(168 days)
MED-TAB, is a computer hardware/software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems. Images and data can be stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. Mammographic images may only be interpreted using a monitor that meets technical specifications identified by FDA. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.
MED-TAB is a 13.3" color LCD monitor including a built-in tablet computer for viewing and analyzing of medical images (except those of mammography) from a picture archiving and communication system (PACS). The color panel employs in-plane switching (IPS) technology allowing wide viewing angles. MED-TAB has one regular display mode to visualize non-medical images, and one DICOM factory calibrated display mode to display medical images according to DICOM requlations. The MED-TAB has been calibrated to comply with DICOM Part 14 at the factory. With built-in brightness stabilization circuit. USB adiustment tool and ambient light sensor. stable brightness and persistent calibration can be guaranteed. The MED-TAB can support both landscape and portrait mode. The anti-reflection coated protective screen can prevent display damage under heavy operating conditions. The tablet-PC is designed in conformity with IEC60601-1, and IEC60601-1-2 standards. Off-the-shelf (OTS) software is used for the mobile viewer application. It supports DICOM image files as well as other common image formats and PDF files.
The provided document, a 510(k) Summary of Safety and Effectiveness for the MED-TAB device, describes the device's intended use and compares its technological characteristics to a predicate device, but it does not contain a detailed study with acceptance criteria and device performance results in the format requested.
The document states:
- "The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures."
- "The data presented in the submission demonstrates that MED-TAB performs as required according to the functional requirements specified in the Software Requirements Specification and the User Manual with no errors that had an impact on safety or efficacy."
However, it does not provide the specific acceptance criteria, the reported device performance against those criteria, or the details of a formal study as outlined in your request (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).
Based on the provided text, I can only extract limited information related to the device and its testing:
Key Information from the Document:
- Device Name: MED-TAB
- Intended Use: Viewing of images acquired from CT, MR, CR, DR, US, and other DICOM compliant medical imaging systems. It can store, communicate, process, and display images and data.
- Restriction: Mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.
- DICOM Compliance: The device has been calibrated to comply with DICOM Part 14 at the factory.
- Standards Compliance: Designed in conformity with IEC60601-1 and IEC60601-1-2 standards.
- Hazard Analysis: "Level of Concern for potential hazards has been classified as 'Moderate'."
- Predicate Device: IQ-SYSTEM PACS SYSTEM (K062488)
Since the document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device, it emphasizes functional similarity rather than detailed clinical performance studies for novel AI algorithms. The "testing" mentioned appears to be internal validation against functional requirements, not a separate clinical efficacy study.
Therefore, I cannot populate the requested table and answer many of the questions because the document does not contain that specific level of detail regarding acceptance criteria and study data.
Here is what I can infer or explicitly state based only on the provided text, acknowledging that much of your request cannot be fulfilled:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied from text) | Reported Device Performance (Implied from text) |
|---|---|
| Compliance with DICOM Part 14 | "The MED-TAB has been calibrated to comply with DICOM Part 14 at the factory." |
| Stable brightness and persistent calibration | "With built-in brightness stabilization circuit. USB adjustment tool and ambient light sensor, stable brightness and persistent calibration can be guaranteed." |
| Conformity with IEC60601-1, and IEC60601-1-2 standards | "The tablet-PC is designed in conformity with IEC60601-1, and IEC60601-1-2 standards." |
| Performance according to functional requirements and user manual | "The data presented in the submission demonstrates that MED-TAB performs as required according to the functional requirements specified in the Software Requirements Specification and the User Manual with no errors that had an impact on safety or efficacy." |
| No significant failures in pre-determined testing criteria | "The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures." |
| No diagnostic assistance to the physician | "The software does not provide any diagnostic assistance to the physician." (This is a functional characteristic, not a performance metric per se, but stated as part of its operation) |
| No control of life-sustaining devices | "MED-TAB does not contact the patient, nor does it control any life sustaining devices." (Functional characteristic) |
| Support for specified image viewing functions and tools (e.g., level window, panning, zooming, MPR, MIP, measurements, annotations) | The device description lists these as "major image viewing functions" and states they are "well-established" and "standard tools." (Implies successful implementation and function) |
| No primary diagnosis or image interpretation of mammographic images | "Mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation." (This is a limitation of use, not a performance claim, but implies the device does not meet higher standards for specific mammography viewing). |
2. Sample size used for the test set and the data provenance: Not provided in the document. The text refers to "in-house pre-determined testing criteria," which suggests internal validation rather than a clinical study with a defined test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided in the document.
