Rapid ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. The Software automatically registers images and segments and analyzes ASPECTS Regions of Interest (ROIs). Rapid ASPECTS extracts image data for the ROI(s) to provide analysis and computer analytics based on morphological characteristics. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score. Rapid ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. This device provides information that may be useful in the characterization of early ischemic brain tissue injury during image interpretation (within 6 hours). Rapid ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS atlas definitions and atlas display including highlighted ROIs and numerical scoring.

Device Description

Rapid ASPECTS provides an automatic ASPECT score based on the case input file for the physician. The score includes which ASPECT regions are identified based on regional imaging features derived from non-contrast computed tomography (NCCT) brain image data. The results are generated based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines and provided to the clinician for review and verification. At the discretion of the clinician, the scores may be adjusted based on other clinical factors the clinician may integrate though the Rapid Platform User Interface.

The ASPECTS software module processing pipeline performs four major tasks:

Orientation and spatial normalization of the input imaging data (rigid registration/alignment with anatomical template);
Delineation of pre-defined regions of interest on the normalized input data and computing numerical values characterizing underlying voxel values within those regions;
Identification and highlighting previous/old stroke areas along with areas of early ischemic change; and
Labeling of these delineated regions and providing a summary score reflecting the number of regions with early ischemic change as per ASPECTS guidelines.

Subsequently, the system notifies the physician of the ASPECT score which then requires the confirmation by the physician that a Large Vessel Occlusion (LVO) is detected. The ASPECTS information is then available for the physician to review and edit prior to pushing the data to a PACS or Workstation. The final summary score together with the regions selected and underlying voxel values are then sent to the Picture Archiving and Communication System (PACS) to become a part of the permanent patient medical record.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the Rapid ASPECTS device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (e.g., minimum accuracy, sensitivity, specificity thresholds). Instead, the performance is demonstrated through a comparative effectiveness study showing improvement in human reader agreement.

Acceptance Criteria Category	Specific Criteria (Implicitly from study goals)	Reported Device Performance (as stated in document)
Clinical Efficacy	Improvement in agreement with expert consensus read for ASPECTS scoring.	Readers (neurologists, radiologists, emergency medicine, neurocritical care specialists) significantly increased their agreement with an expert consensus read when using Rapid ASPECTS (P<0.0001). Readers agreed, on average, with almost ½ a region (0.425, 95% CI 0.11 - 0.74) more per scan with Rapid ASPECTS than without. Non-neuroradiologists improved their agreement from 73.6% to 79.8% with Rapid ASPECTS, which is comparable to the agreement achieved by expert neuroradiologist readers with each other. The software allows the non-expert physician to perform at the expert-like level.
Safety	Minimizing risks associated with incorrect scoring, misuse, and device failure.	Identified risks include incorrect scoring (false positive/negative), misuse (unintended patient population/incompatible hardware), and device failure. The document concludes that probable benefits outweigh probable risks, given general and special controls and application of mitigating measures. The device is unlikely to decrease diagnostic performance, and misuse risks are comparable to other radiological image processing devices. A gating condition of Large Vessel Occlusion (LVO) determination guides ASPECTS use, averting many stroke mimic confounding risks.
Technical Performance	Accurate representation of key processing parameters and adherence to design requirements/specifications.	Extensive performance validation testing, software verification, and validation testing demonstrated that the Rapid ASPECTS module provides accurate representation of key processing parameters under a range of clinically relevant parameters and perturbations. The module met all design requirements and specifications.

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

Sample size for the test set: 50 cases. Each case had 10 regions scored independently.
Data Provenance: Retrospective data from case data. The country of origin is not specified in the provided document.

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

Number of experts: Three experts.
Qualifications of experts: The document refers to them as "expert neuroradiologist readers." Specific years of experience or other detailed qualifications are not provided.

4. Adjudication Method for the Test Set

Adjudication method: "Data truthing was performed by three experts." This implies an expert consensus method, but the specific process (e.g., whether it was 2+1, 3+1, or another form of consensus) is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Improvement

MRMC Comparative Effectiveness Study: Yes, an MRMC study was done, described as a "concurrent read, cross-over study design."
Effect size of improvement:
- Readers (neurologists, radiologists, emergency medicine, neurocritical care specialists) significantly increased their agreement with an expert consensus read (p<0.0001).
- With Rapid ASPECTS, readers agreed, on average, with 0.425 more regions (95% CI 0.11 - 0.74) per scan than without Rapid ASPECTS.
- Non-neuroradiologists improved their level of agreement with experts from 73.6% to 79.8%.

