The AIMI-Triage CXR PTX Application is a notification-only triage workflow tool for use by hospital networks and clinics to identify and help prioritize chest X-rays acquired in the acute setting for review by hospital radiologists. The device operates in parallel to and independent of standard of care image interpretation workflow. Specifically, the device uses an artificial intelligence algorithm to analyze images for features suggestive of moderate to large sized pneumothorax; it makes caselevel output available to a PACS/workstation for worklist prioritization or triage. Identification of suspected cases of moderate to large sized pneumothorax is not for diagnostic use beyond notification.

The AIMI-Triage CXR PTX Application is limited to analysis of imaging data as a guide to possible urgency of adult chest X-ray image review, and should not be used in lieu of full patient evaluation or relied upon to make or confirm diagnoses. Notified radiologists are responsible for engaging in appropriate patient evaluation as per local hospital procedure before making care-related decisions or requests. The device does not replace review and diagnosis of the X-rays by radiologists. The device is not intended to be used with plain film X-rays.

Device Description

The AIMI-Triage CXR PTX provides a chest X-ray prioritization service for use by radiologists to identify features suggestive of moderate to large sized pneumothorax. The artificial intelligence algorithm, trained via pattern recognition, processes each chest X-ray and flags those that appear to contain a moderate to large sized pneumothorax for urgent radiologist review. X-rays without an identified anomaly are placed in the worklist for routine review, which is the current standard of care. The user interface is minimal, consisting of the radiologist's existing picture archiving and communication system (PACS) viewer and worklist in which positively identified images are flagged by the software to notify of the suspected anomaly. Images are not marked or otherwise altered, and no diagnoses are provided.

The device does not have any direct accessories. However, it interacts with hospital communication and database systems in order to read and analyze cases in the worklist of the hospital's PACS system in order to identify suspected abnormal findings and transmit corresponding notifications to reflect its recommended prioritization of patient examinations for radiologist review. The software output is compatible with any PACS viewer and worklist.

AI/ML Overview

Acceptance Criteria and Study Details for AIMI-Triage CXR PTX

1. Acceptance Criteria and Reported Device Performance

Criteria	Accepted Performance Goal	Reported Device Performance
Overall AUC	Substantially equivalent to the predicate device, meeting a required performance goal (specific numerical value not explicitly stated, but implied to be in line with predicate's performance).	0.967 (95% CI: [0.950, 0.984])
Sensitivity	Not explicitly stated as an acceptance criterion, but device performance is reported.	92% (95% CI: [86%, 96%]) and 90% (95% CI: [84%, 95%]) for unspecified categories/cohorts within the overall dataset.
Time to Analyze and Notify	Substantially equivalent to the predicate device (22.1 seconds).	20.3 seconds
Performance by Dataset and Region	Not explicitly stated as acceptance criteria, but further detailed performance is provided for evaluation.	NIH (US): Sensitivity 97.6% (93.2,99.2), Specificity 90.8% (84.5,94.7), AUROC 0.987 (0.973,0.999) PADCHEST (OUS): Sensitivity 85.3% (79.0,90.8), Specificity 89.7% (83.6,93.9), AUROC 0.949 (0.918,0.979)
Performance by Scanner Spatial Resolution	Not explicitly stated as acceptance criteria, but further detailed performance is provided for evaluation.	High range (<0.145 lp/mm): Sensitivity 89.5% (83.0,94.1), Specificity 85.1% (77.7,90.6), AUROC 0.976 (0.944,0.999) Mid range (0.145-0.170 lp/mm): Sensitivity 92.6% (84.3,96.7), Specificity 93.4% (85.7,97.4), AUROC 0.983 (0.961,0.999) Low range (>0.170 lp/mm): Sensitivity 93.1% (84.8,98.3), Specificity 91.4% (80.7,96.5), AUROC 0.946 (0.911,0.980)

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

Sample Size: 300 frontal chest X-rays (PA/AP).
Data Provenance: Collected from US and OUS (Outside US) patients, representative of the intended population. The datasets are specifically identified as NIH (US) and PADCHEST (OUS). The study was retrospective.
- Patient Demographics: 168 (56%) male with mean age 51.6 years (SD=18.6, range 18-91), and 132 (44%) female with mean age 51.8 years (SD=16.2, range 23-86).

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

Number of Experts: 3 independent radiologists.
Qualifications: US-board certified radiologists.

