CuriePACS (Dicom PACS Software) Software is a software device that receives digital images and data from various sources (Computed Radiography, Magnetic Resonance Imaging, Ultrasound, Endoscopy, Computed Tomography, Digital X-Ray Mammography, Nuclear Medicine Imaging, Secondary Capture, Radio Fluoroscopy, X-Ray or other Angiograms such as CT Angio). Images and data can he captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Description

CuriePACS is a comprehensive solution for Dicom imaging needs. This scalable PACS solution provides electronic viewing, storage and communication in a secure environment. The device consists of: 1. Dicom Server (MD Athena) - For storage and connectivity with all the modalities and 2. Image Viewer (MD Vision) - To connect to the server and retrieve images based on search criteria and other workflow requirements. Image modalities supported: CR. CT. DX. MG. MR. NM. RF. SC. US. XA (x-ray), and ES.

AI/ML Overview

The provided FDA 510(k) summary for CuriePACS (K102148) describes a Picture Archiving and Communication System (PACS) software. A PACS system is primarily for viewing, storing, and communicating medical images, and not typically an AI-powered diagnostic device that produces specific performance metrics like sensitivity, specificity, or accuracy in detecting disease. Therefore, the information requested regarding acceptance criteria and a study proving performance in the context of diagnostic accuracy, human reader improvement with AI, or standalone algorithm performance, is not generally applicable to this type of submission.

Instead, the acceptance criteria for a PACS system like CuriePACS would revolve around its ability to:

Receive, store, communicate, process, and display DICOM-compliant medical images and data from various modalities.
Maintain data integrity and security.
Provide image processing tools (e.g., brightness/contrast, zoom, pan, measurements).
Meet system requirements and compatibility with specified hardware.
Adhere to relevant regulatory standards (e.g., DICOM 3 compliance).
Demonstrate substantial equivalence to a legally marketed predicate device.

The study that proves the device meets these types of acceptance criteria for a PACS system is typically a combination of non-clinical tests, primarily focusing on software validation and risk analysis, rather than clinical efficacy studies with patient data.

Here's an attempt to structure the answer based on the provided document and the understanding of PACS submissions:

Acceptance Criteria and Device Performance for CuriePACS (K102148)

Based on the provided 510(k) summary (K102148) for CuriePACS (Dicom PACS Software), the acceptance criteria and the study conducted are focused on its functionality as a PACS system rather than a diagnostic AI device. The primary method for demonstrating safety and effectiveness is through a comparison to a legally marketed predicate device and non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a PACS software, the "acceptance criteria" are derived from its intended use, technological characteristics, and comparison to the predicate device. "Device performance" refers to its demonstrated capabilities through testing and its stated specifications.

Acceptance Criteria (Inferred)	Reported Device Performance/Characteristics
DICOM 3 Compliance & Multimodality Connectivity (Ability to receive and store images from various sources)	Connects all DICOM Modalities (CR, CT, DX, MG, MR, NM, RF, SC, US, XA, ES). Receives digital images and data from Computed Radiography, Magnetic Resonance Imaging, Ultrasound, Endoscopy, Computed Tomography, Digital X-Ray Mammography, Nuclear Medicine Imaging, Secondary Capture, Radio Fluoroscopy, X-Ray, or other Angiograms (CT Angio).
Image Processing Tools (Basic manipulation and measurement capabilities)	Supports: Stack, Window/Level, Zoom, Pan, Magnifying Glass, Probe, Spatial Locator, Draw Shutter, Ruler, Elliptical ROI, Rectangular ROI, Polygonal ROI, Text Area, Text Callout, Protractor.
Data Handling (Capture, storage, communication, processing, display across networks)	Images and data can be captured, stored, communicated, processed, and displayed within the system and/or across computer networks at distributed locations.
Security	SSL Encryption.
Compatibility with Standard Hardware/Software	Runs on Microsoft® Windows® XP SP2+ or Vista SP1+, .Net Framework 3.5 SP1, Internet Explorer 7+. Requires Intel Core 2 Duo, 320 GB HDD, 2 GB RAM (Min), graphics card with min 1440x900 resolution (DVI out), Gigabit Ethernet Adaptor.
Mammography Handling (Specific restrictions for mammographic images)	"Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA." (This is a condition of use rather than a performance metric of the software itself).
Equivalence to Predicate Device	The device is deemed "substantially equivalent" to the Voyager PACS System (Voyager Imaging, K062062) in indications for use, key features, multimodality connectivity, image sources, target hardware, image processing tools, and security.

