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 acceptance criteria and study for the FireCR Spark Computed Radiography Scanner:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Predicate Device K102619)	Reported Device Performance (FireCR Spark)
Spatial Resolution: 3.71 lp/mm @ 100μm	Spatial Resolution: 3.7 lp/mm @ 100μm
DQE: 23.5% @ 0.5 lp/mm	DQE: 25% @ 0.5 lp/mm
MTF: 79% @ 0.5 lp/mm	MTF: 80% @ 0.5 lp/mm
Image Matrix (35cm x 43cm @ 100μm): 3500 x 4300	Image Matrix (35cm x 43cm @ 100μm): 3500 x 4300
Image Matrix (35cm x 43cm @ 200μm): 1750 x 2150	Image Matrix (35cm x 43cm @ 200μm): 1750 x 2150
Image Matrix (25cm x 30cm @ 100μm): 2500 x 3000	Image Matrix (24cm x 30cm @ 100μm): 2400 x 3000 (slight difference)
Image Matrix (25cm x 30cm @ 200μm): 1250 x 1500	Image Matrix (24cm x 30cm @ 200μm): 1200 x 1500 (slight difference)
Common new panel size: N/A (Pred. device does not have this size)	Image Matrix (18cm x 24cm @ 100μm): 1800 x 2400 (new size)
Common new panel size: N/A (Pred. device does not have this size)	Image Matrix (18cm x 24cm @ 200μm): 900 x 1200 (new size)
Dynamic Range: 16 bit	Dynamic Range: 16 bit
Defect Compensation: By Calibration	Defect Compensation: By Calibration

Acceptance Criteria for Clinical Study: Implicitly, the FireCR Spark was accepted if its image quality was considered "equivalent" to the predicate device by radiologists.

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

Sample Size for Test Set: Not explicitly stated in the provided text. The document mentions "Clinical considerations" and "Clinical Study" but doesn't quantify the number of cases or images used.
Data Provenance: Not explicitly stated. The submission is from a Korean company (3D Imaging & Simulations Corp., Daejeon, Korea), so the data could be from Korea, but this is not confirmed. It is also not specified whether the data was retrospective or prospective.

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

Number of Experts: Not explicitly stated. The document refers to "radiologists" (plural), indicating more than one, but no specific number is given.
Qualifications of Experts: Only stated as "radiologists." No detail on their experience (e.g., years of experience, subspecialty) is provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The text only says, "The rating was considered equivalent by radiologists." This suggests a consensus or comparison, but the specific method (e.g., 2+1, 3+1) is not detailed.

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

MRMC Study: The document implies a comparison between the FireCR Spark and the predicate device by radiologists ("As a result of Clinical Study, FireCR Spark is considered that Image quality is equivalent to the Predicate Device"). However, it does not explicitly describe a formal MRMC comparative effectiveness study designed to quantify improvement with AI assistance. This device is a Computed Radiography Scanner, not an AI-powered diagnostic tool, so the concept of "human readers improve with AI vs without AI assistance" does not directly apply here. The study focused on demonstrating equivalence in image quality to a predicate device.
Effect Size of Human Readers Improvement with AI: Not applicable, as this is not an AI-assisted diagnostic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: Yes, non-clinical performance data (DQE, MTF, Spatial Resolution, Image Matrix, Dynamic Range, Defect Compensation) were reported for the device itself against the predicate. This is a standalone technical performance evaluation. The clinical study, though involving radiologists, served to confirm the image quality equivalence produced by the algorithm/device for human interpretation, rather than evaluating human-in-the-loop performance.

7. Type of Ground Truth Used

Type of Ground Truth: For the technical performance metrics (DQE, MTF, Spatial Resolution, etc.), the ground truth is established by physical measurements and engineering specifications.
For the clinical study, the ground truth was expert consensus/opinion from radiologists regarding image quality equivalence to the predicate device. It does not mention pathology or outcomes data.

8. Sample Size for the Training Set

Sample Size for Training Set: The document does not mention a "training set" in the context of an AI/ML algorithm. This device is a Computed Radiography Scanner, and its performance is based on its physical and functional characteristics, not on a machine learning algorithm trained on data. Therefore, this question is not directly applicable to the information provided.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a machine learning training set.

Summary

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510(k) Summary K133106

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

Date prepared: December 12, 2013

JAN 1 5 2014

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
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

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 throughput.

Scanning Resolution: User selectable resolution of 100um 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	K133106
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 platerecording media.
PhysicalCharacteristics	OverallDimensions	Reader464 x 703 x 117mm	Reader445 x 795 x 80 mm
	Imaging Area	14" x 17" (35cm x 43cm)10" x 12" (25cm x 30cm)	35cm x 43cm SAME24cm x 30cm (SLIGHTDIFFERENCE)18cm x 24cm (NEW SIZE)
	Effective PixelPitch	100μm, 200μm	100μm, 200μm
	SpatialResolution	3.71p/mm @ 100μm	3.7lp/mm @ 100μm
	Image Matrix(Pixel)	35cm x 43cm3500 x 4300 @ 100μm1750 x 2150 @ 200μm25cm x 30cm2500 x 3000 @ 100μm1250 x 1500 @ 200μm	35cm x 43cm SAME:3500 x 4300 @ 100μm SAME1750 x 2150 @ 200μm SAME24cm x 30cm (SLIGHTDIFFERENCE):2400x3000 @ 100μm (SLIGHTDIFFERENCE)1200 x 1500 @ 200μm (SLIGHTDIFFERENCE)18cm x 24cm (NEW SIZE):1800 x 2400 @ 100μm900 x 1200@ 200μm
	Weight	30kg	19.5kg
	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
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-ray Absorber	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 Ip/mm	80% @ 0.5 lp/mm
	DefectCompensation	By Calibration	By Calibration
	Dynamic Range	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 Fire 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 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

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R133106
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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.

Laser scanning to

Image /page/3/Figure/3 description: The image shows two diagrams comparing single-layer and multi-layer fiber bundles used in fluorescence imaging. The first diagram illustrates a single-layer fiber bundle collecting fluorescence signals from an imaging plate stimulated by laser scanning. The second diagram shows a multi-layer fiber bundle collecting fluorescence signals from an imaging plate also stimulated by laser scanning. The diagrams highlight the difference in fiber bundle arrangement and their respective roles in collecting fluorescence signals.

(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 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 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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines extending from its body, resembling wings or flowing elements. 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 % Daniel Kamm, P.E. Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K133106

Trade/Device Name: Fire CR Spark 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 or any I coonal statues and 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 device-related adverse ovenas) (21 OFF Part 820); and if applicable, the electronic fordination control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Kamım

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/ReportalProblem/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,

Image /page/5/Picture/7 description: The image shows a logo with the letters "FDA" in a stylized, geometric font. The letters are interconnected and have a maze-like appearance due to the use of parallel lines. There is a signature-like flourish that overlays the letters, adding a personal touch to the design.

for

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

Enclosure

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Indications for Use

510(k) Number (if known): K133106

Device Name: Computed Radiography Scanner / FireCR Spark

Indications for Use:

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)

(Division Sign-Off)

Division of Radiological Health

Office of In Vitro Diagnostics and Radiological Health

510(k) _______________________________________________________________________________________________________________________________________________________________________

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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.