(120 days)
ILUMAVision is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, PET or 3D Ultrasound.
It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, and distribute DICOM 3.0 compliant images, utilizing standard PC hardware.
Additionally, ILUMAVision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments.
ILUMAVision is not intended for use with mammography.
ILUMAVision is an image management software application used for the display and 3D visualization of medical image files obtained from scanning devices, such as computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET) or three-dimensional (3D) ultrasound.
ILUMAVision uses image filtering, 3D reconstruction and quantitative algorithms to view, measure, and annotate images. ILUMA Vision can be used to make panoramic images and to monitor treatment progress, capture images, bookmark certain items in a treatment, generate and edit reports, and export datasets. The application can also query and import images directly from a Picture Archiving and Communication System (PACS) over a TCP/IP network.
It distributes DICOM 3.0 compliant images, using standard personal computer (PC) hardware. Images can also be saved in JPEG format.
The software is intended to run on a personal computer (PC).
Here's an analysis of the provided text regarding the acceptance criteria and study for the ILUMAVision, v. 2.2 device:
1. A table of acceptance criteria and the reported device performance
Based on the provided document, ILUMAVision v.2.2 is a software application for medical imaging and 3D visualization. The submission is a 510(k) premarket notification asserting substantial equivalence to a predicate device (ILUMAVision v.2.0).
Therefore, the acceptance criteria are primarily focused on demonstrated equivalence to the predicate device and the successful implementation of new features, rather than quantitative performance metrics for diagnostic accuracy.
| Acceptance Criteria | Reported Device Performance (ILUMAVision v.2.2) |
|---|---|
| Maintain identical Indications for Use as predicate device (v.2.0) | Retains the same Indications for Use: display and 3D visualization of CT, MRI, PET, 3D Ultrasound; intended for medical professionals; preoperative software for dental implants, orthodontics, and surgical treatments; not for mammography. |
| Maintain compatibility with existing computer platforms | Minimum Requirement: Intel®-based PC running Microsoft® Windows® (No change). |
| Maintain communications protocols | TCP/IP (No change). |
| Maintain DICOM compliance | DICOM 3.0 (No change). |
| Maintain JPEG compliance | Images may be saved in JPEG format (No change). |
| Maintain input image format | DICOM 3.0 (No change). |
| Maintain output image format | DICOM 3.0 (No change). |
| Maintain image archive capabilities | Computer hard drive, CD, DVD. Added PACS capability to archiving. |
| Maintain image display specifications | Color/Grayscale CRT or LCD (No change). |
| Maintain printing capabilities | Print to standard PC connected printers (No change). |
| Implement new "Import from PACS" functionality | Functionality added and verified/validated. |
| Implement new "Export to PACS" functionality | Functionality added and verified/validated. |
| Maintain volume rendering features | Radiographic Projection, Surface rendering, Fly-through (No change). |
| Maintain image editing features | Multi-tissue opacity control, volume sculpting, segmentation (No change). |
| Maintain Region of Interest (ROI)/Volume of Interest (VOI) tools | 2D region and 3D volume of interest selection tools (No change). |
| Maintain 2D measurements | 2D measurement tools including distance and angle (No change). |
| Maintain 3D measurements | 3D measurement tools including distance and angle (No change). |
| Maintain implant planning tools | Tools for pre-surgical planning of dental implant placement (No change). |
| Stent Fabrication (Note: Predicate feature was not incorporated into final release) | Not a current feature (No change relative to predicate's actual final release). |
| Maintain Orthodontic Treatment Planning tools | Tools for planning orthodontic treatment (No change). |
| Implement new "Temporal Bone Module" | New feature added: used to isolate and examine the temporal bone. Verified/validated. |
| Implement new "Endoscope Module" | New feature added: allows the user to perform a virtual endoscopy. Verified/validated. |
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 provide details about a specific test set in the conventional sense (e.g., patient cases) for evaluating clinical performance. The validation discussed refers to the software verification and validation of features, not a clinical study on diagnostic accuracy. Therefore, information on sample size, country of origin, or retrospective/prospective nature of data for clinical testing is 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 provided in the document. As stated above, the validation appears to be software-centric rather than a clinical performance study requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
A multi-reader, multi-case (MRMC) comparative effectiveness study was not mentioned or described in the provided document. The device is a "Picture Archiving and Communications System" software with added visualization and planning features; it's not described as an AI-assisted diagnostic tool designed to improve human reader performance in the context of a clinical trial.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study focused on algorithmic output without human input was not mentioned or described. The device is a user-controlled visualization and planning tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the nature of the device (image management and visualization software) and the context of a 510(k) for substantial equivalence, the "ground truth" for its functionality would likely involve software testing protocols, functional verification against specifications, and validation that the new features (e.g., temporal bone module, virtual endoscopy, PACS import/export) operate as intended and produce expected visual outputs or measurements accurately. This is not "clinical ground truth" like pathology or expert consensus on a diagnostic finding, but rather proof that the software functions correctly. Specific details on how this functional ground truth was established are not detailed beyond the general statement "The additional software features have been suitably verified and validated."
