ReadeR is a dental imaging system indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media.

ReadeR system is intended to be used only by dentist and other qualified dental professionals to process x-ray images exposed to the imaging plates from the intraoral complex of the skull.

Device Description

The ReadeR is a computer radiography system which produces the x-ray diagnostic image in digital format instead of using traditional screens and film. This device does not have a wireless transmission. The 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 plates 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 and offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, the 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 provided text is a 510(k) summary for the Trident s.r.l. device, ReadeR, VieweR, QuickScan PSP. It asserts substantial equivalence to a predicate device, the NICAL SMART MICRO CR System. However, it does not contain information about a study proving the device meets acceptance criteria in the way typically expected for a new device's performance claims.

Instead, the document's core argument for substantial equivalence is that the subject device is, in essence, the same as the predicate device with minor external differences and re-branding. This means the acceptance criteria and performance are essentially inherited from the predicate device.

Here's an attempt to extract and format the information as requested, with caveats due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission based on the subject device being "the same" as the predicate, there are no specific "acceptance criteria" for the subject device beyond matching the predicate's specifications. The reported performance is essentially identical to the predicate.

Characteristic	Acceptance Criteria (Predicate)	Reported Device Performance (Subject)
Imaging Plate Sizes	Size 0 (22x31mm), Size 1 (24x40mm), Size 2 (31x41mm), Size 3 (27x54mm)	Size 0 (22x31mm), Size 1 (24x40mm), Size 2 (31x41mm), Size 3 (27x54mm)
Effective Pixel Pitch	30 µ	30 µ
Spatial Resolution	10.5 lp/mm @ 30µm	10.5 lp/mm @ 30µm
Image Matrix	Size 0: 343x484 @ 64um, 628x885 @ 35umSize 1: 375x625 @ 64um, 685x1143 @ 35umSize 2: 484x640 @ 64um, 886x1171 @ 35umSize 3: 891x1783 @ 30um	Size 0: 343x484 @ 64um, 628x885 @ 35umSize 1: 375x625 @ 64um, 685x1143 @ 35umSize 2: 484x640 @ 64um, 886x1171 @ 35umSize 3: 891x1783 @ 30um
Weight	4.7 kg	4.6 kg (minor difference)
Imaging Device	High Sensitivity Photo Multiplier Tube (s-PMT)	High Sensitivity Photo Multiplier Tube (s-PMT)
Operating Temperature	10 - 40 °C	15 - 30 °C (minor difference)
Operating Humidity	30 - 90% RH	15% - 95% RH (minor difference)
Power	100-240V, 50/60Hz	100-240V, 50/60Hz
Method of Imaging	Register Patient -> X-ray Exposure	Register Patient -> X-ray Exposure
Image Receptor	Imaging plate	Imaging plate
Output Data	DICOM 3 compatible	DICOM 3 compatible
MTF (Performance)	70 kV 0.08 sec exposure: 55% @ 1 lp/mm, 11% @ 3 lp/mm	65Kv 0.1 sec exposure: 100% @ 1 lp/mm, 95% @ 3 lp/mm, 80% @ 5 lp/mm, 30% @ 10 lp/mm (Note: Different exposure parameters)
Defect Compensation	By Imaging plate calibration	By Imaging plate calibration
Dynamic Range	16 bit	16 bit
Image Processing	Single image processing parameter is used	Single image processing parameter is used
IP Composition	BaSrFBrl:Eu phosphor	BaSrFBrl:Eu phosphor
IP Thickness	approx. 350 mm	approx. 350 mm
Typical Luminescence	400 nm	400 nm
Image Retention	Recommended within 1 hour of exposure	Recommended within 1 hour of exposure
Imaging Software	Nical Image Plus	Deep-View (OBL of same original software)

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

Sample Size for Test Set: The document mentions "Clinical images were provided" but explicitly states they "were not necessary to establish substantial equivalence" and that "bench performance data" was the primary basis. No specific sample size for a test set of clinical images used for a performance study is provided.
Data Provenance: Not specified for any clinical images provided. The bench testing (e.g., electrical safety, EMC, software validation) was performed by laboratories in Italy and the USA.

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

Not applicable. The document relies on the predicate device's established performance and bench testing of the subject device. There is no mention of expert-established ground truth for a clinical test set for the ReadeR device itself.

4. Adjudication Method for the Test Set

Not applicable, as no described clinical performance test set requiring adjudication is detailed.

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

No MRMC or comparative effectiveness study is mentioned. This device is an imaging system, not an AI-powered diagnostic tool, and the focus is on substantial equivalence to an existing device rather than reader improvement with AI.

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

Not applicable. This is a hardware imaging system with associated software, not a standalone algorithm.

7. The Type of Ground Truth Used

For the technical specifications, the "ground truth" is the established technical specifications and performance of the legally marketed predicate device, backed by bench test results for the subject device.
"Clinical images were provided" but their role in establishing "ground truth" or performance criteria for this 510(k) is downplayed.
No pathology or outcomes data is referenced for the subject device.

