MRCAT imaging is intended to provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning.

Indications for use:

MRCAT is indicated for radiotherapy treatment planning for prostate cancer patients.

Device Description

MRCAT is a software application to Ingenia 1.5T and 3T MR systems. MRCAT is available to the customer as an option to Ingenia MR-RT package, which is a set of accessories for Ingenia systems.

Automated generation of MRCAT images takes place at the MR console of Ingenia. The embedded image post-processing runs in the background parallel to image acquisition. MRCAT algorithms enable automatic tissue characterization of five tissue types; air, fat, water-rich tissue, spongy bone and compact bone. Subsequent bulk-density assignment provides MRCAT images with CT-based density information.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and the comprehensive study that proves the device meets them in the format requested. However, it offers some insights into the validation process and the claims made.

Here's an attempt to extract and infer information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document mentions gamma analysis with criterion of 3%/3mm as a method to show the robustness of the MRCAT algorithm for producing equivalent dose plans to CT using MRCAT images. This implies that the acceptance criterion is that the dose plans generated using MRCAT images should be equivalent to those generated using CT, with a 3%/3mm gamma pass rate.

Acceptance Criteria	Reported Device Performance
Robustness of MRCAT algorithm for producing equivalent dose plans to CT using gamma analysis with criterion of 3%/3mm (implicitly, a high pass rate would be required)	"The robustness of the MRCAT algorithm for producing equivalent dose plans to CT using gamma analysis with criterion of 3%/3mm is shown by post-processing MRCAT images from prostate cancer patients, and calculating dose using the MRCAT images." (No specific pass rate percentage is provided in this summary.)

Additional acceptance criteria related to software development and validation were mentioned in the "Summary of Non-Clinical Tests," but these are general quality assurance measures rather than specific performance metrics for the final output:

Risk Analysis
Testing on unit level (Subsystem verification)
Integration testing (System verification)
Final acceptance testing (Validation)
Performance testing (Verification)
Safety testing (Verification)

The document states, "All the tests performed for MRCAT software were successful. All defects have been analyzed and are confirmed that they are not safety defects and will not cause any hazardous situation on using this application."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states, "The robustness of the MRCAT algorithm... is shown by post-processing MRCAT images from prostate cancer patients."

Sample Size: The exact number of prostate cancer patients used in the clinical test is not specified.
Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The ground truth for dose plan comparison is implicitly assumed to be CT-based dose plans, but the expert involvement in establishing this ground truth or comparing the MRCAT-derived plans is not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

MRMC Study: No MRMC comparative effectiveness study involving human readers and AI assistance is described. The device's primary function is to generate images for treatment planning, not to assist human interpretation directly in a diagnostic workflow. The "clinical test" described focuses on the comparison of dose plans generated by the algorithm (MRCAT) against CT, not human performance.

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

Yes, the clinical test described appears to be a standalone performance evaluation of the MRCAT algorithm. The "robustness of the MRCAT algorithm for producing equivalent dose plans to CT" was shown by "post-processing MRCAT images... and calculating dose using the MRCAT images." This implies an algorithm-to-algorithm comparison (MRCAT-generated dose plans vs. CT-generated dose plans).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for comparison in the clinical test was CT-based dose plans. The intent is for MRCAT images to provide "radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning," implying that the standard for attenuation estimation is conventional CT. The gamma analysis compares the dose distributions calculated from MRCAT images to those calculated from CT images.

8. The sample size for the training set

This information is not provided in the document. The description focuses on the clinical evaluation of the algorithm's output rather than its development or training data.

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

This information is not provided in the document.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 25, 2016

Philips Medical Systems MR Finland % Janne Marvola, Ph.D. Regulatory Engineer Ayritie 4 Vantaa, 01510 FINLAND

Re: K151435

Trade/Device Name: MRCAT software Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: January 15, 2016 Received: January 19, 2016

Dear Dr. Marvola:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara

For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

K151435 510(k) Number (if known): _

Device Name: MRCAT software

Indications for use:

MRCAT is used with Ingenia 1.5T and 3.0T MR systems.

Intended Use:

MRCAT imaging is intended to provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning.

Indications for use:

MRCAT is indicated for radiotherapy treatment planning for prostate cancer patients.

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Section 5: 510(k) Summary

MRCAT software

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Philips Medical Systems MR Finland Äyritie 4 01510 Vantaa Finland T: +358-9-615-800

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Owner/Contact/Date (807.92(a)(1):

Date:	February 24, 2016
Owner/Submitter:	Philips Medical Systems MR FinlandÄyritie 401510 VantaaFINLANDPhone: +358-9-615 800
	Fax: +358-9-3487 2406
Primary Contact Person:	Janne MarvolaRegulatory EngineerPhilips Medical Systems MR FinlandPhone: +358-40-126 1214Fax: +358-9-3487 2406E-mail: regulatory.mr.therapy@philips.com
Secondary Contact Person:	Osku IlvonenRegulatory ManagerPhilips Medical Systems MR FinlandPhone: +358-40-552-6197Fax: +358-9-3487-2406E-mail: osku.ilvonen@philips.com

