The Canary System is intended to be used by qualified dental professionals as an aid in the detection and monitoring of dental canes, and as an intra-oral camera to record anatomical details.

The Canary System is indicated as an aid in the detection and monitoring of dental caries and as an intraoral camera to visualize and record anatomical details.

The Canary System is intended to be used by qualified dental professionals as an aid in the diagnosis of dental caries, and as an intra-oral camera to visualize and record anatomical details.

Device Description

The Canary System™ uses a low powered 660 nm wavelength laser to examine the tooth surface. When this laser light is shone on the tooth the laser light is scattered and absorbed. An absorbed portion of the light is converted into heat and emits thermal infrared (Photothermal Radiometry, PTR) and another part of the light excites the tissue and emits optically converted light (Luminescence; LUM), which shows the difference between what appears to be healthy tooth structure and areas suspected of being carious tooth structure. Compared to a healthy tooth, areas suspected of being canous or possibly having other defects such as micro cracks absorb more light and generate higher PTR signals and lower LUM signals. The Canary System is very safe because the temperature rise on the tooth surface by the laser is only 1 - 2℃, which is much lower temperature than hot beverages.

Modulated laser light hitting the tooth surface generates a thermal diffusion (heat transfer) wave. The depth that this wave can penetrate is determined by the modulation frequency. Even though its sensitivity is lower than PTR, modulated light scattering also gives information from deep inside the enamel by luminescence. The Canary System can detect suspect areas, up to a depth of 5mm because The Canary System uses a 2Hz frequency modulation that penetrates deeper than higher frequencies (100s or 1000s Hz) and the detected PTR/LUM signals deliver integrated information from the surface to the penetration depth.

The measured PTR and LUM signals are combined into a Canary Number. As the suspicion of a carious lesion develops, the Canary Number increases. With remineralization treatment, or lesion reduction in size, the Canary Number appears to decrease.

The Canary System is associated with a photographic image of the tooth surface being examined. The images are displayed on an accompanying monitor for immediate chair-side review with the patient. Images are also shown in Canary Reports incorporating Canary Numbers and color codes for the examined teeth. The Canary software is able to record and store the Canary Numbers, images of the surfaces examined, along with the dentist's treatment recommendation.

AI/ML Overview

The provided document describes "The Canary System," a device intended as an aid in the detection and monitoring of dental caries and as an intra-oral camera. However, it does not explicitly state acceptance criteria in a quantitative manner or present a detailed study proving the device meets specific performance criteria. The document focuses on demonstrating substantial equivalence to predicate devices, outlining technical specifications and general capabilities rather than rigorous performance metrics against a defined standard.

Therefore, many of the requested details, such as specific acceptance criteria, reported performance values against those criteria, sample sizes for test and training sets, expert qualifications, and adjudication methods for a standalone or MRMC study, are not explicitly provided in the given text.

Below, I will extract and infer information where possible based on the provided text, and explicitly state when information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide explicit quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or ROC AUC thresholds) that The Canary System must meet. Instead, it relies on demonstrating comparable functionality and technical specifications to predicate devices. The "performance" described leans towards descriptive capabilities rather than quantitative metrics from a clinical study.

Acceptance Criteria (Implied/Functional)	Reported Device Performance (as described in the document)
Aid in the detection and monitoring of dental caries	The Canary System detects suspect areas up to 5mm depth using a 2Hz frequency modulation of a 660nm laser. It combines Photothermal Radiometry (PTR) and Luminescence (LUM) signals into a "Canary Number." - Canary Numbers < 20 suggest a healthy tooth surface. - Canary Numbers > 70 suggest possible advanced decay. - Canary Numbers 21-70 suggest early lesion/decay (treatment depends on location and patient risk factors). It can examine interproximal, pit & fissure, smooth surface caries, possible caries around restorations, and possible subsurface caries lesions. It can detect areas of suspect incipient caries.
Function as an intra-oral camera to visualize and record anatomical details	Images are displayed on an accompanying monitor for immediate chair-side review. Images are also shown in Canary Reports incorporating Canary Numbers and color codes. The software records and stores Canary Numbers and images. Camera: CMOS, Resolution: 640 x 480 pixels.
Safety (e.g., temperature rise)	The temperature rise on the tooth surface by the laser is only 1 - 2℃, which is much lower than hot beverages, indicating safety.
Output a report for patients and providers	YES – Reports generated for patients and dentists, which can be printed or stored on The Canary for later review.
User Interface	Graphical, numeric and audible tones. Visual image of surface under examination and surface that was examined previously.
Sterilization and Disinfection	Disposable, one-time use plastic sleeve and plastic tip. The unit and cables can be disinfected with alcohol-based solutions.