8. The Sample Size for the Training Set

Not applicable. This document describes a medical imaging device, not an AI/machine learning model that would typically have a "training set."

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

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

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

March 10, 2016

Trident s.r.l. % Mr. Claude Berthoin President Denterprise International, Inc. 100 East Granada Blvd., Suite 219 ORMOND BEACH FL 32176

Re: K160386 Trade/Device Name: ReadeR. VieweR. OuickScan PSP Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 08, 2016 Received: February 11, 2016

Dear Mr. Berthoin:

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.

{1}------------------------------------------------

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 Oels

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K160386

Device Name ReadeR, VieweR, QuickScan PSP

Indications for Use (Describe)

ReadeR is a dental imaging system 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)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image is a black and white drawing of an eagle. The eagle is facing to the right, and its wings are spread out. The eagle's head is turned to the side, and its beak is open. The eagle's feathers are detailed, and the overall image is well-drawn. The eagle appears to be in flight.

510k FDA Consulting

Medical Device Clearance

100 East Granada Blvd., Suite 219

Ormond Beach, FL 32176

386-506-8711

510(k) Summary

Submitter/Applicant

Trident s.r.l. Via Verdi 20 Assago, Milan 20090, Italy Phone: +39-02-87072380 Fax: +39-02-87072381 Contact: Giorgio Rizzo, President (giorgio.rizzo33@gmail.com)

Date Prepared: February 08, 2016

Preparer/Consultant

Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176

Phone: 386-506-8711 Fax: 855-235-7902 Contact: Joyce St. Germain, Regulatory Executive (Joyce@510kfda.com) Secondary Contact: Claude Berthoin, President (Claude@denterpriseintl.com)

Device Classification

Trade/Model Names:	ReadeR, VieweR, QuickScan PSP
Common Name:	Computed Radiography Scanner System
Classification Name:	System, X-Ray, Extraoral Source, Digital
Regulation Name:	Extraoral source x-ray system
Regulation Number:	21 CFR 872.1800
Product Code:	MUH
Regulatory Class:	2
510k Review Panel:	Radiology
Regulation Medical Specialty:	Dental

{4}------------------------------------------------

Predicate Device

The subject device claims equivalence to the following legally marketed predicate:

510(k) Number:	K143703
Date Cleared	March 18, 2015
Trade Name:	NICAL SMART MICRO CR System for Intraoral DentalImages
Common Name:	Computed Radiography Scanner System
Classification Name:	System, X-ray, Extraoral Source, Digital
Regulation Name:	Extraoral source x-ray system
Regulation Number:	21 CFR 872.1800
Product Code:	MUH
Regulatory Class:	2
Medical Specialty:	Dental
510k Review Panel:	Radiology

Indications for Use

ReadeR is a dental imaging system indicated for capturing, digitization and processing of intraoral x-ray images stored in imaging plate recording media.

Intended Use

ReadeR system is intended to be used only by dentist and other qualified dental professionals to process x-ray images exposed to the imaging plates from the intraoral complex of the skull.

It is possible for both tooth decay and periodontal disease to be missed during a clinical exam, and radiographic evaluation of the dental and periodontal tissues is a critical segment of the comprehensive oral examination. In some cases extensive decay has been overlooked by a number of dentists prior to radiographic evaluation. So, the sensors and the PSP plates are in the best interest of the patient for improved healthcare. The ReadeR is a necessity for the dental office that is using the PSP plates.

Device Description

{5}------------------------------------------------

After acquisition of the latent image from the x-ray storage phosphor plate, it is erased thoroughly to be reused.

Comparison of Technological Characteristics with Predicate

The indications for use of the subject and predicate devices are identical and the technologies are substantially equivalent.

The imaging plates are exposed to x-rays while in the patient's mouth. The plates are removed and scanned by the scanning device. The images can be viewed by the dentist and stored on a personal computer. The plates are then erased and reused.

Patient cross contamination is prevented by the use of disposable, single use plate covers.

The imaging plates are identical to those used in the predicate device, as both systems are sharing the main part (CR Reader), the only difference with the subject and predicate device is the outside cover of the devices for private labeling. (The predicate device is horizontal and the subject device is vertical.)

The following table compares technological and other characteristics of the subject and predicate device.

		TridentReadeR510(k) number unknown	Nical Smart Microchip CRK 143703
Intended Use		The ReadeR system is indicatedfor capturing, digitization andprocessing of intra oral X-Rayimages stored in imaging platerecording media.	Nical Smart Microchip CR systemis indicated for capturing,digitization and processing ofintra oral X-Ray images stored inimaging plate recording media.
Physicalcharacteristics	Imagingplate size	Size 0 (22mm x 31mm),Size 1 (24mm x 40mm),Size 2 (31mm x 41mm),Size 3 27mm x 54mm)	Size 0 : 22 x 31mmSize 1 : 24 x 40mmSize 2 : 31 x 41mmSize 3 : 27 x 54mm

