(20 days)
OmniVision is intended to be used for the acquisition, storage, communication and viewing of medical Images.OmniVision receives images from imaging modalities via DICOM or imported directly. It archives and displays these images for the use of medical specialists who are qualified to operate radiological equipment and to record and diagnose medical images.
It provides the user with a range of tools to assist them in viewing the images, such as zoom, filters and measurements, and with facilities to exchange images with other specialists.
OmniVision is not intended for the acquisition of mammographic image data.
OmniVision is a Picture Archiving and Communications System (PACS), as is the predicate Device dicomPACS. All of them have been developed to acquire, store, communicate, display and process medical images. They offer features (e.g. window leveling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and orthopaedists, and required of all PACS solutions.
OmniVision has a modular system architecture, It consists of the basic application viewer for image viewing and processing, image storage and communication, and a number of other modules for database management, image acquisition, printing etc.
OmniVision conforms to the DICOM (Digital Image and Communications in Medicine) standard.
The provided text describes the OmniVision Picture Archiving and Communications System (PACS) and its substantial equivalence to the predicate device, dicomPACS. However, it does not explicitly detail specific acceptance criteria in a quantitative manner or describe a study that involves performance metrics such as accuracy, sensitivity, or specificity.
The document primarily focuses on demonstrating that OmniVision provides comparable functionality, technological characteristics, and intended use as its predicate device to prove substantial equivalence for regulatory clearance. It confirms that the device has been tested according to the specifications documented in this notification and conforms to the DICOM standard.
Therefore, based solely on the provided text, the answer will reflect the absence of such detailed information.
Here's an analysis based on the provided input:
1. Table of acceptance criteria and the reported device performance
The provided document does not explicitly state quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity) or the direct results of a performance study against such criteria. The document claims "substantial equivalence" to the predicate device, dicomPACS, based on functional and technological comparisons.
Instead, the comparison table focuses on functional similarities between OmniVision and dicomPACS:
| Feature/Characteristic | OmniVision Performance (as claimed by the document) | Predicate Device (dicomPACS) | Acceptance Criteria (Implicitly: Similarity to Predicate) |
|---|---|---|---|
| System Architecture | Server & Client, Web-based versions, local servers & remote archiving | Server & Client, Web-based versions, local servers & remote archiving | Similarity |
| Operating System | Window XP | Window XP | Similarity |
| Hardware | HP, Dell, IBM | HP, Dell, IBM | Similarity |
| System failure Alert | Available | Available | Similarity |
| DICOM Worklist | Yes | Yes | Similarity |
| DICOM Storage | Yes | Yes | Similarity |
| DICOM Printer | Yes | Yes | Similarity |
| Image Acquisition | DICOM radiology systems, Digital film scanner, Other imaging modalities | DICOM radiology systems, Digital film scanner, Other imaging modalities | Similarity |
| Rotation | Yes | Yes | Similarity |
| Invert | Yes | Yes | Similarity |
| Zoom In/Out | Yes | Yes | Similarity |
| W/L Adjustment | Yes | Yes | Similarity |
| Pan Image | Yes | Yes | Similarity |
| Flipping | Yes | Yes | Similarity |
| Image Crop | Yes | No | Enhancement (OmniVision has this, predicate does not) |
| Secondary Processing | Organ Specific Type | Organ specific type | Similarity |
| Length Measurement | Yes | Yes | Similarity |
| Angle Measurement | Yes | Yes | Similarity |
| Multiple Length Measurement | Yes | Yes | Similarity |
| Storage Backup method | CD/DVD, Flash Drive, URL | CD/DVD, Flash Drive | Improvement (OmniVision adds URL) |
| Export Format | DICOM, BMP | DICOM, TIFF, BMP, JPEG, PNG | Difference (OmniVision exports fewer formats) |
| Support | 24/7 customer support for application software | 24/7 customer support for application software | Similarity |
| Training | On/off site available | On/off site available | Similarity |
The "acceptance criteria" here appear to be primarily functional equivalence and adherence to DICOM standards, rather than specific performance metrics like diagnostic accuracy. The study described is essentially a comparison study against a predicate device.
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for any test set or the provenance (e.g., country of origin, retrospective/prospective) of any data used for performance evaluation that would typically be described in clinical validation studies. The testing mentioned refers to conformity with DICOM standards and specifications in the notification, not independent clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe a study involving expert-established ground truth for a test set. The device is a PACS system for image handling and viewing, not a diagnostic AI tool that generates a finding requiring ground truth for validation. The premise is that "medical specialists who are qualified to operate radiological equipment and to record and diagnose medical images" will use the system, implying human experts will interpret the images.
4. Adjudication method for the test set
Not applicable, as no described test set required adjudication for ground truth.
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
There is no mention of an MRMC comparative effectiveness study or any study evaluating human reader improvement with or without AI assistance. OmniVision is described as a PACS system providing tools like zoom, filters, and measurements, which are standard functionalities, not an AI-driven diagnostic assistance tool in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. OmniVision is a PACS system intended for human-in-the-loop use by medical specialists. It is not an algorithm designed to provide standalone diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no described study involved establishing ground truth for diagnostic accuracy.
