The FireCR Dental imaging system is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media

Device Description

The FireCR Dental is Computed Radiography Reader 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 (Imaging Plate) 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 collected 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 a breakdown of the acceptance criteria and study information for the FireCR Dental Imaging System (K131442), based on the provided text:

Acceptance Criteria and Device Performance

The provided document compares the FireCR Dental to a predicate device, DIGORA Optime, across various technical specifications. The acceptance criteria seem to implicitly be substantial equivalence to the predicate device in key performance metrics.

Acceptance Criteria / Performance Metric (Predicate)	Reported Device Performance (FireCR Dental)	Met (Y/N)
Intended Use	Dental Computed Radiography System for producing digital X-Ray images for dental radiography (intra oral) purposes.	This device is a Dental Computed Radiography System and intended for use in producing digital X-Ray images for dental radiography (intra oral) purposes.
Physical Characteristics
Overall Dimensions	Reader: 190 x 200 x 383mm	Reader: 185 x 100 x 293mm
Imaging Area	Size 0, 1, 2, 3, 4c (Specific dimensions for each size as listed)	Size 0, 1, 2, 3, 4c (Specific dimensions for each size as listed)
Effective Pixel Pitch	35um, 64um	35um, 64um
Spatial Resolution	14.3 lp/mm @ 35um, 7.8 lp/mm @ 64um	14.3 lp/mm @ 35um, 7.8 lp/mm @ 64um
Image Matrix	Specific dimensions for each IP size at 64um and 35um	Specific dimensions for each IP size at 64um and 35um
Weight	9.8kg	4.7kg
Imaging Device	High Sensitivity Photo Multiplier Tube (s-PMT)	High Sensitivity Photo Multiplier Tube (s-PMT)
Operational Characteristics
Operating Condition	Temperature: 10 - 40 °C, Humidity: 30 - 90% RH	Temperature: 15 - 30°C, Humidity: 15% - 95% RH
Power Requirements	100 - 240V, 50/60Hz	100 - 240V, 50/60Hz
Methods of Exposure	Register Patient -> X-ray Exposure	Register Patient -> X-ray Exposure
X-ray Absorber	Imaging plate	Imaging plate
Functional Characteristics
Output Data	DICOM 3.0 Compatible	DICOM 3.0 Compatible
DQE @ 10% eff.	2.4 lp/mm	2.6 lp/mm
MTF @ 3 lp/mm	32%	34%
Defect Compensation	By Calibration	By Calibration
Dynamic Range Image	14bit	16bit
Processing	DICOM 3.0 Compliant	DICOM 3.0 Compliant
DICOM Compatibility	DICOM 3.0 Compliant	DICOM 3.0 Compliant

Conclusion on Acceptance Criteria: The FireCR Dental is deemed to meet acceptance criteria by demonstrating substantial equivalence to the predicate device, with some technical specifications (like DQE, MTF, and Dynamic Range) showing slight improvements. The overall conclusion is that its performance is equivalent to the predicate.

Study Information

The document describes a "Clinical Study" and non-clinical/performance testing.

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

Test Set Sample Size: Not explicitly stated. The text mentions "As a result of Clinical Study, FireCR Dental is considered that Image quality is equivalent to the Predicate Device." This implies a patient-level or image-level comparison, but the number of cases or patients is not provided.
Data Provenance: Not explicitly stated, but the "Clinical Study" implies human data. The location of the study (e.g., country of origin) is not mentioned. It is unclear if the data was retrospective or prospective.

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

Number of Experts: Not explicitly stated how many "dentists" were involved.
Qualifications of Experts: Described as "dentists." No further details on their experience (e.g., years of experience, specialization) are provided.

3. Adjudication method for the test set:

Adjudication Method: Not explicitly stated. The text says "The rating was considered equivalent by dentists," which suggests a consensus or comparison approach, but the specific method (e.g., majority vote, independent review with arbitration) is not detailed.

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:

MRMC Study: No. This device is a Computed Radiography Scanner System, not an AI-assisted diagnostic tool. The "clinical study" focused on comparing the image quality of the new device to a predicate device, as evaluated by dentists, rather than on reader performance with or without AI assistance.
Effect Size of AI: Not applicable, as this is not an AI device.

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

Standalone Performance: Yes, in a sense. The comparison of technical specifications (DQE, MTF, Spatial Resolution, Dynamic Range) between the FireCR Dental and the predicate device can be considered standalone performance assessments of the device's imaging capabilities. However, this isn't a "standalone algorithm" performance as the device's primary function is image acquisition, not autonomous diagnosis. The device's output (digital images) is intended for human interpretation.

