NICAL SMART MICRO CR system for intraoral dental images is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.

Device Description

The NICAL/SMART MICRO is a Computed Radiography System which produces the Xray 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 the latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused.

AI/ML Overview

The NICAL SMART MICRO CR System for Intraoral Dental Images (K143703) was deemed substantially equivalent to its predicate device, the FireCR Dental by 3D Imaging & Simulations Corp. (K131442), based on technical performance and indications for use.

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating equivalence to the predicate device, rather than explicit "acceptance criteria" against regulatory standards (beyond general safety and quality). However, the comparison table provided acts as a de facto set of acceptance criteria, where the NICAL device is expected to perform comparably or better than the predicate.

Characteristic	Acceptance Criteria (Predicate - FireCR Dental K131442)	Reported Device Performance (NICAL/SMART MICRO Dental Imaging System K143703)
Physical Char.
Overall Dimensions	Reader: 185 x 100 x 293mm	Reader: 110x154x270 mm (Smaller)
Imaging Area	Size 0-3, 4c available	Size 0-3 available (Size 4c N/A)
Effective Pixel Pitch	35um, 64um	30 um (Smaller, indicating better resolution)
Spatial Resolution	9.0lp/mm @ 35um	10.5 lp/mm @ 30um (Higher, indicating better resolution)
Image Matrix	Various sizes @ 64um & 35um	Various sizes @ 30um (Higher resolution)
Weight	4.7kg	4.6kg (Slightly lighter)
Imaging Device	High Sensitivity Photo Multiplier Tube (s-PMT)	High Sensitivity Photo Multiplier Tube (s-PMT) (Same)
Operational Char.
Operating Condition	Temperature: 15-30°C; Humidity: 15%-95% RH	Temperature: 10 - 40 °C; Humidity: 30 - 90% RH (Wider operating range)
Power	100 – 240V, 50/60Hz	100 – 240V, 50/60Hz (Same)
Methods of Exposure	Register Patient -> X-ray Exposure	Register Patient -> X-ray Exposure (Same)
X-ray Absorber	Imaging plate	Imaging plate (Same)
Functional Char.
Output Data	Dicom3.0 Compatible	Dicom3.0 Compatible (Same)
Performance (MTF)	70 kV 0.08sec dose. 55% 1 lp/mm, 11% 3 lp/mm	65Kv 0.1 sec dose. 100% 1 lp/mm, 95% 3 lp/mm, 80% 5 lp/mm, 30% 10 lp/mm (Superior)
Defect Compensation	By Calibration	By Calibration (Same)
Dynamic Range	16 bit	16 bit (Same)
Image Processing	Single image processing parameter is used	Single image processing parameter is used (Same)
DICOM Compatibility	DICOM 3.0 Compliant	DICOM 3.0 Compliant (Same)
Imaging Plate Comp.
Imaging Plate Composition	BaSrFBrl:Eu phosphor	BaSrFBrl:Eu phosphor (Same)
Plate Sizes	Size 0-4c	Size 0-3 (Similar, 4c not available)
Thickness	approx. 350 mm	approx. 350 mm (Same)
Typical luminescence	400 nm	400 nm (Same)
Image Retention	As described	As described (Same)

2. Sample size used for the test set and the data provenance

Test Set Sample Size: The document does not specify a distinct "test set" in terms of a number of images or cases for non-clinical image quality testing. It mentions a "verification report on image testing" to check image quality and resolution.
Data Provenance: Not explicitly stated for the non-clinical image testing or clinical images. The clinical images were reviewed by a "Board Certified US based radiologist," implying the images themselves might be from a US context or at least reviewed by a US expert.

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

Number of Experts: One.
Qualifications of Experts: "Board Certified US based radiologist." No years of experience are specified.

4. Adjudication method for the test set

Adjudication method: Not applicable/not described as a formal adjudication process. The document states, "Clinical Images were reviewed by a Board Certified US based radiologist and were found to be of excellent quality, suitable for the intended use." This suggests a single expert opinion rather than a multi-reader adjudication.

