DYNA VUE 3-D IMAGING PRODUCT by IMD SYSTEMS, INC.

This device will be used in the same manner as all three dimensional imaging products are used, similar to the Voxel System. It can be used with any two and three dimensional spinning image data such as MRI, CAT, DSA and Ultrasound produced data and converts the data into complete and real 3D images in rotational and static fashion. The device is used to aid the surgeon by permitting more precise morphological diagnosis especially in aneurysms, atherosclerotic lesions and bile duct carcinomas due to the improved view of the data. It may also facilitate highly selective interventional procedures for vascular surgeons because of the improved three dimensional vascular road map the physician sees. The system does not take the place of the physician it is only a tool to assist the physician in his diagnosis, it does not make the diagnosis for him. Decisions about what to do and how to perform a procedure rest firmly with the physician.

This device is used primarily by physicians and health care workers, and is normally used under the supervision of a physician. It is not sold to the general public but may be available as a teaching tool to Universities and Medical Schools without the requirement of physician supervision.

Device Description

The DynaVue 3-D spinning Image System (3DSI) takes a stream of images (frames) and as a first step duplicates the frames and pairs them by delaying one image stream. This is done by the 3DSI's field delay circuit.

With the paired image, the system has now created a parallax. In order to see a 3-D image the system creates a sequence of left or right images on the screen. After the paired images are coded " left" and " right", the information is transmitted to a controller/emitter. The emitter converts the left and right information into an infrared signal which activates the left or right shutter. The emitted 3-D images are observed with active viewing eyewear.

The system can also be used with an active monitor screen, the same principles as above apply except that the infrared emitter is not needed and the active viewing evewear is replaced by passive polarizing glasses.

AI/ML Overview

The provided text is a 510(k) summary for the Dyna Vue 3-D spinning Image System (3DSI). It describes the device's function, intended use, and claims of substantial equivalence to predicate devices (Voxel System and Zeiss Endolive System). However, it does not contain information about specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided document.

Here's a breakdown of what can be extracted and what is missing:

Information Present:

Device Name: Dyna Vue 3-D spinning Image System (3DSI)
Intended Use: As an accessory to MRI's, CAT Scans, DSA and Ultrasound systems to permit viewing of data in true 3-D. It is used to aid the physician in visualizing anatomy, seeing tumors and other ailments, facilitating morphological diagnosis (aneurysms, atherosclerotic lesions, bile duct carcinomas), and guiding interventional procedures. It is a tool to assist, not replace, the physician in diagnosis and procedure decisions.
Predicate Devices: Voxel System (Voxel Digital Holography), Zeiss Endolive System (3 D Endoscope).
Claimed Substantial Equivalence: To Voxel System for 3-D imaging and aid to visualization; to Zeiss Endolive for the method of producing the 3-D image (shuttering effect and glasses).
Mechanism of Action: Takes a stream of images, duplicates and pairs them by delaying one image stream to create parallax. Codes images as "left" and "right" and transmits to a controller/emitter (infrared signal for active eyewear) or directly to an active monitor for passive polarizing glasses.

Missing Information (Crucial for Acceptance Criteria and Study Details):

Specific Acceptance Criteria: The document discusses the functionality and intended use of the device but does not define quantifiable performance metrics (e.g., accuracy, resolution, speed, error rates) that would constitute "acceptance criteria."
Reported Device Performance: No performance data, test results, or metrics are provided.
Sample Size for Test Set: Not mentioned.
Data Provenance (Test Set): Not mentioned.
Number of Experts for Ground Truth (Test Set): Not mentioned.
Qualifications of Experts: Not mentioned.
Adjudication Method (Test Set): Not mentioned.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned.
Effect size of human readers with AI vs. without AI assistance: Not applicable as no MRMC study or AI-assistance is described. The device is a 3D visualization tool, not an AI diagnostic aid in the modern sense.
Standalone Performance (Algorithm Only): Not applicable as the device is for human visualization.
Type of Ground Truth Used: Not mentioned.
Sample Size for Training Set: Not mentioned (likely not applicable as it's a visualization system, not a machine learning model that requires a training set in the typical sense).
How Ground Truth for Training Set was Established: Not applicable.

Summary of Available Information:

Given the limitations, here's what can be provided:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document.	No performance data reported.
The general implication is that the device must be able to:
- Convert 2D/3D imaging data (MRI, CAT, DSA, Ultrasound) into true 3D images.	This functionality is described as how it works, but no performance metrics are given.
- Display these 3D images in rotational and static fashion.	This functionality is described, but no performance metrics are given.
- Aid physicians in visualizing anatomy, tumors, and ailments.	Implied by substantial equivalence to predicate device, but no study results are presented.
- Be substantially equivalent to the Voxel System and the method of 3D projection of the Zeiss Endolive system.	A qualitative claim of substantial equivalence is made based on intended use and projection method.