4. Adjudication Method for the Test Set

The ground truth was established by 3 independent US-board certified radiologists.
Each "Truther" involved in the ground truthing process was blinded to any other Truther's results, to any existing report, and to the results obtained by the AIMI-Triage CXR PTX software. This implies that the ground truth was established by individual assessment and likely involved a consensus or majority vote among the 3 radiologists, although the specific "2+1" or "3+1" method is not explicitly stated. The emphasis on independent and blinded assessment supports a robust adjudication process.

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

It is not explicitly stated that an MRMC comparative effectiveness study was done to measure human reader improvement with AI assistance. The study focuses on standalone AI performance compared to a ground truth established by experts.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was conducted. The "AIMI-Triage CXR PTX output was compared to the ground truth established by 3 independent US-board certified radiologists." This indicates the algorithm's performance without direct human-in-the-loop assistance during the evaluation.

7. Type of Ground Truth Used

Expert Consensus: The ground truth was established by "3 independent US-board certified radiologists." While "consensus" isn't explicitly used, the involvement of multiple blinded experts suggests a robust process to define the true positive/negative cases.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It only mentions that the artificial intelligence algorithm was "trained via pattern recognition."

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

The document does not specify how the ground truth for the training set was established. It only indicates that the algorithm was "trained via pattern recognition."

Summary

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RADLogics, Inc. % John J. Smith, M.D., J.D. Partner Hogan Lovells US LPP 555 13th Street NW WASHINGTON DC 20004

Re: K193300

Trade/Device Name: AIMI-Triage CXR PTX Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: OFM Dated: March 9, 2020 Received: March 9, 2020

Dear Dr. Smith:

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

April 8, 2020

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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 (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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K193300

Device Name

AIMI-Triage CXR PTX

Indications for Use (Describe)

The AIMI-Triage CXR PTX Application-only triage workflow tool for use by hospital networks and clinics to identify and help prioritize chest X-rays acquired in the acute setting for review by hospital radiologists. The device operates in parallel to and independent of care image interpretation workflow. Specifically, the device uses an artificial intelligence algorithm to analyze images for features suggestive of moderate to large sized pneumothorax; it makes case-level output available to a PACS/workstation for triage. ldentification of suspected cases of moderate to large sized pneumothorax is not for diagnostic use beyond notification.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY K193300 RADLogics Inc.'s AIMI-Triage CXR PTX

Submitter

RADLogics Inc. 24 Westland Ave. #28 Boston, MA 02115

Phone: (408) 905-8054

Contact Person: Moshe Becker

Date Prepared: April 2, 2020

Name of Device: AIMI-Triage CXR PTX

Common or Usual Name: CADt software

Classification Name: Radiological computer-aided triage and notification software

Regulatory Class: II

Product Code: QFM

Predicate Device: Zebra Medical Vision Ltd.'s HealthPNX (K190362)

Device Description

Intended Use / Indications for Use

The AIMI-Triage CXR PTX Application is a notification-only triage workflow tool for use by hospital networks and clinics to identify and help prioritize chest X-rays acquired in the acute setting for

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review by hospital radiologists. The device operates in parallel to and independent of standard of care image interpretation workflow. Specifically, the device uses an artificial intelligence algorithm to analyze images for features suggestive of moderate to large sized pneumothorax; it makes caselevel output available to a PACS/workstation for worklist prioritization or triage. Identification of suspected cases of moderate to large sized pneumothorax is not for diagnostic use beyond notification.

Summary of Technological Characteristics

AIMI-Triage CXR PTX is technologically similar to the predicate device. Both are based on algorithms which have been trained to analyze images suggestive of pre-defined lung abnormalities and notify an appropriate clinician of these findings in parallel to standard of care image interpretation. The algorithms function similarly and with the same purpose of signaling potential pneumothorax without providing diagnosis or altering the original datasets. There are no notable technological differences between the subject and predicate devices. A table comparing the key features of the subject and predicate devices is provided in the substantial equivalence table below.

Performance Data

The AIMI-Triage CXR PTX was evaluated and verified in a blinded, retrospective and multi-center study for detecting pneumothorax in chest X-rays. A total of 300 frontal chest X-rays (PA/AP) were collected from US and OUS patients representative of the intended population. 168 (56%) were male with mean age 51.6 years and SD=18.6 (range 18-91), and 132 (44%) were female with mean age 51.8 and SD=16.2 (range 23-86).