5. 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, an MRMC comparative effectiveness study was not done. This submission is for a Computed Radiography System, not an AI-based diagnostic aid that assists human readers.

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

Standalone Performance: Not applicable in the context of an AI algorithm. The device itself is a standalone imaging system. The performance metrics reported (MTF, spatial resolution) are inherent to the device's image acquisition capabilities.

7. The type of ground truth used

For the non-clinical image quality and resolution tests (e.g., MTF, spatial resolution), the "ground truth" would be established by physical measurements using standardized phantoms and imaging protocols.
For the clinical images, the "ground truth" was effectively the expert opinion of a single Board Certified US based radiologist, who deemed them "of excellent quality, suitable for the intended use." This is closer to expert consensus (though only one expert) on diagnostic suitability rather than pathology or outcomes data.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This device is a Computed Radiography System; it is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary

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

March 18, 2015

NICAL SPA % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K143703

Trade/Device Name: NICAL SMART MICRO CR System for Intraoral Dental Images Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: January 28, 2015 Received: March 6, 2015

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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Exhibit 4.

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Indications for Use

510(k) Number (if known)

K143703

Device Name NICAL SMART MICRO CR system for intraoral dental images

Indications for Use (Describe)

NICAL SMART MICRO CR system for intraoral dental images is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Exhibit 1. 510(k) SUMMARY

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510(k) Summary, K143703 This 510(k) summary information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date prepared: March 2, 2015

1. Company and Correspondent: NICAL SPA Via Soffredini, 43 -20126 Milano Italy Phone +39 022571110 -Fax +39 022572207 www.nical.com Prepared by: Roberto Niccolucci, President
1. Device

Trade/Proprietary Name: NICAL/SMART MICRO Common Name: Computed Radiography Scanner System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH

1. Predicate Device: FireCR Dental, made by 3D Imaging & Simulations Corp., K131442.
1. Indications for Use: The NICAL/SMART MICRO Dental Imaging System is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.
1. Description: The NICAL/SMART MICRO is a Computed Radiography System which produces the Xray 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 the latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused. Details: A laser diode is focused on the plate with a diameter of 30 µm, total power is 35 mW (CW) at wavelength from 620 to 650 µm. The blue light (400 nm) is collected from a light guide (NICAL patent) and sent to a Hamamatzu photomultiplier (PMT). Wavelength (Peak): 420 nm. The signal output from PMT is digitized from a 16 bit A/D converter. The 16 bit digitized imaging signal is sent to an FTDI 2232HL IC that contains all the logic to interface to USB2 standard. The time to read a full image depends on the size of the plate: size 0: 5 seconds; size 3: 9 seconds.
1. Comparison with predicate device: The indications for use and the technologies employed are virtually identical to those of the predicate. Imaging plates are exposed to x-rays while in the patient's mouth. The plates are removed and scanned by the scanning device. The resulting images can be viewed by the dentist and stored on a personal computer. The plates are then

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erased and can be reused. Patient cross contamination is prevented by the use of single use barrier envelopes placed over the plates. The imaging plates are identical to those used in the predicate device. Comparison of the test results: The MTF performance (see chart below) is superior on the Nical system as compared to the predicate. The effective pixel pitch is smaller, 30 um vs 35 um giving slightly better overall resolution. This shows up in a comparison of the spatial resolution: 9.0lp/mm @ 35um on the predicate vs. 10.5 lp/mm @ 30um on the Nical device. A detailed comparison table follows.