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

The document implies that the primary performance evaluation was focused on the AI-assisted human reading. While the device "provides an automatic ASPECT score," the clinical study focuses on how humans improve with the device. The "Performance Data" section mentions "extensive performance validation testing and software verification and validation testing of the Rapid ASPECTS module both as standalone software and as integrated within the Rapid Platform," indicating that standalone testing for technical performance (e.g., accuracy against a "truth" ASPECTS score) was performed, but specific performance metrics for this standalone algorithm were not provided in this summary. The clinical efficacy, however, is reported in the context of human-in-the-loop.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Type of Ground Truth: Expert consensus. "Data truthing was performed by three experts" and the device performance was measured against "an expert consensus read."

8. The Sample Size for the Training Set

The sample size for the training set is not explicitly stated in the provided text. The document refers to "historical training data" but does not give a number.

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

The document states that the "Rapid ASPECTS analytics calculates morphological characteristics of brain tissue using the historical training data." It further explains that "The results are generated based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines." However, the specific method for establishing the ground truth for this "historical training data" (e.g., number of experts, their qualifications, adjudication method) is not detailed in this summary. It can be inferred that it likely also involved expert assessment based on ASPECTS guidelines.

Summary

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June 26, 2020

iSchemaView, Inc. % Mr. James Rosa VP Quality and Regulatory 433 Park Point Drive, Suite 220 GOLDEN CO 80401

Re: K200760

Trade/Device Name: Rapid ASPECTS Regulation Number: 21 CFR 892.2060 Regulation Name: Radiological computer-assisted diagnostic software for lesions suspicious of cancer Regulatory Class: Class II Product Code: POK Dated: May 23, 2020 Received: May 27, 2020

Dear Mr. Rosa:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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.

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) K200760

Device Name Rapid ASPECTS

Rapid ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image automatically registers images and segments and analyzes ASPECTS Regions of Interest (ROIs). Rapid ASPECTS extracts image data for the ROI(s) to provide analysis and computer analytics based on morphological characteristics. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score. Rapid ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. This device information that may be useful in the characterization of early issue mury during mage interpretation (within 6 hours). Rapid ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS atlas definitions and atlas display including highlighted ROIs and numerical scoring.

Limitations:

1. Rapid ASPECTS is not intended for primary interpretation of CT images, it is used to assist physician evaluation.
1. Rapid ASPECTS has been validated in patients with known MCA or ICA Occlusion prior to ASPECT scoring.
1. Use of the Rapid ASPECTS Module in clinical settings other than early brain ischemia (within 6 hours) caused by known ICA or MCA occlusions has not been tested.
1. Rapid ASPECTS has been validated and is intended to be used on GE Lightspeed VCT Scanners.

Contraindications/Exclusions/Cautions:

· Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate.
· Hemorrhagic Transformation, Hematoma
· Very thin or no Ventricles

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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Section 5: 510(k) Summary

510(k) Summary

iSchemaView, Inc.'s Rapid ASPECTS

This document contains the 510(k) summary for the iSchemaView Rapid ASPECTS. The content of this summary is based on the requirements of 21 CFR Section 807.92(c).

Applicant Name and Address:

Name:	iSchemaView, Inc.
Address:	433 Park Point DriveSte. 220Golden, CO 80401
Official Contact:	Jim RosaPhone: (303) 704-3374Email: rosa@ischemaview.com

May 23, 2020 Summary Preparation Date:

Device Name and Classification:

Trade Name:	Rapid ASPECTS
Common Name:	CADx
Classification:	II
Product Code:	POK
Regulation No:	21 C.F.R. §892.2060
Classification Panel:	Radiology Devices

Predicate Devices:

The iSchemaView Rapid is claimed to be substantially equivalent to the following legally marketed predicate device:

QuantX (DEN170022)

Device Description:

Rapid ASPECTS Module

The ASPECTS software module processing pipeline performs four major tasks:

Orientation and spatial normalization of the input imaging data (rigid ● registration/alignment with anatomical template);

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Section 5: 510(k) Summary

Delineation of pre-defined regions of interest on the normalized input data . and computing numerical values characterizing underlying voxel values within those regions;
. Identification and highlighting previous/old stroke areas along with areas of early ischemic change; and
Labeling of these delineated regions and providing a summary score reflecting the number of regions with early ischemic change as per ASPECTS guidelines.

