RSI-MRI+ is indicated for use as automatic post-acquisition image processing software for analysis of diffusionweighted and anatomical magnetic resonance imaging data.

RSI-MRI+ is intended for automatic fusion of derived diffusion-weighted MRI data with anatomical T2-weighted MR images.

RSI-MRI+ is additionally intended to provide automatic prostate segmentation, and reporting of derived image metrics.

RSI-MRI+ is not intended for use in pediatric populations.

RSI-MRI+ is not intended to diagnose, treat, or prevent diseases or conditions.

RSI-MRI+ is intended to be used in a variety of settings such as hospitals, clinics, and medical offices.

Device Description

RSI-MRI+ is standalone software that is used by radiologists, and other clinicians to assist with analysis and interpretation of medical images. RSI-MRI+ accepts DICOM images using supported protocols and performs automatic post-acquisition analysis of diffusion-weighted magnetic resonance imaging (DWI) data and optional automated fusion of derived image data with anatomical T2weighted MR images.

Some of the features of RSI-MRI+ include:

Restricted Signal Map: The derived image data produced by RSI-MRI+ includes an enhanced DWI map (the Restricted Signal Map), which demonstrates improved conspicuity of restricted diffusion compared to standard DWI maps.
Color Fusion Series: RSI-MRI+ can be configured to produce a color fusion series which overlays the Restricted Signal Map intensity onto the anatomical T2-weighted image series.
Automated Prostate Segmentation: RSI-MRI+ uses artificial intelligence (Al) powered by a deep learning algorithm to automatically segment the prostate on anatomical T2-weighted images. The segmentation result is provided in the separate Prostate Seqmentation Series.
Automated Segmentation Report: RSI-MRI+ generates a report of segmentation volume and images of the segmented prostate as a colored outline on the anatomical image.
Export: RSI-MRI+ outputs are provided in standard DICOM format, which is compatible with most third-party commercial PACS workstation software.

AI/ML Overview

The provided 510(k) summary for RSI-MRI+ (K191278) mentions performance testing related to "Accuracy of automated segmentation compared to manual radiologist segmentations" but does not explicitly state acceptance criteria or the full details of the study that proves the device meets those criteria in a structured format. Similarly, it mentions "Increased conspicuity of the RSI-MRI+ Restricted Signal Map to standard DWI maps," but without specific metrics or studies described.

Based on the available text, I can infer and assemble some of the requested information, but certain details regarding the study for acceptance criteria are not fully elaborated.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. However, it states that "Accuracy of automated segmentation compared to manual radiologist segmentations" was tested. Without specific thresholds, it's difficult to formulate a complete table.

Inferred Acceptance Criteria (for prostate segmentation) and Reported Performance:

Acceptance Criteria (Inferred)	Reported Device Performance
Prostate Segmentation Accuracy	Successfully compared to manual radiologist segmentations. (Specific metrics like Dice score, Hausdorff distance not provided in the summary)
BIFROST (Restricted Signal Map Conspicuity)	"Increased conspicuity of the RSI-MRI+ Restricted Signal Map to standard DWI maps in regions of restricted diffusion." (No quantitative metric provided)
Diffusion Signal Normalization	Successful normalization across acquisitions and scanners. (No quantitative metric provided)

2. Sample Size Used for the Test Set and Data Provenance

The document states:
"Retrospective clinical data (including professionally labeled regions-of-interest, T2-weighted anatomical data, and raw diffusion image series) were used for verification and validation of the diffusion analysis (diffusion signal normalization and Restricted Signal Map conspicuity)."

Sample size for the test set: Not explicitly stated.
Data Provenance: Retrospective clinical data. The country of origin of the data is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document states:
"...professionally labeled regions-of-interest..."

Number of experts: Not explicitly stated (it mentions "radiologist segmentations" in plural, implying more than one, but no specific number is given).
Qualifications of experts: The experts performed "manual radiologist segmentations" and provided "professionally labeled regions-of-interest." This implies they were radiologists, but specific experience levels (e.g., "10 years of experience") are not provided.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth from the expert segmentations. It only mentions "manual radiologist segmentations."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not indicate that an MRMC comparative effectiveness study was done comparing human readers with AI assistance vs. without AI assistance. The performance testing focuses on the standalone algorithm's accuracy for segmentation and conspicuity of the Restricted Signal Map.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance evaluation was conducted. The assessment described for "Accuracy of automated segmentation compared to manual radiologist segmentations" and "Increased conspicuity of the RSI-MRI+ Restricted Signal Map" appears to be an algorithm-only evaluation against established ground truth.

7. The Type of Ground Truth Used

For prostate segmentation, the ground truth was established by expert consensus/manual radiologist segmentations.
For diffusion analysis and conspicuity, it was based on "professionally labeled regions-of-interest."

