Braid is a software teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web. Braid is used by hospitals, clinics, imaging centers, and radiologist reading practices.

Braid can optionally be used for mobile diagnostic use for review and analysis of CR, DX, CT, and MR images and medical reports. Braid mobile diagnostic use is not intended to replace workstations and should only be used when there is no access to a workstation. Braid mobile diagnostic use is not intended for the display of mammography images for diagnosis.

When images are reviewed and use as an element of diagnosis, it is the trained physician to determine if the image quality is suitable for their clinical application.

Contraindications: Braid is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose radiological image data.

Device Description

Braid is a web-based software platform that allows a user to view DICOM-compliant images for diagnostic and mobile-diagnostic purposes. Braid may be used with FDA-cleared diagnostic monitors and mobile devices including iPhones, and iPads . It is a picture archiving and communication system (PACS), product code LLZ, intended to provide an interface for the display, annotation, and review of reports and demographic information. Braid allows for multispecialty viewing of medical images including Computed Radiography (CR), Computer Tomography (CT), Digital Radiography (DX), Magnetic Resonance (MR), as well as associated non-imaging data such as report text.

. Braid can be used for primary diagnosis on FDA-cleared diagnostic monitors. Braid is intended for use by trained and instructed healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to review patient images, perform non-destructive manipulations, annotations, and measurements. When used for diagnosis, the final decision regarding diagnoses resides with the trained physician, and it is up to the physician to determine if image quality is suitable for their clinical application.
. Braid can also be used for reference and diagnostic viewing on mobile devices. Braid diagnostic use on mobile devices is not intended to replace full diagnostic workstations and should only be used only be used for when there is no access to workstation. When used for diagnosis, the final decision regarding diagnoses resides with the trained physician, and it is up to the physician to determine if image quality is suitable for their clinical application.

Braid has the following viewer technology and features:

Grayscale Image Rendering
Localizer Lines
Localizer Point
Orientation Markers
Distance Markers
Study Data Overlays
Stack Navigation Tool
Window/Level Tool
Zoom Tool
Panning Tool
Color Inversion
Text Annotation
Maximum Intensity Projection
Reslicing (MPR)
Area Measurement Annotation
Angle Measurement Annotation

In addition, Braid has:

Added Hardware accelerated rendering
Support for high resolution Retina displays
Keyboard shortcuts for all tools and all annotation types
Touchscreen support
Quick image manipulation and navigation via multitouch gestures, on touchscreens or multitouch capable trackpads

AI/ML Overview

The provided text is a 510(k) summary for the device "Braid" and contains information about its performance data and substantial equivalence to predicate devices. However, it does not include a specific table of acceptance criteria and reported device performance with numerical metrics typically found in a clinical study report. It states that "clinical validation testing was conducted to support the diagnostic quality of Braid™ on mobile devices as well as the use of Braid™ features such as reslicing (MPR)." and "Results demonstrated that the images displayed by Braid™ were of appropriate diagnostic quality in all conditions." but does not elaborate on the specific acceptance criteria or quantitative performance metrics.

Therefore, the following response will extract all available information related to your request and explicitly state where information is not provided in the document.

Description of Acceptance Criteria and Study Proving Device Meets Criteria (Based on Provided Text)

The provided submission does not explicitly detail a quantitative table of acceptance criteria with corresponding reported device performance metrics in the way a typical clinical study report for an AI/CADe device would. Instead, the "Performance Data" section describes bench testing and clinical validation testing intended to demonstrate that the device's image display quality is "appropriate for Braid™'s intended use" and "of appropriate diagnostic quality." The acceptance is based on the subjective evaluation of image quality by board-certified radiologists, rather than specific numerical thresholds for metrics like sensitivity, specificity, or AUC, which are common for diagnostic AI algorithms.

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

A direct table of acceptance criteria with numerical performance metrics is not provided in the given document. The document states general qualitative acceptance regarding image quality:

Acceptance Criterion (Inferred from text)	Reported Device Performance (Qualitative)
Images displayed by Braid™ on FDA-cleared diagnostic monitors are of appropriate diagnostic quality.	"Results demonstrated that the images displayed by Braid™ were of appropriate diagnostic quality in all conditions."
Images displayed by Braid™ on intended mobile devices (iPhone 11, iPad Pro 3) are of appropriate diagnostic quality.	"Results demonstrated that the images displayed by Braid™ were of appropriate diagnostic quality in all conditions."
Functionality of Braid™ features (e.g., reslicing/MPR) is acceptable for diagnostic purposes.	Board-certified radiologists "were asked to evaluate all braid features and to provide multiple scores for the quality of the Braid™ images... These performance data including image quality evaluations by qualified radiologists are adequate to support substantial equivalence of Braid™ to the predicate devices."
Mobile device screens (iPhone 11, iPad Pro 3) meet display quality standards for the proposed indications.	Bench testing "demonstrated that the designated hardware platforms are appropriate for Braid™'s intended use."

