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

The Eclipse II image processing software, like the original Eclipse image processing software, enhances projection radiography acquisitions captured from digital radiography imaging receptors (computed radiography (CR) and direct radiography (DR)).

The original Eclipse image processing software used a 4 band frequency decomposition method to enhance the output image. By comparison, the Eclipse (subject) image processing software uses 4 or more band frequency decomposition method. The additional number of bands allows for flexibility in frequency adjustments.

AI/ML Overview

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

Device: Eclipse II (image processing software)
Purpose: Digital enhancement of radiographic images generated by an x-ray device for adult and pediatric x-ray images (excluding mammography).

While the provided document mentions a "clinical Reader Study" was performed and that its results "demonstrate that the Eclipse II Software provides diagnostic quality images," it does not provide the specific details required to fully address all parts of your request. The 510(k) summary is a high-level overview and often refers to detailed study reports that are not included in this public facing document.

Therefore, many of the requested fields will be marked as "Not provided in the document" or "Inferred/Assumed based on typical FDA submission practices" where possible.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance (Result)
Primary Endpoints (Inferred)
Diagnostic Quality of Enhanced Images	"Results of the Reader Study demonstrate that the Eclipse II Software provides diagnostic quality images." (Specific metrics like AUC, sensitivity, specificity, or reader confidence improvements are not provided).
Equivalence/Non-inferiority to Predicate Device (Inferred)	The submission aims to demonstrate substantial equivalence to the predicate device (Kodak Eclipse Image Processing Software). The study results are intended to support this. Specific quantitative measures for equivalence are not provided.
Secondary Endpoints (Inferred)
Intended Workflow Compliance	"These studies demonstrated the intended workflow..." (No specific quantitative metric provided.)
Overall Function	"...overall function..." (No specific quantitative metric provided.)
Verification and Validation of Requirements for Intended Use	"...verification and validation of requirements for intended use..." (No specific quantitative metric provided.)
Reliability of the Software	"...reliability of the software." (No specific quantitative metric provided.)
Conformance to Specifications	"Non-clinical test results have demonstrated that the device conforms to its specifications." (No specific quantitative metric provided.)

Study Details

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not provided in the document.
- Data Provenance: Not provided in the document (e.g., country of origin, specific hospitals). The document states it processes "adult and pediatric x-ray images," implying a diverse patient population.
- Retrospective or Prospective: Not specified, but reader studies typically use retrospective image sets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not provided in the document.
- Qualifications of Experts: Not provided in the document, but it can be assumed they were radiologists or clinicians experienced in interpreting radiographic images.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided in the document. For reader studies, consensus or majority vote among multiple readers is common for establishing ground truth or for assessing agreement.
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:
- The document explicitly states "A clinical Reader Study was performed." This strongly suggests an MRMC study design, as reader studies are primarily MRMC by nature.
- Effect size of improvement: Not provided in the document. The document only states the study "demonstrate[s] that the Eclipse II Software provides diagnostic quality images," but offers no comparative metrics against human readers without AI assistance or a specific effect size (e.g., AUC uplift, confidence score change).
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The primary focus is on a "Reader Study," which implies human-in-the-loop (i.e., humans reading images processed by the software).
- The phrase "Non-clinical test results have demonstrated that the device conforms to its specifications" could encompass some standalone algorithm performance testing, but specific metrics for standalone performance (e.g., image quality metrics like PSNR, SSIM, or specific contrast/detail enhancement measures) are not provided as acceptance criteria for this public summary.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Given it's a "Reader Study" for image enhancement, the ground truth for image quality or diagnostic utility would typically be established by expert consensus or a "truth panel" of experienced radiologists, often based on clinical findings, follow-up, or other imaging modalities, though this is not explicitly stated in the document.
The sample size for the training set:
- Not provided in the document. The document describes the software's function (enhancing images using frequency decomposition) rather than an AI model that requires a distinct training phase. If Eclipse II uses deep learning, training set details would be relevant, but the description points more towards traditional image processing algorithms ("4 or more band frequency decomposition method").
How the ground truth for the training set was established:
- Not applicable/Not provided. Based on the description of 4+ band frequency decomposition, this is likely a rule-based or algorithmic image processing software rather than a machine learning model that relies on a labeled training set for learning. If it did involve machine learning, the mechanism for establishing ground truth for training would be crucial, but it's not discussed here.

Summary

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Carestream Health, Inc Diane Koetter Sr. Manager, Regulatory Affairs and Quality Systems 150 Verona Street Rochester, New York 14608

June 21, 2018

Re: K180809

Trade/Device Name: Eclipse II Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MOB Dated: March 23, 2018 Received: March 28, 2018

Dear Diane Koetter:

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 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);

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Page 2 - Diane Koetter

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael D. O'Hara For

Robert A. 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) K180809

Device Name Eclipse II

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Carestream

"510(k) Summary"

510(k) Owner Name:510(k) Owner Address:	Carestream Health, Inc.150 Verona StreetRochester, New York 14608
510(k) Owner Phone:510(k) Owner Fax:	585-627-6505585-627-8802
Contact Person & Info:	Diane KoetterSr. Manager, Regulatory Affairs and Quality Systemsdiane.koetter@carestream.com585-627-6505
Date Summary Prepared:	June 18, 2018
Device Trade Name:Device Common Name:Classification Name:	Eclipse IISolid State X-Ray Imager (Flat Panel/Digital Imager)Stationary x-ray system
Device Class:Device Code:Regulation Number:	Class IIMQB21 CFR 892.1680
Predicate Devices:	Kodak Eclipse Image Processing SoftwareManufactured by: Eastman Kodak Company510(k) No.: K060137 (March 16, 2006)

Device Description:

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Indications for Use / Intended Use:

The Indications for Use for the device, as described in its labeling, are:

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

The intended use for this device, as determined by descriptions and the proposed labeling contained in this submission, is similar to the Indications for Use statement provided above.

The subject device's proposed Indications for Use are different from the predicate device. The indications for K060137 are outdated as the statement refers primarily to a computed radiography base product. Therefore, this traditional 510(k) for Eclipse II is proposing an entirely new Indication for Use statement for the modified software device. The proposed Indications for Use of the subject device fall within the Intended Use of the predicate device and can be considered for substantial equivalence. Any variation in features or technical specifications have been identified and addressed through testing (described below) to support a substantial equivalence determination.

Comparison of Technological Characteristics:

Based upon information provided within this submission, we believe that the Eclipse II is substantially equivalent to the legally marketed Eclipse (predicate device). The Eclipse II image processing software, like the original Eclipse image processing software, enhances projection radiography acquisitions captured from digital radiography imaging receptors (computed radiography (CR) and direct radiography (DR)).

The image processing chain is the same for both the predicate and the subject devices. It involves segmenting the image into anatomically relevant image areas and decomposing the image into frequency bands. The frequency bands are enhanced and recombined resulting in the production of an improved diagnostic quality image. The original Eclipse (predicate) software utilizes a 4 frequency band decomposition method. The Eclipse II (subject) software uses a 4 or more frequency band decomposition method. The additional number of bands allows for flexibility in frequency adjustments.

Discussion of Testing

The performance characteristics and operation / usability of the Eclipse II software were evaluated in non-clinical (bench) testing. These studies demonstrated the intended workflow, related performance, overall function, verification and validation of requirements for intended use, and reliability of the software. Non-clinical test results have demonstrated that the device conforms to its specifications.

A clinical Reader Study was performed. Results of the Reader Study demonstrate that the Eclipse II Software provides diagnostic quality images.

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.