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 adult patients presenting for diagnostic imaging workup, 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 for ischemic stroke patient (typically < 24 hours since last known well) during image interpretation following the standard of care. 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. Rapid ASPECTS presents the original and annotated images for concurrent reads.

Device Description

The Rapid platform is Software as a Medical Device (SaMD), which provides for the visualization and study of changes in tissue and vasculature using digital images captured by diagnostic imaging systems including CT (Computed Tomography), CTA (CT Angiography), MRI (Magnetic Resonance Imaging) and MRA (MR Angiography) as an aid to physician diagnosis. Rapid can be installed on a customer's Server or it can be accessed online as a virtual system. It provides viewing, quantification, analysis, and reporting capabilities. The Rapid platform has multiple modules a clinician may elect to run and provide analysis for decision making.

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 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 availability of the ASPECT Score with an overlayed atlas. The ASPECTS information is then available for the physician to review and edit prior to sending 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

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for iSchemaView, Inc.'s Rapid ASPECTS (v3) CADx software.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for Rapid ASPECTS (v3)

Criterion	Reported Device Performance (Rapid ASPECTS v3)
Standalone Performance: Percent agreement of Rapid ASPECTS to the reference at the ASPECTS region level.	82.8%
Standalone Performance: Percent agreement of Rapid ASPECTS to the reference at the scan level.	82.8% (comparable, with overlapping CI, to pairwise agreement between any two of the three experts)
Clinical Validation Reader Improvement: Demonstrate that reader scoring of the 10 ASPECT regions is more closely aligned with the reference standard when read in conjunction with Rapid ASPECTS than without Rapid ASPECTS.	The fixed effect of the Rapid assist increases the percent agreement on average by about 0.02. Agreement increases from 82% without assistance to 84% with assistance (excluding the expert). The average agreement increases from 80.4% without assistance to 83.3% with assistance. A statistically significant improvement in the accuracy of the 6 readers' scores was demonstrated when scoring was performed with Rapid ASPECTS output. Most substantial benefit for non-neuroradiologist expert readers. No significant impact (positive or negative) on the expert neuroradiologist's score was observed.
Supplemental Confounder/Mimic Sensitivity Assessment: Assess impact of confounders/mimics.	Only 3 out of 115 reads (2.6%) changed based on Rapid results, showing minimal effect of confounders/mimics on ASPECTS performance.

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

Standalone Performance Test Set Sample Size: 88 scans (from the "Suspected Stroke" category)
Reader Improvement Test Set Sample Size: 102 scans (including 88 "Suspected Stroke" and 14 "Stroke Mimic" cases)
Supplemental Confounder/Mimic Sensitivity Assessment Sample Size: This involved a separate set of supplemental data. While the number of scans directly used for this specific assessment is not explicitly stated as a single total, the types and counts of cases are listed: Abscess (3), Dural AVF (4), Hydrocephalus (4), Hypertensive Encephalopathy (2), Isodense SDH (4), Multiple Sclerosis (3), and Traumatic Brain Injury (3). These cases were reviewed for 115 reads.
Data Provenance: The data included both US (79.41% for the reader improvement study test set) and OUS (20.59%) cases. It's a combination of different scanner manufacturers: GE (23), Siemens (28), Cannon/Toshiba (22), and Philips (29). The description suggests it is retrospective data, as it describes a collection of existing scans.

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

The ground truth for both the standalone performance and the reader improvement study was established using:

Three experts to establish the reference standard for the standalone performance study.
The clinical reader study involved one expert neuroradiologist and five non-expert typical readers. While the specific qualifications for "typical readers" aren't detailed, the text implies they represent general clinicians who evaluate CT scans in community hospitals and primary stroke centers. The neuroradiologist is explicitly identified as an expert.

4. Adjudication Method for the Test Set

The document explicitly states: "The primary reader improvement endpoint is to demonstrate that reader scoring of the 10 ASPECT regions is more closely aligned with the reference standard when read in conjunction with Rapid ASPECTS than without Rapid ASPECTS." And for standalone performance: "The percent agreement of Rapid ASPECTS to the reference at the ASPECTS region level and at the scan level is 82.8%. Both are comparable (overlapping CI) to the pairwise agreement between any two of the three experts."

This indicates that a reference standard was established by experts. While the specific method of reaching this reference standard (e.g., 2+1, consensus) is not explicitly detailed, the mention of "pairwise agreement between any two of the three experts" for the standalone performance suggests that the ground truth was derived from a consensus or adjudicated process involving these three experts.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Yes, a multi-reader multi-case (MRMC) comparative effectiveness study was done. This is referred to as the "Clinical Validation Reader Improvement" study.

