Rapid PE Triage and Notification (PETN) is a radiological computer aided triage and notification software indicated for use in the analysis of CTPA images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of central pulmonary embolism (PE) pathology in adults. The software is only intended to be used on single-energy exams.

Rapid PETN uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

The results of Rapid PETN are intended to be used in conjunction with other patient information and based on ther professional judgment, to assist with trage/proritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care. Rapid PETN is validated for use on GE, Siemens and Toshiba scanners.

Device Description

Rapid PETN is a radiological computer-assisted triage and notification software device. The Rapid PETN module is a contrast enhanced CTPA processing module which operates within the integrated Rapid Platform to provide triage and notification of suspected Central Pulmonary Emboli (PE). The PETN module is an AI/ML module. The output of the module is a priority notification to clinicians indicating the suspicion of central PE based on positive findings. The Rapid PETN module uses the basic services supplied by the Rapid Platform including DICOM processing, job management, imaging module execution and imaging output including the notification and compressed image.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for iSchemaView Inc.'s Rapid PE Triage and Notification (PETN) device, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria were defined by the primary endpoint of the standalone performance validation study.

Acceptance Criteria (Primary Endpoint)	Reported Device Performance
Sensitivity ≥ 0.96 (presumably lower bound of CI)	0.96 (95% CI: 0.92 - 0.98)
Specificity ≥ 0.89 (presumably lower bound of CI)	0.89 (95% CI: 0.83 - 0.93)
Processing Time (Secondary Endpoint)	2.64 minutes (2.34-4.80 min)

2. Sample Size and Data Provenance

Test Set (Final Performance Validation): 306 CTPA cases.
Data Provenance: The text does not explicitly state the country of origin. It mentions "multiple sites" for the development data. The study appears to be retrospective as it uses existing CTPA cases.

3. Number of Experts and their Qualifications for Ground Truth

Number of Experts: 3 experts
Qualifications: The document does not explicitly state the qualifications (e.g., radiologist with specific experience) of these experts.

4. Adjudication Method for the Test Set

The ground truth was established by "3 experts using a 2:3 confirmation." This indicates a consensus-based approach where at least two out of three experts had to agree for a particular finding to be considered ground truth.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study focused on the standalone performance of the AI algorithm for triage and notification, not on how human readers' performance improved with AI assistance.

6. Standalone Performance (Algorithm Only)

Yes, a standalone (algorithm only without human-in-the-loop performance) study was conducted. The "Final device validation included standalone performance validation."

7. Type of Ground Truth Used

The ground truth was established by expert consensus (3 experts using a 2:3 confirmation).

8. Sample Size for the Training Set

Algorithm Development (Training and Development Validation): 600 CTPA cases (300 Positive, 300 Negative).
Training Cases: 480 cases (240 Positive, 240 Negative).
Additionally: An extra 276 negative cases were included to further assess specificity. It's not explicitly stated if these were solely for development validation or also incorporated into a later training phase, but their purpose was for model assessment.

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

The document implies that the ground truth for the 600 cases used in algorithm development (training and initial validation) was established in a similar manner to the final validation, but it doesn't explicitly detail the method (e.g., number of experts, adjudication) for the training set itself. Given the context of medical device development, it is highly probable that ground truth for the training set was also established by expert review, likely with a consensus process, to ensure high-quality labels for model training.

Summary

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iSchemaView Inc. % Mr. James Rosa SVP Regulatory and Quality 1120 Washington Ave., Ste 200 GOLDEN CO 80401

May 17, 2022

Re: K220499

Trade/Device Name: Rapid PE Triage and Notification (PETN) Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: April 13, 2022 Received: April 14, 2022

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/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,

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K220499

Device Name Rapid PE Triage and Notification (PETN)

Indications for Use (Describe)

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

iSchemaView, Inc.'s Rapid PE Triage and Notification (PETN)

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

February 12, 2022 Summary Preparation Date:

Device Name and Classification:

Trade Name:	Rapid PE Triage and Notification (PETN)
Common Name:	PACS – Picture Archiving CommunicationsSystem
Classification:	II
Product Code:	Primary: QAS
Regulation No:	21 C.F.R. §892.2080
Classification Panel:	Radiology Devices

Predicate Devices:

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

Aidoc Briefcase (K190072)

Device Description:

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Indications for Use:

The results of Rapid PETN are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care. Rapid PETN is validated for use on GE, Siemens and Toshiba scanners.

