ClearRead CT™ is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest on an asymptomatic population. The ClearRead CT requires both lungs be in the field of view. ClearRead CT provides adjunctive information and is not intended to be used without the original CT series.

Device Description

ClearRead CT is a dedicated post-processing application that generates a secondary vessel suppressed Lung CT series with CADe marks and associated region descriptors intended to aid the radiologist in the detection of pulmonary nodules.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the ClearRead CT device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Localization Receiver Operating Characteristic (LROC) AUC	ClearRead CT found to significantly increase the AUC compared to the unaided read, indicating superior performance for detecting nodules.
Radiologists' Interpretation Time	ClearRead CT found to decrease read times with and without outliers.

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

The document does not explicitly state the exact sample size for the test set (number of cases). It refers to a "multi-reader multi-case (MRMC) study."

The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.

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

The document does not specify the number of experts used to establish ground truth or their qualifications. It mentions a "multi-reader multi-case (MRMC) study," implying multiple readers were involved in the evaluation, but not necessarily in establishing the initial ground truth.

4. Adjudication Method for the Test Set

The document does not explicitly describe the adjudication method used for the test set.

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

Yes, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done.

Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: The study found that using ClearRead CT "significantly increase[d] the AUC" of the LROC response. It also found that ClearRead CT "decrease[d] read times with and without outliers." While a specific numerical effect size (e.g., a percentage increase in AUC or specific time reduction) is not provided in this summary, the terms "significantly increase" and "decrease" indicate a positive and measurable improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document focuses on the multi-reader multi-case study, explicitly stating that ClearRead CT is "designed to aid the radiologist" and "provides adjunctive information and is not intended to be used without the original CT series." This implies the primary evaluation was human-in-the-loop. It also mentions that the device "generates a secondary vessel suppressed Lung CT series with CADe marks," which could be considered a standalone function, but the performance metrics provided are for the combined human-AI workflow.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data).

8. The Sample Size for the Training Set

The sample size for the training set is not mentioned in the provided text.

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

The document does not provide information on how the ground truth for the training set was established.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 9, 2016

Riverain Technologies, LLC % Ms. Jennifer Butsch Director of Regulatory Affairs & Quality Assurance 3020 South Tech Blvd. MIAMISBURG OH 45324

Re: K161201

Trade/Device Name: ClearRead CT Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: OEB, LLZ Dated: September 6, 2016 Received: September 7, 2016

Dear Ms. Butsch:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K161201

Device Name ClearRead CT

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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1.0 510(K) SUMMARY

Submission Date:	April 25, 2016
------------------	----------------

Submitter Information:

Company Name:	Riverain Technologies, LLC.
---------------	-----------------------------

Company Address:	3020 South Tech Blvd., Miamisburg, OH 45342-4860
Contact Person:	Jennifer ButschDirector, Regulatory Affairs and Quality AssuranceRiverain Technologies800.990.3387937.425.6493jbutsch@riveraintech.com

Device Information:

Trade Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:	ClearRead CTTM21 CFR §892.2050Picture archiving and communications systemClass IIOEB/LLZ
Device Description:	ClearRead CT is a dedicated post-processing application thatgenerates a secondary vessel suppressed Lung CT series withCADe marks and associated region descriptors intended to aid theradiologist in the detection of pulmonary nodules.
Indications for Use:	ClearRead CTTM is comprised of computer assisted reading toolsdesigned to aid the radiologist in the detection of pulmonarynodules during review of CT examinations of the chest on anasymptomatic population. The ClearRead CT requires both lungsbe in the field of view. ClearRead CT provides adjunctiveinformation and is not intended to be used without the original CTseries.
Predicate Devices:	syngo.CT Lung CAD(K143196)Siemens AG Medical SolutionsClass IIsyngo.PET&CT Oncology(K093621)

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Siemens AG Medical Solutions Class II

ClearRead Bone Suppression (SoftView) (K092363) Riverain Technologies, LLC Class II

Comparison to Predicate Device Technical Characteristics:

Riverain is of the opinion that the ClearRead CT is substantially equivalent, both in intended use and technical characteristics to the listed predicate devices. Differences in the design and performance from the cited predicate devices do not affect either the safety or the effectiveness of ClearRead CT for its intended use.

	Predicate:syngo.CT LungCAD (SiemensAG MedicalSolutions)K143196	Predicate:syngo.PET &CT Oncology(Siemens AGMedicalSolutions)K093621	Predicate:ClearReadBoneSuppression(RiverainTechnologies)K092363	Subject Device:ClearRead CT(RiverainTechnologies)
Product Code	OEB	LLZ	LLZ	OEB/LLZ
Intended Use	Computer-aideddetection tooldesigned toassistradiologists inthe detection ofsolid pulmonarynodules duringreview ofMDCTexaminations ofthe chest	Viewing,manipulation,3D-Visualization,andcomparisonof medicalimages frommultipleimagingmodalities.	Generatingbonesuppressedimage froman originalPA/AP chestradiograph	Computerassisted readingtools designed toaid theradiologist in thedetection ofpulmonarynodules duringreview of CTexaminations ofthe chest

Testing Summary:

Clinical validation was conducted in a multi-reader multi-case (MRMC) study to validate that the device conformed to the defined user needs and intended uses. The reader study measured the area under the curve (AUC) of the localization receiver operating characteristic (LROC) response when using ClearRead CT relative to the unaided read. The study also measured the radiologists' interpretation time when using ClearRead CT relative to unaided interpretations. ClearRead CT was found to significantly increase the AUC, indicating use of the device is superior to the unaided read for detecting nodules. ClearRead CT was found to decrease read times with and without outliers.

Developmental testing was conducted to verify requirements according to the ClearRead CT device specifications. The Risk Analysis was completed and risk control measures

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implemented to mitigate hazards. Documentation required for software with a Moderate Level of Concern is included as part of the submission. Device labeling together with results from verification & validation testing demonstrate the device is safe and effective.

Conclusion:

In preparing this 510(k) submission, Riverain has carefully considered the relevant statutory and regulatory requirements, and believes that the information contained within satisfies the requirements for demonstrating substantial equivalence.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).