Clinical Characteristics

The images generated by Rapid ASPECTS provide additional diagnostic information, which is derived from the temporal/diffusion/density features of the native CT images. The following figure provides a general layout of the ASPECTS display image as provided from Rapid ASPECTS.

Image /page/4/Figure/8 description: The image shows a CT scan of a brain with ASPECTS scoring. The ASPECTS score is 7. The Hounsfield Units Mean are shown for both the right and left hemispheres, with values for C, IC, L, I, M1, M2, M3, M4, M5, and M6 regions. The image also includes text indicating that the use of Rapid ASPECTS is in a setting other than early brain ischemia and that LVO is confirmed.

Page 5-2 of 5-10

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Section 5: 510(k) Summary

Indications for Use:

Rapid ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score.

This device provides information that may be useful in the characterization of early ischemic brain tissue injury during image interpretation (within 6 hours). Rapid ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS atlas definitions and atlas display including highlighted ROIs and numerical scoring.

Limitations:

1. Rapid ASPECTS is not intended for primary interpretation of CT images. it is used to assist physician evaluation.
1. Rapid ASPECTS has been validated in patients with known MCA or ICA Occlusion prior to ASPECT scoring.
1. Use of the Rapid ASPECTS Module in clinical settings other than early brain ischemia (within 6 hours) caused by known ICA or MCA occlusions has not been tested.
1. Rapid ASPECTS has been validated and is intended to be used on GE Lightspeed VCT Scanners.

Contraindications/Exclusions/Cautions:

· Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate.
· Hemorrhagic Transformation, Hematoma
· Very thin or no Ventricles

Technological Characteristics:

Rapid ASPECTS is a machine learning implementation using the processing pipeline below. Rapid ASPECTS provides an automatic ASPECT score based on the case input file for the physician. The score includes which ASPECT regions are identified based on regional imaging features derived from non-contrast computed tomography (NCCT) brain image data based on the random forest machine learning technique. The results are generated based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines and provided to the clinician for review and verification. At the discretion of the clinician, the scores may be adjusted based on the clinician's judgment as well as other factors the clinician may integrate though the Rapid Platform User Interface.

The red box denotes input data (e.g. patient imaging data) which is processing through the PACS and Rapid platform, the white boxes denote the Rapid ASPECTS architecture which generates analysis data for output results (Green Boxes) for display to the user

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Section 5: 510(k) Summary

through the Rapid platform UI. The Rapid ASPECTS software module processing pipeline performs four major tasks:

Orientation and spatial normalization of the input imaging data (rigid ● registration/alignment with anatomical template);
Delineation of pre-defined regions of interest on the normalized input data and computing numerical values characterizing underlying voxel values within those regions:
Identification and highlighting previous/old stroke areas along with areas of early ischemic change; and
Labeling of these delineated regions and providing a summary score reflecting ● the number of regions with early ischemic change as per ASPECTS guidelines.

Image /page/6/Figure/7 description: The image shows a flowchart of an image processing pipeline. The pipeline starts with an NCCT image, which is then pre-processed and data pre-conditioned. The next step is region outlining, which produces normalized images and region masks. The pipeline then moves to classification pre-processing, classification, and reporting, which produces a report and classified regions.

Rapid ASPECTS Processing Pipeline Architecture

Performance Standards:

Rapid has been developed in conformance with the following standards, as applicable:

ISO 14971:2019	Application of Risk Management to Medical Devices
IEC 62304:2015	Medical device software – Software lifecycle processes
IEC 62366:2015	Application of Usability Engineering to Medical Devices
NEMA PS 3.1 - 3.20	Digital Imaging and Communications in Medicine (DICOM

Performance Data:

Rapid complies with DICOM (Digital Imaging and Communications in Medicine) - Developed by the American College of Radiology and the National Electrical Manufacturers Association. NEMA PS 3.1 - 3.20.