		FireCR Dental3D Imaging & SimulationsCorp.	NICAL/SMART MICRO Dental ImagingSystem
510(k) number		K131442	K143703
Intended Use		The FireCR Dental imagingsystem is indicated forcapturing, digitization andprocessing of intra oral x-ray images stored inimaging plate recordingmedia.	The NICAL/SMART MICRO DentalImaging System is indicated forcapturing, digitization and processing ofintra oral x-ray images stored in imagingplate recording media.
PhysicalChar.	OverallDimensions	Reader185 x 100 x 293mm	Reader110x154x270 mm
	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 (22mm x 31mm),Size 1 (24mm x 40mm),Size 2 (31mm x 41mm),Size 3 (27mm x 54mm)N/A
	Effective PixelPitch	35um, 64um	30 um.
	SpatialResolution	9.0lp/mm @ 35um	10.5 lp/mm @ 30um
	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 0726x1024 pixel 30 um.Size 1792x1321 pixel 30 um.Size 21024x1354 pixel 30 um.Size 3891x1783 pixel 30 um.Not applicable
		FireCR Dental3D Imaging & SimulationsCorp.	NICAL/SMART MICRO Dental ImagingSystem
	Photo	Image: FireCR Dental 3D Imaging	Image: NICAL/SMART MICRO Dental Imaging System
	Weight	4.7kg	4.6kg
	ImagingDevice	High Sensitivity PhotoMultiplier Tube (s-PMT)	High Sensitivity Photo Multiplier Tube(s-PMT)
OperationalChar	OperatingCondition	Temperature :15-30°CHumidity: 15%-95% RH	Temperature: 10 - 40 °CHumidity: 30 - 90% RH
	Power	100 – 240V, 50/60Hz	100 – 240V, 50/60Hz
	Methods ofExposure	Register Patient ->X-ray Exposure	Register Patient →X-ray Exposure
	X-rayAbsorber	Imaging plate	Imaging plate
FunctionalChar.	Output Data	Dicom3.0 Compatible	Dicom3.0 Compatible
	Performance	MTF: 70 kV 0.08sec dose.55% 1 lp/mm11% 3 lp/mm	MTF: 65Kv 0,1 sec dose.100%. 1 lp/mm95%. 3 lp/mm80%. 5 lp/mm30%. 10 lp/mm
	DefectCompensation	By Calibration	By Calibration
	DynamicRange	16 bit	16 bit
	ImageProcessing	Single image processingparameter is used	Single image processing parameter isused
	FireCR Dental3D Imaging & SimulationsCorp.	NICAL/SMART MICRO Dental ImagingSystem
DICOMCompatibility	DICOM 3.0 Compliant	DICOM 3.0 Compliant

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Imaging Plate Comparison
	FireCR Dental3D Imaging & Simulations Corp.	NICAL/SMART MICRO Dental Imaging System
510(k) number	K131442	K143703
Imaging Plate Composition	BaSrFBrl:Eu phosphor	BaSrFBrl:Eu phosphor
Plate Sizes	Size 0 : 22 x 31mm	Size 0 (22mm x 31mm)
	Size 1 : 24 x 40mm	Size 1 (24mm x 40mm)
	Size 2 : 31 x 41mm	Size 2 (31mm x 41mm)
	Size 3 : 27 x 54mm	Size 3 (27mm x 54mm)
	Size 4c : 48 x 54mm	N/A
Thickness	Thickness: approx. 350 mm	Thickness: approx. 350 mm
Typical luminescence	400 nm	400 nm
Image Retention	Recommended within 1 hour of exposure. Two hours after exposure 70% of the stored energy still is present with no visible loss of information upon readout. Image retention still exceeds 45% after 24h	Recommended within 1 hour of exposure. Two hours after exposure 70% of the stored energy still is present with no visible loss of information upon readout. Image retention still exceeds 45% after 24h

1. Description of non-clinical testing: Software validation and risk analysis was performed. Electrical safety and EMC testing was performed by a qualified testing laboratory according to IEC 60601-1 and IEC 60601-1-2. A verification report on image testing was performed to check image quality and resolution. A quality assurance procedure has been established for the incoming inspection of the imaging plates. Biocompatibility of the hygienic envelopes has been verified.
1. Description of clinical testing: Clinical Images were reviewed by a Board Certified US based radiologist and were found to be of excellent quality, suitable for the intended use. These images were not necessary to establish substantial equivalence based on the comparison to the predicate device (Note: X-ray storage phosphor plate that is identical to the predicate image plate) but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended."
1. Conclusion: Based on the similarity to the predicate device in terms of technology, performance, and indications for use, we conclude that the Nicro Dental Imaging System is substantially equivalent to the predicate device named above.

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.