — AI-Rad Companion Prostate MR · Siemens Medical Solutions USA, Inc. · Jul 30, 2020
K193306 — PROView · GE Medical Systems SCS · Nov 17, 2020
K252608 — AI-Rad Companion Prostate MR · Siemens Healthcare GmbH · Sep 9, 2025
K202501 — Quantib Prostate · Quantib B.V. · Oct 11, 2020
K242683 — QP-Prostate® CAD · Quibim S.L. · Mar 18, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". November 22, 2022 Avenda Health, Inc. % Brittany Berry-Pusey, Ph.D. Co-Founder and COO 4130 Overland Avenue CULVER CITY CA 90230 Re: K221624 Trade/Device Name: Avenda Health AI Prostate Cancer Planning Software Regulation Number: 21 CFR 892.2060 Regulation Name: Radiological computer-assisted diagnostic software for lesions suspicious of cancer Regulatory Class: Class II Product Code: POK Dated: October 23, 2022 Received: October 24, 2022 Dear Brittany Berry-Pusey: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, FDA Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221624 #### Device Name Avenda Health AI Prostate Cancer Planning Software ### Indications for Use (Describe) 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. X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Notification K221624 # GENERAL INFORMATION [807.92(a)(1)] # Applicant: Avenda Health, Inc. 4130 Overland Avenue Culver City, CA 90230 USA # Contact Person: Brittany Berry-Pusey, Ph.D. Co-Founder and COO, Avenda Health, Inc. Phone: 310-957-5202 Email: brit@avendahealth.com # Prepared By: Veranex, Inc. Regulatory, Clinical, and Quality Services 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA # Date Prepared: November 18, 2022 # DEVICE INFORMATION [807.92(a)(2)] Trade Name: Avenda Health AI Prostate Cancer Planning Software # Generic/Common Name: Medical Image Software Application and Decision Support Software # Classification: 21 CFR\$892.2060, Radiological computer-assisted diagnostic software for lesions suspicious of cancer # Product Code: POK, Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer {4}------------------------------------------------ # PREDICATE DEVICE [807.92(a)(3)] Quantitative Insights, Inc. QuantX (DEN170022) # DEVICE DESCRIPTION [807.92(a)(4)] 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. # INDICATIONS FOR USE [807.92(a)(5)] 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 AI 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 evaluation of 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 {5}------------------------------------------------ #### 5.0 510(k) SUMMARY 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 AI Prostate Planning Software may also be used as a medical image application, for the viewing, manipulation, 3D-visualization, and comparison of MR prostate images. The 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. # COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)] Avenda Health, Inc. believes that the Avenda Health AI Prostate Cancer Planning Software (the "Proposed Device") is substantially equivalent to the predicate device, Quantitative Insights, Inc. QuantX (DEN170022, "QuantX"). Like QuantX, the Proposed Device is used by physicians to support tasks within the oncological workflow. The range of functionalities supported by the Proposed Device, which include segmentation, lesion characterization, and image overlays (i.e., simulated tool placement to support subsequent treatment planning), in addition to basic magnetic resonance image (MRI) and medical information review functionalities, is similar to those available in the identified predicate device. QuantX is selected as the predicate device because, like the Proposed Device, its primary imaging functionality is to characterize lesions suspicious for cancer through an artificial intelligence-powered algorithm and provide information to support the physician user's interpretation of the patient's medical and imaging information. DynaCAD is selected as a reference device to support the performance testing methodology for the prostate segmentation function. The Proposed Device is substantially equivalent to the identified predicate device. # SUBSTANTIAL EQUIVALENCE The Proposed Device and the predicate device have the same intended use and similar Indications for Use. Both devices also have similar technological characteristics, and any differences in technological characteristics do not raise different questions of safety and effectiveness. The results of performance bench, usability, and reader performance testing demonstrated that the Proposed Device meets the established specifications necessary for consistent performance to achieve its intended use as safely and as effectively as the predicate device. Further, the results of the performance bench, usability, and reader performance testing confirmed that the technological differences do not raise different questions of safety and effectiveness. As such, the Avenda Health AI Prostate Cancer Planning Software is substantially equivalent to the predicate device, QuantX (DEN170022). # PERFORMANCE DATA [807.92(b)] All necessary testing was conducted on the Avenda Health AI Prostate Cancer Planning Software to support a determination of substantial equivalence to the predicate devices. # Non-clinical Testing Summary: {6}------------------------------------------------ Avenda has performed software verification, validation, and usability testing to demonstrate that: 1) the device performs to its intended