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

Test Set Sample Size: The document does not specify the number of images or cases used in the clinical validation testing. It mentions "Images were evaluated across all intended imaging modalities."
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.

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

Number of Experts: The document states "Board-certified radiologists were asked to evaluate all braid features..." The exact number of board-certified radiologists is not specified.
Qualifications of Experts: "Board-certified radiologists." The document does not specify their years of experience or other detailed qualifications beyond board certification.

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

The document does not specify an adjudication method for establishing ground truth or resolving discrepancies among readers. It simply states that radiologists "were asked to evaluate all braid features and to provide multiple scores for the quality of the Braid™ images."

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

A MRMC comparative effectiveness study involving AI assistance for human readers was not conducted or described for this device. Braid is a PACS/viewer, not an AI diagnostic algorithm, so such a study would not be directly applicable to its stated function in this context. The clinical validation focused on the diagnostic quality of the displayed images via human expert review.

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

As Braid is a Picture Archiving and Communications System (PACS) and viewer, not a diagnostic AI algorithm, the concept of "standalone (algorithm only)" performance metrics like sensitivity/specificity for a specific condition is not applicable here. The performance evaluation focuses on the image display capabilities that a human uses for diagnosis.

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

The "ground truth" for the diagnostic quality of the displayed images was established by expert opinion/evaluation of board-certified radiologists who provided "multiple scores for the quality of the Braid™ images." This is a subjective assessment of image quality for diagnostic interpretation.

8. The sample size for the training set

Braid is described as a PACS/viewer, not a machine learning model that requires a "training set" in the conventional sense for a diagnostic algorithm. Therefore, information about a training set sample size is not applicable and not provided.

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

Given that Braid is a PACS/viewer and not an AI diagnostic algorithm, the concept of "ground truth for a training set" is not applicable in this context and is not provided.

Summary

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August 13, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Braid.Health % Ms. Vivian Liu Correspondent 301 Rhode Island St. SAN FRANCISCO CA 94103

Re: K200822

Trade/Device Name: Braid Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: July 16, 2020 Received: July 16, 2020

Dear Ms. Liu:

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) K200822

Device Name Braid

Indications for Use (Describe)

When images are reviewed and use as an element of diagnosis, it is the trained physician to determine if the image quality is suitable for their clinical application.

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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510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for Braid™ is provided below:

SUBMITTER

Submitter:	Braid.Health301 Rhode Island St. B10San Francisco, CA 94103
Contact Person:	Vivian LiuBraid.Health301 Rhode Island St. B10San Francisco, CA 94103vivian@braid.health(617) 335-6866
Date Prepared:	March 27, 2020

DEVICE

Name of Device:	Braid
Common or Usual Name:	Picture archiving and communications system
Classification:	21 CFR 892.2050
Regulatory Class:	Class II
FDA Panel	Radiology
Product Code:	LLZ - System, Image Processing, Radiological

PREDICATE DEVICES 1.

	Primary	Secondary
Predicate Device Name:	BOX DICOM Viewer™	Enterprise Imaging XEROViewer 8.1
Manufacturer:	BOX INC.	Agfa HealthCare N.V.
510(k) Number:	K151957	K170434

K200822

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Reference Devices:

No reference devices are used in this submission.

DEVICE DESCRIPTION 2.

. Braid can be used for primary diagnosis on FDA-cleared diagnostic monitors. Braid is intended for use by trained and instructed healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to review patient images, perform non-destructive manipulations, annotations, and measurements. When used for diagnosis, the final decision regarding diagnoses resides with the trained physician, and it is up to the physician to determine if image quality is suitable for their clinical application.
. Braid can also be used for reference and diagnostic viewing on mobile devices. Braid diagnostic use on mobile devices is not intended to replace full diagnostic workstations and should only be used only be used for when there is no access to workstation. When used for diagnosis, the final decision regarding diagnoses resides with the trained physician, and it is up to the physician to determine if image quality is suitable for their clinical application.