Technological Characteristics and Substantial Equivalence:

Rapid PETN does not raise new questions of safety or effectiveness compared to the previously cleared Briefcase (K190072). Both devices are radiological computer-aided triage and notification software applications for use with CTPA input. There are minor differences in intended use and technical characteristics with the predicate device; however, with the minor change excluding the ICH claims, the clinical use for Rapid PETN is the same as the CTPA indication for the predicate with no additional risk. Thus, the Rapid PETN software is substantially equivalent.

The following table summarizes and compares data on the Briefcase (K190072) to the Rapid PETN that is the subject of this Traditional 510(k) submission.

Parameter	K190072 - Predicate Device	Rapid PETN – Subject Device
Product Code	QAS	QAS
Regulation	21 CFR §892.2080	21 CFR §892.2080
Intended Use/Indications forUse	BriefCase is a radiological computeraided triage and notification softwareindicated for use in the analysis ofnon-enhanced head CT and CTPAimages. The device is intended toassist hospital networks and trainedradiologists in workflow triage byflagging and communication ofsuspected positive findings ofIntracranial Hemorrhage (ICH) andPulmonary Embolism (PE)pathologies. For the PE pathology,the software is only intended to beused on single-energy exams.	Rapid PE Triage and Notification (PETN)is a radiological computer aided triage andnotification software indicated for use inthe analysis of CTPA images. The deviceis intended to assist hospital networks andtrained clinicians in workflow triage byflagging and communication of suspectedpositive findings of central pulmonaryembolism (PE) pathology in adults. Thesoftware is only intended to be used onsingle-energy exams.Rapid PETN uses an artificial intelligencealgorithm to analyze images and highlightcases with detected findings on a server or
Parameter	K190072 - Predicate Device	Rapid PETN – Subject Device
	BriefCase uses an artificialintelligence algorithm to analyzeimages and highlight cases withdetected findings on a standalonedesktop application in parallel to theongoing standard of care imageinterpretation. The user is presentedwith notifications for cases withsuspected findings. Notificationsinclude compressed preview imagesthat are meant for informationalpurposes only and not intended fordiagnostic use beyond notification.The device does not alter the originalmedical image and is not intended tobe used as a diagnostic device.The results of BriefCase are intendedto be used in conjunction with otherpatient information and based ontheir professional judgment, to assistwith triage/prioritization of medicalimages. Notified clinicians areresponsible for viewing full imagesper the standard of care.	standalone desktop application in parallel tothe ongoing standard of care imageinterpretation. The user is presented withnotifications for cases with suspectedfindings. Notifications include compressedpreview images that are meant forinformational purposes only and notintended for diagnostic use beyondnotification. The device does not alter theoriginal medical image and is not intended tobe used as a diagnostic device.The results of Rapid PETN are intended tobe used in conjunction with other patientinformation and based on theirprofessional judgment, to assist withtriage/prioritization of medical images.Notified clinicians are responsible forviewing full images per the standard ofcare. Rapid PETN is validated for use onGE, Siemens and Toshiba scanners.
User	Radiologist	Radiologist, Clinician
Basic PACSFunctions	Software package which interfacesto a PACS or allows viewing withinthe application	Same
Computer Platform	PC	Server or Workstation
Software	AI/ML	AI/ML
DICOM Compliance	Yes, using CT and CTPA	Yes, using CTPA
Segmentation	No, Device does not mark,annotate, or direct users' attentionto a specific location in the originalimage	No, Device does not mark, annotate, ordirect users' attention to a specific locationin the original image
Preview Images	Presentation of a small,compressed, black and whitepreview image that is labeled "Notfor diagnostic use"; The deviceoperates in parallel with thestandard of care, which remainsthe default option for all cases.	Presentation of a small, compressed, blackand white preview image that is labeled "Notfor diagnostic use"; The device operates inparallel with the standard of care, whichremains the default option for all cases.
Alteration oforiginal image	No	No
Removal of cases fromworkflow queue	No	No