Additionally, iSchemaView conducted extensive performance validation testing and software verification and validation testing of the Rapid ASPECTS module both as standalone software and as integrated within the Rapid Platform. This performance validation testing demonstrated that the Rapid ASPECTS module provides accurate representation of key processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software. Software performance, validation and verification testing demonstrated that the Rapid ASPECTS module met all design requirements and specifications.

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Section 5: 510(k) Summary

The reader study design was a concurrent read, cross-over study design with 50 cases with each of 10 regions scored independently. Data truthing was performed by three experts. Eight readers were used to represent the intended use population.

Performance was independently tested against expert neuroradiologist readers and indicated that a wide range of readers (neurologists, radiologists, emergency medicine, neurocritical care specialists) benefited from the Rapid ASPECTS and significantly increased their agreement with an expert consensus read when considering all ASPECTS regions in all patients evaluated (P<0.0001). With Rapid ASPECTS readers agreed, on average, with almost ½ a region 0.425 (95% CI 0.11 - 0.74) more per scan than without Rapid ASPECTS. Use of Rapid ASPECTS led to non-neuroradiologists to improve their level of agreement from 73.6% to 79.8% which is comparable to the agreement achieved by expert neuroradiologist readers with each other.

Prescriptive Statement:

Caution: Federal law restricts this device to sale by or on the order of a physician.

Safety & Effectiveness:

Rapid ASPECTS has been designed, verified and validated in compliance with 21 CFR, Part 820.30 requirements. The device has been designed to meet the requirements associated with EN ISO 14971:2019 (risk management). The Rapid ASPECTS performance has been validated using digital phantoms, retrospective data from case data and through the use of Reader comparison analysis.

Substantial Equivalence:

OuantX (DEN170022) under regulation 21 C.F.R. §892.2060 CADx is the predicate device for Rapid ASPECTS. While the disease/clinical use is different, the generic definition of CADx provides substantial equivalence between the two devices. The QuantX and Rapid ASPECTS assist the radiologists (clinicians) in the assessment and characterization of morphological features of their respective focus areas using imaging data. The software in both, registers, segments and analyzes regions of interest (ROI) to provide computer analytics. The identified/extracted features are then synthesized by artificial intelligence algorithms into clinical reference scores. Both devices provide localization information: the QuantX based on a database of abnormalities with known ground truth; Rapid ASPECTS based on the ASPECTS Atlas regions. The features are compared in the following table, as well as the Risk Benefit Analysis in the next paragraph is comparative to the predicate:

