This device is a Computed Radiography System and intended for use in producing digital X-Ray images for general radiography purposes. It comprises of scanner, cassette with reusable phosphor storage plate (IP) and workstation software. It scans X-Ray exposed image plate and produces X-Ray image in digital form. Then, digital image is transferred to workstation for further processing and routing. This device is intended to be operated in a radiological environment by qualified staff. This device is not intended for the acquisition of mammographic image data.

Device Description

The FireCR Spark is Computed Radiography System which produces the X-ray diagnostic image in digital format instead of using traditional screens and film. This device utilizes reusable X-ray storage phosphor plate (IP) that is sensitive to X-ray and stores latent image when it is exposed to X-ray. After X-ray exposure to the X-ray storage phosphor plate, X-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the X-ray storage phosphor plate is released in a form of light by laser scanning. Then the light is collect and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain & offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, then stored locally, sent to an archive, printed or sent to PACS system. After acquisition of latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused.

AI/ML Overview

Here's an analysis of the provided text regarding the FireCR Spark Computed Radiography Scanner, focusing on the acceptance criteria and the study proving its performance:

Acceptance Criteria and Device Performance for FireCR Spark (K133120)

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (FireCR) rather than establishing novel acceptance criteria for a new device. Therefore, the "acceptance criteria" are largely framed as matching or improving upon the predicate device's performance.

Criterion (Implicit Acceptance Target)	FireCR (Predicate Device) Reported Performance	FireCR Spark (New Device) Reported Performance	Notes
Intended Use	Capturing, digitization, and processing of general radiography images.	Capturing, digitization, and processing of general radiography images.	Equivalent: Stated as the same.
Physical Characteristics			Differences noted in overall dimensions and available imaging area sizes (new 18x24cm size, slight difference in 24x30cm image matrix).
Effective Pixel Pitch	100µm, 200µm	100µm, 200µm	Equivalent: Same.
Spatial Resolution	3.7lp/mm @ 100um	3.7lp/mm @ 100um	Equivalent: Same.
Image Matrix (Pixel)	(Various sizes by µm)	(Various sizes by µm, new 18x24cm size, slight difference in 24x30cm image matrix)	Equivalent/Improved: Similar for existing sizes, new size added, slight difference in one existing size.
Weight	30kg	21.5kg	Improved: Lighter weight.
Imaging Device	High Sensitivity Photo Multiplier Tube (s-PMT)	High Sensitivity Photo Multiplier Tube (s-PMT)	Equivalent: Same.
Operational Characteristics
Operating Condition (Temp/Humidity)	0-40°C, 15%-95% RH	0-40°C, 15%-95% RH	Equivalent: Same.
Power Requirements	100-250VAC +/- 10%, 50/60Hz	100-250VAC +/- 10%, 50/60Hz	Equivalent: Same.
Methods of Exposure	Register Patient → X-ray Exposure	Register Patient → X-ray Exposure	Equivalent: Same.
X-ray Absorber	Imaging plate	Imaging plate	Equivalent: Same.
Functional Characteristics
Output Data	Dicom3.0 Compatible	Dicom3.0 Compatible	Equivalent: Same.
DQE (Detective Quantum Efficiency)	23.5% @ 0.5 lp/mm	25% @ 0.5 lp/mm	Improved: Slightly better DQE.
MTF (Modulation Transfer Function)	79% @ 0.5 lp/mm	80% @ 0.5 lp/mm	Improved: Slightly better MTF.
Defect Compensation	By Calibration	By Calibration	Equivalent: Same.
Dynamic Range	16bit	16 bit	Equivalent: Same.
Image Processing	Parameter selectable by body part	Parameter selectable by body part	Equivalent: Same.
DICOM Compatibility	DICOM 3.0 Compliant	DICOM 3.0 Compliant	Equivalent: Same.
Standards Compliance	IEC 60601-1; IEC 60601-1-2; IEC 62220-1	SAME	Equivalent: Same.

