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

Indications for use:

MRCAT Pelvis is indicated for radiotherapy treatment planning of soft tissue cancers in the pelvic region.

Device Description

MRCAT Pelvis is a software application to Ingenia 1.5T and 3T MR systems. MRCAT Pelvis 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, waterrich tissue, spongy bone and compact bone. Subsequent density assignment provides MRCAT images with CT-like density information.

AI/ML Overview

The provided text is a 510(k) summary for the Philips MRCAT Pelvis device. While it describes the device's intended use and general testing, it does not contain a detailed study demonstrating how the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or expert qualifications.

Therefore, many of the requested details cannot be extracted directly from this document.

Here's a breakdown of what can be inferred or is explicitly stated, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, etc. It only states that the robustness of the algorithm was shown by "producing equivalent dose plans to CT using gamma analysis with criterion of 3%/3mm." This implies an acceptance criterion related to dosimetric accuracy, but no precise performance numbers (e.g., % of plans meeting 3%/3mm gamma) are given.

Acceptance Criteria (Implied)	Reported Device Performance
Production of equivalent dose plans to CT using gamma analysis.	"Robustness... shown by post-processing MRCAT images from patients, and calculating dose using the MRCAT images." (Criterion: 3%/3mm gamma analysis)
Spatial accuracy of radiation attenuation estimates.	"MRCAT Pelvis images are spatially accurate radiation attenuation estimates."
Software compliance with voluntary standards (list provided).	"All requirements are met for the MRCAT Pelvis application."
Successful completion of all tests performed for the software.	"All the tests performed for MRCAT Pelvis software were successful."
No safety defects or hazardous situations from analyzed defects.	"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

Sample size: Not specified. The document only mentions "post-processing MRCAT images from patients." It does not provide the number of patients or cases.
Data provenance: Not specified (e.g., country of origin). It also doesn't explicitly state whether the data was retrospective or prospective, though "post-processing MRCAT images from patients" suggests retrospective analysis of data acquired for other purposes or as part of a study.

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

Not specified. The primary ground truth reference appears to be CT scans for dosimetric comparison, rather than human expert interpretation of the MRCAT images themselves for diagnostic purposes.

4. Adjudication method for the test set

Not applicable/specified. The primary comparison is between MRCAT-derived dose plans and CT-derived dose plans using gamma analysis, not subjective interpretation requiring adjudication among experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study is described. The device is a "software add-on" that generates CT-like density information from MR images for radiation treatment planning. It's not designed for human readers to interpret MR images directly for diagnosis with AI assistance, but rather to provide input for a treatment planning system. Therefore, an MRMC study in the traditional sense of human reader performance with/without AI assistance is not relevant to this device's function as described.

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

Yes, a standalone evaluation was performed. The robustness of the "MRCAT Pelvis algorithm" was evaluated by comparing its output (dose plans from MRCAT images) against a reference (dose plans from CT) using gamma analysis. This is an algorithm-only performance evaluation.

7. The type of ground truth used

The ground truth for evaluating dosimetric accuracy appears to be CT imaging and subsequent dose plan calculations based on CT data. The MRCAT device aims to provide "CT-like density information" and "equivalent dose plans to CT."

8. The sample size for the training set

Not specified. Information about the training set size or methodology for the MRCAT algorithm is not provided in this document.

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

Not specified. How the ground truth for any training data (if machine learning was used extensively to develop the underlying algorithm) was established is not mentioned in this document.

Summary

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

April 30, 2019

Re: K182888

Trade/Device Name: MRCAT Pelvis Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: March 22, 2019 Received: April 1, 2019

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. 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 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182888

Device Name MRCAT Pelvis

Indications for Use (Describe)

MRCAT Pelvis is a software add-on for 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 estimation purposes in photon external beam radiotherapy treatment planning.

Indications for use:

MRCAT Pelvis is indicated for radiotherapy treatment planning of soft tissue cancers in the pelvic region.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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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:

March 22, 2019

Owner/Submitter:	Philips Medical Systems MR FinlandÄyritie 401510 VantaaFINLANDPhone: +358-9-615 800Fax: +358-9-3487 2406
Primary Contact Person:	Janne MarvolaRegulatory Engineer

Regulatory Enginee Philips Medical Systems MR Finland Phone: +358-40-126 1214 Fax: +358-9-3487 2406 E-mail: regulatory.mr.therapy@philips.com

Secondary Contact Person:	Osku IlvonenSenior Manager Q&RPhilips Medical Systems MR FinlandPhone: +358-40-552-6197Fax: +358-9-3487-2406E-mail: osku.ilvonen@philips.com
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Image /page/3/Picture/9 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines that resemble sound waves or water. Above and below the wavy lines are four-pointed stars. The word "PHILIPS" is written in blue at the top of the shield.

