Acculmaging is a software module capable of taking an X-ray image generated by a CR or DR and producing a digitally enhanced image for projection radiography applications. Acculmaging is not indicated for use in mammography.

Device Description

Acculmaging is a Dynamic Link Library (DLL) module that takes a raw X-rav image generated by a CR or DR as its input and produces a fidelity-quality image for diagnostic purposes. It interfaces with radiological software to analyze digital image data and optimize the processing parameters applied to enhance detail and thus images' diagnostic quality. Acculmaging is not a standalone module and does not implement any user interfaces; it provides a dedicated image processing function to a top-level application running in the Microsoft Windows operating system. It is bound into a parent application that provides user interfaces and dynamically loads the DLL module, forming an integrated process; and, it can also be linked to a service module to provide the image processing service to other top-level applications.

AI/ML Overview

Here's an analysis of the acceptance criteria and study as described in the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Criteria/Question	Proposed Device Performance (Expert Opinion)
1. Are both sets of images (proposed device vs. predicate) of diagnostic-quality?	Expert's comparative review supports that both sets of images are of diagnostic-quality.
2. Are the images' features equivalent in terms of detail?	Expert's comparative review supports that the images' features are equivalent in terms of detail.

Study Details:

Sample Size used for the test set and the data provenance:
- Sample Size: Eight image sets were presented.
- Data Provenance: Not explicitly stated, but the context implies these were existing X-ray images, likely retrospective. No country of origin is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: One expert.
- Qualifications of Experts: The document states "an expert." No specific qualifications (e.g., years of experience, subspecialty) are provided.
Adjudication method for the test set:
- Adjudication Method: Not applicable. Only one expert reviewed the images, so no adjudication among multiple readers was performed.
If a multi-reader multicase (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:
- MRMC Study: No, an MRMC study was not done. The study involved a single expert comparing image sets processed by the proposed device and the predicate. It did not assess human reader performance improvement with AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: Yes, in a sense. The core of the study was a qualitative comparison of the output images from the Acculmaging software (proposed device) against images processed by the predicate device. The expert's role was to evaluate these processed images for diagnostic quality and detail equivalence, rather than using the software for a diagnostic task.
The type of ground truth used:
- Ground Truth: Expert opinion/consensus (from a single expert). The expert's answers to the two questions (diagnostic quality and equivalence of detail) served as the basis for the conclusion.
The sample size for the training set:
- Training Set Sample Size: Not provided. The submission focuses on the performance comparison for regulatory clearance, not on the development or training of the algorithm itself.
How the ground truth for the training set was established:
- Training Set Ground Truth: Not provided. As no information about a training set is given, the method for establishing its ground truth is also not mentioned.

Summary

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510(k) SUMMARY

K102849

NOV 2 3 2010

This 510(k) Summary provides the following information, in accordance with 21 CFR 807.92.

SUBMITTER'S INFORMATION [21 CFR 807.92(a)(1)]

Radiology Information Systems, Inc. (RADinfo SYSTEMS) 43676 Trade Center Place, Suite 100 Dulles, VA 20166 Prepared on September 27, 2010 Contact Person: E.J. Smith President, Smith Associates (Consultant to Submitter) 1468 Harwell Ave. Crofton, MD 21114

Phone: 888-729-9674

DEVICE NAME [21 CFR 807.92(a)(2)]

Proprietary Name: Acculmaging Common Name: Acculmaging Classification Name: Solid state x-ray imaging system Regulation Number: 21 CFR 892.1650 · Product Code: MQB Device Class: II

LEGALLY MARKETED PREDICATE DEVICE [21 CFR 807.92(a)(3)]

Company	Trade Name	510(k) Number
Kodak	Eclipse ImageProcessing Software	K060137

DEVICE DESCRIPTION [21 CFR 807.92(a)(4)]

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DEVICE INDICATION FOR USE [21 CFR 807.92(a)(5)]

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [21 CFR 807.92(a)(6)]

The Acculmaging image processing software module is substantially equivalent to the predicate device in both the aspects of the algorithm characteristics and the performance quality, as shown in the table below.

