ODI HD Dental Sensor is intended to be used by dentists and other qualified professionals for providing diagnostic x-ray radiographs of dentition, jaws and other oral structures.

Device Description

The ODI HD Dental Sensors are electronic medical device intra-oral radiographic images. The sensor can be operated by Radiologists, Dental Assistants and other healthcare professionals, who are both trained and competent to take Dental X-ray radiographs. Intra-oral positioning of the sensor is accomplished by the use of dedicated intra-oral positioning devices that facilitate the accurate alignment of the sensor may also be aligned with the assistance of the patient. The ODI HD Dental Sensors is an indirect light converting digital x-ray detector. A scintillating device composed of Cesium lodide (Csl) converts incident x-rays into visible light that is optically coupled to a light detection imager based on CMOS technology. The ODI HD Dental Sensors allow for automatic detection of such incident x-rays in order to generate data. Software interprets this data into images used for dental applications. The ODI HD Dental Sensors support USB 2.0 direct connectivity to personal computers and or laptops with dedicated electronics and a sensor software driver. The subject device does not control the generator, it is only a receiver. The X-ray system and the software used are not a part of this submission.

AI/ML Overview

This document, K190234, is a 510(k) Premarket Notification for a dental sensor. The key argument for substantial equivalence relies on the fact that the device (ODI HD Dental Sensor) is essentially identical to a previously cleared predicate device (Apex Dental Sensor K163282), with the main components sourced from the same supplier. Therefore, the "study" proving the device meets the acceptance criteria is primarily a comparison to the predicate device and adherence to relevant electrical and performance standards.

Here's the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the technical specifications and performance characteristics of the predicate device, as well as adherence to recognized international standards for medical electrical equipment and X-ray detectors. The device performance is demonstrated by its identical (or highly similar) specifications to the predicate and its conformity to these standards.

Acceptance Criteria (Implicitly based on Predicate & Standards)	Reported Device Performance (ODI HD Dental Sensor)
General
Classification and Product Code (Class II, 21 CFR 872.1800, MUH)	Class II, 21 CFR 872.1800, MUH
Common Name (Intraoral Digital X-ray Sensors)	Intraoral Digital X-ray Sensors
Classification Name (Extraoral source X-ray system)	Extraoral source X-ray System
Classification Panel (Dental)	Dental
Intended Use (Providing diagnostic x-ray radiographs of dentition, jaws and other oral structures)	Providing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
Indications for Use (Radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure)	Intended to be used by dentists and other qualified professionals for providing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
Number of Sensors (2 sizes)	2 sizes (S11684-12, S11685-12)
Cable Length (2m)	2m
Pixel Size (20 x 20 µm)	20 x 20 µm
Resolution (20 Lp/mm typ)	20 Lp/mm typ
Technology (CMOS chip + optical fiber plate + Csl scintillator)	CMOS chip + optical fiber plate + Csl scintillator
Sensor Active Area (Size 1: 600mm², Size 2: 884mm²)	Size 1: 600mm², Size 2: 884mm²
Principles of Operation (X-ray → scintillator → fiber optic → CMOS → electronics → PC)	X-ray (radiation) => scintillator (convert to light) => fiber optic (filtering) => CMOS (convert to digital) => electronics => PC (capture & display image)
Connection to Imaging Practice PC (USB 2.0 Interface)	USB 2.0 Interface
Software-Image Management (Apteryx XrayVision)	Apteryx XrayVision
Sensor Board (All control electronics directly integrated on CMOS sensor chip)	All control electronics directly integrated on CMOS sensor chip
Sensor Input Voltage & Current (USB2.0 (5V, 4.25min))	USB2.0 (5V, 4.25min)
Operating Temperature (0°C~+35°C)	0°C~+35°C
Electrical Safety Standards
IEC 60601-1 (Electrical)	AAMI ES 60601-1:2005/(R) 2012 (found to be equivalent to predicate's IEC 60601-1-1)
IEC 60601-1-2 (EMC)	IEC 60601-1-2 Edition 3-2007
IEC 62220-1 (Performance)	IEC 62220-1:2015 – Determination of the Detective Quantum Efficiency Detectors used in Radiographic Imaging (found to be equivalent to predicate's 62220-1)
IEC 60529 (Performance - IP Code)	IEC 60529:2001 - Degrees of Protection Provided by Enclosures (IP Code)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterizes all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on the ODI HD Dental Sensors."