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: Not applicable. The MED-TAB is a viewing device, not an AI-powered diagnostic aid meant to improve human reader performance. The document explicitly states: "The software does not provide any diagnostic assistance to the physician."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. MED-TAB is a display and viewing system, not an algorithm performing a standalone diagnostic task. Its performance is related to accurate display and functionality.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the document. Given the device's nature as a viewing system, "ground truth" would likely refer to the accuracy of DICOM rendering, display calibration, and software functionality, rather than diagnostic outcomes.
8. The sample size for the training set: Not applicable. The MED-TAB is a hardware/software viewing system; it is not described as involving a machine learning model that requires a "training set" in the conventional sense of AI.
9. How the ground truth for the training set was established: Not applicable for the same reason as point 8.
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March 23, 2018
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left and features a stylized eagle. The FDA logo is on the right and includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
PLUM Medical Solutions GmbH % Mr. Carl Alletto Consultant OTech Inc. 8317 Belew Drive MCKINNEY TX 75071
Re: K173241
Trade/Device Name: MED-TAB Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 21, 2018 Received: March 1, 2018
Dear Mr. Alletto:
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 of medical device-related adverse events) (21 CFR 803); 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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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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173241
Device Name MED-TAB
Indications for Use (Describe)
MED-TAB, is a computer hardware/software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems. Images and data can be stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. Mammographic images may only be interpreted using a monitor that meets technical specifications identified by FDA. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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This 510(k) Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
March 21, 2018
Submitter's Information: 21 CFR 807.92(a)(1) Dr. Arpad Bischof, Managing Director PLUM Medical Solutions GmbH Lange Straße 16 Rostock, Germany 18055 Phone: +49 381 496 58 280 Fax: +49 381 496 58 299 Email: bischof@image-systems.biz
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | MED-TAB |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Classification Name: | system, image processing, radiological |
| Product code: | LLZ |
| Classification Name: | display, diagnostic radiology |
| Product Code: | PGY |
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification Name | system, image processing, radiological22 | |
|---|---|---|
| 510(k) Number | K062488 | |
| Device Name | IQ-SYSTEM PACS SYSTEM | |
| Applicant | IMAGE INFORMATION SYSTEMS, LTD. | |
| Applicant Contact | Carl Alletto | |
| Regulation Number | 892.2050 | |
| Classification Product Code | LLZ | |
| Decision Date | 09/19/2006 | |
| Decision | substantially equivalent (SESE) | |
| Requlation Medical Specialty | Radiology | |
| summary | summary | |
| Type | Traditional | |
| Reviewed by Third Party | No | |
| Combination Product | No |
Device Description: 21 CFR 807 92(a)(4)
MED-TAB is a 13.3" color LCD monitor including a built-in tablet computer for viewing and analyzing of medical images (except those of mammography) from a picture archiving and communication system (PACS). The color panel employs in-plane switching (IPS) technology allowing wide viewing angles.
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510(k) Summary of Safety and Effectiveness
MED-TAB has one regular display mode to visualize non-medical images, and one DICOM factory calibrated display mode to display medical images according to DICOM requlations.
The MED-TAB has been calibrated to comply with DICOM Part 14 at the factory. With built-in brightness stabilization circuit. USB adiustment tool and ambient light sensor. stable brightness and persistent calibration can be guaranteed. The MED-TAB can support both landscape and portrait mode. The anti-reflection coated protective screen can prevent display damage under heavy operating conditions. The tablet-PC is designed in conformity with IEC60601-1, and IEC60601-1-2 standards.
Off-the-shelf (OTS) software is used for the mobile viewer application. It supports DICOM image files as well as other common image formats and PDF files.
The major image viewing functions device are:
- . Receive DICOM data per pre-defined communication setup by Picture Archiving and Communication System (PACS)
- . Overview of available patients, including a search function (name, birth date, imaging modality)
- . Selection of to be reviewed DICOM data to download an entire set of data (multiple patients, multiple studies or multiple series)
- Visualization of the DICOM data in a well-established way of DICOM viewing (analogous standard tools for medical image viewing)
- . Assessment of DICOM data by means of standard navigation tools (level window, panning, zooming, etc.)