Device names (807.92(a)(2)):

Trade Name:
Classification:
Regulatory Section:

MRCAT Class II 21 CFR 892.5050

Product Code:

MUJ

Predicate Device(s) (807.92(a)(3):: K130992 Pinnacle 3® Radiation Therapy Planning System (primary) K013644 AcQPlan 5.0 (reference)

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Device Description(807.92(a)(4))::	MRCAT is a software application to Ingenia 1.5T and 3T MR systems. MRCATis available to the customer as an option to Ingenia MR-RT package, which isa set of accessories for Ingenia systems.
	Automated generation of MRCAT images takes place at the MR console ofIngenia. The embedded image post-processing runs in the backgroundparallel to image acquisition. MRCAT algorithms enable automatic tissuecharacterization of five tissue types; air, fat, water-rich tissue, spongy boneand compact bone. Subsequent bulk-density assignment provides MRCATimages with CT-based density information.
Intended Use: (807.92(a)(5):	MRCAT is used with Ingenia 1.5T and 3.0T systems.
	Intended Use:
	MRCAT imaging is intended to provide the operator with information oftissue properties for radiation attenuation estimation purposes in photonexternal beam radiotherapy treatment planning.
	Indications for use:
	MRCAT is indicated for radiotherapy treatment planning for prostate cancerpatients.
Technology (807.92(a)(6))::	MRCAT functionality is implemented in the MR system software and itcontains the following main features:1) Automatic post-processing tool delivering MRCAT images2) Examcard with mDixon imaging protocol3) DICOM export of MRCAT image.
	MRCAT Image Generation
	MRCAT images are generated with an ExamCard post-processing step, whichuses the images from the previous mDixon scan.
	The post-processing logic takes care of launching MRCAT algorithmexecutable calculating a new 3D MRCAT image. The algorithm enablesautomatic tissue characterization of five tissue types; air, fat, water-richtissue, spongy bone and compact bone. Subsequent bulk-density assignmentprovides MRCAT images with CT-based density information. Once theprocess is running, post-processing logic exchanges information with thealgorithm:
	● Image source data to algorithm, and image output data back to thepost-processing step● Progress notifications● Error and warning notifications
	The 3D MRCAT image from the post-processing step is stored into the MRimage database.

image database.

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mDIXON scan

An mDixon imaging protocol, with imaging parameters optimized for MRCAT image post-processing and for geometric accuracy, is delivered as a part of MRCAT option. MRCAT uses fixed parameters for mDixon scan, only the image stack location is configurable.

DICOM Export

The MRCAT post-processing step stores the image data returned by the MRCAT algorithm into MR database.

MRCAT images can be exported in DICOM format enabling the use as primary images in the treatment planning systems.

Hardware platform description

MRCAT does not require any change of the hardware platform of Ingenia 1.5T and 3.0T. The new software extensions introduced by MRCAT run on the MR Host computer.

Summary of Non-Clinical Tests:

The MRCAT software complies with voluntary standards as detailed below. The following quality assurance measures were applied to the development of the system:

. Risk Analysis
Testing on unit level (Subsystem verification)
Integration testing (System verification) ●
Final acceptance testing (Validation)
Performance testing (Verification)
Safety testing (Verification)

The MRCAT software was designed and tested for compliance to the following standards:

1. ANSI/AAMI ES60601-1: 2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance -Third Edition
1. IEC 60601-1-6:2006, Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability.
1. IEC 60601-2-33:2010, Medical electrical equipment - Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis.
IEC 62304:2006, Medical device software Software life-cycle 4.

Determination of Substantial Equivalence, non-clinical (807.92(b)(1))::

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processes

1. ISO 14971:2007, Medical devices. Application of risk management to medical devices
  All requirements are met for the MRCAT application.

The conclusion from these reports is: All the tests performed for MRCAT software were successful. All defects have been analyzed and are confirmed that they are not safety defects and will not cause any hazardous situation on using this application.

Clinical (807.92(b)(2)): Summary of Clinical Tests: The robustness of the MRCAT algorithm for producing equivalent dose plans to CT using gamma analysis with criterion of 3%/3mm is shown by postprocessing MRCAT images from prostate cancer patients, and calculating dose using the MRCAT images. In summary, the MRCAT images provide robust and spatially accurate radiation attenuation estimates that can aid in the photon EBRT planning of prostate cancer. Conclusion (807.92(b)(3)):: MRCAT SW option is a tool to provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning for prostate cancer patients.

lt is the opinion of Philips Medical Systems that the MRCAT SW option for Philips Ingenia is substantially equivalent and raises no new issues of safety or effectiveness compared to the primary predicate Pinnacle3® Radiation Therapy Planning System, K130992 cleared by FDA on June 14, 2013 and the reference device AcQPlan 5.0, K013644, cleared by FDA on September 12, 2002.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.