use in accordance with design specifications, and 2) the technological differences presented in the Proposed Device do not raise different questions of safety and effectiveness. These tests include: - Software verification and validation demonstrated that the Proposed Device performs in ● accordance with its specification for every requirement and functionality. - Standalone performance testing for the prostate segmentation and lesion contouring algorithms within standalone test datasets, established against clinically valid ground truths. Specifically, the prostate segmentation algorithm has been determined to accurately segment the prostate organ in T2-weighted MRI in a standalone test set of 137 patients. Furthermore, the lesion contouring algorithm has been validated for accuracy in contouring GGG >2 lesions in the intended use population within a representative, independent whole mount pathology dataset of N=50 patients. - Human factors usability testing for the Proposed Device has demonstrated that . representative intended users can use the device safely and effectively, without significant use-related risks. # Reader Study Summary: A multi-reader, multi-case (MRMC) study was conducted for the Avenda Health AI Prostate Cancer Planning Software ("Proposed Device") to demonstrate that the device improves reader performance for prostate cancer lesion contouring in the intended use population. Overall, the study dataset consisted of cases within a prostate whole mount pathology database derived from GGG 2-3 patients, which is representative of the device patient population. Each whole mount sample included 3D surfaces and pathology labels representing tumors as annotated on the whole mount prostatectomy slides, which are registered to preoperative T2-weighted MRI. Ten practicing urologists or radiologists from different institutions with a range of experience levels (2 to 23 years of clinical practice experience) participated in this reader study. Each reader reviewed each case. For each case, the reader created a prostate cancer lesion contour based both on standard of care (SOC) practices and with the assistance of the Proposed Device. The lesion contours created with each method were evaluated against whole mount pathology data as ground truth and subsequently compared to one another as well as hemi-gland contours, in order to assess the ability of the Proposed Device to improve reader ability in lesion contouring. The study results demonstrated that lesion contours produced using the Proposed Device had superior sensitivity (mean 97.4% vs 38.2%, p < 0.0001) compared to SOC contours and superior specificity compared to hemi-gland contours (mean 72.1%, p < 0.0001). Furthermore, lesion contours produced using the Proposed Device were superior to both SOC and hemi-gland contours using measures of balanced accuracy (mean 84.7% vs 67.2% & 75.9% respectively, p < 0.0001) and "clinical quality" (in 99% and 60% of cases respectively, p < 0.0001). On average, the readers achieved a complete csPCa encapsulation rate of 72.8% with the Proposed Device, and only 1.6% with SOC methods (p < 0.0001). The outcomes of this study demonstrated improved reader performance, and showed that readers, when using the Proposed Device, can create lesion contours that better fully encapsulate csPCa {7}------------------------------------------------ #### 5.0 510(k) SUMMARY while excluding as much non-csPCa tissue as possible. The proposed device helps resolve the systematic underestimation of csPCa present with SOC manual contouring methods, while simultaneously sparing much of the benign tissue unnecessarily encapsulated with hemi-gland contours. These findings demonstrate that the Proposed Device improves reader performance as intended in the intended user population when used in accordance with the instructions for use. # CONCLUSIONS The Avenda Health AI Prostate Cancer Planning Software (Proposed Device) and the predicate device QuantX (DEN170022) are both intended as a medical image software application for MRI which can be used to support the clinical workflow of oncological diagnostic and interventional procedures. The devices have the same intended use and similar Indications for Use. Both devices also have similar technological characteristics, and any differences in technological characteristics do not raise different questions of safety and effectiveness. The collective performance bench, usability, and reader performance testing results demonstrated that the Proposed Device performed to its intended use in accordance with its specifications, and confirmed the technological differences presented in the Proposed Device do not raise different questions of safety and effectiveness. # SUMMARY The Avenda Health AI Prostate Cancer Planning Software is substantially equivalent to the identified predicate device. {8}------------------------------------------------ | | Avenda Health AI Prostate Cancer Planning Software (Proposed Device) | Predicate Device: Quantitative Insights, Inc. QuantX (DEN170022) | Rationale for Substantial Equivalence | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | 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. | QuantX is a computer-aided diagnosis (CADx) software device used to assist radiologists in the assessment and characterization of breast abnormalities using MR image data. The software automatically registers