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

The document states, "This conclusion [substantial equivalence] is based on indications for use, bench, in vitro studies, as well as EMC, laser and electrical safety testing."

Sample Size for Test Set: Not specified in the provided text. The term "in vitro studies" is mentioned, implying a test set of some kind was used, but details on its size are absent.
Data Provenance: Not specified. It only mentions in vitro studies, implying laboratory-based data, but details on its origin (e.g., country, retrospective/prospective) are not provided.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers improving with AI vs. without AI assistance. The focus is on the device's standalone capabilities and its equivalence to predicate devices, not on human-AI collaboration.

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

Standalone Performance: Yes, the document discusses the device's performance in a standalone context. The description of Canary Numbers, the detection of carious lesions, and the technical specifications are all referring to the algorithm's direct output ("The Canary Number is a combination of the PTR and LUM amplitude and phase readings..."). While it aid dental professionals, the metrics and descriptions provided are for the device independently producing its output.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. For in vitro studies on dental caries, common ground truths include:
- Histology/Pathology: Microscopic examination of tooth sections to confirm the presence and depth of caries.
- Micro-CT or other imaging: High-resolution scans to assess lesion presence.
- Clinical (visual/tactile) assessment combined with radiography: Often used for clinical studies, but for in vitro studies, more definitive lab-based methods are common.

Given the mention of "in vitro studies," pathology or micro-CT would be likely forms of ground truth, but this is an inference as the text does not specify.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not specified. The document does not describe the development or training of the algorithm; it focuses on the device's functionality and comparison for regulatory submission.

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

Ground Truth for Training Set: Not specified. As with the training set size, the document does not delve into the development methodology of the algorithm.

Summary

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OCT 2 6

KIZZA

510(k) Summary

A. Submitter Information

Quantum Dental Technologies Inc. 748 Briar Hill Avenue Toronto. Ontano M6B 1L3, Canada

Contact Person:

Josh Silvertown, PhD Vice President Quantum Dental Technologies Inc. 748 Briar Hill Avenue Toronto, Ontario M6B 1L3, Canada

Phone: 1-866-993-9910 ext 103 Fax: 1-866-993-9916 josh@thecanarysystem.com

Date Prepared: Tuesday, October 09, 2012

B. Device Identification:

Classification Name	Laser fluorescence caries detection device
Proprietary Name	The Canary System
Device Classification	Class II
Panel	Dental
Device Product Code	NBL
Previous FDA Status	The Canary System has no prior FDA Status
Basis for Submission	New Device

C. Identification of Predicate Device:

Device	Applicant	510(k) No.	Date Cleared
DIAGNOdent	KAVO DIAGNODENT	K983658	February 22, 2000
SOPRO Life	SOPRO	K092583	January 13, 2010

D. Device Description:

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K112139

of 5mm because The Canary System uses a 2Hz frequency modulation that penetrates deeper than higher frequencies (100s or 1000s Hz) and the detected PTR/LUM signals deliver integrated information from the surface to the penetration depth.

The Canary System is associated with a photographic image of the tooth surface being The images are displayed on an accompanying monitor for immediate chair-side examined. review with the patient. Images are also shown in Canary Reports incorporating Canary Numbers and color codes for the examined teeth. The Canary software is able to record and store the Canary Numbers, images of the surfaces examined, along with the dentist's treatment recommendation.

