PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM

• K Number: K024147
• Device Name: PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM
• Manufacturer: VARIAN MEDICAL SYSTEMS, INC.
• Date Cleared: 2003-02-12 ( 58 days)
• Product Code: MQB
• Regulation Number: 892.1680
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K982795 , K981556 , K993861 , K992794
• Predicate For: K072766 , K083645 , K092669 , K111312 , K120020

Intended Use

The PaxScan 4030 Medical Digital Imaging System is intended for use in generating radiographic images of human anatomy. It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view. This device is intended for use by qualified medical personnel trained in radiology

Device Description

The PaxScan 4030 Medical Digital Imaging System is composed of an amorphous silicon flat planel imager, Pentium based computer, road runner card, trigger board, imaging software and a power supply. The digital imager uses a large-area amorphous silicon sensor array with a gadolinium oxysulfide scintillator. The 40 x 30 cm panel will display high quality images in approximately five seconds over a wide range of dose settings.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the PaxScan 4030 Medical Digital Imaging System. This is a submission to demonstrate substantial equivalence to already legally marketed devices, rather than a clinical study establishing new acceptance criteria or proving effectiveness of an AI-powered device. Therefore, much of the requested information regarding acceptance criteria, study design for AI devices, and ground truth establishment is not present in this document.

However, based on the provided text, we can infer some "acceptance criteria" through comparison to predicates and the nature of a 510(k) submission. The "study" here is primarily a technical comparison and performance testing against industry standards and predicate devices, rather than a clinical trial in the traditional sense for AI.

Here's an attempt to answer the questions based only on the provided document, acknowledging its limitations:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission for a medical imaging device and not an AI-powered diagnostic tool, the "acceptance criteria" are related to technical performance specifications and substantial equivalence to predicate devices, rather than diagnostic accuracy metrics like sensitivity or specificity. The device is accepted if it performs comparably or better than existing approved devices for its intended use.

Acceptance Criteria (Inferred from Predicate Comparison)	Reported Device Performance (PaxScan 4030 Medical Digital Imaging System)
Detector Material and Type	Amorphous Silicon Sensor Array with Gadolinium Oxysulfide Scintillator
Dimensions (Input Field of View)	16" x 11.5"
Pixel Size	127 x 127 microns
Detector Element Matrix	2232 x 3200
Dynamic Range	12 bits
Spatial Resolution	3.94 lp/mm
External Connectivity	DICOM 3.0 Compatible
Image Processing Time	5 Seconds per Image

Note: These are comparisons to predicate devices to demonstrate substantial equivalence, not necessarily strict "acceptance criteria" that must be met in a standalone clinical trial for an AI device. The general acceptance criterion for a 510(k) is that the device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as the legally marketed predicate device.

Study Details (Based on 510(k) Submission)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a "test set" in the context of an algorithmic performance study. The 510(k) submission primarily relies on technical specifications and comparisons to predicate devices. It is highly likely that internal technical performance testing (e.g., image quality assessment, dose response) was conducted on the physical device, but the number of "images" or "patients" constituting a test set is not specified.
   • Data Provenance: Not specified. As this is a technical submission, any testing would likely be internal to Varian Medical Systems.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not applicable to this 510(k) submission. Ground truth establishment by experts is typical for studies assessing diagnostic accuracy of AI algorithms. This submission focuses on the performance of a digital imaging system itself, not an interpretive AI.

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

   • Not applicable. This is not a study requiring adjudication of diagnostic interpretations.

4. 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:

   • No MRMC study was done, as this is for a standalone digital imaging system, not an AI-assisted interpretation device. Therefore, no effect size for human reader improvement is reported.

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

   • Yes, in a sense, the primary "study" is a demonstration of the standalone technical performance of the imaging system. The performance metrics listed in the table (spatial resolution, dynamic range, image processing time) are inherent properties of the PaxScan 4030 system itself, independent of human interaction beyond operating the device. This is not an algorithm in the AI sense, but rather the performance of the hardware and associated software for image acquisition.

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

   • For the technical specifications, the "ground truth" would be established using physics-based measurements and engineering standards. For example, spatial resolution would be measured using standard test patterns (e.g., line pair phantoms), dynamic range by measuring signal response to varying X-ray exposures, and image processing time by timing the system. There would be no pathology or expert consensus on clinical findings involved at this stage of device approval.

7. The sample size for the training set:

   • Not applicable. This is not an AI algorithm requiring a training set.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for an AI algorithm mentioned.

Summary

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FEB 1 2 2003

510(k) Summary

K024/47

The following information is provided following the format of 21 CFR 807.92 for the PaxScan 4030 Medical Digital Imaging System.

