Medsynapse PACS Software is a WEB software based device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices. secondary capture devices, scanners. imaging gateways, etc.). 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

Medsynapse is a web PACS, which allows distribution of images within and outside the Hospital using networking technology. It does not require installation of any software and can be operated directly from the browser providing ease of use from anywhere.

AI/ML Overview

The provided document is a 510(k) summary for the Medsynapse PACS Software. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, performance data from a clinical or technical study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for such studies.

Instead, the document focuses on:

Device Description: What the Medsynapse PACS Software is, its function as a web-based PACS for image distribution, and its technological characteristics (minimum hardware/software requirements for server and client).
Indications for Use: How the device is intended to be used (receiving, capturing, storing, communicating, processing, and displaying digital images and data from various sources). It also explicitly states limitations for mammographic image review.
Substantial Equivalence Claim: The device claims substantial equivalence to the Voyager PACS System (K062062).
Performance Statement: A general statement about "bench testing (software validation and risk analysis)" indicating "no new issues of safety or effectiveness."

Therefore, many parts of your request cannot be fulfilled as the information is not present in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

Acceptance Criteria and Device Performance

The document states that the results of "bench testing (software validation and risk analysis)" show that the device "poses no new issues of safety or effectiveness, and is therefore substantially equivalent to the predicate device."

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Safety	Poses no new issues of safety.
Effectiveness	Poses no new issues of effectiveness.
Substantial Equivalence	Deemed substantially equivalent to the predicate device (Voyager PACS System, K062062).

2. Sample size used for the test set and the data provenance

Sample Size: Not specified.
Data Provenance: Not specified. The document only mentions "bench testing (software validation and risk analysis)," which typically refers to in-house technical testing, not necessarily clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The document does not describe any test set where ground truth established by experts would be relevant (e.g., a clinical validation study).

4. Adjudication method for the test set

This information is not provided. There's no mention of a test set requiring adjudication in the context of expert review.

5. 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

No MRMC study was mentioned or performed. This device is a PACS software, not an AI-assisted diagnostic tool.

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

The document implies general software validation and risk analysis ("bench testing") but does not detail a "standalone" performance study in the context of diagnostic accuracy for an algorithm. The device itself is an image management system, not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not specified. Given the nature of "bench testing," the "ground truth" would likely be adherence to technical specifications, software functionality, and data integrity, rather than clinical ground truth from patient data.

8. The sample size for the training set

Not applicable. This device is a PACS software, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This device is a PACS software, not a machine learning model that requires a training set with established ground truth.

Summary

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1093247

510(K) Summary K09

DEC - 2 2009

Medsynaptic Private Ltd 47/6, "Vasantika", Opp Yena Bungalow, Paud Road, Kothrud, Pune - 411038, India Tel: 91 - 20 - 25443349 / 25443913 Fax: 91 - 20 - 25443913 URL: http://www.medsynaptic.com Contact: Dr Ashish Dhawad Chief Executive Officer Date prepared: July 23, 2009

1. Trade Name: Medsynapse PACS Software
1. Common Name: PACS Software
1. Classification Name: system, image processing, radiological
Regulation Description Picture archiving and communications system, product code 4. LLZ, Regulation: 892.2050 Class of device: Class II.
ട. The legally marketed device to which we are claiming equivalence Voyager PACS System, Voyager Imaging, K062062.
1. Description of device: Medsynapse is a web PACS, which allows distribution of images within and outside the Hospital using networking technology. It does not require installation of any software and can be operated directly from the browser providing ease of use from anywhere.
Indications for use: Medsynapse PACS Software is a WEB software based device that 7. receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices. secondary capture devices, scanners. imaging gateways, etc.). 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.
1. Technological characteristics: The software is installed on a web connected PACS server with the following minimum requirements:

A) Minimal Hardware Requirement

1. Intel Xeon Quad core Processor 3.0 GHz
1. Intel Server Mother Board
1. 4 GB Fully Buffered ECC RAM
1. 1 TB HDD
1. 1GbPS LAN Port

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B) Minimal Software Requirement

Windows Server 2003 Standard Edition
SQL server 2005 Standard Edition

The client computer requires web access using Internet Explorer with the following minimum configuration:

· Pentium IV core 2 duo processor @ 2.8 GHz or faster

· 1 GB of RAM or more

• High speed video graphic card which will support at least 1024x 768 of resolution in 32 bit color

• High resolution monitor with at least 1024 x 768 resolution support in 32 bit color

• MS Windows 2000, XP, 2003, Vista with MS Internet Explorer 6 or higher

Macintosh and other operating systems and internet browsers are not supported at this time

Internet connection: High speed (Broadband) internet connection with at least 512 KbPS of speed, such as wireless, DSL, Cable internet

Performance: The results of bench testing (software validation and risk analysis) shows 9. that this new device poses no new issues of safety or effectiveness, and is therefore 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 stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

Medsynaptic Private Ltd. % Mr. Daniel Kamm, P.E. Principal Consultant Kamm & Associates 8726 Ferrara Ct. NAPLES FL 34114

DEC - 2 2009

Re: K093247

Trade/Device Name: Medsynapse PACS Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system . Regulatory Class: II Product Code: LLZ Dated: October 7, 2009 Received: October 15, 2009

Dear Mr. Kamm:

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. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

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Page 2 -

Enclosure

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K09 22 47

Device Name:__Medsynapse PACS Software

Indications For Use:

Medsynapse PACS Software is a web software based device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices. secondary capture devices, scanners. imaging gateways, etc.).

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.

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 Device Evaluation (ODE)

Herbert Hoover

Page I of 1

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 09324 510(k) Number _

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).