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Section 5: 510(k) Summary

Substantial Equivalence Table
Comparison Feature	QuantX (DEN170022)	Rapid ASPECTS
Indications for Use	QuantX is a computer-aideddiagnosis (CADx) softwaredevice used to assist radiologistsin the assessment andcharacterization of breastabnormalities using MR imagedata. The software automaticallyregisters images and segmentsand analyzes user-selectedregions of interest (ROI). QuantXextracts image data from the ROIto provide volumetric analysisand computer analytics based onmorphological and enhancementcharacteristics. These imaging (orradiomic) features are thensynthesized by an artificialintelligence algorithm into asinglevalue, the QI score, which isanalyzed relative to a database ofreference abnormalities withknown ground truth.QuantX is indicated forevaluation of patients presentingfor high-risk screening, diagnosticimaging workup, or evaluation ofextent of known disease. Extentof known disease refers to boththe assessment of the boundary ofa particular abnormality as well asthe assessment of the total diseaseburden in a particular patient. Incases where multipleabnormalities are present, QuantXcan be used to assess eachabnormality independently.This device provides informationthat may be useful in thecharacterization of breastabnormalities during imageinterpretation. For the QI scoreand component radiomic features,the QuantX device providescomparative analysis to lesions	Rapid ASPECTS is a computer-aided diagnosis (CADx) softwaredevice used to assist the clinician inthe assessment and characterizationof brain tissue abnormalities usingCT image data. The Softwareautomatically registers images andsegments and analyzes ASPECTSRegions of Interest (ROIs). RapidASPECTS extracts image data forthe ROI(s) to provide analysis andcomputer analytics based onmorphological characteristics. Theimaging features are thensynthesized by an artificialintelligence algorithm into a singleASPECT (Alberta Stroke ProgramEarly CT) Score.Rapid ASPECTS is indicated forevaluation of patients presenting fordiagnostic imaging workup, orevaluation of extent of disease.Extent of disease refers to thenumber of ASPECTS regionsaffected which is reflected in thetotal score.This device provides informationthat may be useful in thecharacterization of early ischemicbrain tissue injury during imageinterpretation. Rapid ASPECTSprovides a comparative analysis tothe ASPECTS standard of careradiologist assessment using theASPECTS atlas definitions andatlas display including highlightedROIs and numerical scoring.Limitations:1. Rapid ASPECTS is not intendedfor primary interpretation of CTimages. It is used to assist physicianevaluation.2. Rapid ASPECTS has beenvalidated in patients with knownMCA or ICA occlusion prior toASPECT scoring.
Substantial Equivalence Table
Comparison Feature	QuantX (DEN170022)	Rapid ASPECTS
	with known outcomes using animage atlas and histogram displayformat.QuantX may also be used as animage viewer of multi-modalitydigital images, includingultrasound and mammography.The software also includes toolsthat allow users to measure anddocument images, and output in astructured report.Limitations: QuantX is notintended for primaryinterpretation of digitalmammography images.	3. Use of the Rapid ASPECTSModule in clinical settings other thanearly brain ischemia (within 6 hours)caused by known ICA or MCAocclusions has not been tested.4. Rapid ASPECTS has beenvalidated and is intended to be usedon GE Lightspeed VCT Scanners.Contraindications/Exclusions/Cautions:• Patient Motion: excessive motionleading to artifacts that make thescan technically inadequate.• Hemorrhagic Transformation,Hematoma• Very thin or no Ventricles
ClinicalApplication/Anatomical Region	Cancer Lesion Detection/Breast	Stroke/Head
Standard of CareRepresentation	QI Scoring	ASPECT Scoring
Primary ImagingModalities	MR	CT
TechnicalImplementation	ML/AI/Neural Network	ML/AI/Random Forest
Image Overlay	ROI box	ASPECTS Atlas ROIs, highlightedby algorithms.
Primary User(s)	Radiologist	Neuroradiologist/Clinician
Alteration of originalimage data base	No	No
Alters Standard ofCare Workflow	In parallel to	In parallel to

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Section 5: 510(k) Summary

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Section 5: 510(k) Summary

Risk Benefit Analysis:

Risk Benefit Summary
Summary of Benefits:	This device provides a systematic, automated analysis ofNCCT scans of the head to provide a standardized, automatedASPECT score for Stroke workup. The clinical reader study,which included 2 expert neuroradiologists and 6 non-experttypical readers demonstrated a statistically significantimprovement in the accuracy of the 8 readers' scores whenscoring was performed in conjunction with the RapidASPECTS output. In a subgroup analysis, the benefit of thesoftware was most substantial among the non-neuroradiologistreaders which typically evaluate CT scans in communityhospitals and primary stroke centers. These non-expertreaders also evaluate CT scans in comprehensive centers,particularly in the acute setting, when expert neuroradiologistsare not immediately available. The software allows the non-expert physician to perform at the expert-like level. Use of thesystem did not appear to have any significant impact (eitherpositive or negative) on the scores of the 2 expertneuroradiologists who were included in the test reader group.Overall this system should provide a more consistent andtimely benefit of standardized reads regardless of physicianand center specialty.
Summary of the Risks	There are minimal potential risks associated with the use ofthe device.
	Incorrect scoring which may result in false positiveresults and result to incorrect patient management withpossible adverse effects such as, unnecessary additionalmedical imaging and/or unnecessary additionaldiagnostic workup.
	Incorrect scoring which may result in false negativeresults may lead to complications, including incorrectdiagnosis and delay in disease management.
	The device could be misused to analyze images from anunintended patient population or on images acquiredwith incompatible imaging hardware or incompatibleimage acquisition parameters, leading to inappropriatediagnostic information being displayed to the user.
	Device failure could lead to the absence of results, delay ofresults or incorrect results, which could likewise lead toinaccurate patient assessment.
However, based on the performance data and theapplication of mitigating measures (general controls andspecial controls established for this device type), use of
Risk Benefit Summary
	the device is unlikely to decrease diagnosticperformance of the user and possible misuse of thedevice does not present additional risks compared withmisuse of other types of radiological image processingdevices.
Summary of otherFactors	The study was enriched to cover the range of ASPECT scores;and, the readers in practice may not experience a significantimprovement in determining ASPECTS.
Conclusions: Do theprobable benefitsoutweigh the probablerisks.	Yes. The probable benefits outweigh the probable risks, giventhe combination of required general controls and the specialcontrols established for this device. The Special Controlswill sufficiently assist in managing risks associated withincorrect brain tissue characterization determiningASPECT scoring, application of the device results to thewrong patient population, analysis of incompatible images,and/or device failure by ensuring proper performance anduse of the device
	By providing a systematic, automated analysis of NCCT scansof the head to provide a standardized, automated ASPECTscore for Stroke workup. The Rapid ASPECTS analyticscalculates morphological characteristics of brain tissue usingthe historical training data and providing results which theattending physician may evaluate and modify based on otherpresenting conditions of the patient. In addition to the RapidASPECTS clinical module, other clinical information is easilyaccessible within the Rapid System framework such as CTAand CTP to inform the clinical decision-making process.
	The clinical reader study demonstrates a statisticallysignificant improvement of ASPECTS reads among a diversesample of 8 typical readers representing multiple specialties,years of practice, and practice settings.
	By using a gating condition of LVO determination to guideASPECTS use, many of the risks of stroke mimicsconfounding the scoring will be averted.
	Overall this system should provide a more consistent andtimely benefit of standardized reads regardless of physicianand center specialty. Therefore, given the availableinformation concerning the benefits, risks, and supportingdata; the probable benefits outweigh the probable risks,given the combination of required general controls andspecial controls established for this device.

