(14 days)
The 3-D Imaging Workstation is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurement and 3-D image registration.
The 3-D Imaging Workstation is designed to display the 2-D live video received from commercially available ultrasound machines and use this 2-D video to reconstruct a 3-D ultrasound image. The system has been designed to work with the clinicians' existing ultrasound machine, end fire TRUS probe, commercially available needle guide and needle gun combination. Additional software features include patient data management, multiplanar reconstruction, segmentation, image measurement and 3-D image registration.
The 3-D Imaging Workstation is comprised of a mechanical assembly that holds the ultrasound probe and tracks probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. The mechanical tracker is connected to a PC-based workstation containing a video digitizing card and running the image processing software. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of the 3-D Imaging Workstation. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, the workstation is able to reconstruct and display a 3-D image and 3-D rendered surface model of the prostate.
The reconstructed 3-D image can be further processed to perform various measurements including volume estimation, and can be examined for abnormalities by the physician. Patient information, notes, and images may be stored for future retrieval.
Locations for biopsies may be selected by the physician, displayed on the 3-D image and 3-D rendered surface model, and stored. Previously stored 3-D models may be recalled and a stored 3-D model may be aligned or registered to the current 3-D model of the prostate.
Finally, the physician may attach a commercially available biopsy needle guide to the TRUS probe and use the probe and biopsy needle to perform tissue biopsy. Whenever the ultrasound machine is turned on by the physician, the live 2-D ultrasound image is displayed on the screen of 3-D Imaging Workstation during the biopsy. As the TRUS probe with attached needle guide is maneuvered by the physician, the position and orientation of the probe is tracked. The 3-D Imaging Workstation is able to add, display and edit plans for biopsy sites as well as an estimate of the probe position and needle trajectory relative to the 3-D image and 3-D rendered surface model of the prostate.
The 3-D Imaging Workstation offers the physician additional 3-D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe based procedures, and the physician always has access to the live 2-D ultrasound image during prostate assessment or biopsy procedure.
Here's an analysis of the acceptance criteria and study information for the 3-D Imaging Workstation, based on the provided text:
Important Note: The provided 510(k) summary is very high-level and does not detail specific acceptance criteria or quantitative performance metrics typically found in a robust validation study report. Instead, it focuses on demonstrating "substantial equivalence" to predicate devices. Therefore, much of the requested information cannot be extracted directly from this document. The answers below reflect what can be found or inferred from the text.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Inferred from "Substantial Equivalence" claim): The device's performance characteristics (e.g., image measurement, multi-planar reformatting, segmentation, image registration, image storage/retrieval, patient information management) are sufficiently similar to the predicate devices (3-Dnet Suite K063107 and XELERIS 2 Processing and K051673) to achieve "substantial equivalence" for its intended use. While no specific quantitative thresholds are stated, the implication is that the performance meets industry standards and is clinically acceptable for its intended purpose.
| Feature | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| 3-D Ultrasound Reconstruction | Ability to reconstruct 3-D ultrasound images from 2-D video. | Reconstructs and displays 3-D images and surface models. |
| Multiplanar Reconstruction | Comparable to predicate devices | Supports multiplanar reconstruction. |
| Segmentation | Comparable to predicate devices | Supports segmentation. |
| Image Measurement | Comparable to predicate devices (e.g., volume estimation). | Supports various measurements, including volume estimation. |
| 3-D Image Registration | Comparable to predicate devices; ability to align previously stored 3-D models to current ones. | Supports 3-D image registration. |
| Patient Data Management | Comparable to predicate devices; ability to store and retrieve patient information, notes, and images. | Supports patient data management, storage, and retrieval. |
| Biopsy Planning/Guidance | Ability to display and edit biopsy plans, estimate probe position, and needle trajectory relative to 3-D image. | Adds, displays, and edits biopsy plans, estimates probe position and trajectory. |
| Clinical Workflow Integration | Minimal changes to existing TRUS probe-based procedures; access to live 2-D ultrasound during procedures. | Integrates without significant changes to workflow; provides live 2-D ultrasound display. |
| Compatibility | Interoperability with existing ultrasound machines and TRUS probes. | Designed to work with clinicians' existing ultrasound machine, end fire TRUS probe, needle guide, and needle gun. |
| Verification & Validation | All product and engineering specifications are verified and validated. | "All product and engineering specifications were verified and validated." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The testing involved "Test phantoms incorporating simulated prostates."
- Data Provenance: The device was tested using "Test phantoms incorporating simulated prostates." This implies the data was generated in a controlled, artificial environment rather than derived from human patient data. There is no mention of country of origin, retrospective, or prospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. It's unclear if human experts were involved in establishing ground truth for the phantom studies, as phantoms often have known, measurable properties that can serve as ground truth directly.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
5. If a multi-reader multicase (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
- MRMC Study: No, a multi-reader multicase (MRMC) comparative effectiveness study was not mentioned or described. This study focuses on validating the device's functionality and its "substantial equivalence" to predicate devices, not on comparing reader performance with and without the device. The device is a "3-D Imaging Workstation," not an AI-assisted diagnostic tool in the sense of directly altering human reader performance outcomes in an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The study described uses "Test phantoms" for "verification, validation... and benchmarking." This type of testing would primarily evaluate the algorithm's performance in reconstructing images, calculating volumes, and tracking, independent of real-time human interaction with live patient data for diagnostic decision-making. Therefore, a form of standalone performance evaluation on simulated data was conducted for the technical aspects of the software. However, it's not a standalone diagnostic performance reported with metrics like sensitivity/specificity for disease detection on clinical data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for the test set was based on the known properties of "Test phantoms incorporating simulated prostates." This implies a known physical standard rather than expert consensus, pathology, or outcomes data from human subjects.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. The document describes a 510(k) submission for a medical imaging workstation, not a machine learning or AI algorithm development process that typically involves a distinct training set. The device's functionality is based on established image processing algorithms, not a trainable model.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As noted above, the device does not appear to be an AI algorithm developed with a training set in the conventional sense. Its ground truth for validation was based on physical phantoms.