Therefore, there was no "test set" in the sense of a clinical dataset used for performance evaluation that would require a sample size or data provenance details. The evaluation was based on engineering and performance testing against standards and comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. As stated above, no clinical data or test set requiring a ground truth established by experts was used. The focus was on engineering performance and substantial equivalence to a predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set requiring adjudication was used.

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 study was done. This device is a dental X-ray sensor, not an AI-powered diagnostic tool. The submission is for hardware that captures the image, not software that assists in interpretation.

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

Not applicable. This is a hardware device (dental sensor), not an algorithm or AI.

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

Not applicable, as no clinical test set requiring ground truth was used. The "ground truth" for this submission are the established technical specifications and performance characteristics of the predicate device and the relevant international standards.

8. The sample size for the training set

Not applicable. This device is a passive sensor, not an AI model that requires a training set.

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

Not applicable. No training set was used.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

CND Global Technologies, Inc. % Ms. Lisa Jager Regulatory Affairs Consultant Regulatory Science Solutions LLC 11576 W. M179 Hwy MIDDLEVILLE MI 49333

March 1, 2019

Re: K190234

Trade/Device Name: ODI HD Dental Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: February 1, 2019 Received: February 6, 2019

Dear Ms. Jager:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara

For

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

Enclosure

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4. Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K190234

Device Name ODI HD Dental Sensor

Indications for Use (Describe)

ODI HD Dental Sensor is intended to be used by dentists and other qualified professionals for providing diagnostic x-ray radiographs of dentition, jaws and other oral structures.

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)

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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:

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K190234

510(k) Summary

Submitted By:	CND Global Technologies, Inc.16 Branch AvenueCumberland, RI 02864319-333-6767
Contact Person	Lisa JagerRegulatory Affairs Consultant11576 W. M179 HwyMiddleville, MI 49333regulatorysciencesolutions@gmail.com616-802-2364
Date of SummaryPreparation	January 30, 2019
Trade Name	ODI HD Dental Sensors
Submission Number	K190234
Common Name	Intraoral Digital x-ray Sensors
Classification Name	Extraoral source x-ray system
Classification	Class II per 21 CFR 872.1800
Product Code	MUH
Classification Panel	Dental

Predicate Device Information

Submitted By:	Masterlink LLC
Trade Name	Apex Dental Sensors
Submission Number	K163282
Common Name	Intraoral Digital x-ray Sensors
Classification Name	Extraoral source x-ray system
Classification	Class II per 21 CFR 872.1800
Product Code	MUH
Classification Panel	Dental

Device Description

The following hardware and software requirements need to be taken into account to ensure successful integration of ODI HD Dental Sensors with the X-ray systems.

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Hardware requirements:

The type of x-ray systems that integrate with the Apex Dental Sensors are wall-mounted x-ray generators (both AC and DC) with a tube current between 1 and 15 mA inclusive, and with a tube voltage between 50 and 100 kV inclusive, with in-built controls to set exposure parameters. Generators allow variable mA/K/ to be selected, all will control the exposure time.

The subject device is only a receiver, and not a controller. The subject device and the software cannot act as the controller of an x-ray generators are controlled by built-in controllers and are not part of the subject device.

Premium Plus Disposable Barrier Sleeve (K163447) - Premium Plus Disposable Barrier Sleeve is intended to be used as a disposable barrier sleeve for ODI HD Dental Sensors. The Premium Plus Disposable Barrier Sleeve is non-sterile and intended for single patient use only.

Software requirements:

The Apteryx XrayVision software needs assistance from a TWAIN driver to recognize X-ray images. The recommended requirements for PC hardware for the sensor and software combination would be:

. Processor: Intel core i5-250m 2.5GHz or Higher
. Memory: 4G or higher
Hard disk: Above 20G, 60G recommended
Interface: USB 2.0 ●
Display: Resolution 1024 × 758 (15") or above .
Operating System: .
- O Microsoft Windows 10(64/32 bit)
- o Microsoft Windows 8.1(64-bit)
- Microsoft Windows 8(64-bit) O
- Windows 7 SP1 32 and 64-bit o
. The computer connected to system shall be in accordance with IEC 60950-1:2005

Indications for Use

ODI HD Dental Sensor is intended to be used by dentists and other qualified professionals for providing diagnostic xray radiographs of dentition, jaws and other oral structures.

