(52 days)
Table is a software application used for the display and 3D visualization of medical image files from scanning devices such as CT and MRI. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, and assist in diagnosis, utilizing standard PC hardware.
This device is not indicated for mammography use.
Table is a volumetric imaging software designed specifically for clinicians, doctors, physicians, and other qualified medical professionals. The software runs in Windows operating systems and visualizes medical imaging data on the computer screen. Users are able to examine anatomy on a computer screen and use software tools to move and manipulate images by turning, zooming, flipping, adjusting contrast and brightness, cutting, and slicing using either touch control or a mouse. The software also has the ability to perform measurements of angle and length. There are multiple tools to annotate and otherwise mark areas of interest on the images. Additionally, Table has the ability to demonstrate pathology examples of patient data for educational purposes.
The provided 510(k) summary (K140093) describes the Anatomage Table as a volumetric imaging software for 3D visualization of medical image files (CT, MRI) for diagnosis assistance.
No specific quantitative acceptance criteria are explicitly stated in the provided document. The device's performance is primarily established through a qualitative comparison to a predicate device and general confirmation of stability and designed operation.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Qualitative Equivalence to Predicate Device: The software should be as effective as its predicate in essential functions. | "Testing confirms that Table is as effective as its predicates in its ability to perform its essential functions of measurement and rendering of DICOM data." |
| Stability and Operating as Designed: The software should function reliably and as intended. | "Testing confirmed that the software is stable and operating as designed." |
| Hazard Evaluation and Risk Reduction: Identified hazards should be evaluated, and risks reduced to acceptable levels. | "Testing also confirmed that the software has been evaluated for hazards and that risk has been reduced to acceptable levels." |
| Accuracy of Measurement Tools: Essential linear and angular measurements should be accurate. | "This testing included testing of measurement tools in both predicate and subject software..." (Implied accuracy through expert evaluation) |
| Rendering of DICOM Data: The software should accurately visualize DICOM data. | "...and rendering of DICOM data." (Implied accuracy through expert evaluation) |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Bench testing of the software with predicate software was performed by evaluation of images rendered by Table and predicate software." However, it does not specify the sample size (number of images or cases) used for this test set nor the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts and their Qualifications for Ground Truth
The testing and evaluation of the bench test were performed by "an expert in the field of radiology." Only one expert is mentioned. The document does not provide further specific qualifications (e.g., years of experience) for this expert.
4. Adjudication Method for the Test Set
The document mentions evaluation by "an expert." This suggests a single-expert assessment rather than a multi-expert adjudication method (like 2+1 or 3+1). Therefore, the adjudication method appears to be "none" in the sense of multiple experts resolving discrepancies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The evaluation described is a bench test comparing the software's output to a predicate, assessed by a single expert. There is no mention of human readers improving with AI assistance or without.
6. Standalone Performance Study
Yes, a standalone performance study was done in the sense that the "Table" software's performance was evaluated independently in a "bench testing" scenario, comparing its outputs (rendered images and measurements) with those of a predicate software. This evaluation focused on the algorithm's capabilities without explicit human-in-the-loop performance measurement.
7. Type of Ground Truth Used
The ground truth for the test set was implicitly established through comparison to the predicate software's output and evaluation by a single radiology expert. This leans towards an expert-based assessment of accuracy and equivalence rather than pathology or outcomes data.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This suggests that if machine learning was used (which is not explicitly clear for this type of software described), the details of its training are not included in this summary. Given the description, it appears to be more of a deterministic image processing and visualization software rather than an AI/ML-driven diagnostic algorithm.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned or detailed, the document does not describe how ground truth for a training set was established.
