The software performs digital enhancement of a radiographic image generated by an x-ray device. The software can be used to process adult and pediatric x-ray images. This excludes mammography applications.

Device Description

Eclipse software runs inside the Image View product application software (not considered stand-alone software). Smart Noise Cancellation is an optional feature (module) that enhances projection radiography acquisitions captured from digital radiography imaging receptors (Computed Radiography (CR) and Digital Radiography (DR). Eclipse II with Smart Noise Cancellation supports the Carestream DRX family of detectors which includes all CR and DR detectors.

The Smart Noise Cancellation module consists of a Convolutional Network (CNN) trained using clinical images with added simulated noise to represent reduced signal-to-noise acquisitions.

Eclipse II with Smart Noise Cancellation incorporates enhanced noise reduction prior to executing Eclipse image processing software. The software has the capability to lower dose up to 50% when processed through the Eclipse II software with SNC, resulting in improved image quality. A 50% dose reduction for CSI panel images and 40% dose reduction for GOS panel images when processed with Eclipse II and SNC results in image quality as good as or better than nominal dose images

AI/ML Overview

The provided document describes the modification of the Eclipse II software to include a Smart Noise Cancellation (SNC) module. The primary goal of this modification is to enable lower radiation doses while maintaining or improving image quality. The study discussed is a "concurrence study" involving board-certified radiologists to evaluate diagnostic image quality.

Here's the breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a table format with specific numerical thresholds for image quality metrics. Instead, it describes the objective of the study which effectively serves as the performance goal for the device.

Acceptance Criterion (Implicit Performance Goal)	Reported Device Performance
Diagnostic quality images at reduced dose.	Statistical test results and graphical summaries demonstrate that the software delivers diagnostic quality images at 50% dose reduction for CsI panel images and 40% dose reduction for GOS panel images.
Image quality at reduced dose	Image quality with reduced radiation doses is equivalent to or exceeds the quality of nominal dose images of exams.

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

Sample Size for Test Set: Not explicitly stated. The document mentions "clinical images" and "exams, detector types and exposure levels" were used, but a specific number of images or cases for the test set is not provided.
Data Provenance: Not explicitly stated. The document refers to "clinical images," but there is no information about the country of origin or whether the data was retrospective or prospective.

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

Number of Experts: Not explicitly stated. The study was performed by "board certified radiologists." The number of radiologists is not specified.
Qualifications of Experts: "Board certified radiologists." No information is given regarding their years of experience.

4. Adjudication Method for the Test Set:

Adjudication Method: Not explicitly stated. The document mentions a "5-point visual difference scale (-2 to +2) tied to diagnostic confidence" and a "4-point RadLex scale" for evaluating overall diagnostic capability. However, it does not describe how multiple expert opinions were combined or adjudicated if there were disagreements (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

MRMC Study: The study appears to be a multi-reader study as it was "performed by board certified radiologists." However, it is not a comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance. The study's aim was to determine if the software itself (Eclipse II with SNC) could produce diagnostic quality images at reduced dose, assessed by human readers. It's evaluating the output of the software, not the improvement of human readers using the software as an assistance tool.
Effect Size: Not applicable, as it's not an AI-assisted human reading study.

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

Standalone Performance: No, a standalone (algorithm only) performance evaluation was not done. The evaluation involved "board certified radiologists" assessing the diagnostic quality of the images processed by the software. This is a human-in-the-loop assessment of the processed images, not a standalone performance of the algorithm making diagnoses.

7. The Type of Ground Truth Used:

Type of Ground Truth: The ground truth for image quality and diagnostic capability was established by expert consensus (or at least expert assessment), specifically "board certified radiologists," using a 5-point visual difference scale and a 4-point RadLex scale. This is a subjective assessment by experts, rather than an objective ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not explicitly stated. The document mentions that the Convolutional Network (CNN) was "trained using clinical images with added simulated noise." However, no specific number of images or cases used for training is provided.

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

Ground Truth for Training Set: The document states the CNN was "trained using clinical images with added simulated noise to represent reduced signal-to-noise acquisitions." This implies that the ground truth for training likely revolved around distinguishing actual image data from added simulated noise. This is an intrinsic ground truth generated by the method of simulating noise on known clean clinical images, rather than a clinical ground truth established by expert review for diagnostic purposes.

Summary

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January 14, 2022

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Carestream Health, Inc. % Gina Maiolo Regulatory Affairs Manager 150 Verona St ROCHESTER NY 14608

Re: K213307

Trade/Device Name: Eclipse II with Smart Noise Cancellation Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: December 10, 2021 Received: December 13, 2021

Dear Gina Maiolo:

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

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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 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,

Laurel Burk Assistant Director Diagnostic X-ray Systems Team 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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Indications for Use

510(k) Number (if known) K213307

Device Name

Eclipse II with Smart Noise Cancellation

Indications for Use (Describe)

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

K213307

510(k) Owner Name Carestream Health, Inc. 510(k) Owner Address 150 Verona Street Rochester, New York 14608 510(k) Owner Contact Information Gina Maiolo Regulatory Affairs Manager Phone (Work) 585.627.6543 Phone (Mobile) 516.395.0597 Date Summary Prepared Sept 30 2021 Device Trade Name Solid State X-Ray Imager Stationary X-ray system

Device Common Name Classification Name Device Class Device Code Regulation Number Predicate Device

Eclipse II with Smart Noise Cancellation Class II MOB 21 CFR 892.1680 Eclipse II 510(k) K202441

Indications for Use

"The software performs digital enhancement of a radiographic image generated by an x-ray device. The software can be used to process adult and pediatic x-ray images. This excludes mammography applications."

