COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE by ANALOGIC CORP.

The WebRad Computed Radiography Quality Assurance (CR/QA) Workstation is a Web based software product that will allow the user to view computed radiography images acquired from a FUJI Computed Radiography System and other imaging modalities.

Device Description

WebRad Computed Radiography Quality Assurance (CR/QA) Workstation is a Web based software product.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the WebRad Computed Radiography Quality Assurance (CR/QA) Workstation, dated April 2, 1998. It primarily confirms substantial equivalence to a predicate device and outlines general regulatory obligations.

Crucially, the provided text does not contain any information regarding specific acceptance criteria for the device's performance, nor does it detail any studies conducted to prove the device meets such criteria.

Therefore, I cannot fulfill your request for the detailed information as the document lacks it.

Here's a breakdown of why I cannot answer your specific points based on the provided text:

A table of acceptance criteria and the reported device performance: Not present. The letter is a regulatory clearance, not a performance report.
Sample sized used for the test set and the data provenance: Not present. No study details are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No study details are provided.
Adjudication method for the test set: Not present. No study details are provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not present. No study details are provided.
If a standalone performance was done: Not present. No study details are provided.
The type of ground truth used: Not present. No study details are provided.
The sample size for the training set: Not present. No information about AI/ML models or training sets is included.
How the ground truth for the training set was established: Not present. No information about AI/ML models or training sets is included.

The document only states that the WebRad system is a "Web based software product that will allow the user to view computed radiography images acquired from a FUJI Computed Radiography System and other imaging modalities." The FDA determined it to be "substantially equivalent" to predicate devices, which means it has the same intended use and technological characteristics as a legally marketed device without raising new questions of safety and effectiveness. This determination does not inherently require a detailed performance study with acceptance criteria to be submitted or described in the clearance letter itself.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract caduceus, a symbol often associated with healthcare and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 1998

K980168

Ronald Luich, P.E. Consultant Analogic Corporation c/o RJL Associates, LLC 86 Boston Post Rd. Waterford, CT 06385

Re:

WebRad Computed Radiography Quality Assurance Workstation Dated: January 7, 1998 Received: January 16, 1998 Regulatory class: Unclassified Procode: 90 LLZ

Dear Mr. Luich:

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 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 (OS) 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 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 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 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/cdrb/dsmaldsmamain.html".

Sincerely yours,

Killian Yu

Lillian Yin, Ph.D. 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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510 (k) Number (if known): K980068

Device Name: WEBRAD Computed Radiography Quality Assurance (CR/QA) Workstation

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Vinit A. Srymm

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 216 510(k) Number

Prescription Use (Per 21 CPR 801.109) OR

Over-The-Counter-Use

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).