The crucial "acceptance criterion" for this 510(k) submission is to demonstrate that the FireCR Spark is substantially equivalent to the predicate device, FireCR, and that any differences do not raise new questions of safety or effectiveness. The device's performance, particularly in DQE and MTF, actually exceeds that of the predicate, which is presented as an enhancement rather than a deviation from acceptance.

2. Sample Size Used for the Test Set and Data Provenance

The document states:

"In clinical considerations, - The rating was considered equivalent by radiologists."
"As a result of Clinical Study, FireCR Spark is considered that Image quality is equivalent to the Predicate Device."
"Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" was performed."

Sample Size for Test Set: The document does not explicitly state the sample size (number of images or patients) used for the clinical study.

Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given the submitter's address in Korea, it is possible the clinical data originated there, but this is not confirmed.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: The document states that "The rating was considered equivalent by radiologists." It does not specify the number of radiologists involved.
Qualifications of Experts: The document identifies them as "radiologists" but does not provide details on their experience level (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study ratings. It simply states that "The rating was considered equivalent by radiologists."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not explicitly stated or performed as described in the provided text. The clinical study aimed to show equivalence in image quality between the FireCR Spark and the predicate device, FireCR, through radiologist ratings, but it does not evaluate the improvement of human readers with AI assistance versus without AI assistance. The device itself is a Computed Radiography Scanner, not an AI-powered diagnostic tool for interpretation assistance.

6. Standalone (Algorithm Only) Performance Study

This section is not applicable as the FireCR Spark is a Computed Radiography Scanner, a hardware device for capturing and digitizing X-ray images, not a standalone algorithm/AI for image interpretation without human interaction. Its performance metrics (DQE, MTF) are intrinsic to the device's image acquisition capabilities.

7. Type of Ground Truth Used

For the clinical study on image quality, the ground truth was based on expert consensus/ratings by radiologists. The document explicitly states: "The rating was considered equivalent by radiologists." and "FireCR Spark is considered that Image quality is equivalent to the Predicate Device."

For the technical performance metrics (DQE, MTF), the "ground truth" would be established through physical measurements and standardized testing methodologies (e.g., per IEC 62220-1).

8. Sample Size for the Training Set

The document describes a hardware device (Computed Radiography Scanner) and its associated acquisition software. It does not mention a "training set" in the context of machine learning or AI. The term "training set" is not relevant to this type of device, which is not an AI algorithm.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a "training set" for an AI algorithm, this question is not applicable to the information provided. The device performs signal processing, digital filtering, gain & offset correction, and flat fielding, which are standard image processing techniques, not machine learning that would require a ground-truthed training set.

Summary

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Page 1 of 4

JAN 15 2014

510(k) Summary K133120

This 510(k) summary information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date prepared: December 12, 2013

Company and Correspondent making the submission: Name - 3D Imaging & Simulations Corp. Address - 815. Tamnip-Dong, Yuseong-Gu, Daejeon, Korea Telephone - +82-42-931-2100 Fax - +82-42-931-2299 Contact - Jiin Jung / Vice President E-mail - jiinjung@3-disc.com

1. Device :

Trade/proprietary name:	FireCR Spark
Common Name:	Computed Radiography Scanner
Classification Name:	Stationary x-ray system

1. Predicate Device :

Manufacturer:	3D Imaging & Simulations Corp.
Device:	FireCR
510(k) Number:	K102619 (Decision Date – Mar. 1. 2011)

4. Classifications Names & Citations :

21CFR 892.1680, MQB - Stationary x-ray system, Class 2

5. Description :

5.1 General
The FireCR Spark is Computed Radiography System which produces the X-ray diagnostic image in digital format instead of using traditional screens and film. This device utilizes reusable X-ray storage phosphor plate (IP) that is sensitive to X-ray and stores latent image when it is exposed to X-ray. After X-ray exposure to the X-ray storage phosphor plate, X-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the X-ray storage phosphor plate is released in a form of light by laser scanning. Then the light is collect and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain & offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, then stored locally, sent to an archive, printed or sent to PACS system. After acquisition of latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused.

