The Ebit Sanità Org@nizer software is a medical image management software device intended to be used for digital acquiring, viewing, processing, archiving, reporting and communicating ultrasound medical studies by qualified medical professionals, after proper installation on an appropriate hardware platform.

This medical device is intended for the sole use of digital acquiring, viewing, processing, archiving reporting and communicating digital ultrasound studies. It does not have any influence in the way the medical image is produced, nor it is intended to control ionizing emissions or monitor vital physiological processes. The medical device is able to manage stand-alone or distributed medical image archives. It specifically provides the following added-value:

®Connecting diagnostic modalities for the purpose of centralising the image archiving for later image viewing, processing and reporting;

@Establishing distributed points of access on conventional PCs for distributed image and report viewing and access.

Device Description

The Ebit Sanità Org@nizer software is a medical Image Management software device used for digital acquisition, viewing, processing, archiving, reporting and communicating ultrasound studies.

AI/ML Overview

The provided text is related to a 510(k) submission for the "Ebit Sanità Org@nizer Software." This document describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain any information regarding specific acceptance criteria, study data proving performance, sample sizes, expert involvement, adjudication methods, or ground truth establishment.

The document is a regulatory submission for premarket notification, designed to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission generally relies on comparing specifications and intended use rather than performing new clinical efficacy studies with specific performance metrics.

Therefore, I cannot fulfill your request for the detailed table and study information because the provided text does not contain this information.

Here's what I can extract based on the available text (though it won't address most of your questions):

Device Name: Ebit Sanità Org@nizer Software
Intended Use: For digital acquiring, viewing, processing, archiving, reporting, and communicating ultrasound medical studies by qualified medical professionals on an appropriate hardware platform. It connects diagnostic modalities for centralized image archiving and establishes distributed access points for viewing and reporting.
Predicate Device: Applicare Radworks Medical Imaging Software with Quality Control Module (K982862)
Regulatory Class: II (under 21 CFR 892.2050, Picture archiving and communications system, Product Code 90-LLZ)

Missing Information (and why it's missing from this type of document):

Acceptance criteria and reported device performance: This document doesn't define quantitative acceptance criteria for image processing or display accuracy, as it's not a performance study. It establishes functional equivalence.
Sample size, data provenance: Not applicable in this context; no performance study is detailed.
Number of experts, qualifications, adjudication method: Not applicable; no ground truth establishment for a performance study.
MRMC comparative effectiveness study: Not conducted or reported in this submission.
Standalone performance study: Not conducted or reported in this submission. The "study" mentioned isn't a performance study of the algorithm/software, but rather a comparison for regulatory purposes.
Type of ground truth used: Not applicable; no performance study is detailed.
Training set sample size: The device is an image management software, not an AI/ML algorithm that requires a "training set" in the typical sense for medical image analysis.
Ground truth for training set: Not applicable for the same reason as above.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through a comparison of features and intended use with a predicate device, rather than providing data from a clinical performance study with specific acceptance criteria.

Summary

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K030363

510(k) Ebit Sanità Org@nizer Software Ebit Sanità, S.p.A.

MAR 2 7 2003

510(k) Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).

807.92(a)(1)

Submitter Information

Colleen Hittle Densmore, Official Correspondent
The Anson Group, an Aventor company
7992 Castleway Drive
Indianapolis, IN 46250

Phone:	(317) 849-1916
Facsimile:	(317) 577-9070

Contact Person: Colleen Hittle Densmore

Date:	January 15, 2003
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807.92(a)(2)

Trade Name:	Ebit Sanità Org@nizer Software
Common Name:	System, Image Processing

Classification:
Regulatory Class:	II

	FR Number	Product Code
Image Processing System	892.2050	90-LLZ

807.92(a)(3)
Predicate Device(s)

Applicare	Radworks Medical Imaging Software
	W/ Quality Control Module
	K982862

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

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510(k) Ebit Sanità Org@nizer Software Ebit Sanità, S.p.A.

807.92(a)(4)

Device Description

The Ebit Sanità Org@nizer software is a medical Image Management software device used for digital acquisition, viewing, processing, archiving, reporting and communicating ultrasound studies.

807.92(a)(5)

Intended Use(s)

The Ebit Sanita Org@nizer software is intended to be used for digital acquiring, viewing, processing, archiving, reporting and communicating ultrasound medical studies by qualified medical professionals, after proper installation on an appropriate hardware platform.

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Product	Ebit Sanità Org@nizerSoftware(This submission)	Applicare Medical ImagingRadworks Medical ImagingSoftware with Quality ControlModuleK982862
Classification	892.2050 LLZClass II	892.2050 LLZClass II
Intended use	The Ebit Sanità Org@nizer softwareis a medical image managementsoftware device intended to be usedfor digital acquiring, viewing,processing, archiving, reporting andcommunicating ultrasound medicalstudies by qualified medicalprofessionals, after properinstallation on an appropriatehardware platform	The RadWorks Quality Control Module isintended to be used by authorized staff toperform various quality control operations onRadWorks imaging studies before they are madeavailable to other locations on the network.These operations include confirming or editingpatient characteristics, reviewing the statushistory of the study, adding or removing images,combining with another study, renumberingimages, editing patient orientation information,and setting or editing routing information.
Graphic User Interface	Yes	Yes
Platform	PC	PC
Operating System	Microsoft Windowsbased	Microsoft Windowsbased
Display Resolution	1280x1024	2048x2560
Image Resolution	From 8 bits grayscale and 24 bitscolor	From 8 bits, 256 levels to 24 bits color
Image Communication	DICOM Compliant	DICOM Compliant
Image Compression	No image compression techniquesare utilized	Jpeg Loss-less;Jpeg lossy
Image Archiving (HardDisk)	Yes	Yes
Image Archiving(Removable Media)	CD-R; DVD-R, other Dicom Entities	CD-R; MOD; DVD-R, other Dicom Entities
Image Review	Still frame, Cine-loops, Window-level, Zoom, Panning, Configurablelayout	Still frame, Cine-loops, Window-Level, Zoom,Panning, Configurable layout
Image Processing	Annotation:text, lines	Annotation:arrows, text, lines, Circles
	Measurements: Distance, area,perimeter, velocity	Measurements: distances, angles, pixel values,pixel distribution, grey level statistics
Image Database	Yes	Yes
Image Management	Uncompressed / JPEG Lossy /JPEG Loss-less	Uncompressed / JPEG Lossy /JPEG Loss-less

Comparison Chart for Substantial Equivalence

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 2003

Ebit Sanita, S.p.A. % Ms. Colleen Densmore The Anson Group 7229 Castleway Drive INDIANAPOLIS IN 46250

Re: K030363

Trade/Device Name: Org(@nizer Version 3.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: January 31, 2003 Received: February 4, 2003

Dear Ms. Densmore:

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

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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Indications for Use Statement

Applicant:	Ebit Sanità S.p.A.
510(k) Number (if known):	K030363

Ebit Sanità Org@nizer Software Device Name:

Indication For Use:

®Connecting diagnostic modalities for the purpose of centralising the image archiving for later image viewing, processing and reporting;

@Establishing distributed points of access on conventional PCs for distributed image and report viewing and access.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use / OR Over The Counter _

(PER 21 CFR, 801 109)

(optional Format 1-2-96)

David A. Symm

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030363

510(K) FILE - ORG@NIZER SOFTWARE

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).