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Section 5: 510(k) Summary

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Section 5: 510(k) Summary

Conclusion:

The Rapid ASPECTS and the predicate device are intended to aid in the assessment of specific disease states using standard of care scoring using machine learning/artificial intelligence algorithms. The devices use ROI based assessments. The Rapid ASPECTS ROIs are based on an ASPECTS defined atlas; the Quantx ROI is selected by the user. Both devices are SaMD's with similar algorithm development approaches using variants of artificial intelligence implementations. Both devices analyze imaging modalities to highlight morphological and feature differences. While the clinical focus of the two devices are different, the approaches undertaken generically fit within the CADx designation.

The company proposes the Rapid ASPECTS is substantially equivalent to the QuantX predicate.

Regulation Number and Section

§ 892.2060 Radiological computer-assisted diagnostic software for lesions suspicious of cancer.

(a)
Identification. A radiological computer-assisted diagnostic software for lesions suspicious of cancer is an image processing prescription device intended to aid in the characterization of lesions as suspicious for cancer identified on acquired medical images such as magnetic resonance, mammography, radiography, or computed tomography. The device characterizes lesions based on features or information extracted from the images and provides information about the lesion(s) to the user. Diagnostic and patient management decisions are made by the clinical user.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, and algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will improve reader performance as intended.
(iii) Results from performance testing protocols that demonstrate that the device improves reader performance in the intended use population when used in accordance with the instructions for use. The performance assessment must be based on appropriate diagnostic accuracy measures (
e.g., receiver operator characteristic plot, sensitivity, specificity, predictive value, and diagnostic likelihood ratio). The test dataset must contain sufficient numbers of cases from important cohorts (e.g., subsets defined by clinically relevant confounders, effect modifiers, concomitant diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals of the device for these individual subsets can be characterized for the intended use population and imaging equipment.(iv) Standalone performance testing protocols and results of the device.
(v) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; and description of verification and validation activities including system level test protocol, pass/fail criteria, results, and cybersecurity).(2) Labeling must include:
(i) A detailed description of the patient population for which the device is indicated for use.
(ii) A detailed description of the intended reading protocol.
(iii) A detailed description of the intended user and recommended user training.
(iv) A detailed description of the device inputs and outputs.
(v) A detailed description of compatible imaging hardware and imaging protocols.
(vi) Warnings, precautions, and limitations, including situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality or for certain subpopulations), as applicable.(vii) Detailed instructions for use.
(viii) A detailed summary of the performance testing, including: Test methods, dataset characteristics, results, and a summary of sub-analyses on case distributions stratified by relevant confounders (
e.g., lesion and organ characteristics, disease stages, and imaging equipment).