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AI/ML Module Development:

Algorithm development, including development validation, was performed using 600 (Pos:300, Neg:300) CTPA cases from multiple sites. The data was split into 480 (Pos:240, Neg:240) training cases and 120 (Pos:60, Neg:60) development validation cases. The optimal design performance for the final solution showed a Sensitivity = 0.98 and Specificity = 0.97. The development data included the following distributions:

Table 1: Age Distribution for Development & Training
PE status	Mean age	Median age	Min age	Max age
Positive (N=300)	63	64	22	93
Negative (N=300)	51	51	17	89

Table 2: Gender Distribution for Development & Training
PE status	Female	Male	Unknown
Positive (N=300)	52%	47%	< 1%
Negative (N=300)	63%	37%	0%

Table 3: Scanner Distribution for Development & Training
PE status	GE	Siemens	Philips	Toshiba	Unknown
Positive (N=300)	39%	22%	13%	24%	< 2%
Negative (N=300)	72%	9%	< 1%	19%	0%

An additional 276 negative cases were included to further assess the specificity of the final model. The data included the following distributions:

Table 4: Age Distribution for Development Validation
PE status	Mean age	Median age	Min age	Max age
Negative (N=276)	56	58	19	91

Table 5: Gender Distribution for Development Validation
PE status	Female	Male	Unknown
Negative (N=276)	55%	45%	0%

Table 6: Scanner Distribution for Development Validation
PE status	GE	Siemens	Philips	Toshiba	Unknown
Negative (N=276)	25%	4%	0%	72%	0%

Clinical Characteristics:

The primary users of Rapid PETN software are medical imaging professionals who analyze CTPA images. Rapid PETN provides notification to the physicians of suspected Central PE. The physicians must evaluate the cases for determination of PE through their normal standard of care review once prioritization is received. The Rapid PETN is intended for Adult cases.

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Performance Standards:

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

EN ISO 14971:2019	Application of Risk Management to Medical Devices
IEC 62304:2016	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 PE 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 PETN module. Final device validation included standalone performance validation. This performance validation testing demonstrated the Rapid PETN device provides accurate representation of key processing parameters under a range of clinically relevant perturbations associated with the intended use of the software. Software performance, validation and verification testing demonstrated that the Rapid PETN Module met all design requirements and specifications.

Final performance validation included 306 CTPA cases with ground truth established by 3 experts using a 2:3 confirmation. The primary endpoint passed with Sensitivity = 0.96 (0.92.0.98) and Specificity = 0.89 (0.83.0.93). The cases were split Male:47%, Female 53% with an age range of 22-95 years. The samples were mixed from GE, Philips, Toshiba and Siemens scanners. The secondary endpoint was passed at 2.64 minutes (2.34-4.80 min) processing time, with negligible notification time using wireless and cellular communications. The following tables provide sub-stratification for demographic and scanner performance:

Gender	Measure	Estimate	Lower 95%CI	Upper 95%CI
Female (162)	Sensitivity	0.934	0.855	0.972
	Specificity	0.930	0.856	0.968
Male (144)	Sensitivity	0.986	0.927	0.998
	Specificity	0.829	0.724	0.899
Table 2: Age
Age	Measure	N	Estimate	Lower 95%CI	Upper 95%CI
unknown	Sensitivity	72	0.972	0.904	0.992
	Specificity	4	0.250	0.046	0.699
< 50	Sensitivity	3	1.000	0.439	1.000
	Specificity	34	0.914	0.776	0.970
50 - 70	Sensitivity	33	0.970	0.847	0.995