Effect Size of Human Readers Improve with AI vs. without AI assistance: The fixed effect of the Rapid assist increases the percent agreement on average by about 0.02. Specifically, agreement increases from 82% without assistance to 84% with assistance (excluding the expert). When including the non-expert readers, the average agreement increases from 80.4% without assistance to 83.3% with assistance.
- The benefit was most substantial among the non-neuroradiologist expert readers.
- The system allowed non-expert physicians to perform at an "expert-like level."
- There was no significant impact (positive or negative) on the score of the expert neuroradiologist.

6. Standalone Performance (i.e., algorithm only without human-in-the-loop performance)

Yes, a standalone performance study was done.

Results: The percent agreement of Rapid ASPECTS to the reference at both the ASPECTS region level and at the scan level was reported as 82.8%. This was found to be comparable (with overlapping confidence intervals) to the pairwise agreement between any two of the three experts who established the ground truth.

7. The Type of Ground Truth Used

The ground truth used was expert consensus / expert reading. It was established by a panel of experts. The text refers to "the reference" established by "three experts" for the standalone performance and a "reference standard" for the reader improvement study.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It only describes the test sets used for validation.

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

As the training set sample size is not provided, the method for establishing its ground truth is also not specified in the provided text.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

iSchemaView, Inc. Jim Rosa SVP Regulatory and Quality 1120 Washington Ave. Suite 200 Golden, Colorado 80401

January 19, 2024

Re: K232156

Trade/Device Name: Rapid ASPECTS (v3) 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: December 22, 2023 Received: December 26, 2023

Dear Jim 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K232156

Device Name

Rapid ASPECTS (v3)

Indications for Use (Describe)

Limitations:

The ASPECTS score should be only used for ischemic stroke patients following the standard of care.
Rapid ASPECTS is an adjunct tool and is not intended to replace a clinicians review of the original imaging or their clinical judgement.
Physicians should not use the CAD generated output as the primary interpretation without their concurrence.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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iSchemaView, Inc.'s Rapid ASPECTS (v3) (K232156)

This document contains the 510(k) summary for the iSchemaView Rapid ASPECTS (v3). 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:	1120 Washington AveSte. 200Golden, CO 80401
Official Contact:	Jim RosaPhone: (303) 704-3374Email: rosa@ischemaview.com

Summary Preparation Date: 9 January 2024

Device Name and Classification:

Trade Name:	Rapid ASPECTS (v3)
Common Name:	CADx
Classification:	II
Product Code:	POK
Regulation No:	21 C.F.R. §892.2060
ClassificationPanel:	Radiology Devices

Predicate Devices:

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

Rapid ASPECTS (K200760)

Device Description:

Rapid Platform

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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).
. 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 primary users of Rapid Platform software are medical imaging professionals. 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.

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510(k) Summary

Image /page/6/Figure/2 description: The image shows a series of brain scans with corresponding Hounsfield Unit measurements. The scans are segmented into different regions, labeled C, IC, L, I, M1-M6, with numerical values for both the right and left hemispheres. The left hemisphere shows lower Hounsfield Unit values in several regions, particularly M3, M5, and M6, which are marked with an asterisk. The ASPECTS score is displayed as 9.

Indications for Use:

Rapid ASPECTS is indicated for evaluation of adult patients presenting for diagnostic imaging workup, 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 for ischemic stroke patient (typically < 24 hours since last known well) during image interpretation following the standard of care. 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. Rapid ASPECTS presents the original and annotated images for concurrent reads.

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510(k) Summary

Limitations:

1. The ASPECTS score should be only used for ischemic stroke patients following the standard of care.
1. Rapid ASPECTS is an adjunct tool and is not intended to replace a clinicians review of the original imaging or their clinical judgement.
Physicians should not use the CAD generated output as the primary interpretation without their 3. concurrence.

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. 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.

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)

Rapid has been designed to meet cybersecurity requirements using design Vulnerability Assessments, SBOM's, and PEN Testing.

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.

iSchemaView conducted extensive performance validation testing and software verification and validation testing of the Rapid ASPECTS module as standalone software and as integrated within the Rapid System. 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. Design Verification and Validation according to 21 CFR 820.30 passed.

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510(k) Summary

The Rapid ASPECTS Standalone Performance and Clinical Validation Protocol (VCP) passed. No deviations were found during the execution of the testing.

Standalone Performance: The percent agreement of Rapid ASPECTS to the reference at the ASPECTS region level and at the scan level is 82.8%. Both are comparable (overlapping CI) to the pairwise agreement between any two of the three experts.