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

Ground Truth Type: Expert opinion/evaluation by "dentists" on image quality, implicitly against the predicate device's image quality. The statement "FireCR Dental is considered that Image quality is equivalent to the Predicate Device" suggests a comparison where the predicate's image quality serves as the reference, and the dentists' ratings are the mechanism for assessing equivalence. It's not based on pathology or outcomes data.

7. The sample size for the training set:

Training Set Sample Size: Not applicable. This device is a Computed Radiography scanner, which processes X-ray signals into digital images. It does not use machine learning or AI that would require a "training set" in the conventional sense for training an algorithm.

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

Ground Truth for Training Set: Not applicable, as there is no mention of a training set or AI model being developed for this device. The device's "processing" involves digital filtering, gain & offset correction, and flat fielding, which are standard image processing techniques not typically "trained" on labeled ground truth data.

Summary

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510(k) Summary for K131442

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

Date Prepared: September 3, 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 / COO E-mail - jij@3DISCimaging.com

SEP 06 2013

2. Device :

Trade/proprietary name	: FireCR Dental
Common Name	: Computed Radiography Scanner System
Classification Name	: Extraoral source x-ray system

1. Predicate Devices :

Manufacturer	: Soredex
Device	: DIGORA Optime
510(k) Number	: K041050 (Decision Date - Apr. 19. 2004)

4. Classification Name & Citations :

Extraoral source x-ray system., 21 CFR 872.1800, Pro Code MUH.

5. Description :

5.1 General
The FireCR Dental is Computed Radiography Reader 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 (Imaging Plate) 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 collected and converted into a form of digital image. The signal processing is made to

815, Tamnip-Dong, Yuseong-Gu, Daejeon, Korea

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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 Feature

Experience the Benefits of Digital Imaging

The full-featured Fire CR Dental Reader from 3D Imaging & Simulations Corp. rapidly and affordably delivers high-quality digital images for busy dental practices.

Compact & Affordable

The FireCR Dental Reader is compact and affordable, helping to increase patient throughput and improve the overall productivity of your practice. With its small footprint, the reader fits seamlessly into even the most space-challenged dental offices and exam rooms.

Elegant Design & Streamlined Operation

The FireCR Dental Reader's elegant design belies a powerful yet easy-to-use system that gets the job done day in and day out.

The reader is DICOM 3.0 compatible with existing systems and uses a full range of low-cost, reusable bitewing and intraoral imaging plates that are easier and faster to position than intraoral digital sensors.

5.3 Product features

Photomultiplier Tube .(PMT)
IP size : 0, 1, 2, 3 and 4c
Wide dynamic range with 16-bit digitization
DICOM3.0 standard compliance
User Selectable Scanning Resolution : 35um and 64um

6. Indication for use :

The FireCR Dental imaging system is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media

7. Comparison with predicate device :

3D Imaging & Simulations Corp. believes that the Dental Computed Radiography Reader

10.53 - 10.0 - 10.0 - 10.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 - 1.0 -

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(FireCR Dental) is substantially equivalent to DIGORA Optime of Soredex.

		FireCR Dental3D Imaging & Simulations Corp.	DIGORA OptimeSoredex
	510(k) number	-	K041050
	Intended Use	This device is a DentalComputed Radiography Systemand intended for use inproducing digital X-Ray imagesfor dental radiography (intra oral)purposes.	The Digora Optime imagingsystem is indicated for capturing,digitization and processing ofintra oral x-ray images stored inimaging plate recording media.
PhysicalChar.	OverallDimensions	Reader185 x 100 x 293mm	Reader190 x 200 x 383mm
	Imaging Area	Size 0 : 22 x 31mmSize 1 : 24 x 40mmSize 2 : 31 x 41mmSize 3 : 27 x 54mmSize 4c : 48 x 54mm	Size 0 : 22 x 31mmSize 1 : 24 x 40mmSize 2 : 31 x 41mmSize 3 : 27 x 54mmSize 4c : 48 x 54mm
	Effective PixelPitch	35um, 64um	35um, 64um
	SpatialResolution	14.3 lp/mm @ 35um7.8 lp/mm @ 64 um	14.3 lp/mm @ 35um7.8 lp/mm @ 64 um
	Image Matrix	Size 0343 x 484 @ 64um628 x 885 @ 35umSize 1375 x 625 @ 64um685 x 1143 @ 35umSize 2484 x 640 @ 64um886 x 1171 @ 35umSize 3421 x 843 @ 64um771 x 1542 @ 35umSize 4c750 x 843 @ 64um1370 x 843 @ 35um	Size 0343 x 484 @ 64um628 x 885 @ 35umSize 1375 x 625 @ 64um685 x 1143 @ 35umSize 2484 x 640 @ 64um886 x 1171 @ 35umSize 3421 x 843 @ 64um771 x 1542 @ 35umSize 4c750 x 843 @ 64um1370 x 843 @ 35um
	Weight	4.7kg	9.8kg
	Imaging Device	High Sensitivity Photo MultiplierTube (s-PMT)	High Sensitivity Photo MultiplierTube (s-PMT)

