The AETmed Medical image processing Software is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and communicating medical images, such as cardiac catheterization, echo-cardiography, and general radiological studies.

Device Description

The Version 3.0 DICOMed Family Software System consists of the following components:

DICOMed DIG.IT image acquisition and CD recording station
DICOMed P@CS image archiving manager
DICOMed Review Cardio review workstation for cardiology
DICOMed Review diagnostic review workstation for radiology

AI/ML Overview

The provided text is a 510(k) summary for the AETmed Image Processing Software. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria.

Therefore, many of the requested items cannot be extracted directly from this document. The document primarily uses a Substantial Equivalence Comparison Chart (Table 1) to compare the features of the AETmed Image Processing Software with predicate devices. This comparison implicitly serves as the "study" for acceptance, indicating that if the new device has comparable or superior features to legally marketed predicate devices, it is considered substantially equivalent.

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

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

The document does not explicitly state "acceptance criteria" in the traditional sense of measurable performance metrics with thresholds. Instead, it demonstrates "substantial equivalence" by comparing device features with legally marketed predicate devices. The "reported device performance" is implicitly shown through this feature comparison.

Feature	Acceptance Criteria (Implied: Substantially Equivalent to Predicates)	Reported Device Performance (AETmed Image Processing Software)
Manufacturer	AETmed	AETmed
Classification	892.2050; Class II	892.2050; Class II
Intended Use	Comparable to predicates for medical image capture, viewing, processing, archiving, and communication for cardiac catheterization, echocardiography, and general radiological studies.	Capturing, retrieving, viewing, processing, printing, archiving, and communicating medical images (cardiac catheterization, echo-cardiography, general radiological studies). Similar to predicates.
Graphical User Interface	Yes	Yes (Matches predicates)
Platform	PC	PC (Matches predicates)
Operating System	Windows NT, Windows 2000 (at least Windows NT as per predicates)	Windows NT, Windows 2000 (Broader than one predicate, similar to another)
Display Resolution	Up to 2048x2560 (Comparable to leading predicates)	Up to 2048x2560 (Matches leading predicates)
Gray scale resolution	From 8 bits, 256 levels to 24 bits true color (Comparable to leading predicates)	From 8 bits, 256 levels to 24 bits true color (Matches leading predicates)
Multi-monitor support	Yes	Yes (Matches predicates)
Patient Demographics	Yes	Yes (Matches predicates)
Networking	TCP/IP	TCP/IP (Matches predicates)
Image Communication	DICOM Compliant	DICOM Compliant (Matches predicates)
DICOM Compliant	Yes	Yes (Matches predicates)
Image Compression	JPEG loss-less (at least)	JPEG loss-less (Comparable/matches some predicates)
Video signals grabbing	Yes	Yes (Matches predicates)
Analogic Video Input format	525, 625, 1023, 1049, 1249; interlaced or progressive (Comparable to predicates)	525, 625, 1023, 1049, 1249; interlaced or progressive (Matches one predicate, exceeds another)
Analogic Video Input rate	<= 30 fps	<= 30 fps (Matches predicates)
Image Archiving (Hard Disk)	Yes	Yes (Matches predicates)
Image Archiving (Removable media)	CD-R, MOD, DVD, DLT, other DICOM Entities (Comparable to predicates)	CD-R, MOD, DVD, DLT, other DICOM Entities (Broader than one predicate, similar to others)
Image Review	Still images, cine-loops, Window, level, zoom, magnifying lens, Configurable layout (Comparable to predicates)	Still images, cine-loops, Window, level, zoom, magnifying lens, Configurable layout (Similar to predicates)
Image Processing	Annotations, Distances, Angles, Pixel Values, Pixel Distribution, Grey level statistics, Quantitative Coronary Analysis, Left Ventricle Analysis (Comparable to leading predicates)	Annotations, Distances, Angles, Pixel Values, Pixel Distribution, Grey level statistics, Quantitative Coronary Analysis, Left Ventricle Analysis (Matches a leading predicate, exceeds others)
3D Image Processing	MPR, MIP, mip, Volume rendering (Comparable to leading predicates)	MPR, MIP, mip, Volume rendering (Matches a leading predicate, exceeds others)
Quality Control	Yes	Yes (Matches known predicates)
Workflow Management	Yes	Yes (Matches known predicates)
Image Database	Yes	Yes (Matches predicates)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not describe a "test set" in the context of a performance study with patient data. It is a comparison of product features. Therefore, this information is not applicable and not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable as no "test set" with ground truth established by experts is described for a performance study. The ground truth for feature comparison is the specifications of the predicate devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no test set or adjudication process for clinical performance is described.