Braid has the following viewer technology and features:

Grayscale Image Rendering
Localizer Lines
Localizer Point
Orientation Markers
Distance Markers
Study Data Overlays
Stack Navigation Tool
Window/Level Tool
Zoom Tool
Panning Tool
Color Inversion
Text Annotation

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Maximum Intensity Projection
Reslicing (MPR)
Area Measurement Annotation
Angle Measurement Annotation

In addition, Braid has:

Added Hardware accelerated rendering
Support for high resolution Retina displays
Keyboard shortcuts for all tools and all annotation types
Touchscreen support
Quick image manipulation and navigation via multitouch gestures, on touchscreens or multitouch capable trackpads

3. INDICATIONS FOR USE

Braid™ is a software teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web. Braid™ is used by hospitals, clinics, imaging centers, and radiologist reading practices.

Braid™ can optionally be used for mobile diagnostic use for review and analysis of CR, DX, CT, and MR images and medical reports. Braid mobile diagnostic use is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. Braid™ mobile diagnostic use is not intended for the display of mammography images for diagnosis.

When images are reviewed and use as an element of diagnosis, it is the responsibility of the trained physician to determine if the image quality is suitable for their clinical application.

Contraindications: Braid™ is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose radiological image data.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 4. WITH THE PREDICATE DEVICE

Table 1 below compares the key technological features of the subject devices to the predicate devices BOX DICOM Viewer 10 (K151957) and Enterprise Imaging XERO Viewer 8.1, (K170434). While there are several differences in the technological features of Braid1M compared to the predicate devices, these differences do not raise new questions of safety and effectiveness and are supported by performance testing in order to establish substantial equivalence.

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No.	Function	Subject Device(BraidTM)	Primary Predicate DeviceBOX DICOM ViewerTM(K151957)	Secondary PredicateDeviceEnterprise ImagingXERO Viewer 8.1(K170434)	FunctionComparison
1	Applicant	Braid.Health	OTech, Inc	Agfa HealthCare N.V.
2	Device Name	BraidTM	BOX DICOM ViewerTM	Enterprise ImagingXERO Viewer 8.1
3	Product Code	LLZ	LLZ	LLZ	Same
4	RegulationNumber	21 CFR 892.2050	21 CFR 892.2050	21 CFR 892.2050	Same
5	Indications forUse	BraidTM is a softwareteleradiology systemused to receiveDICOM images,schedulinginformation andtextual reports,organize and storethem in an internalformat, and to makethat informationavailable across anetwork via web.BraidTM is used byhospitals, clinics,imaging centers, andradiologist readingpractices.BraidTM can optionallybe used for mobilediagnostic use forreview and analysis ofCR, DX, CT, and MRimages and medicalreports. Braid mobilediagnostic use is notintended to replace fulldiagnosticworkstations andshould only be usedwhen there is noaccess to aworkstation. BraidTMmobile diagnostic useis not intended for thedisplay ofmammography imagesfor diagnosis.When images arereviewed and use as an	The BOX DICOMViewerTM is a softwareTeleradiology system usedto receive DICOMimages, schedulinginformation and textualreports, organize and storethem in an internal format,and to make thatinformation availableacross a network via weband customized userinterfaces. The BOXDICOM ViewerTM is usedby hospitals, imagingcenters, radiologistreading practice.Contraindications: TheBOX DICOM ViewerTMis not intended for theacquisition ofmammographic imagedata and is meant to beused by qualified medicalpersonnel only who arequalified to create anddiagnose radiologicalimage data.	Agfa HealthCare'sEnterprise ImagingXERO Viewer 8.1 is asoftware applicationused for reference anddiagnostic viewing ofmulti-specialty medicalimaging and non-imaging data withassociated reports anddocuments and, as such,fulfills a key role in theEnterprise ImagingSolution. XEROViewer 8.1 enableshealthcareprofessionals, including(but not limited to)physicians, surgeons,nurses, andadministrators toreceive and view patientimages, documents anddata from multipledepartments andorganizations withinone multi-disciplinaryviewer. XERO Viewer8.1 allows users toperform imagemanipulations(includingwindow/level, markups,3D visualization) andmeasurements.When images arereviewed and use as anelement of diagnosis, itis the responsibility ofthe trained physician todetermine if the image	The proposedindications for useare similar to bothpredicates. Theindications includemobile diagnosticindications whichare present in thesecondary predicatebut absent in theprimary predicate.Mobile diagnosticuse is supported byperformance testingin order to establishsubstantialequivalence.

