AI-Rad Companion Prostate MR is a post-processing image analysis software that assists clinicians in viewing, manipulating, analyzing and evaluating MR prostate images for US guided MR-US fusion biopsy support.

Device Description

AI-Rad Companion Prostate MR aims to assist the radiologist in the preparation of MR prostate images for targeted biopsies of the prostate gland using MR-Ultrasound fusion biopsy. It allows the radiologist to communicate the location and spatial extent of lesions and the prostate volume in prostate MR images to a urologist in order to help perform biopsies.

AI-Rad Companion Prostate MR is a cloud-based image processing software that provides quantitative and qualitative information based on prostate MR DICOM images. More specifically, it provides information on the prostate volume which can be used to support the planning of prostate biopsies in the case of ultrasound guided MR-US fusion biopsies of the prostate gland. It is enabled via artificial intelligence algorithms and a cloud infrastructure.

The primary features of AI-Rad Companion Prostate MR include:

Automatic prostate segmentation and volume estimation, with the possibility of manual adjustments
Manual determination of location and size of lesions in a suitable user interface
Calculation of the PSA density, based on the input of the PSA value of the patient by the clinical user
Export in a suitable format for reading and archiving in PACS, as well as in a second format that can be imported by ultrasound systems (e.g. RTStruct), allowing the urologist to perform targeted MR-US fusion biopsy

AI/ML Overview

The document provided refers to AI-Rad Companion Prostate MR and states that no clinical tests were conducted to test the performance and functionality of the modifications introduced within AI-Rad Companion Prostate MR (Page 8, Section 9. Clinical Tests). Therefore, the information requested regarding acceptance criteria and performance based on a clinical study cannot be fully provided from the given text.

However, based on the non-clinical tests and the comparison to the predicate device, here's what can be inferred and stated:

1. Table of acceptance criteria and the reported device performance

The document does not provide specific quantitative acceptance criteria or reported device performance metrics from a clinical study. It mentions non-clinical tests were conducted to assess performance claims and substantial equivalence. These tests included functionality, software validation, and bench testing (Unit, System, and Integration tests). All testable requirements in the Requirement Specifications and Risk Analysis were verified.

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

Since no clinical tests were conducted, details about a clinical test set are not available. For the non-clinical software "bench" testing, sample sizes for the test data are not explicitly stated in the provided text. The data provenance (e.g., country of origin, retrospective/prospective) for these internal tests is also not mentioned.

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

The document does not mention the use of experts to establish ground truth for a clinical test set, as no clinical tests were performed. For internal software testing, the ground truth would typically be defined by design specifications and expected outputs.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication by experts is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical tests were conducted to test the performance and functionality of the modifications introduced within AI-Rad Companion Prostate MR." (Page 8, Section 9. Clinical Tests).

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

The document indicates that software "bench" testing was performed, which would be a form of standalone testing for the algorithm's functionality and performance against its requirements. However, specific results or detailed methodologies are not provided for "algorithm only" performance. The device's functionalities, such as "Automatic prostate segmentation and volume estimation," imply standalone algorithm components.

7. The type of ground truth used

For the non-clinical software testing, the ground truth would be based on the software's design specifications and expected outputs as defined by the developers (e.g., correct segmentation results against internal references, accurate volume calculations based on known inputs).

8. The sample size for the training set

The document does not mention the sample size for a training set. While the device utilizes "artificial intelligence algorithms" (Page 5), details about the training data used to develop these algorithms are not provided within this document.

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

The document does not provide information on how the ground truth for any potential training set was established, as details about the AI algorithm's development and training are not included.

Summary

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July 30, 2020

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Siemens Medical Solutions USA Inc. % Lauren Bentley Senior Manager, Regulatory Affairs 40 Liberty Blvd. Mail Code 65-3 MALVERN PA 19355

Re: K193283

Trade/Device Name: AI-Rad Companion Prostate MR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QIH, LNH Dated: July 2, 2020 Received: July 6, 2020

Dear Lauren Bentley:

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/cfpmp/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 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

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193283

Device Name

AI-Rad Companion Prostate MR

Indications for Use (Describe)

AI-Rad Companion Prostate MR provides the following functionalities:

Automatic segmentation and quantitative analysis of the prostate gland
Manual annotation of relevant findings

Type of Use (Select one or both, as applicable)

Presentation and export of results for further processing and reporting

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY FOR AI-RAD COMPANION PROSTATE MR K193283

Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: November 25, 2019

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR §807.92.