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K 140093
Page 1 of 3
5. 510K Summary
:
| MAR - 7 2014 | |
|---|---|
| Submitter | Anatomage Inc.111 N. Market Street #800San Jose, CA 95113Phone: (408) 885-1474Fax: (408) 295-9786 |
| Regulatory Contact Person | Mike Mendez, Quality ManagerPhone Number: (408) 885-1474 ext 119Cell: (415) 370-9794 |
| Device Name | Table |
| 510(k) Preparation Date | January 07, 2014 |
| Common Name | System, Image Processing, Radiological |
| Classification | Class II |
| Classification Name | Imaging Processing System, LLZ, 21 CFR 892.2050 |
| Product Code | LLZ, 21 CFR 892.2050 |
| Device Description | Table is a volumetric imaging software designed specifically forclinicians, doctors, physicians, and other qualified medicalprofessionals. The software runs in Windows operating systemsand visualizes medical imaging data on the computer screen.Users are able to examine anatomy on a computer screen and usesoftware tools to move and manipulate images by turning.zooming, flipping, adjusting contrast and brightness, cutting, andslicing using either touch control or a mouse. The software alsohas the ability to perform measurements of angle and length.There are multiple tools to annotate and otherwise mark areas ofinterest on the images. Additionally, Table has the ability todemonstrate pathology examples of patient data for educationalpurposes. |
| Intended Use | Table is a software application used for the display and 3Dvisualization of medical image files from scanning devices such asCT and MRI. It is intended for use by radiologists, clinicians,referring physicians and other qualified individuals to retrieve,process, render, review, and assist in diagnosis, utilizing standardPC hardware. |
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Equivalent Devices
Technological Characteristic
This device is not indicated for mammography use. K123519 Anatomage, InVivoDental
visualized as volume or 2D images.
Table and the predicate device are standalone software. These software devices are designed to be installed on standard off-theshelf x86 processor based computers running the Windows operating system. DICOM data from medical imaging devices are
A difference between Table and the predicate software is the touch interface that has been designed to complement a standard interface of mouse and keyboard. This interface is designed to provide a convenient way of using the software but does not change the functionality of the device from a system designed for keyboard and mouse controlled only. Also, the Table is designed to run on 64 bit operating systems only while InVivoDental is able to run on both 64 and 32 bit. While In VivoDental can perform volume and area measurements. Table performs the essential linear and angular measurement only. In VivoDental is designed with specialized tools for dental implant planning. Table does not have this feature. InVivoDental has tools for looking at custom cross-sectional troughs. This dental feature is not included in Table. Table cannot superimpose images nor perform cephalometric analysis. Table cannot save case workups, nor does it display imbedded patient information.
Testing confirmed that the software is stable and operating as designed.
The following quality assurance measures were applied to the development of the system:
Risk Analvsis
- · Requirements Reviews
· Design Reviews
· Performance testing (Verification)
· Safety testing (Verification)
· Final acceptance testing (Validation)
· Bench testing to compare with predicate software
Testing confirmed that the software is stable and operating as designed. Testing also confirmed that the software has been evaluated for hazards and that risk has been reduced to acceptable levels.
Bench testing of the software with predicate software was performed by evaluation of images rendered by Table and
Non-Clinical Test Results
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K140093
Page 3 of 3
predicate software. This testing and evaluation included testing of measurement tools in both predicate and subject software and was evaluated by an expert in the field of radiology. This testing confirms that Table is as effective as its predicates in its ability to perform its essential functions of measurement and rendering of DICOM data.
Based on the intended use, product, performance, and testing information provided in this notification. the subject device has been shown to be substantially equivalent in technology, functionality, and indicated use to the currently marketed predicate device.
Summary
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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-like symbol with three curved lines representing its wings or body. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2014
Anatomage, Inc. % Mr. Mike Mendez Quality Manager 111 N. Market Street #800 SAN JOSE CA 95113
Re: K140093
Trade/Device Name: Table Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 7, 2014 Received: January 14, 2014
Dear Mr. Mendez:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) 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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Page 2-Mr. Mendez
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entilled, "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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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4. Indications For Use Statement
510(k) Number (if known): K140093
Device Name: __ Table
Indications for Use:
Table is a software application used for the display and 3D visualization of medical image files from scanning devices such as CT and MRI. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, and assist in diagnosis, utilizing standard PC hardware.
This device is not indicated for mammography use.
Over-The-Counter Use Prescription Use V AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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Division Sign-Off Office of In Vitro Diagnostics and Radiological Health (OIR) Evaluation and Safety 510(k) K140093
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§ 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).