1. Submitter:
Varian Medical Systems
3100 Hansen Way M/S H055
Palo Alto, CA 94304-1129
Contact Name: Linda S. Nash
Corporate Director, Regulatory Affairs and
Quality Assurance
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Date: November 21, 2002

2. Device Name:

Classification Name:	Solid State X-ray Imaging Device
Common/Usual Name:	Flat Panel Digital Imager
Proprietary Name:	PaxScan 4030 Medical Digital Imaging System

3. Equivalent Devices:

Proprietary Names:	Philips BuckyVision	Canon X-RayDigital Camera	Fugi CRSystem	InfimedStringray DR
510(K) Numbers:	K982795	K981556	K993861	K992794
Common Name:	Solid State X-Ray Imager
Regulatory Class:	Class II, 21 CFR 892.6150/630
Panel:	Radiology
Product Code:	90MQB

4. Device Description:

The PaxScan 4030 Medical Digital Imaging System is composed of an amorphous silicon flat planel imager, Pentium based computer, road runner card, trigger board, imaging software and a power supply. The digital imager uses a large-area amorphous silicon sensor array with a gadolinium oxysulfide scintillator. The 40 x 30 cm panel will display high quality images in approximately five seconds over a wide range of dose settings.

5. Statement of Intended Use:

The PaxScan 4030 Medical Digital Imaging System is intended for use in generating radiographic images of human anatomy. It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view.

6. Comparison to substantially equivalent devices: The PaxScan 4030 is substantially equivalent to:

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Philips Bucky Vision Canon X-Ray Digital Camera Fuji CR System Infimed Stingray DR

510(k) No. K982795 510(k) No. K981556 510(k) No. K993861 510(k) No. K992794

The following comparison chart depicts the comparison characteristics.

	Varian 4030RFlat Panel Imager	Philips BuckyVision	Canon X-RayDigital Camera	Fuji CR System	InfiMed Stingray DR
510(k)Number	N/A	K982795	K981556	K993861	K992794
Flat PanelProducer	Varian MedicalSystems	Trixell	Canon	Fuji	Trixell
DetectorMaterial	Amorphous SiliconSensor Array withGadoliniumOxysulfideScintillator	Amorphous SiliconSensor Array withGadoliniumOxysulfideScintillator	Scintillator overAmorphousSilicon Sensorwith thin filmTransistor Array	Photostimulablephosphor imagingplate europiumactivated bariumflurohalidecompounds incrystal form	Amorphous SiliconSensor Array withGadoliniumOxysulfide Scintillator
Dimensions	16" x 11.5"	17" x 17"	17" x 17"	17" x 17"	17" x 17"
Pixel Size	127 x 127 microns	143 x 143 microns	160 x 160microns	Standard mode200 microns ;high densitymode 100 microns	143 x143 microns
DetectorElementMatrix	2232 x 3200	2981 x3021	2688 x 2688	2140 x 2140	2981 x 3021
DynamicRange	12 bits	14 bits	14 bits	10 bits	14 bits
SpatialResolution	3.94 lp/mm	3.5 lp/mm	3.1 lp/mm	4.0+ lp/mm	3.5 lp/mm
ExternalConnectivity	DICOM 3.0Compatible	DICOM 3.0Compatible	DICOM 3.0Compatible	DICOM 3.0Compatible	DICOM 3.0Compatible
OperatorConsole	Graphical UserInterface BasedPentium PC	Graphical UserInterface BasedSun Ultra SPARC	Graphical UserInterface BasedPentium PC	Graphical UserInterface BasedPentium PC	Graphical UserInterface BasedPentium PC
ImageProcessor	Hard Drive	Hard Drive	Hard Drive	Hard Drive	Hard Drive
Image Storage	Hard Drive	Hard Drive	Hard Drive	Hard Drive	Hard Drive
OperatingSystem	Windows NT,2000	UNIX	Windows NT	Windows 98, NT	Windows NT
ImageProcessingTime	5 Seconds perImage	8 Seconds per Image	30 Seconds perImage	3-5 Minutes perImage	8 Seconds per Image
PowerRequirements	100-240 VAC50/60 Hz	230 V 50/60 Hz	110/120 V &230/240 V 50/60Hz	200-240 V 50/60Hz100-120 V 50/60Hz	110/120 V & 230/240V 50/60 Hz

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 2003

Ms. Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038

Re: K024147 Trade/Device Name: PaxScan 4030 Medical Digital Imaging System Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system Regulatory Class: II

Product Code: 90 MQB Dated: November 20, 2002 Received: December 16, 2002

Dear Ms. Nash:

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 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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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	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

Page 2

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Statement of Indications for Use

510(k) Number (if known): K024147

Device Name:	PaxScan 4030 Medical Digital Imaging System
Indications For Use:	The PaxScan 4030 Medical Digital Imaging System is intended for use in generating radiographic images of human anatomy. It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view.This device is intended for use by qualified medical personnel trained in radiology
Contraindications for Use:	The use of the PaxScan 4030 Medical Digital Imaging System are contraindicated when, in the judgment of the physician, procedures would be contrary to the best interests of the patient.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use L (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

Naruse Brogdon

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

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.