images, and segments and analyzes user-selected regions of interest (ROI). QuantX extracts image data from the ROI to provide volumetric analysis and computer analytics based on morphological and enhancement characteristics. These imaging (or radiomic) features are then synthesized by an artificial intelligence algorithm into a single value, the QI score, which is analyzed relative to a database of reference abnormalities with known ground truth. | Similar to the predicate device. | | | The Avenda Health AI Prostate Cancer Planning Software's lesion characterization functions are intended for use on patients with a pathology-confirmed Gleason Grade Group (GGG) $\geq$ 2 lesion and for whom corresponding biopsy coordinate information have been uploaded. These functions are indicated for the evaluation of the extent of known disease. Extent of known disease refers to the boundary of a pathology confirmed lesion of GGG $\geq$ 2 for a particular patient. Specifically, using prostate MR images, | QuantX is indicated for evaluation of patients presenting for high-risk screening, diagnostic imaging workup, or evaluation of extent of known disease. Extent of known disease refers to both the assessment of the boundary of a particular abnormality as well as the assessment of the total disease burden in a particular patient. In cases where multiple abnormalities are present, QuantX can be used to assess each abnormality independently. | | | | | This device provides information that may be useful in the characterization of breast abnormalities during image interpretation. For the QI score and component radiomic features, the QuantX device provides | | | | Avenda Health AI Prostate Cancer Planning Software (Proposed Device) | Predicate Device: Quantitative Insights, Inc. QuantX (DEN170022) | Rationale for Substantial Equivalence | | | 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 AI Prostate Planning Software may also be used as a medical image application, for the viewing, manipulation, 3D-visualization, and comparison of MR prostate images. The 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. | comparative analysis to lesions with known outcomes using an image atlas and histogram display format. QuantX may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software also includes tools that allow users to measure and document images, and output in a structured report. Limitations: QuantX is not intended for primary interpretation of digital mammography images. | | | Regulation Number | §892.2060, Radiological computer-assisted diagnostic software for lesions suspicious of cancer. | §892.2060, Radiological computer- assisted diagnostic software for lesions suspicious of cancer. | Same as the predicate device. | | | Avenda Health AI Prostate Cancer Planning Software (Proposed Device) | Predicate Device: Quantitative Insights, Inc. QuantX (DEN170022) | Rationale for Substantial Equivalence | | Product Codes: | POK, Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | POK, Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | Same as the predicate device. | | Primary Intended User | Trained physicians in the intended workflow (Radiologist/Urologist) | Trained physicians in the intended workflow (Radiologist) | Same as the predicate device – intended for use by the appropriate trained physicians. | | Anatomical Site: | Prostate only | Breast only | Different, but same intended use and the differences do not raise different questions of safety or effectiveness. | | Oncological Workflow of Interest | Prostate Cancer | Breast Cancer | Different, but same intended use within the workflow and the differences do not raise different questions of safety or effectiveness. | | Clinical Workflow Steps Where Used: | Image Review and Workflow Support Interventional/Treatment Planning and Guidance for Diagnostic and Interventional Procedures | Image Review and Workflow Support | Similar to the predicate device. | | Platform/Architecture | Cloud-only solution | Software-only platform | Similar – both devices are Web-based software devices. | | DICOM Compatible | Yes | Yes | Same as the predicate device. | | Type of Scans | MR, DICOM-compatible | MR, DICOM-compatible | Same as the predicate device. | | Image Navigation Tools | ● Pan, zoom, rotate, slice scroll (view multiple slices) | ● Pan, zoom, rotate, change in contrast, slice scroll (view multiple slices) | Same as the predicate device. | | | Avenda Health AI Prostate Cancer Planning Software (Proposed Device) | Predicate Device: Quantitative Insights, Inc. QuantX (DEN170022) | Rationale for Substantial Equivalence | | | • Adjust window level, minimize/maximize | | | | Image Review tools: | • 2D | • 2D | Similar to the predicate device. | | | • 3D | • 3D | | | | • MPR | • MIPS | | | Image Manipulation and Analysis | Interventional tool, trajectory, and damage volume overlay (overlay profiles customizable by the user) | Measure and document images | Different, but same intended use and the differences do not raise different questions of safety or effectiveness. | | Image Segmentation: | Algorithm-driven segmentation of the prostate gland with the possibility of manual adjustment | Automated segmentation of the ROI | Similar to the predicate device. | | Measurement Functionalities | Prostate gland: • Volume • ROIs within the prostate For each Lesion: • Location • Volume | For each lesion: • Volume • Surface Area…