ClearRead +Confirm is intended to generate an enhanced, secondary digital radiographic image of the chest to facilitate confirmation of line/tubes. The enhanced AP or PA image of the chest provides improved visibility of lines and tubes. The ClearRead +Confirm image provides adjunctive information and is not a substitute for the original PA/AP image. This device is intended to be used by trained professionals, such as physicians, radiologists, and technicians, on patients with lines and tubes and is not intended to be used on pediatric patients.

Device Description

ClearRead +Confirm is a dedicated post-processing application that generates an enhanced, secondary digital radiographic image of the chest to facilitate confirmation of line/tubes.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the specified format:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Primary Endpoints: Reduction in time required by radiologists to localize the tips of tubes, lines, and electrical cardiac wires (TLW) when using ClearRead +Confirm.	ClearRead +Confirm was found to significantly decrease read times in analyses both including and excluding outliers.
Secondary Endpoints: Radiologists' accuracy in localizing the TLW when using ClearRead +Confirm.	The difference from true locations in ClearRead +Confirm reads and unaided reads were not found to be statistically significant.
Overall Conclusion: Is the device a useful adjunct?	The results indicated that ClearRead +Confirm is a useful adjunct for the interpretation of chest radiographs when looking for TLW.

Study Details

Sample size used for the test set and the data provenance: Not explicitly stated in the provided text. The text mentions it was a "multi-reader multicase (MRMC) study," implying a collection of cases, but the specific number is not given. However, the study was "clinical validation," implying prospective or retrospective clinical data. No country of origin is specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The study involved "radiologists" as readers, but how many established ground truth, or their specific qualifications (e.g., years of experience), is not detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not explicitly stated. The text mentions "true locations," implying that a ground truth was established, but the method of adjudication (e.g., consensus, by an expert panel) is not described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Yes, a multi-reader multicase (MRMC) study was done.
- Effect Size: The study found a "significant decrease" in read times when using ClearRead +Confirm. The specific quantitative "effect size" (e.g., percentage reduction, time saved in seconds) is not provided, only that it was statistically significant. For accuracy, no statistically significant difference from true locations was found between ClearRead +Confirm reads and unaided reads.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document does not explicitly state whether a standalone performance study was conducted. The focus is on the human-in-the-loop performance through the MRMC study, where the device provides "adjunctive information."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The text refers to "true locations" of tubes, lines, and electrical cardiac wires (TLW). This broadly suggests an expert-determined ground truth, likely based on anatomical knowledge and possibly confirmed by other imaging or clinical data, but the exact method (e.g., expert consensus) is not specified.
The sample size for the training set: Not provided in the document.
How the ground truth for the training set was established: Not provided in the document.

Summary

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Traditional 510(k) Premarket Notification ClearRead +Confirm™

Riverain Technologies Page 6

DEC 2 7 2012

510(K) SUMMARY 3.0

November 15, 2012 Submission Date:

Submitter Information:

Company Name: Riverain Technologies, LLC.

Company Address: 3020 South Tech Blvd., Miamisburg, OH 45342-4860

Contact Person:

Jennifer Butsch Director, Regulatory Affairs and Quality Assurance Riverain Technologies 800.990.3387 937.425.6493 jbutsch@riveraintech.com

Device Information:

Trade Name: Regulation Number: Regulation Name: Regulatory Class: Product Code:

ClearRead +Confirm™ 21 CFR §892.2050 System, Image Processing, Radiological Class II LLZ

Predicate Devices:

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

DRX-Revolution (K120062) Carestream Health, Inc. Class II

Device Description:

Intended Use:

ClearRead +Confirm is a dedicated post-processing application that generates an enhanced, secondary digital radiographic image of the chest to facilitate confirmation of line/tubes.

ClearRead +Confirm is intended to generate an enhanced, secondary digital radiographic image of the chest to facilitate confirmation of line/tubes.

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Indications for Use:	ClearRead +Confirm is intended to generate an enhanced,secondary digital radiographic image of the chest to
	facilitate confirmation of line/tubes. The enhanced AP orPA image of the chest provides improved visibility of linesand tubes. The ClearRead +Confirm image provides
	adjunctive information and is not a substitute for the
	original PA/AP image. This device is intended to be usedby trained professionals, such as physicians, radiologists,
	and technicians, on patients with lines and tubes and is notintended to be used on pediatric patients.

Comparison to Predicate Devices Technical Characteristics:

ClearRead +Confirm uses the same bone suppression mechanism as the Riverain ClearRead Bone Suppression predicate device, with enhancements to improve the visibility of lines and tubes. ClearRead +Confirm and ClearRead Bone Suppression also share a common user platform for DICOM communication and system configuration.

ClearRead +Confirm and the Carestream DRX-Revolution are similar in that both include software with the ability to enhance lines and tubes on AP/PA chest radiographs.

Differences in the design and performance from the cited predicate devices do not affect either the safety or the effectiveness of ClearRead +Confirm for its intended use.

Functional verification testing and development validation were conducted to verify that the design output met the design input requirements. Documentation outlining the functional verification testing of the ClearRead +Confirm software (E030-D V&V Test Plan and E032-A V&V Test Report) is provided in Appendix B.

Clinical validation was conducted in a multi-reader multicase (MRMC) study to validate that the device conformed to the defined user needs and intended uses. The reader study measured the reduction in time required by the radiologists to localize the tips of tubes, lines, and electrical cardiac wires (TLW) when using ClearRead +Confirm. The study also measured the radiologists' accuracy in localizing the TLW when using ClearRead +Confirm. ClearRead Confirm was found to significantly decrease read times in analyses both including and excluding outliers. The

Testing Summary:

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difference from true locations in ClearRead Confirm reads and unaided reads were not found to be statistically significant. The results indicated that ClearRead +Confirm is a useful adjunct for the interpretation of chest radiographs when looking for TLW. Documentation of clinical validation testing in the ClearRead +Confirm Reader Study (E045-A Protocol and E046-A Report) is provided in Appendices C and D.

Substantial Equivalence:

The reader study described above used similar methods to the reader study that was reviewed by FDA when clearing the ClearRead Bone Suppression predicate device (K092363). In both cases, an image processing application generates a secondary image for the radiologist to view. Both devices enable reviewing, storing, printing, and distribution of DICOM-compliant images across hospital networks.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 27,2012

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

Re: K123526

Trade/Device Name: ClearRead +Confirm 1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: LLZ Dated: November 15, 2012 Received: November 15, 2012

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.

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

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Page 2 - Ms. Sarah Harrington

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de recordinated adverse or and (2) regulation (21 CFR Part 820); and if applicable, the electronic form in and qualify of ovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 I ou may obtain other generers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Michael J. D. O'Hara

Janine M. Morris 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): K123526

Device Name:_ClearRead +Confirm™

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign Off)

Page 1 of 1

Division of Radiological Health

Office of In Vitro Diagnostics and Rediological Health

510(k) K123526

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).