Device Description

The Smart Noise Cancellation module consists of a Convolutional Network (CNN) trained using clinical images with added simulated noise to represent reduced signal-to-noise acquisitions.

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arestream

dose reduction for GOS panel images when processed with Eclipse II and SNC results in image quality as good as or better than nominal dose images

Technological Characteristics

The technological characteristics of the Eclipse II with Smart Noise Cancellation remain the same. Reference the Comparison Table for a summary of changes.

Eclipse II software enhances projection radiography acquisitions captured from digital radiography imaging receptors (Computed Radiography (CR) and Digital Radiography (DR) which is the same as the predicate software K202441. The software was modified to include the support for Smart Noise Cancellation. This Smart Noise Cancellation module consists of a Convolutional Network (CNN), trained using clinical images with added simulated noise to represent reduced signal-to-noise acquisitions. The main difference between the modified and predicate device is the Smart Noise Cancellation module only. The comparison chart below demonstrates the similarities to further support that the overall image processing architecture is the same between predicate and modified.

. Both the predicate and modified device is software designed for the enhancement of the raw images captured from the digital flat panel detectors (detectors have obtained separate clearances). The enhancement image processing intends to present an image with proper image quality attributes (brightness, latitude, overall contrast and detail, sharpness, and noise appearance) for the purpose of helping radiologists and physicians to make a diagnosis (same as the predicate).
. The difference in the modified software is the implementation of noise suppression prior to enhancement processing. The Smart Noise Cancellation operation passes the acquired preprocessed image through a specially trained Convolutional Network (CNN) based on a U-Net architecture to generate a 2D map of the estimated noise found in the image, identified in the document as a "Noise Field." This change does not raise new questions regarding safety and effectiveness. Risks were assessed in accordance to ISO 14971 and evaluated and reduced as far as possible with risk mitigations and mitigation evidence.
The modifications to the Image View software, (acquisition software for digital radiography systems) has been modified to enable/disable the Eclipse II with Smart Noise Cancellation. These user interface changes are described in detail in the Substantial Equivalence discussion and do not introduce new risks or raise new questions pertaining to safety and effectiveness.
. The difference in image processing paths between the predicate and modified device demonstrate that the noise level in images processed thru the modified software (Eclipse II with Smart Noise Cancellation) is greatly reduced when compared with the image processed thru the predicate software. Eclipse II.

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arestream

Summary of Non-Clinical Testing

No additional non-clinical testing was required to demonstrate substantial equivalence between the predicate device labeling and the modified labeling.

Summary of Clinical Testing

A concurrence study was performed by board certified radiologists in accordance with FDA "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and Carestream standard procedure for concurrence studies and Carestream standard procedure for concurrence studies.

The images were evaluated using a 5-point visual difference scale (-2 to +2) tied to diagnostic confidence. Additionally, the overall diagnostic capability of each image was evaluated using the 4-point RadLexscale. The statistical test results and graphical summaries demonstrate that the software delivers diagnostic quality images at 50% dose reduction for Csl panel images and 40% dose reduction for GOS panel reduced radiation doses that are equivalent to or exceed the quality of nominal dose image of exams, detector types and exposure levels.

Conclusion of Testing

Clinical testing validates the modifications to the device description.

	Predicate(K202441)	Subject Device
Trade Name	Eclipse II with Smart Noise Cancellation	same
Manufacturer	Carestream Health	same
Indications for Use	"The software performs digital enhancement of aadiographic image generated by an x-ray device.The software can be used to process adult andpediatric x-ray images. This excludesmammography applications."	same
Grid Suppression	Removes grid frequencies from the image.	same
Image Segmentation	Image analysis that identifies the anatomy ofinterest by detecting direct exposure andcollimator blades.	same
Recognition	Optional tech assist features on chest exams thatprovide auto-orientation (head-up), identifyclipped lung bases and provide a CNR imagequality metric.	same
Parameter Prediction	Automatic determination of rendering parametersbased upon features extracted from histograms ofthe image in support of (4) to (10) frequencybands.	same
Enhanced Noise	Yes	same
Reduction Support
Device Description	Eclipse software runs inside the ImageViewproduct application software (not consideredstand-alone software). Smart Noise Cancellation isan optional feature (module) that enhances	Addition:The software has the capability to lowerdose up to 50% when processedthrough Eclipse II SNC, resulting inimproved image quality. A 50% dosereduction for CsI panel images and 40%dose reduction for GOS panel imageswhen processed with Eclipse II andSNC results in image quality as good asor better than nominal dose images

A comparison chart provides similarities and differences between the modified and predicate device.

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Carestream

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.