8. The sample size for the training set
The document does not describe a machine learning algorithm requiring a "training set." Therefore, information on training set sample size is not applicable and not provided.
9. How the ground truth for the training set was established
As there is no mention of a machine learning component or a training set, this information is not applicable and not provided.
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APR 3 0 2010
Premarket Notification (510(k)) Summary
1. Sponsor Information
3M IMTEC
2401 North Commerce
Ardmore, OK 73401
Ginger Cantor, RAC Contact Person: Regulatory Affairs Specialist Phone Number: (651) 733-1317 FAX Number: (651) 737-9665 e-mail: gcantor@mmm.com Date of Summary: December 29, 2009
2. Device Name and Classification:
| Common or Usual Name: | Software application for medical purposes (diagnostic imaging) |
|---|---|
| Proprietary Name: | ILUMAVision, v. 2.2 |
| Classification Name: | Picture Archiving and Communications System, Class II device, 21 CFR §892.2050 |
| Performance Standards: | None |
3. Predicate Device:
ILUMAVision, version 2.0 (K081347)
ILUMAVision 2.2 510(k) 29 Dec 2009
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4. Description of Device:
ILUMAVision is an image management software application used for the display and 3D visualization of medical image files obtained from scanning devices, such as computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET) or three-dimensional (3D) ultrasound.
ILUMAVision uses image filtering, 3D reconstruction and quantitative algorithms to view, measure, and annotate images. ILUMA Vision can be used to make panoramic images and to monitor treatment progress, capture images, bookmark certain items in a treatment, generate and edit reports, and export datasets. The application can also query and import images directly from a Picture Archiving and Communication System (PACS) over a TCP/IP network.
It distributes DICOM 3.0 compliant images, using standard personal computer (PC) hardware. Images can also be saved in JPEG format.
The software is intended to run on a personal computer (PC).
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5. Intended Use/Indications for Use:
ILUMAVision is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, PET or 3D Ultrasound.
It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, and distribute DICOM 3.0 compliant images, utilizing standard PC hardware.
Additionally, ILUMAVision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments.
ILUMAVision is not intended for use with mammography.
Substantial Equivalent Determination 6.
Version 2.2 includes additional features of a temporal bone module, a virtual endoscope module and the functionality of exporting directly from the application
The additional software features have been suitably verified and validated; the table below identifies the equivalence between the modified ILUMAVision software (v. 2.2) and the cleared predicate ILUMA Vision software (v. 2.0).
While new features have been added, ILUMA Vision version 2.2 as modified in this pre-market notification submission has the same intended use, same intended users and indications for use as the predicate device ILUMA Vision version 2.0.