- . Take pictures for wound documentation and send them as a DICOM file to your PACS including all necessary meta information
- . Calibration routine to adjust the display of grey values on a device - DICOM Greyscale Standard Display Function
- . Create simple textual reports and store them as a DICOM file
- . Load and create level window presets
- Manual measurement of structures of interest on 2D slices including angular and . length measurements as well as statistical computations in a region of interest
- . Adding text annotations to images
- . Multiplanar reconstruction for CT datasets (MPR)
- . Thick slices by means of maximum intensity projection for up to 11 slices (MIP)
- . Browse PACS by DICOM Query (C-FIND)
- Request data by DICOM Retrieve (C-MOVE) .
- . Encryption and compression of data stored/transmitted
- . Sending messages / images / key images to colleagues, which are shown in a contact list
MED-TAB does not contact the patient, nor does it control any life sustaining devices. The software does not provide any diagnostic assistance to the physician. Any diagnostic determination or treatment is solely determined by a physician and not the software. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.
Indications for Use: 21 CFR 807 92(a)(5)
MED-TAB, is a computer hardware/software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems. Images and data can be stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations.
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Mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. Mammographic images may only be interpreted using a monitor that meets technical specifications identified by FDA. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.
Technological Characteristics: 21 CFR 807 92(a)(6)
MED-TAB, does not contact the patient, nor does it control any life sustaining devices.
A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed. The general features and functions of the device are as follows:
| Item description | Predicate device: iQ SystemsPACS K062488 | New Device:MED-TAB |
|---|---|---|
| Computer platform(minimum requirements) | Pentium IV CPU > 1.5 GHz orcomparable AMD processor.minimum 20 GB hard disk, dependingon the volume of the data to be savedtemporary, and with DMA33 ability3D graphics card nVidia GeForce ≥5600 or higher, ATI ≥ Radeon 9600,with at least 64 MB of RAManalogous color monitor, resolution of1024 × 768CD-R drive to install the program fromCD-ROM | • CPU: Quad core Intel-compatible x86 64bit Processor• HDD: 32GB |
| System RAM | ≥ 1 GB main memory, dependingon the 3D datasets | • RAM: 1GB |
| Operation System | Microsoft Windows 2000, or WindowsXP | • Android 4.4.4• Android 6.0• Android 7.0• iOS 10.0.2• Windows 10 x64• Windows 7 x64 |
| Image Acquisition | Frame grabber or Vidar DiagnosticPro film scanner system or similar | There is no frame grabber in theSubject Device. |
| Transmission resolution(max.) | 1280 x 1024, 8-bit display or 12 bitsdeep | 1920 x 1080 Pixel, 11 Bitinternally, 8-bit display |
| Image Compression: | Compression mode: none, Lossless(Differential Pulse Code Modulation),or Lossy (Wavelet/JPEG) | No compression or Lossless only. |
| Modality Support | DICOM and non-DICOM images fromComputer Radiography, CT, MRI,Nuclear Medicine, Ultra Sound,Secondary Capture SecondaryCapture | Same as predicate |
| NetworkingCommunications Protocol | DICOM 3.0 | Same as predicate |
| Standard Interfaces | SCSI or Modem. Network connectionwith at least 10 MBit/s | Same as predicate |
| Image Storage | On board hard disk size &compression dependent. Can store toShort or Long-Term Archives | Same as predicate |
| Item description | Predicate device: iQ SystemsPACS K062488 | New Device:MED-TAB |
| Image Interaction Features | 'Level Window'●'Thickness'● | Same as predicate |
| Image Tools | 'Panning'●'DICOM Cine'●●'Zoom':'Create report'● | Same as predicate |
| Image Annotations | ●'Measurement''Note'●'Arrow'●'Region of interest'●'Angle'●'Remote angle':●●"Length ratio"'Save key image (to PACS)●●"List of annotations' | Same as predicate |
| Image Search | Overview about all available●patients, including a searchfunction (name, birth date,imaging modality) | Same as predicate |
| Multiplanar reconstructionfor CT datasets (MPR | Yes | Yes |
| Sending messages /images / key images tocolleagues, which areshown in a contact list | Yes | Yes |
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510(k) Summary of Safety and Effectiveness
Testing
The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures. The data presented in the submission demonstrates that MED-TAB performs as required according to the functional requirements specified in the Software Requirements Specification and the User Manual with no errors that had an impact on safety or efficacy.
Conclusion: 21 CFR 807 92(b)(1)
The 510 (k) Pre-Market Notification for MED-TAB contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. MED-TAB has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "Moderate".
§ 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).