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

The 510(k) summary does not mention a clinical 'test set' with patient data, as this is typically not required for PACS software. The "test set" for this type of device would refer to the internal software verification and validation activities.

Test Set Sample Size: Not specified in terms of patient data. The testing involves DICOM 3 compliance testing and bench testing (software validation and risk analysis). This typically means the software was tested with a variety of DICOM images (potentially synthetic or anonymized real-world images) and data structures to ensure proper handling, display, and functionality. The number of such test cases or images is not detailed.
Data Provenance: Not applicable in the context of patient data for diagnostic performance. The data used for testing would be standard DICOM files and simulated scenarios.

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

This information is not applicable to this 510(k) submission. A PACS system primarily handles and displays images; it does not perform diagnostic interpretation or generate reports that require expert ground truth for evaluating diagnostic accuracy. The "ground truth" for a PACS system is adherence to technical standards (e.g., DICOM) and correct software functionality.

4. Adjudication Method for the Test Set

Not applicable. Since there is no clinical "test set" requiring diagnostic interpretation or a human-in-the-loop component for evaluating diagnostic performance, no adjudication method (e.g., 2+1, 3+1) is mentioned or implied.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. Such studies are typically conducted for AI-powered diagnostic aids to assess human reader performance with and without AI assistance. CuriePACS is a PACS system, not an AI diagnostic tool, so this type of study is not relevant to its 510(k) submission. Therefore, no effect size for human reader improvement is reported.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study was not done in the context of diagnostic accuracy (e.g., sensitivity, specificity). CuriePACS is not an algorithm that provides diagnostic results; it is a software platform for image management. Its "performance" is evaluated based on its functional compliance and equivalence to a predicate device.

7. Type of Ground Truth Used

The "ground truth" for the testing of CuriePACS is based on:

DICOM 3 standards compliance: Ensuring the software correctly handles and displays DICOM-formatted images and data according to the industry standard.
Functional specifications: Verifying that all programmed features (e.g., image manipulation tools, storage, communication) work as intended.
Risk analysis: Ensuring potential software hazards are identified and mitigated.

There is no "expert consensus, pathology, or outcomes data" ground truth as this device does not perform diagnosis.

8. Sample Size for the Training Set

Not applicable. CuriePACS is a PACS software, not a machine learning or AI algorithm that requires a "training set" of data for model development.

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

Not applicable. As a PACS software, there is no "training set" in the context of machine learning, and thus no ground truth establishment process for such a set.

Summary

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510(K) Summary K102148

Moksha Digital Software PVT Limited #1611, Janardhana Towers, 7th Cross, 19th Main, Sector 1, HSR Layout, Bangalore 560034, India Phone : +91 (80) 4110 1208 Fax : +91 (80) 4110 1824 E-mail : sales@mokshadigital.com Contact: Deepak Sharma, Managing Director Date prepared: August 12, 2010

AUG 1 7 2010

1 . Trade Name: CuriePACS Dicom PACS Software Common Name: PACS Software Classification Name: System, image processing, radiological
1. Regulation Description Picture archiving and communications system, product code LLZ, Regulation: 892.2050 Class of device: Class II.
1. The legally marketed device to which we are claiming equivalence Voyager PACS System, Voyager Imaging, K062062.
1. Description of device: CuriePACS is a comprehensive solution for Dicom imaging needs. This scalable PACS solution provides electronic viewing, storage and communication in a secure environment. The device consists of: 1. Dicom Server (MD Athena) - For storage and connectivity with all the modalities and 2. Image Viewer (MD Vision) - To connect to the server and retrieve images based on search criteria and other workflow requirements. Image modalities supported: CR. CT. DX. MG. MR. NM. RF. SC. US. XA (x-ray), and ES.
న. Indications for use: CuriePACS (Dicom PACS Software) Software is a software device that receives digital images and data from various sources (Computed Radiography, Magnetic Resonance Imaging, Ultrasound, Endoscopy, Computed Tomography, Digital X-Ray Mammography, Nuclear Medicine Imaging, Secondary Capture, Radio Fluoroscopy, X-Ray or other Angiograms such as CT Angio). Images and data can he captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA.
Technological characteristics: The software is installed on a network connected PACS server 6. with the following minimum requirements:
- Microsoft® Windows® XP Service Pack 2 or above .
- Microsoft® Windows® Vista Service Pack 1 or above .
- . Microsoft .Net Framework 3.5 SP1
- Microsoft Internet Explorer 7 or above .
- Intel Core 2 Duo Processor .
- 320 GB HDD .