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No.	Function	Subject Device(BraidTM)	Primary Predicate DeviceBOX DICOM ViewerTM(K151957)	Secondary PredicateDeviceEnterprise ImagingXERO Viewer 8.1(K170434)	FunctionComparison
		element of diagnosis,it is the responsibilityof the trainedphysician to determineif the image quality issuitable for theirclinical application.Contraindications:BraidTM is notintended for theacquisition ofmammographic imagedata and is meant to beused by qualifiedmedical personnelonly who are qualifiedto create and diagnoseradiological imagedata.		quality is suitable fortheir clinicalapplication. Lossycompressedmammography imagesand digitized filmimages should not beused for primary imageinterpretation.Uncompressed or non-lossy compressed "forpresentation" imagesmay be used fordiagnosis or screeningon monitors that areFDA-cleared for theirintended use.XERO Viewer 8.1 canoptionally beconfigured for FullFidelity Mobile, whichis intended for mobilediagnostic use, reviewand analysis of CR, DX,CT, MR, US, ECGimages and medicalreports. XERO ViewerFull Fidelity Mobile isnot intended to replacefull diagnosticworkstations and shouldonly be used when thereis no access toworkstation. XEROViewer Full FidelityMobile is not intendedfor the display ofmammography imagesfor diagnosis.
6	Modalities	CR, DX, CT, MR	CT, MR, US, PET	CR, DX, CT, MR, US,ECG	BraidTM offers asubset of theimaging modalitieswhen compared tothe secondarypredicate. Theabsence of thesemodalities does notraise any issues ofsubstantialequivalence, andperformance data isprovided to supportthose modalities thatare included.

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No.	Function	Subject Device(BraidTM)	Primary Predicate DeviceBOX DICOM ViewerTM(K151957)	Secondary PredicateDevice Enterprise ImagingXERO Viewer 8.1(K170434)	FunctionComparison
7	Communication	DICOM	DICOM	DICOM	Same
8	Network Access	Web Browser	Web Browser	Web Browser	Same
9	Web BrowserSoftware	Google Chrome,Safari	Google Chrome for allfeatures. Microsoft InternetExplorer & Mozilla Firefox forfeatures except the DICOM Viewer.	Microsoft InternetExplorer, Google Chrome,Safari, Mozilla Firefox	Similar — each product offers a listof compatible internet browsers.The proposed browsers for Braidare supported by performance testing.
10	MobilePlatforms	iPhones, iPads	None	iPads	Similar — both Braid and Xero havedesignated mobile platforms thatthey support. This functionality issupported by performance testingfor the intended mobile platforms.
11	UserInterface/Input	Mouse and keyboard,Touchscreens	Mouse and keyboard	Mouse and keyboard,Touchscreens	Similar, Braid and Xero both providetouchscreen functionality. Thisfunction is supported byperformance testing to supportsubstantial equivalence.
12	Drag and DropImport	Yes	Yes	Yes	Same
13	Image Storage	Yes	Yes	Yes	Same
14	DatabaseSoftware	CouchDB,IndexedDB, LevelDB	MySQL	unknown	IndexedDB is an alternative to theWebSQL (deprecated) database, andrelational databases such as MySQL.Such as LevelDB and CouchDB, it isa key-value pair NoSQL database,which can provide the samefunctionalities. IndexedDB is nowthe native and high-performance

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No.	Function	Subject Device(BraidTM)	Primary Predicate DeviceBOX DICOM ViewerTM(K151957)	Secondary PredicateDeviceEnterprise ImagingXERO Viewer 8.1(K170434)	FunctionComparison
15	Grayscale imagerendering	Yes	Yes	Yes	Same
16	RGB imagerendering	No	Yes	Yes	Braid does not havethis feature, but theabsence of thisfeature does notraise questions ofsafety andeffectiveness oraffect the intendeduse of the device.
17	DistanceMarkers	Yes	Yes	Yes	Same
18	Study DataOverlays	Yes	Yes	Yes	Similar - both Braidand BOX DICOMoffer overlays withstudy data, whileXero includes thisinformation in aheader bar. Thisdifference does notimpact safety oreffectiveness.
19	Stack navigation	Yes	Yes	NA	Same
20	Window Level	Yes	Yes	Yes	Same
21	Zoom in onImage	Yes	Yes	Yes	Same
22	Panning	Yes	Yes	Yes	Same
23	Invert Image	Yes	Yes	Yes	Same
24	Text Annotation	Yes	Yes	Yes	Same
25	MIP/MPRReconstruction	Yes	No	Yes	Braid offers MIPand MPRreconstruction asdoes the XeroViewer predicate.Compared to theBOX predicate thisis an additionalfeature. This featuredoes not raise newquestions of safety