5.2 Main Features

Modern Scanning Mechanism

FireCR Spark adopts an updated scanning mechanism constructed in a compact and rigid structure. High Throughput: Its unique scanning mechanism enables to improve the efficiency and high throughout.

Scanning Resolution: User selectable resolution of 100um and 200um allows user to make diagnosis on variable purposes.

Detector

High sensitivity photomultiplier tube supplied in the FireCR Spark delivers high gain, wide dynamic range and high speed response for radiographic imaging.

Acquisition and Diagnostic Software: QuantorMed Plus Acquisition and Diagnostic Software's accurate and rapid data processing make the scanner powerful.

5.3 Product features

Photomultiplier Tube (PMT)
35cm x 43cm, 24cm x 30cm, 18cm x 24cm imaging area.
Wide dynamic range with 16-bit digitization

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Image process parameters are selectable according to the body part to make best images for diagnosis
DICOM3.0 standard compliance
User Selectable Scanning Resolution : 100µm and 200µm
1. Indications for use :

7. Comparison with predicate device :

3D Imaging & Simulations Corp. believes that the FireCR Spark is substantially equivalent to FireCR.

		FireCR3D Imaging & Simulations Corp.	FireCR Spark3D Imaging & Simulations Corp.
510(k) number		K102619	K133120
Intended Use		The FireCR imaging system isindicated for capturing, digitizationand processing of generalradiography images stored inimaging plate recording media.	The FireCR Spark imaging system isindicated for capturing, digitization andprocessing of general radiographyimages stored in imaging plate recordingmedia.
PhysicalCharacteristics	OverallDimensions	Reader464 x 703 x 117mm	Reader445 x 795 x 134mm
	Imaging Area	14" x 17" (35cm x 43cm)10" x 12" (25cm x 30cm)	35cm x 43cm SAME24cm x 30cm (SLIGHT DIFFERENCE)18cm x 24cm (NEW SIZE)
	Effective PixelPitch	100µm, 200µm	100μm, 200μm
	SpatialResolution	3.7lp/mm @ 100um	3.7lp/mm @ 100um
	Image Matrix(Pixel)	35cm x 43cm3500 x 4300 @ 100um1750 x 2150 @ 200um25cm x 30cm2500 x 3000 @ 100um1250 x 1500 @ 200um	35cm x 43cm SAME:3500 x 4300 @ 100um SAME1750 x 2150 @ 200um SAME24cm x 30cm (SLIGHT DIFFERENCE):2400x3000 @ 100um (SLIGHTDIFFERENCE)1200 x 1500 @ 200um (SLIGHTDIFFERENCE)18cm x 24cm (NEW SIZE):1800 x 2400 @ 100um900 x 1200@ 200um
	Weight	30kg	21.5kg
	Imaging Device	High Sensitivity Photo MultiplierTube (s-PMT)	High Sensitivity Photo Multiplier Tube (s-PMT)

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		FireCR3D Imaging & Simulations Corp.	FireCR Spark3D Imaging & Simulations Corp.
Photo		Image: FireCR	Image: FireCR Spark
OperationalCharacteristics	OperatingCondition	Temperature : 0-40°CHumidity: 15%-95% RH	Temperature : 0-40°CHumidity: 15%-95% RH
	PowerRequirements	100-250VAC +/- 10%,50/60Hz	100-250VAC +/- 10%,50/60Hz
	Methods ofExposure	Register Patient → X-ray Exposure	Register Patient → X-ray Exposure
	X-rayAbsorber	Imaging plate	Imaging plate
FunctionalCharacteristics	Output Data	Dicom3.0 Compatible	Dicom3.0 Compatible
	DQE	23.5% @ 0.5 lp/mm	25% @ 0.5 lp/mm
	MTF	79% @ 0.5 lp/mm	80% @ 0.5 lp/mm
	DefectCompensation	By Calibration	By Calibration
	DynamicRange	16bit	16 bit
	ImageProcessing	Image processing parameter isselectable by body part	Image processing parameter isselectable by body part
DICOM Compatibility		DICOM 3.0 Compliant	DICOM 3.0 Compliant
Standards		IEC 60601-1; IEC 60601-1-2IEC 62220-1	SAME

The FireCR Spark's imaging principle, physical characteristics, target population and intended use are the same as those of FireCR. However, the differences in the design are follows:

The technical specification (including DQE, MTF), mechanical structure and physical appearance of the FireCR Spark is a little different from the FireCR. - The testing of the FireCR Spark demonstrates that the performance is substantially equivalent to the predicate devices cited above.

