Plug 'n View 3D is a software application for the display and 3D visualization of medical image data derived from CT and MRI scans. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.

Device Description

AI/ML Overview

The provided 510(k) submission for the "Plug 'n View 3D" device does not contain a study that demonstrates the device meets specific acceptance criteria in the manner typically expected for AI/ML-based medical devices today. This submission, dated November 5, 1999, predates the common practice of extensive clinical validation studies with detailed performance metrics.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device ("Pro Vision Diagnostic Workstation") based on technical features and intended use. The "acceptance criteria" here are implicitly the feature set and functionality of the predicate device, which the new device aims to match or exceed.

Here's an analysis based on the provided text, addressing the requested information:

1. A table of acceptance criteria and the reported device performance

Since this is a submission based on substantial equivalence to a predicate device rather than performance against pre-defined clinical acceptance criteria, the "acceptance criteria" are the features and capabilities of the predicate device, and the "reported device performance" is a comparison to those features.

Feature / Acceptance Criteria (from Predicate Device)	Plug 'n View 3D Performance (vs. Predicate)
Computer platform	Pentium MMX, Windows 95, 98 or NT (Different platform, but considered equivalent for functionality).
DICOM compliance	DICOM-3 for CT, MRI, NM, CR, SC, Ultrasound (Single Frame) images (Comparable, with added Ultrasound support).
2D imaging	2D image viewer with real-time window-level, zoom, pan, rotate, flip and cine. Multiple grid layouts (Same).
Measurement	2D measurement tools including line, angle and ROI statistics (Same).
Multi-Planar Reformatting (MPR)	MPR into any user-defined linear plane (Predicate also has curved plane; a difference, but likely not considered a lack of safety/effectiveness for the claimed use).
Volume Rendering	Volume rendering with interactive opacity/transparency control, clipping VOI, zoom, pan and rotate (Same).
Maximum Intensity Projection (MIP)	MIP with interactive window-level, clipping VOI, zoom, pan and rotate (Same).
Image editing	Tools for removal of obscuring anatomy (Same).
Printing	Printing to standard Windows printers (Predicate has DICOM printing and non-DICOM laser imagers; a difference, but not affecting core visualization).
Ease of use	Visualization presets. Semi-automated steps for typical image review procedures (Comparable to predicate's customized presets).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission does not mention any specific test set, sample size, or data provenance for a performance study. The evaluation relies on a comparison of technical specifications and features to a predicate device, not on a clinical performance study with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment is described, as the submission does not involve a performance study with a test set requiring expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is mentioned as there is no described test set or expert review process.

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 "Plug 'n View 3D" is a 3D visualization and image processing tool, not an AI-assisted diagnostic device, and no MRMC study is mentioned. The submission is from 1999, prior to widespread AI in medical imaging.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a user-operated visualization tool; it is not an autonomous algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No ground truth is mentioned. The device's "acceptance" is based on functional equivalence to a predicate, not diagnostic accuracy against a ground truth.

8. The sample size for the training set

Not applicable. As this device is a software application for image display and 3D visualization, and not an AI/ML diagnostic algorithm, there is no mention of a training set for machine learning.

9. How the ground truth for the training set was established

Not applicable. There is no training set mentioned.

Summary

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NOV - 5 1999

510(k) Summary

1. Company Identification

K992654

Voxar Ltd Bonnington Bond 2 Anderson Place Edinburgh, EH6 5NP UK

2. Official Correspondent

Conrad Chin Head of Engineering

3. Date of Submission

August 6, 1999

4. Device Name

Classification Name

Common Name

Proprietary Name

Picture Archiving and Communications System (Image Processing Sub-System) (892.2050) Image processing, management and 3D visualization system Plug 'n View 3D

5. Predicate Device

Pro Vision Diagnostic Workstation (K980648), manufactured by Algotec Systems Ltd.

6. Device Description and Intended Use

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Feature	Plug 'n View 3D	Pro Vision
Computer platform	Pentium MMX, underWindows 95, 98 or NT.	Silicon Graphics O2, underIRIX.
DICOM compliance	DICOM-3 compliance forCT, MRI, NM, CR, SC andUltrasound (Single Frame)images.	DICOM-3 compliance forCT, MRI, NM, CR, RF andSC images.
2D imaging	2D image viewer withreal-time window-level,zoom, pan, rotate, flipand cine.• Multiple grid layouts.	Same.
Measurement	2D measurement toolsincluding line, angle andROI statistics.	Same.
Multi-PlanarReformatting (MPR)	MPR into any user-definedlinear plane.	MPR into any user-definedlinear or curved plane.
Volume Rendering	Volume rendering withinteractive opacity /transparency control,clipping volume of interest(VOI), zoom, pan and rotate.	Same.
Maximum IntensityProjection (MIP)	MIP with interactivewindow-level, clipping VOI,zoom, pan and rotate.	Same.
Image editing	Tools for removal ofobscuring anatomy.	Same.
Printing	Printing to standardWindows printers.	• DICOM printing.• Printing to all major non-DICOM laser imagers.
Ease of use	• Visualization presets.• Semi-automated steps fortypical image reviewprocedures	Customized presets perimaging procedure.

7. Substantial Equivalence Comparison Table

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Image /page/2/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 1999

Rob Mackean Director Voxar Ltd. Bonnington Bond 2 Anderson Place Edinburgh, Scotland EH6 SNP U.K.

Re:

K992654 Plug' n View 3D, Version 1.0 Dated: August 6, 1999 Received: August 9, 1999 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Mackean:

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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 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 predicate device results in 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Applicant:

Voxar Ltd., Bonnington Bond, 2 Anderson Place, Edinburgh EH6 5NP, UK

510(k) Number (if known)

K992654

Unknown

Device Name

Plug 'n View 3D

Indications For Use

Umid C. Begum

uctive, Abdominal, ENT:
Radiological Devices

umber K492654

Prescription Use (Per 21 CFR 801.109)

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).