Characteristic	Proposed Device	Predicate Device
Intended use	Acculmaging is a softwaremodule capable of taking anX-ray image generated by aCR or DR and producing adigitally enhanced image forprojection radiographyapplications. Acculmaging isnot indicated for use inmammography.	The image processingsoftware, used with a clearedCR or DR device, providesdiagnostic quality images toaid physicians with diagnosis.This excludes mammographyapplications.
Materials	Software application	Software application
Where used	Radiology department andmedical imaging center	Radiology department andmedical imaging center
Technology	Software image processingalgorithms enhance the imagein both grayscale and K-space.	Software image processingalgorithms enhance the imagein both grayscale and K-space.
Performance	Performance data wascollected. The certification ofthe equivalence of theperformance between theproposed device and thepredicate device wasprovided.	Performance data wascollected. The certification ofthe equivalence of theperformance between theproposed device and thepredicate device wasprovided.
Image data source	CR reader or DR	CR reader or DR
Image data format
	The input and output imagepixel data is the raster data.The photometricrepresentation of the imagepixel data is provided.	The input and output imagepixel data is the raster data.The photometricrepresentation of the imagepixel data is provided.
	Operating systems	Microsoft Windows
	Noise reduction	The noise reduction isrealized with a weightedaverage of local image pixelvalues with a profile close toGaussian distribution. Inaddition, the mediate value ofadjacent pixels is picked up toreplace the value of a single-pixel random noise peak.
	Perceptual ToneScale (PTS),mapping the linearpixel value toperceptual tonescale.	The image pixel valueobtained from an imageacquisition instrument isusually related to the input X-ray intensity in a non-logarithmic function, typicallya linear or square-rootfunction. This pixel value ismapped to perceptual tone asa logarithmic-like function ofthe X-ray intensity at theimager detector. The low-intensity wing of the mappingfunction is modified from thelogarithmic function for arecovery from scattered light.
Edge Enhancement	The edge enhancement isrealized with a high-frequencyband-pass wavelet filter.	Although the detailedalgorithm is unknown, theprocessed image implies thatthe high-frequencycomponent is enhanced.
EnhancedVisualization	The enhanced visualizationprocessing increases the	The detailed algorithm isunknown. The processedimage indicates that a basic
Processing (EVP)	reducing its contrast, hencereducing the need for theradiologist to manipulate theimage. In the EVP, typicallythe DC component of theimage is suppressed while thegradient information of theimage is persisted.	DC component suppressionalgorithm is applied.
Signal-dependentalgorithm tooptimize localizedfeatures and noisereduction	Adaptive algorithms deal withnoise reduction and intensityenergy leaks.	The noise reduction isenhanced at the low-exposurearea.
Type of softwareprogram	A dynamic link library moduleas a part of the imageacquisition control program.	A component of the imageacquisition control program.

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COMPARISON OF DIFFERENCES

Characteristic	Proposed Device	Predicate Device
Indications for UseStatements	Acculmaging is a softwaremodule capable of taking anX-ray image generated by aCR or DR and producing adigitally enhanced image forprojection radiographyapplications. Acculmaging isnot indicated for use inmammography.	The CR Systems are compactlaser scanners capable ofreading the latent imageformed on a storage phosphorimaging plate and producing adigital image for projectionradiography applications. Thisexcludes mammographyapplications for the KodakEktascan Storage PhosphorReader and the KodakEclipse image ProcessingSoftware in the United States.

DISCUSSION OF NONCLINICAL TESTS [21 CFR 807.92(b)(1)]

Eight image sets were presented to an expert. The expert was asked to read these images and then answer the following questions:

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1. In your professional opinion, do you feel that both sets of images are of diagnostic-quality?
1. In your professional opinion, do you feel that the images' features are equivalent in terms of detail?

The answers provided by the expert's comparative review support substantial equivalence and show that the new device does not introduce questions of safety or effectiveness when compared with the predicate device.

DISCUSSION OF CLINICAL TESTS [21 CFR 807.92(b)(1)]

No clinical testing data is being submitted for this Premarket Notification submission.

CONCLUSION OF PERFORMANCE DATA ASSESSMENTS [21 CFR 807.92(b)(1)]

Based on the above comparisons and the comparative testing between the Acculmaging software module and the predicate device (Section 18) raises no new issues of safety and effectiveness.

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Image /page/5/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that suggest movement and flight. The overall design is simple and recognizable, conveying a sense of authority and trustworthiness.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Radiology Information Systems, Inc. % Mr. E.J. Smith Regulatory Consultant Smith Associates 1468 Harwell Ave. CROFTON MD 21114

AUG 23 2013

Re: K102849

Trade/Device Name: Acculmaging Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 29, 2010 Received: September 29, 2010

Dear Mr. Smith:

This letter corrects our substantially equivalent letter of November 23, 2010.

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

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements 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 notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 spositiv an Artice of In Vitro Diagnostic Device Evaluation and Safety 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 Four may of Small 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/industrv/support/index.html.

Sincerely Yours,

Janine M. Morris

Janine M. Morri Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

NOV 2 3 2010

510(k) Number (if known): Kl 0 2 8 4 9

Device Name: Acculmaging

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Boxico Evaluation (120E).

(Division Sign-Off)

Page 1 of

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
KOSKO

510K K162849

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).