The XiScan 4000 Transportable Imaging System is a compact, mobile, mini C-arm system specifically designed for fluoroscopic imaging of patient extremities. The XiScan 4000 Imaging System can be operated in either manual or automatic exposure rate control (AERC) modes, with options of reduced radiation LOW DOSE and high resolution STANDARD DOSE when using AERC. The XiScan 4000 offers a range of functions for image manipulations. It features touchscreen controls to manage on-screen patient information and image storage.

AI/ML Overview

The provided text is a 510(k) summary for the XiScan 4000 Imaging System, which is a fluoroscopic mini C-arm system. It seeks substantial equivalence to a predicate device, the XiScan 6000 Imaging System.

Based on the information provided, it is not possible to complete the request. Here's why and what information is missing:

This document is a regulatory submission for a medical imaging device. It focuses on demonstrating substantial equivalence to a previously cleared device, not on presenting a detailed study with acceptance criteria for device performance as would be done for a novel AI-powered diagnostic tool. The "study" mentioned here is a bench test comparison to establish equivalence, not a clinical performance study against established ground truth.

Here's a breakdown of why each requested point cannot be answered:

Table of acceptance criteria and reported device performance: This document does not establish specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) for the XiScan 4000. It states the devices have "similar technique factors, SIDs, field-of-view sizes, and image enhancement options" and that "patient X-ray exposure rates for imaging various anatomies are similar." This is the extent of the "performance" discussed, and it's relative to the predicate, not against absolute metrics.
Sample size for the test set and data provenance: No test set in the context of diagnostic performance (e.g., images for classification, images with known disease states) is mentioned. The "bench test comparison" likely involved physical measurements and phantom studies, not a "test set" of patient data.
Number of experts used to establish ground truth and their qualifications: No ground truth establishment by experts is mentioned because no diagnostic performance study is described.
Adjudication method for the test set: Not applicable, as no diagnostic test set is detailed.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This device is an imaging system, not an AI-assisted diagnostic tool. No comparison of human readers with or without AI assistance is present.
Standalone (algorithm-only) performance: Not applicable. This is a hardware imaging system, not an algorithm.
Type of ground truth used: Not applicable. No diagnostic performance study against ground truth (e.g., pathology, outcomes) is described.
Sample size for the training set: Not applicable. This is a hardware device; there is no mention of a "training set" in the context of an AI algorithm.
How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided document describes a regulatory pathway for a conventional medical imaging device, focusing on substantial equivalence to a predicate. It does not contain the type of AI/diagnostic algorithm performance data that would allow for completion of the requested table and information.

Summary

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NOV 1 2 2003

04301 510(k) Summary for

XiScan 4000 Imaging System

1. SPONSOR

XiTec Holdings LLC 4 New Park Road East Windsor, CT 06088

Contact Person: Mr. Steven Hanright 860-292-7055 Telephone:

September 26, 2003 Date Prepared:

DEVICE NAME 2.

Proprietary Name: XiScan 4000 Transportable Imaging System Common/Usual Name: Fluoroscopic mini C-arm systems Image-intensified fluoroscopic X-ray system Classification Name:

PREDICATE DEVICE 3.

XiScan 6000 Imaging System (K003568)

INTENDED USE 4.

The XiScan 4000 Transportable Imaging System is intended for fluoroscopic imaging of patient extremities.

న. DEVICE DESCRIPTION

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5033966

BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

The XiScan 4000 Transportable Imaging System has the same intended use, and similar technical specifications, as compared to the predicate device. Both devices are mobile mini C-arm systems with similar technique factors, SIDs, field-of-view sizes, and image enhancement options. A bench test comparison of the devices confirmed that the patient X-ray exposure rates for imaging various anatomies are similar. Based on these comparisons, the XiScan 4000 Transportable Imaging System is substantially equivalent to the XiScan 6000 Imaging System.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2003

Xitec Holding, LLC % Mr. Daniel J. Dillion, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760 Re: K033066 Trade/Device Name: XiScan 4000 Transportable Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: 90 JAA Dated: October 22, 2003 Received: October 23, 2003

Dear Mr. Dillion:

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.

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.

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Page 2

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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K023066 510(k) Number (if known):

Device Name: __ XiScan 4000 Transportable Imaging System

Indications For Use:

The XiScan 4000 Transportable Imaging System is intended for fluoroscopic imaging of patient extremities.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon
(Division Sign-Off)

Abdom Division of Reproductive. and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use
(Per 21 CFR 801.109)

ાર

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

XiTec Holdings LLC 510(k) XiScan 4000 Imaging System September 26, 2003

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Regulation Number and Section

N/A