8. The sample size for the training set
Not applicable. OmniVision is a PACS system, not an AI algorithm that undergoes "training" in the machine learning sense with a dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned for an AI algorithm.
{0}------------------------------------------------
510(k) Premarket Notification Modern Module Inc. - OminiVision March 30th, 2010
JAN 2 6 2011
Image /page/0/Picture/2 description: The image shows the text "KI10040" at the top, followed by a logo that says "Modern Module". The logo has a stylized "M" with the rest of the text in a simple font. The text is black and the background is white.
510 (K) Summary
Summary of functions of the device and its major components provided as part of the Premarket Notification for OmniVision
ﮧ ..
| Date : | 30 March 2010 |
|---|---|
| Company Name : | Modern Module Inc. |
| Address: | C Bldg., Suite # 809 Woolim Lions Valley,425 CheongChun-dong, Bupyung-kuIncheon, Korea |
| Contact Person: | Samuel Koh / CEO |
| E-Mail : | samuelkoh@e-mmi.com |
| Tel.: | +82-32-623-6721 |
| Fax.: | +82-32-623-6720 |
| Device Trade Name: | OmniVision |
|---|---|
| Device Common Name : | Picture Archiving and Communications System (PACS) |
| Product Code : | LLZ |
| Regulation Number | 892.2050 |
| Device Classification : | Class II |
| Predicate Devices | dicomPACS |
| Predicate Devices | Items | Predicate Device : | Subject Device | Remark | |
|---|---|---|---|---|---|
| Trade Name | dicomPACS | 510(k) No. | K070618 | ||
| Common Name | Picture Archiving and Communications System (PACS) | Trade Name | dicomPACS | OmniVision | |
| Regulation Number | 892.2050 | dicomPACS® is a softwaresystem for the administration,archiving, improvement andcompression of medical imagedata for diagnosis. The imagesare either acquired from imagingmodalities via DICOM or importeddirectly. All images are archivedin a database as DICOMcompliant files. The data isdisplayed on a computer monitor | OmniVision is intended to beused for the acquisition, storage,communication and viewing ofmedical Images.OmniVision receives images fromimaging modalities via DICOM orimported directly. It archivesand displays these images for theuse of medical specialists whoare qualified to operate | ||
| Device Classification | Class II | Indications for use | for diagnosis.dicomPACS® also providesservices for administering thedata.Lossy compressedmammographic images anddigitized film screen images mustnot be reviewed for primary imageinterpretations. Mammographicimages may only be using an FDAapproved monitor that offers atleast 5 MP resolution and meetsother technical specificationsreviewed and accepted by FDA.Functions to be carried out usingdicomPACS® are, for example,but not limited to, adjustment ofwindow leveling, rotation, zoom, | radiological equipment and torecord and diagnose medicalimages.It provides the user with a rangeof tools to assist them in viewingthe images, such as zoom, filtersand measurements, and withfacilities to exchange images withother specialists.OmniVision is not intended for theacquisition of mammographicimage data. | |
| Product code | LLZ | ||||
| Manufacturer | Oehm und Rehbein GmbH | ||||
| 510(k) number | K070618 |
: : :
{1}------------------------------------------------
, .
Image /page/1/Picture/1 description: The image shows the words "Modern Module" in a stylized font. The word "Modern" is on the top line, and the word "Module" is on the bottom line. The first letter of "Modern" is stylized with two thick vertical lines.
Image /page/1/Picture/2 description: The image shows a grainy black and white picture. There are some numbers in the image, including 1, 315, and 23. The image is blurry and difficult to make out any specific details.
Comparison between the Predicate Device and the OmniVlsion
:"
{2}------------------------------------------------
510(k) Premarket Notification Modern Module Inc. - OminiVision
| and measurements.dicomPACS® is meant to beused by qualified medicalpersonnel only. All users must bequalified to create and diagnoseradiological image data. | |||
|---|---|---|---|
| Product Availability | Available now | Available now | Similarity |
| System | |||
| Architecture | Server & Client, Web-basedversions,local servers & remotearchiving | Server & Client, Web-basedversions,local servers & remotearchiving | Similarity |
| Operating System | Window XP | Window XP | Similarity |
| Hardware | HP, Dell, IBM | HP, Dell, IBM | Similarity |
| Administration | |||
| System failure Alert | Available | Available | Similarity |
| DICOM Compatibility | |||
| DICOM Worklist | Yes | Yes | similarity |
| DICOM Storage | Yes | Yes | similarity |
| DICOM Printer | Yes | Yes | Similarity |
| Image Acquisition | |||
| Image Acquisition | DICOM radiology systemsDigital film scannerOther imaging modalities | DICOM radiology systemsDigital film scannerOther imaging modalities | Similarity |
| Image Manipulation | |||
| Rotation * | Yes | Yes | similarity |
| Invert | Yes | Yes | similarity |
| Zoom In/Out | Yes | Yes | similarity |
| W/L Adjustment | Yes | Yes | similarity |
| Pan Image | Yes | Yes | similarity |
| Flipping | Yes | Yes | similarity |
| Image Crop | No | Yes | |
| Image Post-Processing | |||
| SecondaryProcessing | Organ specific type | Organ Specific Type | similarity |
| Measurement | |||
| Length Measurement | Yes | Yes | similarity |
| Angle Measurement | Yes | Yes | similarity |
| Multiple LengthMeasurement | Yes | Yes | similarity |
| Backup | |||
| Storage Backupmethod | CD/DVD, Flash Drive | CD/DVD, Flash Drive, URL | |
| Export Format | DICOM, TIFF, BMP, JPEG,PNG | DICOM, BMP | |
| Services | |||
| Support | 24/7 customer support forapplication software. | 24/7 customer support forapplication software, | similarity |
| Training | On/off site available | On/off site available | similarity |
: .. . :
・・ .