1. Submitter

Importer/Distributor	Siemens Medical Solutions USA, Inc.40 Liberty BoulevardMail Code: 65-1AMalvern, PA 19355Registration Number: 2240869
Manufacturing Site	Siemens Healthcare GmbHHenkestrasse 127Erlangen, Germany 91052Registration Number: 3002808157

2. Contact Person

Lauren Bentley Senior Manager Regulatory Affairs Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail Code: 65-3 Malvern, PA 19355 Phone: +1 (610) 241 - 6736 Email: lauren.bentley@siemens-healthineers.com

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Healt

3. Device Name and Classification

Product Name:	AI-Rad Companion Prostate MR
Trade Name:	AI-Rad Companion Prostate MR
Classification Name:	Picture Archiving and Communication System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.2050
Secondary CFR Section:	21 CFR §892.1000
Device Class:	Class II
Product Code:	QIH
Secondary Product Code:	LNH

4. Predicate Device

Product Name:	syngo.MR Applications
Propriety Trade Name:	syngo.MR Applications
510(k) Number:	K180336
Clearance Date:	April 19, 2018
Classification Name:	Magnetic Resonance Diagnostic Device
Classification Panel:	Radiology
CFR Section:	21 CFR §892.2050
Secondary CFR Section:	21 CFR §892.1000
Device Class:	Class II
Primary Product Code:	LLZ
Secondary Product Code:	LNH
Recall Information:	N/A

5. Intended Use

AI-Rad Companion Prostate MR is a post-processing image analysis software that assists clinicians in viewing, manipulating, analyzing and evaluating MR prostate images for biopsy support.

AI-Rad Companion Prostate MR provides the following functionalities:

Automatic segmentation and quantitative analysis of the prostate gland
Manual annotation of relevant findings
. Presentation and export of results for further processing and reporting

6. Device Description

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SIEMEN Healthineers

The primary features of AI-Rad Companion Prostate MR include:

. Automatic prostate segmentation and volume estimation, with the possibility of manual adjustments
Manual determination of location and size of lesions in a suitable user interface
Calculation of the PSA density, based on the input of the PSA value of the patient by the clinical user
. Export in a suitable format for reading and archiving in PACS, as well as in a second format that can be imported by ultrasound systems (e.g. RTStruct), allowing the urologist to perform targeted MR-US fusion biopsy

With current tools, it is challenging for the radiologist to show the urologist the location of the lesions to be biopsied. The radiologist can mark the lesion on the abstract sketch of the biopsy on the PI-RADS report. Based on this information, the urologist can draw the lesion on the MR images within his fusion biopsy planning software, where often information and accuracy are lost. If the radiologist chooses to draw the lesions for the urologist, the options are either to go to the biopsy machine or to a separate workstation provided by the biopsy software to draw the lesions.

As an update to the previously cleared device, the following modifications have been made:

1. Modified Indications for Use Statement
1. Automatic prostate segmentation and volume estimation, with the possibility of manual adjustments
1. Calculation of the PSA density, based on the input of the PSA value of the patient by the clinical user
1. Export in a suitable format for reading and archiving in PACS, as well as in a second format that can be imported by ultrasound systems (e.g. RTStruct), allowing the urologist to perform targeted MR-US fusion biopsy
1. Architectural enhancement for the clinical extension to be deployed with the AI-Rad Companion Engine platform in a cloud-based environment

7. Technological Characteristics

The subject device. AI-Rad Companion Prostate MR is substantially equivalent to the predicate device with regards to software, programming languages, operating system, performance and fundamental technology. AI-Rad Companion Prostate MR offers enhancements and improvements to the existing predicate device, syngo.MR Applications SMRVB30A (K180336).

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While these enhancements and improvements offer additional image viewing and evaluation capabilities compared to the predicate device, the conclusions from all verification and validation data suggest that these modifications do not adversely affect the safety and effectiveness of the predicate device.

	Subject Device	Predicate Device
Feature	SiemensAI-Rad CompanionProstate MR	Siemenssyngo.MRApplications(K180336)	Comparison Results
Software	AI-Rad CompanionProstate MR	syngo.MR Applicationswith SMRVB30A	Enhanced The subjectdevice supports newsoftware versionoffering improvementsand enhancements overthe predicate
OrganSegmentation &Annotation	Automatedsegmentation of theprostate gland with thepossibility of manualadjustment andannotation	Manual measurements,segmentations andmarks can be madewithin the prostate	Enhanced The subjectdevice automates theprostate segmentation,while still permittingmanual manipulationand annotation
ImageCommunication	DICOM compatiblewith RTStruct object	DICOM compatible	Enhanced to provideadditional output format
Configuration	Confirmation UI	syngo.via GUI	Equivalent The subjectdevice has beenmodified to specificfunctionality for theProstate MR extension
Confirmation	Configuration UI	syngo.via GUI -configuration	Equivalent The subjectdevice has beenmodified to exposeconfiguration options ofexistent extensions.
Architecture	Cloud only solutionwith no componentsdeployed on customerpremise.	Client-serverarchitecture where theserver processes andrenders the data fromthe connectedmodalities. Clientprovides the UI forinteractive imageviewing and processing.	Modified Architectureof the clinical extensionis adapted to AI-RadCompanion Engine andcloud-baseddeployment.