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It mentions "RSI-MRI+ uses artificial intelligence (AI) powered by a deep learning algorithm to automatically segment the prostate," implying a training phase, but the size of the training data is not provided in this summary.

9. How the Ground Truth for the Training Set Was Established

The method for establishing ground truth for the training set is not explicitly detailed in the provided text. However, given that "professionally labeled regions-of-interest" were used for validation, it is highly probable that similar expert labeling would have been used to generate ground truth for the training of the deep learning algorithm.

Summary

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November 19, 2019

MultiModal Imaging Services Corporation (dba HealthLytix) % Stephen Kosnosky, PMP, ASQ CMQ/OE Quality and Regulatory Manager 4747 Executive Drive, Suite 820 SAN DIEGO CA 92121

Re: K191278

Trade/Device Name: RSI-MRI+ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: November 8, 2019 Received: November 12, 2019

Dear Mr. Kosnosky:

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) K191278

Device Name RSI-MRI+

Indications for Use (Describe)

RSI-MRI+ is indicated for use as automatic post-acquisition image processing software for analysis of diffusionweighted and anatomical magnetic resonance imaging data.

RSI-MRI+ is intended for automatic fusion of derived diffusion-weighted MRI data with anatomical T2-weighted MR images.

RSI-MRI+ is additionally intended to provide automatic prostate segmentation, and reporting of derived image metrics.

RSI-MRI+ is not intended for use in pediatric populations.

RSI-MRI+ is not intended to diagnose, treat, or prevent diseases or conditions.

RSI-MRI+ is intended to be used in a variety of settings such as hospitals, clinics, and medical offices.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for HealthLytix. To the left of the company name is a circular design made up of many small circles. The name HealthLytix is in blue, with the "Health" portion in a darker blue and the "Lytix" portion in a lighter blue.

510(k) Summary

K191278

Submission Information:

Submitter's Name	MultiModal Imaging Services Corporation (dba HealthLytix)
Submitter's Address	4747 Executive Drive, Suite 820San Diego, CA 92121
Submitter Telephone	+001.619.340.0503
Contact Name	Stephen Kosnosky PMP, ASQ CMQ/OE
Date Prepared	Sept 18, 2019
Trade or ProprietaryName	RSI-MRI+
Common or UsualName	Picture Archiving and Communications System
Classification Name	System, Image Processing, Radiological) (21 CFR 892.2050)
Regulatory Class	Class II
Product Code	LLZ
Predicate Device	Eigen ProFuse CAD (K173744)As of submission date this predicate device has not been subject toa design-related recall.No reference devices were used in this submission.

Device Description:

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Image /page/4/Picture/0 description: The image contains the logo for HealthLytix. The logo consists of a circular design on the left, made up of many small dots arranged in concentric circles. To the right of the circular design is the company name, "HealthLytix", with the "Health" part in a darker blue and the "Lytix" part in a lighter blue.

Some of the features of RSI-MRI+ include:

Restricted Signal Map: The derived image data produced by RSI-MRI+ includes an enhanced DWI map (the Restricted Signal Map), which demonstrates improved conspicuity of restricted diffusion compared to standard DWI maps.
. Color Fusion Series: RSI-MRI+ can be configured to produce a color fusion series which overlays the Restricted Signal Map intensity onto the anatomical T2-weighted image series.
Automated Prostate Segmentation: RSI-MRI+ uses artificial intelligence (Al) powered by a deep learning algorithm to automatically segment the prostate on anatomical T2-weighted images. The segmentation result is provided in the separate Prostate Seqmentation Series.
. Automated Segmentation Report: RSI-MRI+ generates a report of segmentation volume and images of the segmented prostate as a colored outline on the anatomical image.
. Export: RSI-MRI+ outputs are provided in standard DICOM format, which is compatible with most third-party commercial PACS workstation software.

NOTE: The RSI-MRI+ supported protocols differ from PI-RADS v2.1 in that they have lower in-plane resolution for T2W images and thicker slices for the GE DWI.

Indications for Use:

RSI-MRI+ is indicated for use as automatic post-acquisition image processing software for analysis of diffusion-weighted and anatomical magnetic resonance imaging data.

RSI-MRI+ is intended for automatic fusion of derived diffusion-weighted MRI data with anatomical T2-weighted MR images.

RSI-MRI+ is additionally intended to provide automatic prostate segmentation, quantification, and reporting of derived image metrics.

RSI-MRI+ is not intended for use in pediatric populations.

RSI-MRI+ is not intended to diagnose, treat, or prevent diseases or conditions.

RSI-MRI+ is intended to be used in a variety of settings such as hospitals, clinics, and medical offices.

Substantial Equivalence:

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Image /page/5/Picture/0 description: The image shows the Healthlytix logo. The logo consists of a circular arrangement of blue dots on the left and the word "HealthLytix" on the right. The word "Health" is in a darker blue color, while "Lytix" is in a lighter blue color.