In clinical considerations, - The rating was considered equivalent by radiologists.

As a result of Clinical Study, FireCR Spark is considered that Image quality is equivalent to the Predicate Device.

Summary of comparison:

The FireCR Spark described in this 510(k) has the same intended use and similar technical characteristics to the FireCR. The similarities and differences between these systems are described in the table shown above.

The similarities are as follows:

Intended use with FireCR; Capturing image, Image Processing, and DICOM compatible features with FireCR

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K133120
Page 4 of 4

X-ray exposing technique with FireCR: Effective Pixel Pitch with FireCR: Spatial resolution with FireCR: X-ray absorber material with FireCR; Image making process with FireCR; Energy Sources, Source to skin distance with FireCR; Workstation and operating system with FireCR

Differences are as follows:

(1) Difference in Mechanical Structure and Physical Appearance (Now the structure is more modular) Mechanical structure and physical appearance of FireCR Spark is different from those of FireCR. (2) Difference in DQE and MTF: FireCR Spark shows slightly better DQE and MTF compared to the FireCR. This is due to the uses of a multi layer fiber bundle.

Image /page/3/Figure/4 description: The image shows a close-up of a layered material. The top layer appears to be composed of many small, vertical fibers or strands. Below this is a solid, dark layer, and at the bottom, there is a row of small, white, spherical objects embedded within another dark layer.

Single Layer Fiber Bundle

Image /page/3/Picture/6 description: The image is a close-up shot of a dark, possibly black, surface. A thin, white line runs horizontally across the lower portion of the image, creating a stark contrast against the dark background. The texture of the surface appears smooth, with subtle variations in tone that suggest a slight sheen or reflection. The composition is simple, focusing on the interplay between the dark surface and the bright, linear element.

Multi Layer Fiber Bundle

(3) A new panel size is now available, allowing the user greater imaging flexibility (see table above). In summary, The FireCR Spark does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.

8. Safety, EMC, Biocompatibility and Performance Data :

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2(2001). Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory.

9. Conclusions :

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification 3D Imaging & Simulations Corp. concludes that the Computed Radiography Reader System (FireCR Spark) is safe and effective and substantially equivalent to predicate device as described herein. These modifications pose no risk to safety and effectiveness because they enhance reliability (modular construction) and they provide slightly better performance characteristics (multi layer fiber bundle) rendering the modifications substantially equivalent to our predicate device. There is also an added imaging plate size which gives the user a greater choice in their imaging needs (18cm x 24cm NEW SIZE, 1800 x 2400 @ 100um and 900 x 1200@ 200um.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image contains the logo for the U.S. Department of Health and Human Services. The logo features a stylized emblem with an abstract human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 15, 2014

3DISC Americas % Mr. Daniel Kamm. P.E. Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K133120

Trade/Device Name: Fire CR Flash Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: December 12, 2013 Received: December 16, 2013

Dear Mr. Kamm:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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-Mr. Kamm

: :.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Smith

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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Indications for Use

510(k) Number (if known): K133120

Device Name: Computed Radiography Scanner / FireCR Flash

Indications for Use:

1. 1. 1. 1. : : : : : ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

This device is not intended for the acquisition of mammographic image data.

Prescription Use X

AND/OR

Over-The-Counter Use _

(21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Image /page/6/Picture/12 description: The image contains a stylized signature or logo. The signature is illegible, but it appears to be written in cursive. The signature is surrounded by a geometric pattern of dashed lines, which creates a border around the signature. The overall impression is that of a stylized and abstract design.

(Division Sign-Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

K133120 510(k)

Page 1 of 1

Page 17 of 594

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.