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 comparative effectiveness study is mentioned or implied. The device is image processing software, not an AI diagnostic tool designed to assist human readers in a diagnostic task that can be quantified with an effect size.

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

The device is image processing software intended for use by "qualified medical professionals." It is not described as a standalone diagnostic algorithm. The demonstration of substantial equivalence focuses on functional features, not independent diagnostic performance.

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

The document does not report a ground truth based on clinical data or expert consensus in relation to diagnostic accuracy. The "ground truth" for the substantial equivalence claim is the features and specifications of the predicate devices.

8. The sample size for the training set

Not applicable. The document describes image processing software, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for a machine learning model described.

Summary

{0}------------------------------------------------

K012093

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

AETmed, S.p.A. Viale Cembrano, 4C 16148 Genova, Italy Phone: 39010307091 390103070937 Facsimile: Contact Person: Massimiliano Peri April 30, 2001 Date: 807.92(a)(2) Trade Name: AETmed Image Processing Software Common Name: Image Processing Software Classification Name(s): System, Image Processing Classification Number: LLZ 807.92(a)(3) Predicate Device(s) Electromed View NT K000474 Applicare Radworks Medical Imaging K982862 Software with Quality Control Module Cemax-Icon Accurad Image management System; K955092

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

AutoRad Regustr

{1}------------------------------------------------

807.92(a)(4)

Device Description

The AETmed Medical image processing Software is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and mard ware planeral, tor cardiac cathererization, echocardiography, and general radiological studies.

The Version 3.0 DICOMed Family Software System consists of the following components:

DICOMed DIG.IT image acquisition and CD recording station o
DICOMed P@CS image archiving manager o
DICOMed Review Cardio review workstation for cardiology o
DICOMed Review diagnostic review workstation for radiology o

{2}------------------------------------------------

807.92(a)(5)

Intended Use(s)

{3}------------------------------------------------

Feature	Product	AETmed ImageProcessing software(This submission)	VIEW NTTM	Radworks MedicalImaging Softwarewith Quality ControlModule
Manufacturer	AETmed	Electromed	Applicare	Cemax Icon
510(k) Number	K000474	K982862	K955092
Classification	892.2050; Class II	892.2050; Class II	892.2050; Class II	892.2050; Class II
Intended Use	The AETmed Medicalimage processingSoftware is a softwaredevice intended to beused by qualifiedmedical professionals,after proper installationon an appropriatehardware platform, forcapturing, retrieving,viewing, processing,printing, archiving, andcommunicatingmedical images, suchas cardiaccatheterisation, echo-cardiography, andgeneral radiologicalstudies.	VIEW NT is apowerful real-timecardiac imageacquisition, display,processing andcommunication systemenhancing theperformance of aCathlab and itsconnection to theDigital ImageArchiving network.Both QuantitativeCoronary Analysis andVentricular AnalysisSoftware's are includedwith the VIEW NT.	The RadWorksMedical ImagingSoftware, fromApplicare MedicalImaging, B.V., wheninstalled on anappropriate hardwareplatform, is intended toprovide capability forthe acceptance, display,storage, and digitalprocessing of medicalimages. Options allowfor additionalcapability, includingtransmission of imagesover local areanetworks or publiccommunicationschannels, digitizationof film images,acceptance of digitalimages directly fromdifferent medical imagemodalities, and qualitycontrol review andrevision of studies.	Cemax Icon providesPACS, computedradiography andteleradiology software.The software isscalable and addressesall aspects of medicalimage acquisition,viewing, storage andprinting.
Graphical UserInterface	Yes	Yes	Yes	Yes
Platform	PC	PC	PC	Workstation
Operating System	Windows NT,Windows 2000	Windows NT	Windows NT	UNIX
Display Resolution	Up to 2048x2560	1024x768	Up to 2048x2560	Up to 2048x2560