Table of Comparison

{6}------------------------------------------------

	TridentReadeR510(k) number unknown	Nical Smart Microchip CRK 143703
Effectivepixel pitch	30 μ	30 μ
Spatialresolution	10.5 lp/mm @ 30μm	10.5 lp/mm @ 30μm
	Size 0: 343 x 484 @ 64um628 x 885 @ 35um	Size 0: 343 x 484 @ 64um628 x 885 @ 35um
ImageMatrix	Size 1: 375 x 625 @ 64um685 x 1143 @ 35um	Size 1: 375 x 625 @ 64um685 x 1143 @ 35um
	Size 2: 484 x 640 @ 64um886 x 1171 @ 35um	Size 2: 484 x 640 @ 64um886 x 1171 @ 35um
	Size 3: 891 x 1783 @ 30 um	Size 3: 891x 1783 pixel 30 um
Weight	4.6 kg	4.7 kg
Imaging device	High Sensitivity Photo MultiplierTube (s-PMT)	High Sensitivity Photo MultiplierTube (s-PMT)

Operationalcharacteristics	Operating	Temperature :15-30°C	RH Temperature: 10 - 40 °C
	Conditions	Humidity: 15%-95%	Humidity: 30 - 90% RH
	Power	100-240V, 50/60Hz	100-240V, 50/60Hz
	Method ofimaging	Register Patient -> X-rayExposure	Register Patient -> X-rayExposure
	Imagereceptor	Imaging plate	Imaging plate

Functionalcharacteristics	Output data	DICOM 3 compatible	DICOM 3 compatible
	Performance	MTF: 65Kv 0,1 sec exposure.100%. 1 lp/mm95%. 3 lp/mm80%. 5 lp/mm30%. 10 lp/mm	MTF: 70 kV 0.08 sec exposure.55% 1 lp/mm11% 3 lp/mm
	Defectcompensation	By Imaging plate calibration	By Imaging plate calibration
	Dynamicrange	16 bit	16 bit
	ImageProcessing	Single image processingparameter is used	Single image processingparameter is used
	Imaging platecharacteristics	Composition	BaSrFBrl:Eu phosphor
		Thickness	approx. 350 mm
		Typicalluminescence	400 nm
		ImageRetention	Recommended within 1 hour ofexposure.
Imagingsoftware		Deep-View	Nical Image Plus
	The two acquisition and imaging software are two Own Brand Labeling (OBL) ofthe same original software Archimed Suite, that is CE certified with certificate1575/MDD issued by IMQ (Italy).Deep-View holds the CE certificate number 1749/MDD, while Nical Image Plusholds certificate number 1748/MDD, both release by IMQ (Italy).
	The two software packages have the same functionalities, and differ only from theaesthetic screens.

{7}------------------------------------------------

{8}------------------------------------------------

The above comparison shows the subject and predicate devices are substantially equivalent in technology characteristics. The differences are highlighted and none of these differences make the subject device any less safe and effective as the predicate device. The devices vary in weight by 0.1 kg. (ReadeR being lighter in weight) due to the outer covering of the devices. The operating temperatures vary, but these devices are used in an office setting and the temperature will be controlled to a comfortable median temperature of the operating temperature range. This is also due to the outer covering of the two devices being different. The MTF on performance is listed above and the variation is that the subject device is at 0.1 sec dose and the predicate is at 0.08 sec dose, so the percentages are different. All other technological characteristics are identical. The subject and predicate devices are identical except for the outer cover and the subject device stands vertically and the predicate device is horizontal.

Non-Clinical Performance Data

The following performance data is provided in support of the substantial equivalence determination. All tests performed are included in this submission.

Biocompatibility ... This device does not require a biocompatibility evaluation. The plate covers are commonly used and have previous approval.

Electrical Safety and EMC ... testing was performed by a qualified testing laboratory according to IEC 60601-1 and IEC 60601-1-2. The device met the requirements according to these standards and was performed by Prima Ricercaq & Sviluppo S.r.1. of Italy.

Software ... validation of software (EN 62304) and risk analysis (ISO 14971:2012) were performed and were met according to these standards. IEC 62366:2007 for use in conjunction with 60601-1-6:2010 was performed by TUV Rheinland North America and the standards were met.

Performance Testing ... Image testing was performed to check image quality and resolution. Some of these test results are shown in the comparison table above. A quality assurance procedure and inspection was performed on the imaging plates and all testing was approved and standards were met since the predicate has CE mark and the same accessories are supplied for the subject device. Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modification of the device (note CR reader technology that is identical to the predicate) but they provide further evidence in addition to the bench performance data to show that the CR system works as intended.

Conclusion

The subject and predicate devices have the same intended use and are substantially equivalent in technological characteristics and performance (since they are, in fact, the same device, with different branding for marketing purposes). The ReadeR does not raise any

{9}------------------------------------------------

questions regarding safety and effectiveness since it is the same as the predicate device. The non-clinical data supports and demonstrates the safety of the device.

The conclusion is that ReadeR (VieweR and QuickScan PSP) warrants a finding of substantial equivalence to the legally marketed original Nical Smart Micro CR System, and therefore, should have clearance for premarket activities in the United States.

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.