OperationalChar	OperatingCondition	Temperature : 15-30°CHumidity: 15%-95% RH	Temperature: 10 - 40 °CHumidity: 30 - 90% RH
	PowerRequirements	100 - 240V, 50/60Hz	100 - 240V, 50/60Hz
	Methods ofExposure	Register Patient ->X-ray Exposure	Register Patient →X-ray Exposure
	X-ray Absorber	Imaging plate	Imaging plate
FunctionalChar.	Output Data	Dicom3.0 Compatible	Dicom3.0 Compatible
	DQE @ 10% eff.	2.6 lp/mm	2.4 lp/mm
	MTF @ 3 lp/mm	34%	32%
	DefectCompensation	By Calibration	By Calibration
	Dynamic RangeImage	16bitSingle image processing	14bitSingle image processing

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3D Imaging & Simulations Corp

	FireCR Dental3D Imaging & Simulations Corp.parameter is used	DIGORA OptimeSoredexparameter is used
Processing	DICOM 3.0 Compliant	DICOM 3.0 Compliant
DICOMCompatibility	DICOM 3.0 Compliant	DICOM 3.0 Compliant

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

The technical specification (including Spatial Resolution, Operating Condition, DQE, MTF, Dynamic range), mechanical structure and physical appearance of the FireCR Dental is little different from the DIGORA Optime. Additional information can also be found in the FireCR Dental Operation Manual provided in this submission.
The testing of the FireCR Dental demonstrates that the performance is substantially equivalent to the predicate devices cited above.

In clinical considerations,

The rating was considered equivalent by dentists.
- As a result of Clinical Study, FireCR Dental is considered that Image quality is equivalent to the Predicate Device. And FireCR Dental represents an effect for diagnosis of patient.

The FireCR Dental described in this 510(k) has the same intended use and similar technical characteristics as the DIGORA Optime of Soredex. The similarities and differences between these systems are described in the table shown above.

The similarities are as follows.

Similarity of Intended use with DIGORA Optime

Similarity of Capturing image, Image Processing, and DICOM compatible features with DIGORA Optime

Similarity of X-ray exposing technique with DIGORA Optime
Similarity of Effective Pixel Pitch.

Similarity of Spatial resolution.

Similarity of X-ray absorber material with DIGORA Optime
Similarity of Image making process with DIGORA Optime

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K131442
Page 5 of 5

3D Imaging & Simulations Corp.

Similarity of Energy Sources, Source to skin distance with DIGORA Optime Similarity of workstation and operating system with DIGORA Optime

A difference is as follows.

(1) Difference in Dynamic Range

DIGORA Optime's dynamic range is 14bit but FireCR Dental is 16bit. Therefore FireCR Dental shows more dynamic range in image than DIGORA Optime.

In summary, The FireCR Dental does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device.

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 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 Scanner System (FireCR Dental) is safe and effective and substantially equivalent to predicate devices as described herein.

1. 3D Imaging & Simulations Corp. will update and include in this summary any other information deemed seasonably necessary by the FDA.
  END

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Ticalih Service

Food and Drug Administration 10903 New Hammshire Avenue Document Control Center - WO060-G099 Silver Spring, MD 20993-0002

September 6. 2013

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

Re: K131442

FireCR Dental Imaging System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: July 29, 2013 Received: July 31, 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. Insting 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

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Page 2 - Daniel Kamm, P.E.

device-related adverse events) (21 CFR 803); good manufacturing practive requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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/Safets/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/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 htmg//www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

l'or

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): K131442

Device Name: FireCR Dental Imaging System

Indications for Use:

The Fire R Dental Imaging System is indicated for capturing, digitization and processing of intra-oral x-ray images stored in imaging plate recording media.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(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)

$(m h.7)$

(Division Sign-OM) Division of Radiological Bealth Office of In Viro Diagnostics and Radiological Health

510(k) K131442

Page 1 of 1

Regulation Number and Section

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.