Sample size used for the test set and the data provenance: Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 mentioned. The device is a 3D visualization tool, not an AI-assisted diagnostic system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a visualization system for human use, so "standalone" performance in the sense of an AI algorithm is not applicable. Its entire purpose is to be "human-in-the-loop."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided. This document claims substantial equivalence based on intended use and mechanism, not on direct performance validation against a ground truth.
The sample size for the training set: Not applicable based on the description of the device's technology. It's a hardware-based visualization tool, not a machine learning algorithm requiring a training set in the modern sense.
How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided 510(k) summary focuses on describing the device's technology, its intended use, and its similarities to legally marketed predicate devices to establish substantial equivalence. It does not include the detailed performance study results, acceptance criteria, or ground truth methodology that might be expected for newer, AI-driven medical devices. The regulatory framework for this device (1997-1998) would have placed more emphasis on demonstrating safety and efficacy through substantial equivalence to existing technologies, rather than requiring extensive quantitative performance studies as might be seen today for novel diagnostic algorithms.

Summary

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K97 4755

510-k Summarv

Pursuant to 21 CFR 807.92 the following summary is submitted.

MAR - 4 1998

1. Submitter's name-IMD Systems. Inc. 509A Rt.22 Purdys, NY 10578 (914) 277-5454 Contact Person-Kenneth M. Nicoll (603) 672-3161 November 25, 1997

Dyna Vue 3-D spinning Image System (3DSI) for use as an accessory to MRI's, CAT Scans, DSA and Ultrasound systems and to permit individual sale of 3DSI for permitting this data to be viewed in true 3-D.
We are claiming substantial equivalence to the Voxel System manufactured by Voxel Digital Holography which is used in a similar manner and permits 3-D imaging just as our 3DSI system does. We are also claiming substantial equivalence to the manner in which the 3D Imaging is generated as the Endolive System ( 3 D Endoscope) produced by Carl Zeiss Germany.
The DynaVue 3-D spinning Image System (3DSI) takes a stream of images (frames) and as a first step duplicates the frames and pairs them by delaying one image stream. This is done by the 3DSI's field delay circuit.

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510-k Summary Page 2

This device will be used in the same manner as the Voxel System is used, except that the 3DSI may permit real time viewing of the three dimensional data. These types of devices are used to aid the physician in visualizing the anatomy of the patient and because they provide three dimensional images, they permit the physician to see tumors and other ailments which may have otherwise been difficult to see. The system does not take the place of the physician they are only a tool used to assist the physician with his diagnosis. They do not make the diagnosis for him. They may also be used to assist the surgeon in visualizing the surgical site better prior to surgery. Decisions about what to do and how to perform a procedure still rest firmly with the surgeon. This system incorporates the intended uses of the Voxel system and now our system may also be used real time.
The 3DSI is substantially equivalent to the Voxel system made by Voxel Digital Holography, Both of these systems are used to aid the physician in visualizing the anatomy of the patient. They both permit the physician to see tumors and other ailments which may have otherwise been difficult to see.

The primary differences between the two systems are the hardware that the two systems use to project the image. The Voxel system takes the slices of three dimensional data and lavers them on Voxfilm. This film is then placed in a special viewing box which the physician can look at and even walk around to view in 3-D.

The 3DSI uses a Field Delay Converter which takes the three dimensional data and delays and pairs it into two streams. This data is then fed into a monitor. If it is not an active monitor an emitter is used and the person viewing must use active eyewear. If an active monitor is used then passive polarizing glasses may be used. The image that is projected is a true 3-D image which can also show motion. While the hardware is different the image that is projected and the intended uses of the systems are virtually the same.

The 3DSI and the Zeiss Endolive system are substantially equivalent in the manner in which they project 3-D. They use much of the same hardware and both rely on the shuttering effect and glasses to view the 3-D image. The Endolive system is an endoscope that is invasive, the 3DSI is not invasive at all, it never contacts the patient. The 3DSI relies on a Field Delay Converter while the Endolive relies on another hardware piece to generate the delay. Other than this the systems are very similar in their projection and viewing of the 3-D image. We do not claim any of the intended uses of the Zeiss Endolive system we are only claiming substantial equivalence to the method of producing the 3-D image.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of what appears to be an eagle or bird-like figure with three distinct, curved lines representing its body or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kenneth M. Nicoll Regulatory Consultant IMD Systens, Inc. 74 Spring Road Amherst, NH 03031

Re:

K974755

Dyna Vue 3-D Imaging System Dated: November 25, 1997 Received: December 19, 1997 Regulatory class: Unclassified Procode: 90 LLZ

MAR - 4 1998

Dear Mr. Nicoll:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 Commic Act (Act). 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, isting of devices, good manufacturing practice, labeling, and problems against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Feleral Resultations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D Director, Division of Reprod Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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CONFIDENTIAL

INDICATIONS

510-k Number: No K-number yet, new submission. IC97 4753

Device Name: DynaVue 3-D Spinning Image System

Indications For Use:

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

David Chapman

Regulation Number and Section

§ 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).