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No.	Function	Subject Device(BraidTM)	Primary Predicate DeviceBOX DICOM ViewerTM(K151957)	Secondary PredicateDeviceEnterprise ImagingXERO Viewer 8.1(K170434)	FunctionComparison
					and effectiveness,but requiredperformance data tosupport its function.
26	AreaMeasurementAnnotation	Yes	Yes	Yes	Same
27	AngleMeasurementAnnotation	Yes	Yes	Yes	Same
28	User InterfaceText Styles,colors, Fontsand Icons	None	BOX Styles	None	BOX offers customstyling for userpreference, whereasthe proposed deviceand Xero do not.This is a userpreference that hasno impact on safetyor effectiveness.
29	WebGLrenderingoptimization	Yes	Yes	Unknown	Hardwareacceleration is used.WebGL (WebGraphics Library) isa JavaScript API forrenderinginteractive 3Dcomputer graphicsand 2D graphicswithin anycompatible webbrowser without theuse of plug-ins. Theuser of thistechnology raises nonew questions ofsafety andeffectiveness and issupported byperformance testing.
30	Support for highresolutionRetina display	Full pixel density onall displays	Full pixel density on alldisplays	Full Fidelity Mode	Both Braid and Boxdisplay the full pixeldensity of the savedimage, while theXero Viewer has anoptional full fidelitymode. Thisdifference does notimpact safety andeffectiveness, as thereduced resolutionoption on the Xeroviewer is just a userpreference that mayreduce loadingtimes when fullfidelity is notdesired

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No.	Function	Subject Device(BraidTM)	Primary Predicate DeviceBOX DICOM ViewerTM(K151957)	Secondary PredicateDeviceEnterprise ImagingXERO Viewer 8.1(K170434)	FunctionComparison
31	Keyboardshortcuts	Yes	Yes	Yes	Same

PERFORMANCE DATA ട്.

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

Software Verification and Validation Testing

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 Submissions for Software Contained in Medical Devices." The software for this device was considered as a moderate level of concern.

Mobile Device Bench Testing

Bench testing in accordance with AAPM Report No. 270 - Display Quality Assurance (2019) and AAPM on-line report No. 03, "Assessment of Display Performance for Medical Imaging Systems" was performed to evaluate the ability of the intended mobile device screens to support the proposed indications for use. This testing was conducted on the iPhone 11 and iPad Pro 3. The following display performance characteristics were evaluated:

Spatial Resolution ●
Luminance Response ●
DICOM GSDF ●
Artifacts ●
Temporal Response ●
Color & Greyscale Tracking ●
Reflection diffuse ●
Reflection specular ●
Ambient Light ●
Uniformity .

This bench testing demonstrated that the designated hardware platforms are appropriate for Braid™'s intended use and supports substantial equivalence of Braid™ to the predicate devices.

Clinical Validation Testing

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Clinical validation testing was conducted to support the diagnostic quality of Braid™ on mobile devices as well as the use of Braid™ features such as reslicing (MPR). Board-certified radiologists were asked to evaluate all braid features and to provide multiple scores for the quality of the Braid™ images on both an FDA-cleared diagnostic monitor as well as the intended mobile devices. Images were evaluated across all intended imaging modalities and in both office and bright lighting conditions. Results demonstrated that the images displayed by Braid™ were of appropriate diagnostic quality in all conditions. These performance data including image quality evaluations by qualified radiologists are adequate to support substantial equivalence of Braid 1 to the predicate devices.

CONCLUSIONS 6.

Braid™ has the same intended use as a picture archiving and communication system as both predicate devices, BOX DICOM Viewer™ (K151957) and Enterprise Imaging XERO Viewer 8.1 (K170434). Braid™ has similar technological characteristics as both predicates, but differs in some features when compared to each, such as diagnostic use on mobile platforms when there is no access to a diagnostic workstation, the specific imaging modalities, or features such as reslicing. These differences do not raise new questions of safety and effectiveness, but are supported by performance testing including software verification testing, bench testing, and clinical validation testing. Based on the acceptable results of the performance testing, it is determined that Braid™ is substantially equivalent to the predicate devices.

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).