Clinical Validation Reader Improvement: The primary reader improvement endpoint is to demonstrate that reader scoring of the 10 ASPECT regions is more closely aligned with the reference standard when read in conjunction with Rapid ASPECTS than without Rapid ASPECTS. We find that the fixed effect of the Rapid assist increases the percent agreement on average, by about 0.02. That is, agreement increases from 82% without assistance to 84% with assistance excluding the expert, the average agreement increases from 80.4% without assistance to 83.3% with assistance.

Supplemental Confounder/Mimic Sensitivity Assessment: Additionally, supplemental data was evaluated to further assess confounders which may appear in case processing. The supplemental data included: Abscess (3), Dural AVF (4), Hydrocephalus (4), Hypertensive Encephalopathy (2), Isodense SDH (4), Multiple Sclerosis (3) and Traumatic Brain Injury (3). Five readers were used to review the confounder supplemental cases for 115 reads. Three of the 115 reads (2.6%) changed based on Rapid results, showing minimal effect of confounders/mimics on ASPECTS performance.

Demographic & Clinical Subcategories:

Demographics are provided for the 102 scans used in the reader improvement study and 88 used for the standalone performance. Case counts are included for reference:

Overview of Case Counts
Case Category	N	Include in Stand Alone	Include in Reader Improvement
Suspected Stroke	88	Yes	Yes
Stroke Mimic(non-ischemic stroke etiology)	14	No	Yes
Technical Exclusion due to contrast	3	No	No
Total	105	88	102

Age: Age ranged from 23 to 99 with a median of 66 years of age.

Image /page/8/Figure/10 description: The image shows a histogram, boxplot, and summary statistics for the variable 'Age'. The histogram displays the distribution of ages, while the boxplot provides a visual representation of the quartiles and outliers. The summary statistics include the mean (64.865979), standard deviation (16.358375), median (66), minimum (23), and maximum (99), along with other quantile values and the number of valid (97) and missing (8) observations.

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510(k) Summary

Gender:

Gender	N	Column %
F	53	51.96%
M	49	48.04%
All	102

LVO Status:

Stroke LVO	N	Column %
no	37	36.27%
unknown	14	13.73%
yes	51	50.00%
All	102	100.00%

US/OUS Status

US/OUS	N	Column %
OUS	21	20.59%
US	81	79.41%
All	102	100.00%

Last Known Well

Last Known Well (6 Hour Splits)	N	Column %
<6	27	31.03%
≥6 - <16	21	24.14%
≥16 - 24	5	5.75%
UNK	34	39.08%
All	87	100.00%

Data Distribution:

Demographics are provided for the 102 scans used in the reader improvement study and 88 used for the standalone performance. The data was distributed from GE (23), Siemens (28), Cannon/Toshiba (22) and Philips (29). The data included 14 confounders/mimics in the primary data set with non-stroke etiology. Standalone Performance cases included US (75) vs OUS (13) for 85% US. Additionally, supplemental data was evaluated to further assess sensitivity of confounders which may appear in case processing. The supplemental data included: Abscess (3), Dural AVF (4), Hydrocephalus (4), Hypertensive Encephalopathy (2), Isodense SDH (4), Multiple Sclerosis (3) and Traumatic Brain Injury (3).

Prescriptive Statement:

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

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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).

Substantial Equivalence:

Rapid ASPECTS (K200760) under regulation 21 C.F.R. §892.2060 CADx is the predicate device for Rapid ASPECTS v3. The disease and clinical use are identical and substantially equivalent. There are slight differences between the two versions which do not provide new risks. The Rapid ASPECTS assists the radiologists (clinicians) in the assessment and characterization of morphological features of their respective focus areas using imaging data. The software 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. Rapid ASPECTS provides localization information showing which ASPECTS regions are affected. The features are compared in the following table, as well as the Risk Benefit Analysis in the next paragraph is comparative to the predicate:

Substantial Equivalence Table
ComparisonFeature	Rapid ASPECTS (K200760)	Rapid ASPECTS v3
Indications for Use	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 withknown MCA or ICA occlusion, forevaluation of extent of disease.	Rapid ASPECTS is a computer-aideddiagnosis (CADx) software device usedto assist the clinician in the assessmentand characterization of brain tissueabnormalities using CT image data.The Software automatically registersimages and segments and analyzesASPECTS Regions of Interest (ROIs).Rapid ASPECTS extracts image datafor the ROI(s) to provide analysis andcomputer analytics based onmorphological characteristics. Theimaging features are then synthesizedby an artificial intelligence algorithminto a single ASPECT (Alberta StrokeProgram Early CT) Score.Rapid ASPECTS is indicated forevaluation of adult patients presentingfor diagnostic imaging workup, forevaluation of extent of disease. Extentof disease refers to the number ofASPECTS regions affected which isreflected in the total score. This device
	Extent of disease refers to thenumber of ASPECTS regionsaffected which is reflected in thetotal score. This device providesinformation that may be useful in thecharacterization of early ischemicbrain tissue injury during imageinterpretation (within 6 hours).Rapid ASPECTS provides acomparative analysis to theASPECTS standard of careradiologist assessment using theASPECTS atlas definitions and atlasdisplay including highlighted ROIsand numerical scoring.	provides information that may be usefulin the characterization of early ischemicbrain tissue injury for ischemic strokepatient (typically < 24 hours since lastknown well) during image interpretationfollowing the standard of care. RapidASPECTS provides a comparativeanalysis to the ASPECTS standard ofcare radiologist assessment using theASPECTS atlas definitions and atlasdisplay including highlighted ROIs andnumerical scoring. Rapid ASPECTSpresents the original and annotatedimages for concurrent reads.
	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.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.	Limitations:1. The ASPECTS score should be onlyused for ischemic stroke patientsfollowing the standard of care.2. Rapid ASPECTS is an adjunct tooland is not intended to replace aclinicians review of the originalimaging or their clinical judgement.3. Physicians should not use the CADgenerated output as the primaryinterpretation without theirconcurrence.
	Contraindications/Exclusions/Cautions:• Patient Motion: excessive motionleading to artifacts that make thescan technically inadequate.• Hemorrhagic Transformation,Hematoma• Very thin or no Ventricles	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	Stroke/Head	Stroke/Head
Standard of CareRepresentation	ASPECT Scoring	ASPECT Scoring
Imaging	CT	CT
TechnicalImplementation	AI/Random Forest	AI/Random Forest
Image Overlay	ASPECTS Atlas ROIs, highlighted by algorithms	ASPECTS Atlas ROIs, highlighted by algorithms
Primary User(s)	Neuroradiologist/Clinician	Neuroradiologist/Clinician
Alteration oforiginal imagedata base	No	No
Alters Standardof CareWorkflow	In parallel to	In parallel to
AnalysisWindow	≤ 6 hours	≤ 24 hours

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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 1 expert neuroradiologist and 5 non-experttypical readers demonstrated a statistically significantimprovement in the accuracy of the 6 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-neuroradiologistexpert reader which typically evaluates CT scans incommunity hospitals and primary stroke centers. These non-expert readers also evaluate CT scans in comprehensivecenters, particularly in the acute setting, when expertneuroradiologists are not immediately available. The softwareallows the non-expert physician to perform at the expert-likelevel. Use of the system did not appear to have any significantimpact (either positive or negative) on the score of the expertneuroradiologist included in the test reader group. Overall,this system should provide a more consistent and timelybenefit of standardized reads regardless of physician andcenter 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 results to incorrect patient management withpossible adverse effects such as, unnecessary additional
Risk Benefit Summary
	medical 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 ofthe 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 other Factors	The study was enriched to cover the range of ASPECT scoresand scanner manufacturers and the readers in practice may notexperience a significant improvement in determiningASPECTS.
Conclusions: Do theprobable benefits outweighthe probable risks.	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 Rapid.
Risk Benefit Summary
ASPECTS clinical module, other clinical information is easily accessible within the Rapid System framework such as CTA and CTP to inform the clinical decision-making process.
The clinical reader study demonstrates a statistically significant improvement of ASPECTS reads among a diverse sample of 6 typical readers representing multiple specialties, years of practice, and practice settings.
Overall, this system should provide a more consistent and timely benefit of standardized reads regardless of physician and center specialty. Therefore, given the available information concerning the benefits, risks, and supporting data; the probable benefits outweigh the probable risks, given the combination of required general controls and special controls established for this device.

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Conclusion:

The Rapid ASPECTS subject to this filing is equivalent to the predicate. It is intended to aid in the assessment of a specific disease state using standard of care scoring using machine learning/artificial intelligence algorithms. The device uses ROI based assessments. The Rapid ASPECTS ROIs are based on an ASPECTS defined atlas. The device is a SaMD with algorithm development approaches using variants of artificial intelligence implementations. The device analyzes highlights morphological and feature differences. The minor differences to extend the analysis window based on the current standard of care and to expand scanner brands does not add additional risk.

The Rapid ASPECTS (v3) with minor differences is substantially equivalent to the Rapid ASPECTS 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).