A tabular comparison of the subject device is provided in Table 1 below.

Table 1: Predicate Device Comparison Table

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8. Nonclinical Tests

Non-clinical tests were conducted to test the functionality of AI-Rad Companion Prostate MR. Software validation and bench testing have been conducted to assess the performance claims as well as the claim of substantial equivalence to the predicate device.

AI-Rad Companion Prostate MR has been tested to meet the requirements of conformity to multiple industry standards. Non-clinical performance testing demonstrated that AI-Rad Companion Prostate MR complies with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) as well as with the following voluntary FDA recognized Consensus Standards listed in Table 2 below.

RecognitionNumber	Product Area	Title of Standard	ReferenceNumber andDate	StandardsDevelopmentOrganization
5-114	General	Medical Devices -Application of usabilityengineering to medicaldevices [includingCorrigendum 1 (2016)]	62366-1:2015-02	IEC
5-40	General	Medical Devices -application of riskmanagement to medicaldevices	14971:2007	ISO
13-79	Software/Informatics	Medical device software -software life cycleprocesses [IncludingAmendment 1 (2016)]	62304:2006/A1:2016	AAMIANSIIEC
12-300	Radiology	Digital Imaging andCommunications inMedicine (DICOM) Set	PS 3.1 - 3.20(2016)	NEMA
12-261	Radiology	Information Technology -Digital Compression andcoding of continuous -tonestill images: Requirementsand Guidelines [including:Technical Corrigendum1(2005)]	10918-11994-02-15	ISOIEC

Table 2: Voluntary Conformance Standards

Verification and Validation

Software documentation for a Moderate Level of Concern software, per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices

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containing software. Non-clinical tests were conducted on the subject device during product development.

Software "bench" testing in the form of Unit. System and Integration tests were performed to evaluate the performance and functionality of the new features and software updates. All testable requirements in the Requirement Specifications and the Risk Analysis have been successfully verified and traced in accordance with the Siemens Healthineers DH product development (lifecycle) process. Human factor usability validation is addressed in system testing and usability validation test records. Software verification and regression testing have been performed successfully to meet their previously determined acceptance criteria as stated in the test plans.

Siemens Healthineers adheres to the cybersecurity requirements as defined the FDA Guidance "Content of Premarket Submissions for Management for Cybersecurity in Medical Devices," issued October 2, 2014 by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.

9. Clinical Tests

No clinical tests were conducted to test the performance and functionality of the modifications introduced within AI-Rad Companion Prostate MR. Verification and validation of the enhancements and improvements have been performed and these modifications have been validated for their intended use. The data from these activities were used to support the subject device and the substantial equivalence argument.

No animal testing has been performed on the subject device.

10. Safety and Effectiveness

The device labeling contains instructions for use and any necessary cautions and warnings to ensure safe and effective use of the device.

Risk management is ensured via ISO 14971:2007 compliance to identify and provide mitigation of potential hazards in a risk analysis early in the design phase and continuously throughout the development of the product. These risks are controlled via measures realized during software development, testing and product labeling.

Furthermore, the device is intended for healthcare professionals familiar with the post processing of magnetic resonance images.

11. Substantial Equivalence and Conclusion

AI-Rad Companion Prostate MR version VA20 is substantially equivalent to the follow predicate device (Table3):

Predicate Device	FDA ClearanceNumber	FDA ClearanceDate	Main Product Code
syngo.MR Applications	K180336	April 19, 2018	LLZ, LNH

Table 3: Predicate device for AI-Rad Companion Prostate MR

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Image /page/9/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.

AI-Rad Companion Prostate MR has the same intended use and basic technical characteristics compared to the predicate device, syngo.MR Applications SMRVB30A (K180336), with respect to the software features and functionalities. While Al-Rad Companion Prostate MR offers enhancements and improvements to the already cleared basic MR workflow and applications, the conclusions from all verification and validation data suggest that the modifications do not adversely impact the safety and effectiveness of the predicate device. The modifications and improvements enhance the user's workflow and reduce the complexity of certain MR imaging procedures. Siemens is of the opinion that AI-Rad Companion Prostate MR is substantially equivalent to the currently marketed device syngo.MR Applications SMRVB30A (K180336).

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).