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2 GB RAM (Min) •
Dedicated or Onboard Graphics card with minimum 1440 x 900 resolution and DVI output. •
. Gigabit Ethernet Adaptor
. Display: The display used for diagnosis purposes should be FDA approved self calibrating medical grade monitor which is driven by a digital input (DVI output from graphics card).

Characteristic	Predicate DeviceVoyager PACS System, VoyagerImaging, K062062	CuriePACS (Dicom PACS Software)(This submission)
Indications forUse	Voyager PACS System is a software based device that receives digital images and data fromvarious sources (i.e. CT scanners, MR scanners,ultrasound systems, R/F Units,computed & direct radiographic devices.secondary capture dev ices, scanners, imaginggateways, etc.). Images and data can becaptured, stored, communicated, processed anddisplayed within the system and or acrosscomputer networks at distributed locations.Lossy compressed mammographic images anddigitized film screen images must not bereviewed for primary image interpretation.Mammographic images may only be interpretedusing an FDA approved monitor that offers atleast 5 Mpixel resolution and meets othertechnical specifications reviewed and acceptedby FDA.	CuriePACS (Dicom PACS Software) Softwareis a software device that receives digitalimages and data from various sources(Computed Radiography, Magnetic ResonanceImaging, Ultrasound, Endoscopy, ComputedTomography, Digital X-Ray Mammography,Nuclear Medicine Imaging, SecondaryCapture, Radio Fluoroscopy, X-Ray or otherAngiograms such as CT Angio). Images anddata can be captured, stored, communicated,processed and displayed within the system andor across computer networks at distributedlocations. Lossy compressed mammographicimages and digitized film screen images mustnot be reviewed for primary imageinterpretation. Mammographic images mayonly be interpreted using an FDA clearedmonitor that offers at least 5 Megapixelresolution and meets other technicalspecifications reviewed and accepted by FDA.
Use, key featureConnection	Medical professionals, WEB basedWEB and Ethernet	SAME
MultimodalityConnectivity,DICOMcompatibility	Voyager PACS can receive with easeany DICOM compliant image,irrespective of the source	Connect all DICOM Modalities CR,CT, DX, MG, MR, NM, RF, SC,US, XA (x-ray), and ES.
Image Sources	Dicom, JPEG and JPEG 2000 compliant	SAME
Target hardware	PC compatible	SAME
Image ProcessingTools	• Brightness/ Contrast• Mouse button operation for quickimage manipulation • Selectablemultiple image view• Magnify, zoomand pan• Flip (left/ right, top/bottom)and rotate• Image inversion• Measurement and angles	All processing tools Stack,Window/Level, Zoom, Pan,Magnifying Glass, Probe, SpatialLocator, Draw Shutter, Ruler,Elliptical ROI, Rectangular ROI,Polygonal ROI, Text Area, TextCallout, Protractor.
Security	SSL Encryption	SAME

7. Comparison Table

Performance: The results of nonclinical tests submitted showing Dicom 3 compliance, 8. along with bench testing (software validation and risk analysis) shows that this new device has equivalent indications and performs in an equivalent fashion to the named predicate. Therefore this device poses no new issues of safety or effectiveness, and is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.

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

Moksha Digital Software PVT Limited % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313

AUG 1 7 2010

Re: K102148

Trade/Device Name: CuriePACS (Dicom PACS Software) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and Communications System Regulatory Class: II Product Code: LLZ Dated: July 29, 2010 Received: July 30, 2010

Dear Mr. Job:

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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Enclosure

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 809), please contact the Office 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 Division 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/industry/support/index.html.

Sincerely yours,

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Indications for Use

K102148

510(k) Number (if known): K102148.

Device Name: CuriePACS (Dicom PACS Software)

Indications For Use:

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA.

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)

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510K K102148

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).