Technological Characteristics

The ODI HD Dental Sensors (Subject Device) makes use of a Predicate Device, Apex Dental Sensors (K163282). The detectors in the ODI HD Dental Sensors are the detectors in the predicate device. The subject device and the predicate device are identical and sourced from the same supplier Hamamatsu. The model numbers of the ODI HD Dental Sensors are:

S11684-12 is Size #1 S11685-12 is Size #2

Attribute	Subject Device-ODI HD Dental Sensors	Predicate Device-Apex Dental Sensors (K163282)	Equivalence	Difference andJustification
General
Manufacturer	CND Global Technologies Inc.	Masterlink LLC
Classification andProduct Code	Class II21 CFR 872.1800MUH	Class II21 CFR 872.1800MUH	Equivalent	No difference
Common Name	Intraoral Digital X-ray Sensors	Intraoral Digital X-ray Sensors	Equivalent	No difference
Classification Name	Extraoral source X-ray System	Extraoral source X-ray System	Equivalent	No difference
Classification Panel	Dental	Dental	Equivalent	No difference
Intended Use	Providing diagnostic x-ray radiographs ofdentition, jaws and other oral structures.	Radiographic examinationto assist with diagnosis ofdiseases of the teeth, jaw,and oral structure.	Equivalent	No difference
Indications for Use	ODI HD Dental Sensors is intended to be used bydentists and other qualified professionals forproviding diagnostic x-ray radiographs ofdentition, jaws and other oral structures.	The Apex Dental Sensors isintended to be used for aradiographic examination bya dental professional to assistin the diagnosing of diseasesof the teeth, jaw and oralstructures.	Equivalent	No difference
Number of Sensors	2	2	Equivalent	No difference
Cable Length	2m	2m	Equivalent	No difference
Pixel Size	20 x 20 µm	20 x 20 µm	Equivalent	No difference
Resolution	20 Lp/mm typ(S11684-12)	20 Lp/mm typ(S11684-12)	Equivalent	No difference
Technology	CMOS chip +optical fiberplate + Csl scintillator	CMOS chip +optical fiber plate +Csl Scintillator	Equivalent	No difference
Matrix dimensions(mm²)	Sensor Active Area:600mm² (Size 1)884mm² (Size 2)	Sensor Active Area:600mm² (Size 1)884mm² (Size 2)	Equivalent	No difference
Principles ofOperation	X-ray (radiation) =>scintillator (convert tolight) => fiber optic(filtering) => CMOS(convert to digital)=>electronics=> PC (capture& display image)	X-ray (radiation) =>scintillator (convert tolight) => fiber optic(filtering) => CMOS(convert to digital)=>electronics=> PC (capture& display image)	Equivalent	No difference
	Other Requirements
Recommended PCRequirements	Processor: Intel core i5-250m 2.5GHz orHigher or above; Memory: Above 4G;Hard disk: Above 20G, Interface: USB2.0;Display: Resolution 1024 × 768 (15") oraboveOperating System: Microsoft Windows10(64/32 bit)Microsoft Windows 8.1(64-bit)Microsoft Windows 8(64-bit)Windows 7 SP1 32 and 64-bitThe computer connected tosystem shall be in accordance with IEC60950-1:2005.	Processor: Intel 1.2GHz chip orabove; Memory: Above 1G;Hard disk: Above 40G; Interface:USB 2.0;Display: Resolution 1024 ×758 (15") or aboveOperating System: WindowsХРThe computer connected tosystem shall be in accordancewith IEC60950-1:2005.	Equivalent	The Processor,Memory, Hard Diskand OperatingSystemrequirements forsupporting use ofthe subject andpredicate devicediffer slightly but arefound to beequivalent. Theoutside supportingPC requirements donot impact thedevices intendeduse, technicalrequirements orsafety requirements.No differences arenoted for Displayand Computer IECrequirements.
Connection to ImagingPractice PC	USB 2.0 Interface	USB 2.0 Interface	Equivalent	No difference
Software-ImageManagement	Apteryx XrayVision	Apteryx XrayVision	Equivalent	No difference
Sensor Board	All control electronicsdirectly integrated onCMOS sensor chip	All control electronicsdirectly integrated onCMOS sensor chip	Equivalent	No difference
Sensor input voltageand current	USB2.0 (5V, 4.25min)	USB2.0 (5V, 4.25min)	Equivalent	No difference
OperatingTemperature	0°C~+35°C	0°C~+35°C	Equivalent	No difference
Electrical Safety
Standards ofConformity	IEC 60601-1 (Electrical)IEC 60601-1-2 (EMC)IEC 62220-1 (Performance)IEC 60529 (Performance)	IEC 60601-1-1 (Electrical)IEC 60601-1-2 (EMC)62220-1 (Performance)IEC 61326-1 (EMC)IEC 60601-2-65 (Electrical)	Equivalent	Cited standardsdiffer slightly,however the devicesare still found to beequivalent as themain Electrical, EMCand Performancestandards cited arethe same.