Table 1: Gender

0.924

0.970

0.835

0.847

0.967

0.995

Specificity

Sensitivity

70

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Age	Measure	N	Estimate	Lower 95%CI	Upper 95%CI
	Specificity	66	0.924	0.835	0.967

Mfr	Measure	N	Estimate	Lower 95% CI	Upper 95% CI
GE	Sensitivity	41	0.976	0.874	0.996
GE	Specificity	51	0.882	0.766	0.945
TOSHIBA	Sensitivity	21	0.952	0.773	0.992
TOSHIBA	Specificity	58	0.966	0.883	0.990
SIEMENS	Sensitivity	16	0.938	0.717	0.989
SIEMENS	Specificity	43	0.860	0.727	0.934

Table 3: Scanner Brand

Table 4: Slice Thickness

Slice Thickness	Measure	N	Estimate	Lower 95%CI	Upper 95%CI
<1.5	Sensitivity	96	0.931	0.836	0.973
	Specificity	150	0.910	0.838	0.952
≥1.5	Sensitivity	54	0.978	0.924	0.994
	Specificity	6	0.842	0.726	0.915

Table 5: Detector Rows

Rows	Measure	N	Estimate	Lower 95%CI	Upper 95%CI
Unknown	Sensitivity	2	1.000	-	-
	Specificity	0	-	-	-
16	Sensitivity	3	1.000	0.439	1.000
	Specificity	0	-	-	-
64	Sensitivity	52	0.942	0.844	0.980
	Specificity	39	0.769	0.617	0.874
80	Sensitivity	3	1.000	0.439	1.000
	Specificity	57	0.982	0.907	0.997
128	Sensitivity	4	1.000	0.510	1.000
	Specificity	28	0.786	0.605	0.898
256	Sensitivity	65	0.969	0.895	0.992
	Specificity	20	0.950	0.764	0.991
320	Sensitivity	18	0.944	0.742	0.990
	Specificity	1	0.000	-	-
382	Sensitivity	3	1.000	0.439	1.000
	Specificity	11	1.000	0.741	1.000

Table 6: Scanner Mix w/Convolution Kernel Type

Manufacturer	Reconstruction Method	N	% of Total
GE MEDICAL SYSTEMS	STANDARD	84	27.4%
Manufacturer	Reconstruction Method	N	% of Total
	FC08	2	0.7%
	SOFT	1	0.3%
	B40s	1	0.3%
	B	1	0.3%
	['Br38f', '2']	1	0.3%
	Missing	2	0.7%
SIEMENS	['Br38f', '2']	14	4.6%
	Tr20f	14	4.6%
	['Br40d', '3']	4	1.3%
	Br36f	3	1.0%
	FC08	3	1.0%
	STANDARD	2	0.7%
	['Br40d', '2']	2	0.7%
	['Bv36d', '3']	2	0.7%
	B31s	2	0.7%
	B26s	1	0.3%
	B30f	1	0.3%
	B40s	1	0.3%
	B70s	1	0.3%
	B	1	0.3%
	['Bf37f', '3']	1	0.3%
	['Br36f', '3']	1	0.3%
	['Br38f', '3']	1	0.3%
	Missing	7	2.3%
Toshiba	FC08	54	17.6%
	FC14	11	3.6%
	FC02	2	0.7%
	FC18	2	0.7%
	STANDARD	1	0.3%
	C	1	0.3%
	B	1	0.3%
	Missing	6	2.0%
Other	Other	75	24.3%
Totals	All	306	100.0%

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Prescriptive Statement:

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

Safety & Effectiveness:

Rapid 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 System performance has been validated with phantom and case data.

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Conclusion:

In conclusion, the iSchemaView Rapid PETN device is substantially equivalent in intended use, technological characteristics, safety, and performance characteristics to the legally marketed predicate device, Briefcase (K190072).

Regulation Number and Section

§ 892.2080 Radiological computer aided triage and notification software.

(a)
Identification. Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.(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 notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (
e.g., improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (
e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone 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; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use;
(ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device;
(iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images;
(v) Device operating instructions; and
(vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (
e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.