DeltaView is intended to generate a secondary residual image based on a current and prior chest x-ray image of the same patient, resulting in improved detection of lung nodules that have changed between the two examinations. The DeltaView 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 and radiologists, on patients with risk of having lung nodules, and is not intended to be used on pediatric patients.

Device Description

DeltaView is a dedicated post-processing application which registers current and prior chest exams to provide an image that shows areas of change.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the DeltaView™ device based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Study Objective)	Reported Device Performance
Radiologist's results when using DeltaView images are superior to results when using standard prior and current AP/PA x-ray image pairs alone.	Area under the Localized Receiver Operating Characteristic (LROC) curve (AUCLROC) increased from 0.477 (Unaided) to 0.536 (with DeltaView) (12.4% increase).
The upper 95% confidence limit on the differences in the area under the DeltaView LROC curve (AUCDV) subtracted from the area under the Unaided LROC curve (AUCUA) is greater than or equal to 0.0.	The text states "The research hypothesis indicating superiority was that the upper 95% confidence limit... is greater than or equal to 0.0," and the reported AUCLROC increase supports this.

Study Details

Sample sizes used for the test set and the data provenance:
- The document does not explicitly state the sample size (number of cases or images) used for the test set.
- The document does not specify the data provenance (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts or their qualifications for establishing ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not specify an adjudication method for the test set.
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, an MRMC reader study was done.
- Effect size: The area under the LROC curve (AUCLROC) "increased from 0.477 to 0.536 (12.4%)" when radiologists were aided by DeltaView compared to unaided interpretation. This indicates a 12.4% improvement in the AUCLROC.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- The document does not state that a standalone (algorithm-only) performance study was conducted. The study described focuses on human-in-the-loop performance with the device as an adjunct.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The type of ground truth used is not explicitly stated. However, the study evaluated "the detection of actionable lung nodules," implying that a determination of the presence or change of such nodules constituted the ground truth.
The sample size for the training set:
- The document does not provide information on the sample size used for the training set.
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

{0}------------------------------------------------

Traditional 510(k) Premarket Notification DeltaView™M

Riverain Medical Page 6

510(K) SUMMARY 3.0 .

K111776

June 21, 2011 Submission Date:

Submitter Information:

Company Name:	Riverain Medical Group, LLC.
Company Address:	3020 South Tech Blvd., Miamisburg, OH 45342-4860
Contact Person:	Jennifer Vetter ButschDirector, Regulatory Affairs and Quality AssuranceRiverain Medical800.990.3387937.425.6493jvetter@riverainmedical.com

Device Information:

Trade Name:Regulation Number:Regulation Name:Regulatory Class:Product Code:	DeltaView™21 CFR §892.2050System, Image Processing, RadiologicalClass IILLZ
Predicate Device:	SoftView(K092363)Riverain Medical Group, LLCClass II
Device Description:	DeltaView is a dedicated post-processing application whichregisters current and prior chest exams to provide an imagethat shows areas of change.
Intended Use:	DeltaView is intended to generate a secondary residualimage based on a current and prior chest x-ray image of thesame patient.
Indications for Use:	DeltaView is intended to generate a secondary residualimage based on a current and prior chest x-ray image of thesame patient, resulting in improved detection of lungnodules. The DeltaView image provides adjunctiveinformation and is not a substitute for the original PA/APimage. This device is intended to be used by trainedprofessionals, such as physicians and radiologists, on

{1}------------------------------------------------

patients with risk of having lung nodules, and is not intended to be used on pediatric patients.

Comparison to Predicate Device:

DeltaView is substantially equivalent to the cited predicate device. Differences in the design and performance from the cited predicate device do not affect either the safety or effectiveness of Delta View for its intended use.

Conclusion: DeltaView is a mathematical model of the current medical practice of manually comparing radiographic images. Radiologists routinely compare prior and current chest x-rays from the same patient, when available, to ascertain whether pathological change has occurred. The comparison requires the radiologist to associate regions of interest and neutralize the acquisition effects. Delta View facilitates the comparison process through the automated formation of a difference image, by registering and subtracting a difference of normalized, bone suppressed image pairs. DeltaView achieves this using a variety of advanced image processing and pattern recognition methods. Just as the cited predicate device removes obstructions from a chest X-ray image in order to enhance the radiologist's detection of suspicious structures, so DeltaView obscures the unchanged portions of patient images taken over time in order to enhance the radiologist's detection of suspicious, changed structures. Furthermore, DeltaView uses the same bone suppression mechanism as the predicate device as part of its residual image algorithm. There are no new issues of safety and effectiveness raised by the incorporation of the predicate device's bone suppression in this new device. Reader Study Results: In a multi-reader multi-case (MRMC) reader study, radiologists interpreted pairs of images in order to compare the radiologists' ability to detect valid change when they were aided by the DeltaView image. Localized receiver operating characteristic curves (in terms of the trade-off between sensitivity and specificity when the decision criteria change) were used to evaluate radiologists' diagnostic performance in the detection of actionable lung nodules on chest radiographs with and without the usage of DeltaView. The results indicated that DeltaView should be

{2}------------------------------------------------

a useful adjunct for the interpretation of chest radiographs when looking for a change in a lung nodule.

The objective of the study was to demonstrate that a radiologist's results when using DeltaView images are superior to the radiologist's results when using standard prior and current AP/PA x-ray image pairs alone. Localized Receiver Operating Characteristic (LROC) Analysis and analyses for Sensitivity, Specificity, and Positive and Negative Predictive Value were performed. The research hypothesis indicating superiority was that the upper 95% confidence limit on the differences in the area under the DeltaView LROC curve (AUCDV) subtracted from the area under the Unaided LROC curve (AUCUA) is greater than or equal to 0.0.

There were significant changes when the DeltaView difference image was used. The area under the LROC curve (AUCLROC) increased from 0.477 to 0.536 (12.4%) (p = 2.9E-05)

Substantial Equivalence: The reader study described above used similar methods and achieved similar results to the reader study that was reviewed by FDA when clearing the predicate device (K092363). In both cases, an image processing application generates a secondary image for the radiologist to view, and in both cases, the use of this secondary image resulted in a statistically significant improvement in the radiologist's ability to detect actionable lung nodules.

It should also be noted that Delta View automates the current clinical reading practice of manually comparing a current radiographic image with a prior image from the same patient.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

Ms. Jennifer Vetter Butsch Director, Regulatory Affairs and Quality Assurance Riverain Medical Group, LLC 3020 South Tech Boulevard MIAMISBURG OH 45342-4860

DEC 2 8 2011

Re: K111776

Trade/Device Name: DeltaViewTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 12, 2011 Received: December 14, 2011

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

{4}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice mouncents as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket wifi anow you to begall mains of substantial equivalence of your device to a legally marketed notification. The I Drice results in for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 you desire openie ad receiver you Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 3 150. Theose port 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDA rogalation (DF of es/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 r ou may ookin of Schell Manufacturers, 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,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K111776

Device Name: DeltaView

Indications for Use:

Prescription Use X (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 Diagnostic Devices (OIVD)

Alberto Lutz

Division of Radiologic Office of In Vitro Diagnostic Device Eve

K11726
510K.

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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).