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| Feature | ILUMAVisionversion 2.0(Predicate- K081347) | ILUMAVisionversion 2.2(This submission) | Comment |
|---|---|---|---|
| Indications for Use | A software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, PET or 3D Ultrasound.Intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, and distribute DICOM 3.0 compliant images, utilizing standard PC hardware.Additionally, ILUMA Vision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments.ILUMA Vision is not intended for use with mammography. | A software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, PET or 3D Ultrasound.Intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, and distribute DICOM 3.0 compliant images, utilizing standard PC hardware.Additionally, ILUMA Vision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments.ILUMA Vision is not intended for use with mammography. | No change from original 510(k) |
| Computer Platform | Minimum Requirement:Intel®-based PC runningMicrosoft® Windows® | Minimum Requirement:Intel®-based PC runningMicrosoft® Windows® | No change from original 510(k) |
| Communications | TCP/IP | TCP/IP | No change from original 510(k) |
| DICOM Compliance | DICOM 3.0 | DICOM 3.0 | No change from original 510(k) |
| JPEG Compliance | Images may be saved in JPEG format | Images may be saved in JPEG format | No change from original 510(k) |
| Input Image Format | DICOM 3.0 | DICOM 3.0 | No change from original 510(k) |
| Output Image Format | DICOM 3.0 | DICOM 3.0 | No change from original 510(k) |
| Image Archive | Computer hard drive, CD, DVD | Computer hard drive, CD, DVD or PACS | Added PACS capability to archiving |
| Image Display | Color/Grayscale CRT or LCD | Color/Grayscale CRT or LCD | No change from original 510(k) |
ЗМ ІМТЕС
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| Substantial Equivalence Summary Table | |||||
|---|---|---|---|---|---|
| Feature | ILUMAVisionversion 2.0(Predicate- K081347)) | ILUMAVisionversion 2.2(This submission) | Comment | ||
| Printing | Print to standard PCconnected printers | Print to standard PCconnected printers | No change fromoriginal 510(k) | ||
| Import from PACS | Not in original 510k | New functionality | New feature | ||
| Export to PACS | Not in original 510k | New functionality | New feature | ||
| Volume Rendering | Radiographic Projection,Surface rendering, Fly-through | Radiographic Projection,Surface rendering, Fly-through | No change fromoriginal 510(k) | ||
| Image Edit | Multi-tissue opacitycontrol, volumesculpting, segmentation | Multi-tissue opacitycontrol, volumesculpting, segmentation | No change fromoriginal 510(k) | ||
| Region of Interest(ROI)/Volume of Interest(VOI) | 2D region and 3Dvolume of interestselection tools | 2D region and 3Dvolume of interestselection tools | No change fromoriginal 510(k) | ||
| 2D Measurements | 2D measurement toolsincluding distance andangle | 2D measurement toolsincluding distance andangle | No change fromoriginal 510(k) | ||
| 3D Measurements | 3D measurement toolsincluding distance andangle | 3D measurement toolsincluding distance andangle | No change fromoriginal 510(k) | ||
| Implant Planning | Tools for pre-surgicalplanning of dentalimplant placement | Tools for pre-surgicalplanning of dentalimplant placement | No change fromoriginal 510(k) | ||
| Stent Fabrication | Tools for pre-surgicalfabrication of stents toaid dental implantinsertion | Not a current feature-Note: Feature was neverincorporated into finalrelease of original clearedILUMA Vision, version2.0 | No change fromoriginal 510(k) | ||
| Orthodontic TreatmentPlanning | Tools for planningorthodontic treatment | Tools for planningorthodontic treatment | No change fromoriginal 510k | ||
| Temporal Bone Module | This module is used toisolate and examine thetemporal bone | New feature- not inoriginal 510(k) | New feature | ||
| Endoscope Module | This module allows theuser to perform a virtualendoscopy | New feature - not inoriginal 510(k) | New feature |
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three parallel lines instead of a single staff.
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
3M IMTEC % Ms. Ginger Cantor, RAC Regulatory Affairs Specialist 3M ESPE Dental Products 3M Center, Building 275-2W-08 ST. PAUL MN 55144
Re: K094064
APR 30 2010
Trade/Device Name: ILUMA Vision (Version 2.2) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 29, 2009 Received: December 31, 2009
Dear Ms. Cantor:
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. Iisting 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 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 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,
tmill
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
Enclosure
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Indications for Use
510(k) Number (if known): K094064
Device Name: ILUMA Vision (Version 2.2)
Indications for Use:
ILUMAVision is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT, MRI, PET or 3D Ultrasound.
It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, and distribute DICOM 3.0 compliant images, utilizing standard PC hardware.
Additionally, ILUMA Vision is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments.
ILUMAVision is not intended for use with mammography.
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)
Tobe B. Becker
(Division Sign-Off)
(Division Sign 7)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K094064
Page 1 of 1
§ 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).