{3}------------------------------------------------
510(k) Premarket Notification Modern Module Inc. - OminiVision
.
:
.
000019-3
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the words "Modern Module" stacked on top of each other. The word "Modern" is on the top and the word "Module" is on the bottom. The font is a simple sans-serif font and the text is black.
Description:
OmniVision is a Picture Archiving and Communications System (PACS), as is the predicate Device dicomPACS. All of them have been developed to acquire, store, communicate, display and process medical images. They offer features (e.g. window leveling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and orthopaedists, and required of all PACS solutions.
OmniVision has a modular system architecture, It consists of the basic application viewer for image viewing and processing, image storage and communication, and a number of other modules for database management, image acquisition, printing etc.
OmniVision conforms to the DICOM (Digital Image and Communications in Medicine) standard.
Indications for Use:
OmniVision is intended to be used for the acquisition, storage, communication and viewing of medical images.
OmniVision receives images from modalities via DICOM or imported directly. It archives and displays these images for the use of medical specialists who are qualified to operate radiological equipment and to record and diagnose medical images. It provides the user with a range of tools assist them in viewing the images. such as zoom, filters and measurements, and with facilities to exchange images with other specialists.
OmniVision is not intended for the acquisition of mammographic image data.
Technological Characteristics:
OmniVision is intended to be used for the acquisition, storage, communication and viewing of medical images. OmniVision is an autonomous software and involves no hardware. This largely applies to the predicate device dicomPACS.
OmniVision receives images from modalities via DICOM or imported directly. It archives and displays these images for the use of medical specialists who are qualified to operate radiological equipment and to record
000020
{5}------------------------------------------------
510(k) Premarket Notification
Modern Module Inc. - OminiVision
Image /page/5/Picture/2 description: The image shows the words "Modern Module" stacked on top of each other. The word "Modern" is on the top line, and the word "Module" is on the bottom line. The first letter of the word "Modern" is stylized with a black rectangle and a white letter M. The rest of the letters are in a simple, sans-serif font.
and diagnose medical images. It provides the user with a range of tools assist them in such as zoom, filters and measurements; and with facilities to exchange images with other specialists.
OmniVision does not control any life-sustaining devices. Specialists with adequate expert knowledge for competent human intervention interpret displayed or printed images and information.
.:
Omni/ision runs on any hardware platform meeting the minimum system requirements.
OmniVision can be used with the server operating systems MS Windows XP
Testing:
Omnivision has been tested according to the specifications documented in this notification. It conforms to the DICOM standard as laid out in the included DICOM Conformance Statement. (Tab. 9 section 2)
Conclusion:
Omnivision is a medical device. OmniVision provides functionality comparable to that of its Predicate Device, dicomPACS and is intended for the same user and patient groups as its Predicate Device. Based on the indications for use, Technological Characteristics, performance testing and comparison to predicate device, the proposed OmniVision is substantially equivalent and has been shown to be safe and effective for its intended use
Image /page/5/Picture/12 description: The image is a black and white graphic that appears to be a map or some type of spatial representation. The image is mostly white, with black dots and lines scattered across the surface. The black markings are concentrated in the lower left quadrant of the image, with fewer markings in the upper right quadrant. The overall impression is that of a sparse and abstract representation of a geographical area or network.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure. The logo is black and white.
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
Modern Module Inc c/o Marc M. Mouser Engineering Leader Underwriters Laboratories. Inc. 2600 NW Lake RD. CAMAS, WA 98607
JAN 26 2011
Re: K110040
Trade/Device Name: OmniVision Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 10, 2010 Received: January 6, 2010
Dear Mr. Mouser:
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. Insting 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
{7}------------------------------------------------
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.
Mary S. Postel
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
Indications for Use
510(k) Number (if known): K110040
Device Name: OmniVision
Indications for Use:
OmniVision is intended to be used for the acquisition, storage, communication and viewing of medical Images.OmniVision receives images from imaging modalities via DICOM or imported It archives and displays these images for the use of medical specialists who are qualified directly. to operate radiological equipment and to record and diagnose medical images.
It provides the user with a range of tools to assist them in viewing the images, such as zoom, filters and measurements, and with facilities to exchange images with other specialists.
OmniVision is not intended for the acquisition of mammographic image data.
AND/OR
: '
14 1.15.
Prescription Use X
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) :
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Barl D. Kunn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number
Page 1 of 1
000018
§ 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).