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Similarities

. The ODI HD Dental Sensors and Predicate Device both are available in two sizes
The interface to PC of both ODI HD Dental Sensors and the Predicate is USB ●
Both ODI HD Dental Sensors and the Predicate Sensor use CMOS technology, the pixel size for both sensors is 20 x ● 20 um
. The Sensor Active Area for ODI HD Dental Sensors and Predicate Device is the same i.e., 600mm2 (Size 1) and 884mm2 (Size 2)
The principles of operation of ODI HD Dental Sensors and Predicate Device is the same, i.e., X-ray (radiation)=> . scintillator (convert to light) => fiber optic (filtering) => CMOS (convert to idigital)=> electronics=> PC (capture & display image)
. The Software-Image Management of ODI HD Dental Sensors and Predicate Device is the same, i.e., Apteryx XrayVision which has been cleared by the FDA under (K983111)
Both ODI HD Dental Sensors and Predicate Device have all control electronics directly integrated on CMOS sensor chip .
The sensor input voltage is 5V in both ODI HD Dental Sensors and Predicate Device ●
The operating temperature of ODI HD Dental Sensors and Predicate Device is also comparable, i.e., 0°C~+35°C ●
The ODI HD Dental Sensors and the Predicate Device are tested per IEC 60601-1-2 for Electrical Safety ● and Electromagnetic compatibility
. The recommended PC requirements in ODI HD Dental Sensors and the Predicate Device is also comparable. The processor that is recommended for ODI HD Dental Sensors is Intel core i5-250m 2.5GHz or Higher, whereas the processor for the Predicate Device is Intel 1.2GHz chip or above
The ODI HD Dental Sensors and the Predicate Device have the same sensor resolution ●
The ODI HD Dental Sensors and the Predicate have the same cable lengths. The sensor cable length in ODI HD Dental . Sensors is 2m and in Predicate Device is also 2m.
. The interface for ODI HD Dental Sensors requires USB 2.0, and the Predicate Device also utilizes USB 2.0.

Performance Data

The following Performance testing has been performed on the Subject Device in accordance with appropriate FDA guidance documents and relevant standards, to support the determination of substantial equivalence. The test data showed that the Subject device is safe and effective for its intended use.

Electrical and safety requirements established in AAMI ES 60601-1:2005/(R) 2012 .
Electromagnetic compatibility requirements in IEC 60601-1-2 Edition 3-2007 .
. IEC 62220-1:2015 – Determination of the Detective Quantum Efficiency Detectors used in Radiographic Imaging
. IEC 60529:2001 - Degrees of Protection Provided by Enclosures (IP Code)
The Subject Device is also in compliance with FDA guidance for the submission of 510(k)s for Solid ● State X-ray Imaging Devices

Clinical Performance

Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterizes all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on the ODI HD Dental Sensors.

Conclusion

The ODI HD Dental Sensors are substantially equivalent to the Predicate, and do not raise any new or different questions of safety or effectiveness. The subject and the predicate devices are identical; the only difference exists in the trade names (for marketing purposes).

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.