{0}------------------------------------------------
081093
510(k) Summary
| Submitter's Name: | Eigen LLC | ||||||
|---|---|---|---|---|---|---|---|
| Submitter's Address: | 13366 Grass Valley Avenue, Grass Valley, CA 95945 | ||||||
| Submitter's Telephone: | 530-274-1240 | ||||||
| Contact Name: | Mark A. Hoffman | ||||||
| Date Summary was Prepared: | March 25, 2007 | ||||||
| Trade or Proprietary Name: | 3-D Imaging Workstation | ||||||
| Common or Usual Name: | Medical Image Processing Workstation | ||||||
| Classification Name: | System, Image Processing, Radiological, LLZPicture Archiving and Communications, 21CFR 892.2050 | ||||||
| Predicate Devices: | Device Name 510(k) Number 3-Dnet Suite K063107 XELERIS 2 Processing and K051673 |
Description of the Device and Summary of the Technological Characteristics The 3-D Imaging Workstation is designed to display the 2-D live video received from commercially available ultrasound machines and use this 2-D video to reconstruct a 3-D ultrasound image. The system has been designed to work with the clinicians' existing ultrasound machine, end fire TRUS probe, commercially available needle guide and needle gun combination. Additional software features include patient data management, multiplanar reconstruction, segmentation, image measurement and 3-D image registration.
Review Workstation
The 3-D Imaging Workstation is comprised of a mechanical assembly that holds the ultrasound probe and tracks probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. The mechanical tracker is connected to a PC-based workstation containing a video digitizing card and running the image processing software. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of the 3-D Imaging Workstation. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, the workstation is able to reconstruct and display a 3-D image and 3-D rendered surface model of the prostate.
The reconstructed 3-D image can be further processed to perform various measurements including volume estimation, and can be examined for abnormalities by the physician. Patient information, notes, and images may be stored for future retrieval.
{1}------------------------------------------------
Locations for biopsies may be selected by the physician, displayed on the 3-D image and 3-D rendered surface model, and stored. Previously stored 3-D models may be recalled and a stored 3-D model may be aligned or registered to the current 3-D model of the prostate.
Finally, the physician may attach a commercially available biopsy needle guide to the TRUS probe and use the probe and biopsy needle to perform tissue biopsy. Whenever the ultrasound machine is turned on by the physician, the live 2-D ultrasound image is displayed on the screen of 3-D Imaging Workstation during the biopsy. As the TRUS probe with attached needle guide is maneuvered by the physician, the position and orientation of the probe is tracked. The 3-D Imaging Workstation is able to add, display and edit plans for biopsy sites as well as an estimate of the probe position and needle trajectory relative to the 3-D image and 3-D rendered surface model of the prostate.
The 3-D Imaging Workstation offers the physician additional 3-D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe based procedures, and the physician always has access to the live 2-D ultrasound image during prostate assessment or biopsy procedure.
Substantial Equivalence
5
The product's technical features are substantially equivalent to the 3-Dnet Suite (K063107) and the XELERIS 2 Processing and Review Workstation (K051673). The 3-D Imaging Workstation is primarily a software product that runs on a PC-based workstation. Image data is input to the devices and used to generate 3-D views and perform image processing. Like the two predicate devices, the software has image measurement, multi-planar reformatting, segmentation and image registration abilities, image storage and retrieval, as well as patient information management functions.
The 3-D Net Suite and XELERIS 2 are software products that accept multiple image data types including magnetic resonance, computed tomography and ultrasound. The 3-D Imaging Workstation has been designed for ultrasound imaging, using standard analog NTSC video input from commercially available transrectal ultrasound systems. The 3-D Imaging Workstation incorporates a mechanical device to track the position of an end fire ultrasound probe. Ultrasound system operation and transrectal probe movement all remain under manual control of the physician.
{2}------------------------------------------------
Testing and Performance Data
All product and engineering specifications were verified and validated. Test phantoms incorporating simulated prostates were developed and used to verify system performance through verification, validation (Appendix D) and benchmarking (Appendix F).
Conclusion
5
The results of comparing the intended use, function, technological characteristics, mode of operation and specifications of the 3-D Imaging Workstation with those of the two predicate devices demonstrate that the 3-D Imaging Workstation is substantially equivalent to existing products in the market today.
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Eigen LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
MAY - 1 2008
Re: K081093
Trade/Device Name: 3-D Imaging Workstation Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: LLZ Dated: April 16, 2008 Received: April 17, 2008
Dear Mr. Job:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
{4}------------------------------------------------
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/odri/industry/support/index.html.
Sincerely vours.
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): pending
Device Name: 3-D Imaging Workstation
Indications for Use:
4
Use
The 3-D Imaging Workstation is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. Additional પ્રતિ software features include patient data management, multi-planar reconstruction, segmentation, image measurement and 3-D image registration.
Arry Thithy
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
. :
§ 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).