(49 days)
3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET, SPECT & Ultrasound) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls.
3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. This product is not intended for use with or for diagnostic interpretation of Mammography images.
The 3Di indications for use are processing of Cardiac CT angiography studies, including coronaries analysis, cardiac functional assessment and CT colonoscopy.
3Di is a PACS device which enables users to access medical images over a network and to utilize 3Di's image visualization tools to review the images. It provides the following functions: Web server, patient browser, PACS capabilities, multi-modality viewing, CT Cardiac and Colonoscopy clinical applications.
Here's an analysis of the provided 510(k) summary regarding the 3Di device, addressing your specific questions.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state acceptance criteria in a quantitative or pass/fail threshold manner. Instead, it describes a comparative study against a predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| General functionality of image reformatting (various modalities) | "results of the two devices are very similar" |
| Reliability of orientation annotations displayed | "results of the two devices are very similar" |
| Correctness of measurements | "results of the two devices are very similar" |
| Image quality | "results of the two devices are very similar" |
| Cardiac analysis Graphs and Results | "results of the two devices are very similar" |
| Colon analysis results | "results of the two devices are very similar" |
| Overall Safety and Effectiveness (compared to predicate) | "substantial equivalent in terms of safety and effectiveness to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the sample size used for the comparative performance study. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The 510(k) summary does not provide information on the number of experts or their qualifications. The study described is a comparison of the 3Di device against a predicate device (Philips Brilliance) rather than establishing ground truth against expert consensus.
4. Adjudication Method for the Test Set
The 510(k) summary does not describe an adjudication method. The study appears to be a direct comparison of the 3Di's output with the predicate device's output across various functions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The comparison is between two devices, not human readers with and without AI assistance. Therefore, there is no effect size reported for human readers improving with AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance assessment was effectively done. The summary states: "Its performance has been validated by comparison to the performance of the Philips Brilliance predicate device." This implies an evaluation of the algorithm's output directly against the predicate device's output, without human intervention in the loop during this specific performance validation.
7. Type of Ground Truth Used
The "ground truth" for this study was the performance and output of the legally marketed predicate device (Philips Brilliance). The comparison aimed to demonstrate "substantial equivalence" to this established device, rather than to a clinical ground truth like pathology or patient outcomes.
8. Sample Size for the Training Set
The 510(k) summary does not provide information on the sample size used for the training set. Given the submission date (2010) and the description of the device as a PACS workstation with visualization tools, it's possible that traditional "training sets" in the modern machine learning sense might not have been explicitly documented or emphasized in the same way as they would be for deep learning-based AI devices today. The device focuses on visualization and manipulation tools, which might rely more on established graphics algorithms than on data-driven machine learning models.
9. How the Ground Truth for the Training Set Was Established
The 510(k) summary does not provide information on how ground truth was established for any training set. If internal validation or verification was performed during development, this information is not detailed in the provided text.
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510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807,87(b))
Device Name Proprietary Device Name: 3Di
Establishment Name and Registration Number of Submitter
JAN 1 9 2010
Name: Shina Systems Ltd. Corresponding Official: Dan Laor Sireni 6, Haifa 32972, Israel TEL: 972-4-8246632
Device Classification
Product Code: CFR section: Panel Identification: Device Description: Classification:
LLZ 892.2050 Radiology Picture archiving and communications system II
Reason for 510(k) Submission
Traditional 510(k) Submission
Identification of Legally Marketed Predicate Devices
K070226 CardioCT K090462 Philips Brilliance K082269 Visage PACS/CS
Device Description
3Di is a PACS device which enables users to access medical images over a network and to utilize 3Di's image visualization tools to review the images. It provides the following functions: Web server, patient browser, PACS capabilities, multi-modality viewing, CT Cardiac and Colonoscopy clinical applications.
Intended use and indications for Use
3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET, SPECT & Ultrasound) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls. 3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, cora of image visualization, image processing, reporting and archiving. This product is not intended for use with or for diagnostic interpretation of Mammography images. The 3Di indications for use, are processing of Cardiac CT angiography studies, including coronaries analysis, cardiac functional assessment and CT colonoscopy
Safety & Effectiveness
The device has been designed, verified and validated complying to 21CFR 820.30 regulations. The device has been designed to meet the requirements of ISO 14971 Safety standard. Its performance has been validated by comparison to the performance of the Philips Brilliance predicate device. The following functions have been compared: General functionality of the images reformatting for the different imaging modalities, Reliability of orientation annotations displayed over the images, correctness of measurements, Image quality, Cardiac analysis Graphs and Results and Colon analysis results.
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The comparison demonstrates that the results of the two devices are very similar and substantial equivalent in terms of performance.
Substantial Equivalency
It is Shina System opinion that the 3Di is substantially equivalent in terms of safety and effectiveness to the predicate devices.
3Di submission · Chapter 6
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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written in a serif font to the right of the eagle. The text is in all caps and is horizontally aligned.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
JAN 1 9 2010
Shina Systems, Ltd. % Mr. Dan Laor Quality & Regulatory Advisor 6 Sireni, Haifa, 32972 ISRAEL
Re: K093703
Trade/Device Name: 3Di Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 24, 2009 Received: December 1, 2009
Dear Mr. Laor:
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 indives 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, increase 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 2017 Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish fruther 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 madou cocs afth Act 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
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) 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 vours.
Donald J. Trump
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): K093703
Device Name: 3Di
Indications For Use:
3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET, SPECT & Ultrasound) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls.
3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. This product is not intended for use with or for diagnostic interpretation of Mammography images.
The 3Di indications for use are processing of Cardiac CT angiography studies, including coronaries analysis, cardiac functional assessment and CT colonoscopy.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR . . .
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dmall SHR
(Division Sien-Off) Division of Radiological Devices
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510(k) Number K093703
§ 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).