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 ImageView product application software (also namely console software). The Eclipse image processing software II with Smart Noise Cancellation is similar to the predicate Eclipse image processing software (K180809). Eclipse with Smart Noise Cancellation is an optional feature that enhances projection radiography acquisitions captured from digital radiography imaging receptors (Computed Radiography (CR) and Direct Radiography (DR). The modified software is considered an extension of the software (it is not stand alone and is to be used only with the predicate device supports the Carestream DRX family of detectors, this includes all CR and DR detectors. The primary difference between the predicate and the subject device is the addition of a Smart Noise Cancellation module. 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 with Smart Noise Cancellation (modified device) incorporates enhanced noise reduction prior to executing Eclipse II image processing software.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Based on the provided text, the device Eclipse II with Smart Noise Cancellation is considered substantially equivalent to its predicate Eclipse II (K180809) due to modifications primarily centered around an enhanced noise reduction feature. The acceptance criteria and the study that proves the device meets these criteria are inferred from the demonstrated equivalence to the predicate device and the evaluation of the new Smart Noise Cancellation module.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to the performance of the predicate device and the new feature's ability to maintain or improve upon key image quality attributes without introducing new safety or effectiveness concerns.

Acceptance Criteria (Implied)	Reported Device Performance
Diagnostic Quality Preservation/Improvement: The investigational software (Eclipse II with Smart Noise Cancellation) must deliver diagnostic quality images equivalent to or exceeding the predicate software (Eclipse II).	Clinical Evaluation: "The statistical test results and graphical summaries demonstrate that the investigational software delivers diagnostic quality images that exceed the quality of the predicate software over a range of exams, detector types and exposure levels."
No Substantial Residual Image Artifacts: The noise reduction should not introduce significant new artifacts.	Analysis of Difference Images: "The report focused on the analysis of the residual image artifacts. In conclusion, the images showed no substantial residual edge information within regions of interest."
Preservation/Improvement of Detectability: The detectability of lesions should not be negatively impacted and ideally improved.	Ideal Observer Evaluation: "The evaluation demonstrated that detectability is preserved or improved with the investigational software for all supported detector types and exposure levels tested."
No New Questions of Safety & Effectiveness: The modifications should not raise new safety or effectiveness concerns.	Risk Assessment: "Risks were assessed in accordance to ISO 14971 and evaluated and reduced as far as possible with risk mitigations and mitigation evidence."Overall Conclusion: "The differences within the software do not raise new or different questions of safety and effectiveness."
Same Intended Use: The device must maintain the same intended use as the predicate.	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." (Stated as "same" for both predicate and modified device in comparison chart)

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

Sample Size for Test Set: Not explicitly stated. The text mentions "a range of exams, detector types and exposure levels" for the clinical evaluation, and "clinical images with added simulated noise" for the CNN training.
Data Provenance: Not explicitly stated. The text mentions "clinical images," implying real-world patient data, but does not specify the country of origin or whether it was retrospective or prospective.

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

Number of Experts: Not explicitly stated. The text mentions a "clinical evaluation was performed by board certified radiologists." It does not specify the number involved.
Qualifications of Experts: "Board certified radiologists." No specific years of experience are provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The text mentions images were evaluated using a "5-point visual difference scale (-2 to +2) tied to diagnostic confidence" and a "4-point RadLex scale" for overall diagnostic capability. It does not describe a method for resolving discrepancies among multiple readers, such as 2+1 or 3+1.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Comparative Effectiveness Study: Yes, a clinical evaluation was performed by board-certified radiologists comparing the investigational software to the predicate software. While it doesn't explicitly use the term "MRMC," the description of a clinical evaluation by multiple radiologists comparing two versions of software suggests this type of study was conducted.
Effect Size of Human Readers Improvement with AI vs. without AI Assistance: The text states, "The statistical test results and graphical summaries demonstrate that the investigational software delivers diagnostic quality images that exceed the quality of the predicate software over a range of exams, detector types and exposure levels." This indicates an improvement in diagnostic image quality with the new software (which incorporates AI - the CNN noise reduction), suggesting that human readers benefit from this enhancement. However, a specific effect size (e.g., AUC improvement, percentage increase in accuracy) is not provided in the summary.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Partially. The "Ideal Observer Evaluation" seems to be a more objective, algorithm-centric assessment of detectability, stating that "detectability is preserved or improved with the investigational software." Also, the "Analysis of the Difference Images" checked for artifacts without human interpretation as the primary outcome. However, the overall "diagnostic quality" assessment was clinical, involving human readers.

7. The Type of Ground Truth Used

Type of Ground Truth: The text implies a human expert consensus/evaluation as the primary ground truth for diagnostic quality. The "5-point visual difference scale" and "4-point RadLex scale" evaluated by "board certified radiologists" serve as the basis for assessing diagnostic image quality. For the "Ideal Observer Evaluation," the ground truth likely involved simulated lesions.

8. The Sample Size for the Training Set

Training Set Sample Size: Not explicitly stated. The text mentions "clinical images with added simulated noise" were used to train the Convolutional Network (CNN).