The product's technical features are substantially equivalent to the ProFuse CAD (K173744). Many of the features of the ProFuse CAD (K173744) software are included in RSI-MRI+ is standalone software that runs on a network connected server or PC workstation. The RSI-MRI+ device accepts DICOM image data as input to perform image processing including diffusion series analysis, automatic segmentation, fusion of images, and automated reporting from MRI scans.

At a high level, the subject and predicate devices are based on the following same technological elements:

Software devices ●
DICOM compatibility for input and output
Diffusion-series analysis
Image fusion
Automated reporting
MRI Image analysis
Display and measurement data may be viewed, accepted, or rejected by a clinician
For use in hospital, clinic, or medical office

The following differences exist between the subject and predicate devices:

Image format compatibility (RSI-MRI+ is compatible with DWI-MRI, predicate has additional compatibility with MRI, CT, PET)
Contrast image processing (RSI-MRI+ does not contain this functionality)
Co-registration (RSI-MRI+ does not contain this functionality)
Image annotation (RSI-MRI+ does not contain this functionality)
Manual segmentation (RSI-MRI+ has automatic segmentation, predicate uses manual segmentation)
Image viewing (RSI-MRI+ does not contain this functionality, images are viewable on most 3ª party commercial PACS workstation software)

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Predicate Device:

Function	RSI-MRI+(Subject Device)	ProFuse CAD(K173744)
Product Code	LLZ	LLZ
DICOM Input	DICOM compatible	DICOM compatible
Diffusion - seriesanalysis	Post-processing analysis ofDiffusion MRI data withmulti-compartment RSImodel.	Post-processing analysis ofDiffusion MRI data with singlecompartment DWI model.
Segmentation	Automated ProstateSegmentation: RSI-MRI+software provides automaticprostate segmentation,quantification, and reportingof derived image metrics.	Manual ProstateSegmentation: ProFuse CADhas a marking feature thatallows the user to manuallysegment the prostate andprovides quantification andreporting of derived imagemetrics.
Co-Registration	Does not contain thisfunctionality.	Performs co-registration ofimages.
Fusion	Automated fusion of derivedDiffusion MRI data withanatomical MRI data	Automated fusion of derivedDiffusion MRI data withanatomical MRI data inaddition to other data sources
Report	Yes	Yes
DICOM output	DICOM compatible	DICOM compatible
Data Source	MRI Scanner	MRI Scanner, CT Scanner, PETScanner
Safety	Display/measurement datacan be viewed, accepted, orrejected by a physician.	Display/measurement datacan be viewed, accepted, orrejected by a physician.
Environment foruse	Hospital, Clinic, MedicalOffice	Hospital, Clinic, Medical Office,Home Office

Testing and Performance Data:

The following performance data were provided in support of the substantial equivalence determination:

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket

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Image /page/7/Picture/0 description: The image shows the logo for HealthLytix. The logo consists of a circular design on the left, made up of small blue dots arranged in concentric circles. To the right of the circular design is the company name, "HealthLytix", with "Health" in a darker blue and "Lytix" in a lighter blue.

Submissions for Software Contained in Medical Devices". All product and engineering specifications were verified and validated.

Software validation was performed to demonstrate that RSI MRI+ processes DICOM images and presents the processed images and quantitative results in all instances RSI-MRI+ functioned as intended and outputs were created as expected.

Performance testing included protocols demonstrating;

। Increased conspicuity of the RSI-MRI+ Restricted Signal Map to standard DWI maps in regions of restricted diffusion
-Accuracy of automated segmentation compared to manual radiologist segmentations
-Diffusion signal normalization across acquisitions and scanners

Retrospective clinical data (including professionally labeled regions-of-interest, T2-weighted anatomical data, and raw diffusion image series) were used for verification and validation of the diffusion analysis (diffusion signal normalization and Restricted Signal Map conspicuity).

Nonclinical Testing and Performance Information

Nonclinical and performance testing has been performed by designated individuals as required by HealthLytix quality procedures. Verification & Validation Test Plans were designed to evaluate all input functions, output functions, and actions performed by RSI-MRI+ in each operational mode. RSI-MRI+ has been assessed and tested at the manufacturer's facility and has passed all in-house testing criteria including validating design, function and specifications. Measurement validation was performed on clinically acquired images and shows that RSI-MRI+ is safe and effective. Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met.

Conclusion:

The results of comparing the intended use, features and functionality, technological characteristics, mode of operation, and specifications of RSI-MRI+ with those of the predicate device demonstrate that RSI-MRI+ is substantially equivalent. Any differences between RSI-MRI+ and the predicate device do not raise any new questions of safety or effectiveness.

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).