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

Trade Name: MRCAT Pelvis Classification: Class II Regulatory Section: 21 CFR 892.5050 Product Code: MUJ

Predicate Device(s) K151435 MRCAT (primary) (807.92(a)(3):: K013644 AcQPlan 5.0 (reference device)

Device Description MRCAT Pelvis is a software application to Ingenia 1.5T and 3T MR (807.92(a)(4)):: systems. MRCAT Pelvis 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, waterrich tissue, spongy bone and compact bone. Subsequent density assignment provides MRCAT images with CT-like density information.

Intended Use: (807.92(a)(5): 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 Pelvis is indicated for radiotherapy treatment planning of soft tissue cancers in the pelvic region.

Technology (807.92(a)(6)):: MRCAT Pelvis functionality is implemented as a software plug-in for the MR main software and it contains the following main features:

Automatic post-processing tool delivering MRCAT images 1)
1. Examcard with mDixon imaging protocol

Image /page/4/Picture/12 description: The image features the Philips logo, which is a shield-shaped emblem in a shade of blue. The word "PHILIPS" is displayed in white, bold, sans-serif letters at the top of the shield. Below the text, there are two wavy lines that resemble sound waves or water, and two four-pointed stars are positioned above and below the wavy lines, adding a celestial or dynamic element to the logo.

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DICOM export of MRCAT image.

MRCAT Image Generation

MRCAT images are generated with an ExamCard post-processing step, which uses the images from the previous mDixon scan.

The post-processing logic takes care of launching MRCAT algorithm executable calculating a new 3D MRCAT image. The algorithm enables model based segmentation of bones and soft tissues. Subsequent density assignment provides MRCAT images with CT-like density information. Once the process is running, post-processing logic exchanges information with the algorithm:

Image source data to algorithm, and image output data back to the post-processing step
. Progress notifications
. Error and warning notifications

The 3D MRCAT image from the post-processing step is stored into the MR image database.

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.

Image /page/5/Picture/13 description: The image shows the Philips logo, which consists of the word "PHILIPS" in blue, positioned above a blue shield-like shape. Inside the shield, there are two stylized waves and two four-pointed stars. The overall design is simple and clean, with a focus on the brand name and a symbolic representation of waves and stars.

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Hardware platform description

MRCAT Pelvis does not require any change of the hardware platform of Ingenia scanners. The new software extensions introduced by MRCAT Pelvis run on the MR console of Ingenia.

Summary of Non-Clinical Tests:

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

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 60601-2-33:2015, Medical electrical equipment Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis.
1. IEC 62304:2006, Medical device software Software life-cycle processes
1. ISO 14971:2007, Medical devices. Application of risk management to medical devices

All requirements are met for the MRCAT Pelvis application.

Image /page/6/Picture/18 description: The image shows the Philips logo, which consists of the word "PHILIPS" in a sans-serif font above a shield-like emblem. The emblem is blue and features two wavy lines and four stars. The wavy lines are positioned horizontally in the center of the shield, and the stars are placed above and below the wavy lines.

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The conclusion from these reports is:

All the tests performed for MRCAT Pelvis 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.

Summary of Clinical Tests: Clinical (807.92(b)(2)):
The robustness of the MRCAT Pelvis algorithm for producing equivalent dose plans to CT using gamma analysis with criterion of 3%/3mm is shown by post-processing MRCAT images from patients, and calculating dose using the MRCAT images.

In summary, the MRCAT Pelvis images are spatially accurate radiation attenuation estimates that can aid in the EBRT planning of pelvic soft tissue cancers.

Conclusion (807.92(b)(3)):: MRCAT Pelvis software 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 pelvic cancer patients.

lt is the opinion of Philips Medical Systems MR Finland that the MRCAT Pelvis software option for Philips Ingenia MR scanners is substantially equivalent and raises no new issues of safety or effectiveness compared to the primary predicate Philips MRCAT, K151435 cleared by FDA on February 25, 2016 and the reference device AcQPlan 5.0, K013644, cleared by FDA on September 12, 2002.

Image /page/7/Picture/7 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, there are two wavy lines and two stars. The word "PHILIPS" is written in white at the top of the shield.

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.