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

Ground Truth for Training Set: The ground truth for training the Smart Noise Cancellation module (a Convolutional Network) was established using "clinical images with added simulated noise to represent reduced signal-to-noise acquisitions." This suggests that the model was trained to learn the relationship between noisy images (simulated low SNR) and presumably clean or less noisy versions of those clinical images to perform noise reduction. The text doesn't specify how the "clean" versions were obtained or verified, but it implies a supervised learning approach where the desired noise-free output served as the ground truth.

Summary

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April 2, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Carestream Health, Inc. % Gina Maiolo Sr. Manager Regulatory Affairs, Clearance & Surveillance 150 Verona Street ROCHESTER NY 14608

Re: K202441

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: February 16, 2021 Received: February 19, 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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-leam). 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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara

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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Indications for Use

510(k) Number (if known) K202441

Device Name Eclipse II with Smart Noise Cancellation

Indications for Use (Describe)

"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."

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

510(k) Owner Name	Carestream Health, Inc.
510(k) Owner Address	150 Verona StreetRochester, New York 14608
510(k) Owner Contact Information	Gina MaioloRegulatory Affairs Manageremail: gina.maiolo@carestream.com
Phone (Work)	585.627.6543
Phone (Mobile)	516.395.0597
Date Summary Prepared	March 30 2021
Device Trade Name	Eclipse II with Smart Noise Cancellation
Device Common Name	Solid State X-Ray Imager
Device Class	Class II
Product Code	MQB
Regulation Number	21 CFR 892.1680
Regulation Description	Stationary X-ray system
Predicate Device	Eclipse II 510(k) K180809

Carestream Health, Inc. is submitting this Traditional 510(k) premarket notification for modifications to the Eclipse II with Smart Noise Cancellation. Carestream believes that the modified device is substantially equivalent to the cleared device (K180809).

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

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software (it is not stand alone and is to be used only with the predicate device supports the Carestream DRX family of detectors, this includes all CR and DR detectors. The primary difference between the predicate and the subject device is the addition of a Smart Noise Cancellation module. 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 with Smart Noise Cancellation (modified device) incorporates enhanced noise reduction prior to executing Eclipse II image processing software.

Technological Characteristics

Eclipse software enhances projection radiography acquisitions captured from digital radiography imaging receptors (Computed Radiography (CR) and Direct Radiography (DR) which is the same as the predicate software K180809. 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 the predicate and modified device.

. 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.
O The modifications to the ImageView 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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Summary of Non-Clinical Testing

There are two non-clinical testing reports to demonstrate substantial equivalence.

. The report for the Analysis of the Difference Images is the images processed with the investigational software (Eclipse II with Smart Noise Cancellation) and the predicate software (Eclipse II). The report focused on the analysis of the residual image artifacts. In conclusion, the images showed no substantial residual edge information within regions of interest.
. The report for the Ideal Observer Evaluation is based on simulated lesions on chest images. The evaluation demonstrated that detectability is preserved or improved with the investigational software for all supported detector types and exposure levels tested.

A complete list of the supported detectors:

. DRX Plus 3543 & DRX Plus 4343 (K150766), DRX-L (GOS) (K190611)
DRX Plus 3543C & DRX Plus 4343C (K153142), Lux 3543C (CsI) (K203159) .
. DRX Plus 2530C (K183245)
. Carestream DRX-1 System w/DRX-1 Detector (K090318)
DRX-1C (K120062), DRX 2530C (CsI) (K130464) .

Summary of Clinical Testing

A clinical evaluation was performed by board certified radiologists.

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 RadLex scale. The statistical test results and graphical summaries demonstrate that the investigational software delivers diagnostic quality images that exceed the quality of the predicate software over a range of exams, detector types and exposure levels.

Conclusion of Testing

The software modifications do not significantly affect fundamental design, technology, device materials, or packaging. Additionally, the investigational and predicate are substantially equivalent as a result of the following:

. The performance of the investigational software is the same as or better than the predicate software.
The differences within the software do not raise new or different questions of safety and . effectiveness.
. The intended use for both the investigational and predicate software remain the same.

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Carestream

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

Attribute	Eclipse II Predicate Device(K180809)	Eclipse II with SmartNoise Cancellation(K202441)
Indications for Use	"The software performs digital enhancement of aradiographic image generated by an x-ray device. Thesoftware can be used to process adult and pediatric x-rayimages. This excludes mammography applications."	same
Grid Suppression	Analysis for and removes grid frequencies from theimage.	same
Image Segmentation	Image analysis that identifies the anatomy of interestby detecting direct exposure and collimator blades.	same
Recognition	Optional tech assist features on chest exams thatprovide auto-orientation (head-up), identify clippedlung bases and provide a CNR image quality metric.	same
Parameter Prediction	Automatic determination of rendering parametersbased upon features extracted from histograms of theimage in support of (4) to (10) frequency bands.	same
EnhancedNoiseReduction Support	no	yes
Rendering (frequencydecomposition andenhancement)	(4) to (10) frequency bands.	same

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.