Feature
Product	AETmed ImageProcessing software(This submission)	VIEW NTTM	Radworks MedicalImaging Softwarewith Quality ControlModule	Accurad ImageManagement System,AutoRad Regustr
Gray scale resolution	From 8 bits, 256 levelsto 24 bits true color	8 bits, 256 levels	From 8 bits, 256 levelsto 24 bits true color	From 8 bits, 256 levelsto 24 bits true color
Multi-monitorsupport	Yes	Yes	Yes	Yes
Patient Demographics	Yes	Yes	Yes	Yes
Networking	TCP/IP	TCP/IP	TCP/IP	TCP/IP
ImageCommunication	DICOM Compliant	DICOM Compliant	DICOM Compliant	DICOM Compliant
DICOM Compliant	Yes	Yes	Yes	Yes
Image Compression	JPEG loss-less	JPEG loss-less, JPEGlossy	JPEG loss-less, JPEGlossy	JPEG loss-less, JPEGlossy
Video signalsgrabbing	Yes	Yes	Yes	Unknown
Analogic Video Inputformat	525, 625, 1023, 1049,1249; interlaced orprogressive	525, 625, 1023, 1049,1249; interlaced orprogressive	525, 625; interlaced orprogressive	N/A
Analogic Video Inputrate	<= 30 fps	<= 30 fps	< 30 fps	N/A
Image Archiving(Hard Disk)	Yes	Yes	Yes	Yes
Image Archiving(Removable media)	CD-R, MOD, DVD,DLT, other DICOMEntities	CD-R, other DICOMEntities	CD-R, MOD, DVD,DLT, other DICOMEntities	CD-R, MOD, DVD,DLT, other DICOMEntities
Image Review	Still images, cine-loops, Window, level,zoom, magnifying lens,Configurable layout	Still images, cine-loops, Window, level,zoom, magnifying lens	Still images, cine-loops, Window, level,zoom, magnifying lens,Configurable layout	Still images, cine-loops, Window, level,zoom, magnifying lens,Configurable layout
Image Processing	Annotations, Distances,Angles, Pixel Values,Pixel Distribution,Grey level statistics,Quantitative CoronaryAnalysis, LeftVentricle Analysis	Annotations, Distances,Angles, Pixel Values,Pixel Distribution,Grey level statistics,Quantitative CoronaryAnalysis, LeftVentricle Analysis	Annotations, Distances,Angles, Pixel Values,Pixel Distribution,Grey level statistics	Annotations, Distances,Angles, Pixel Values,Pixel Distribution,Grey level statistics
3D Image Processing	MPR, MIP, mip,Volume rendering	No	MPR, MIP, mip,Volume rendering	Unknown
Quality Control	Yes	Unknown	Yes	Yes
Workflowmanagement	Yes	Unknown	Yes	Yes
Image Database	Yes	Yes	Yes	Yes

Table 1 – Substantial Equivalence Comparison Chart

{4}------------------------------------------------

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three horizontal lines extending from its head, representing the department's mission to protect and promote the health and well-being of Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 2001

AETmed S.P.A. % Ms. Colleen Hittle Partner The Anson Group, LLC 7992 Castleway Drive INDIANAPOLIS IN 46250 Re: K012093

Trade/Device Name: AETmed Image Processing Software PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications Sys Regulatory Class: II Product Code: 90 LLZ Dated: July 3, 2001 Received: July 5, 2001

Dear Ms. Hittle:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encreated of the enactment date of the Medical Device Amendments, or to commerce pror to thay 20, 1978, as tax can and with the provisions of the Federal Food, Drug, do noos mat hat ( 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 r ou may, diererors, mainer and act include requirements for annual registration, listing of general controls proficiting 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 your dovies is classified not one of . Existing major regulations affecting your device can be it may be subject to additions, 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 I reaso be devised that I Dr resean that your device complies with other requirements of the Act that I Dr Has Intact and regulations administered by other Federal agencies. You must or car) I vith all the Act's requirements, including, but not limited to: registration and listing oonly - nattan and 1100 included to the Part 801); good manufacturing practice requirements as set (21 OF ICP art 807), accommy (21 CFR Part 820); and if applicable, the electronic rently and quinny by of the provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

{6}------------------------------------------------

This letter will allow you to begin marketing your device as described in your 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 this 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" (21 CFR Part 807.97). 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 yours,

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

{7}------------------------------------------------

Indications for Use Statement

Applicant: AETmed, S.p.A.

510(k) Number (if known): __ KO12093

Device Name: AETmed Medical image processing software

Indications For Use:

The AETmed Medical image processing Software is a software device intended to be used by THE ALT HEC Medical medically of the proper installation on an appropriate hardware platform, for capturing, retrieving, viewing, processing, printing, archiving, and communicating medical capturing, retrioving, nowlig, provised graphy, and general radiological studies.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over The Counter Prescription Use

(Per 21 CFR. 801.109)

(Optional Format 1-2-96)

Nancy C. Beagdon

(Division Sign-Off
Division of Reproductive, Abdominel,
and Radiological Devices
510(k) Number K012093

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).