The AIMI-Triage CXR PTX output was compared to the ground truth established by 3 independent US-board certified radiologists (Truther involved in the ground truthing process was blinded to any other Truther's results, to any existing report, and to the results obtained by the AlMI-Triage CXR PTX software. Overall, the device was able to demonstrate an area under the curve (AUC) of 96.7% (95.0%, 98.4%)), which is substantially equivalent to the predicate device, and meets the required performance goal. The sensitivity of the device was 92% (95% CI: [86%, 96%]) and 90% (95% CI: [84%, 95%]), respectively.

In addition, the average time it takes the AIMI-Triage CXR PTX to analyze the study and send notification to the PACS worklist was measured to be 20.3 seconds, a timing performance that is substantially equivalent to the predicate (22.1 seconds). Lastly, device performance was evaluated by dataset/region and scanner spatial resolution as summarized in the tables below.

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Category	N	Sensitivity	Specificity	AUROC
NIH (US)	147	97.6%(93.2,99.2)	90.8%(84.5,94.7)	0.987(0.973,0.999)
PADCHEST (OUS)	153	85.3%(79.0,90.8)	89.7%(83.6,93.9)	0.949(0.918,0.979)

Device Performance by Dataset and Region

Device Performance by Scanner Spatial Resolution

Spatial ResolutionCategory	N	Sensitivity	Specificity	AUROC
High range<0.145(above 3.45 lp/mm)	133	89.5%(83.0,94.1)	85.1%(77.7,90.6)	0.976(0.944,0.999)
Mid range0.145-0.170(2.95-3.45 lp/mm)	88	92.6%(84.3,96.7)	93.4%(85.7,97.4)	0.983(0.961,0.999)
Low range>0.170(below 2.95 lp/mm)	64	93.1%(84.8,98.3)	91.4%(80.7,96.5)	0.946(0.911,0.980)

Thus, the device also performs comparably to the predicate in terms of time savings. The AIMI-Triage CXR PTX has a safety and effectiveness profile that is similar to the predicate device.

Conclusions

The AIMI-Triage CXR PTX has the same intended use and very similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the device's intended use and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the device and its predicate raise no new issues of safety or effectiveness. Performance data further demonstrate that the AIMI-Triage CXR PTX is as safe and effective as the HealthPNX (K190362). Thus, the subject device is substantially equivalent to the identified predicate.

Substantial Equivalence Table
	AIMI-Triage CXR PTX	HealthPNX (K190362)
Intended Use / Indications for Use	The AIMI-Triage CXR PTX Application is a notification-only triage workflow tool for use by hospital networks and clinics to identify and help prioritize chest X-rays acquired in the acute setting for review by hospital radiologists. The device operates in parallel to and independent of standard of care image interpretation workflow. Specifically, the device uses an artificial intelligence algorithm to analyze images for features suggestive of moderate to large sized pneumothorax; it makes case-level	The Zebra Pneumothorax device is a software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of Pneumothorax in the medical care environment. HealthPNX analyzes cases using an artificial intelligence algorithm to identify suspected
	AIMI-Triage CXR PTX	HealthPNX (K190362)
	output available to a PACS/workstation for worklistprioritization or triage. Identification of suspectedcases of moderate to large sized pneumothorax isnot for diagnostic use beyond notification.	findings. It makes case-leveloutput available to aPACS/workstation for worklistprioritization or triage.HealthPNX is not intended to
	The AIMI-Triage CXR PTX Application is limited toanalysis of imaging data as a guide to possibleurgency of adult chest X-ray image review, andshould not be used in lieu of full patient evaluationor relied upon to make or confirm diagnoses.Notified radiologists are responsible for engaging inappropriate patient evaluation as per local hospitalprocedure before making care-related decisions orrequests. The device does not replace review anddiagnosis of the X-rays by radiologists. The deviceis not intended to be used with plain film X-rays.	direct attention to specificportions or anomalies of animage. Its results are notintended to be used on astand-alone basis for clinicaldecision-making nor is itintended to rule outPneumothorax or otherwisepreclude clinical assessment ofX-Ray cases.
Classification	21 C.F.R. § 892,2080, Product Code QFM
User	Radiologist
AnatomicalRegion	Lung
ClinicalCondition	Pneumothorax
Modality	Chest X-ray
Segmentationof region ofinterest	No; device does not mark, highlight, or direct users' attention to a specific location inthe original image
Alteration oforiginalimage	No
Relation tostandard ofcare workflow	Independent/parallel; no cases are removed from worklist queue
Algorithm	Artificial intelligence algorithm with database of images
Notification /Prioritization	Yes
Alert toFinding	Passive notification - flagged for review
WhereResults areReceived	PACS / Workstation

Substantial Equivalence Table

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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.