E. Intended Use:

The Canary System is intended to be used by qualified dental professionals as an aid in the detection and monitoring of dental canes, and as an intra-oral camera to record anatomical details.

F. Indications for use:

The Canary System is indicated as an aid in the detection and monitoring of dental caries and as an intraoral camera to visualize and record anatomical details.

G. Substantial Equivalence:

Safety and effectiveness comparison to predicate devices:

COMPARISON OF THE ABILITY TO DETECT AREAS OF SUSPICION BY TOOTH SURFACE
CRITERIA	The Canary System	DIAGNODent	SOPRO
Examination ofInterproximal CariesAreas	YES	NO	NO
Examination of Pitand Fissure Caries	YES	YES	YES
Smooth SurfaceCaries	YES	YES	YES
Evaluation ofPossible CariesAround VisibleMargins ofRestorations	YES	NO	NO
Evaluation ofPossible SubsurfaceCaries lesions	YES	NO	NO

COMPARISON BY FUNCTIONALITY
CRITERIA	The Canary System	DIAGNOdent	SOPRO
Necessary	Removal of pools of	Clean tooth using any	Clean tooth using any

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K112139

pre-treatment ofteeth	saliva using air dryingor dabbing with cotton	method and dry	method
Detection of areas ofsuspect Incipient	YES	YES	YES
Target Population	Dentist's Offices	Dentist's Offices	Dentist's Offices
Printed / ElectronicReport for patientsand providers	YES	NO	YES
Visual Image	YES	NO	YES

TECHNICAL SPECIFICATIONS
CRITERIA	The Canary System	DIAGNODent	SOPRO
Indications for use	An aid in the detectionand monitoring of dentalcaries and as an intraoralcamera to visualize andrecord anatomical details	Aid in the diagnosis ofdental caries	Intended to be used byqualified physicians indentistry as an aid in thediagnosis of dental caries,and as an intraoral camerato visualize anatomicaldetails invisible to the nakedeye or with a mirror.
Core Technology	Combined Photothermalradiometry (PTR) andmodulated luminescence(LUM) caries detectiondevice	Fluorescence cariesdetection device	Light-induced fluorescencecaries detection device
How suspicion ofcaries are detected	The Canary Systemshines a 2 Hz pulsedlaser light (660nm) on thetooth surface and thedevice collects theconverted and emittedinfrared radiation (2-5µm)by heat released from thetooth (1-2 deg. Cmaximum increase inheat) and luminescence(715-800nm) when thelaser modulates. By theinteraction of the laserlight with the crystallinestructure of the enameland dentin, the emittedluminescence andthermal infrared signalprovide information aboutthe health of the toothand areas that might besuspected of havingdental caries .	DIAGNOdent emitsred laser light at awavelength of 655 nmonto a tooth surface.This wavelengthcauses porphyrins(coloured proteinmolecules) in carioustissue to fluoresce,resulting in elevatedscale readings on thedisplay of the system.The presence ofbacterial by-productsis an indirect measurethat caries arepresent.	SOPROLIFE emits blue LED(wavelength of 450 nm) ontoa tooth surface. Thiswavelength excites thedentin, which, in response,reflects a light signal calledfluorescence. The colour ofthe fluorescence signal isgreen when the dentin ishealthy and dark red, whenthe dentin is infected.
How suspicion ofcaries are reported	The Canary Number is acombination of the PTRand LUM amplitude and	Scale of 1 - 100 withreadings below 13suggests a healthy	Colour suggests health ofdentin. Red suggests cariesin the dentin. Green

Quantum Dental Technologies: 510(k) Summary for K112139

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K112139

phase readings at a pointon a tooth surface. TheCanary Number scale isfrom 0 - 100. CanaryNumbers below 20suggest a healthy toothsurface. CanaryNumbers above 70suggest the possiblepresence of advanceddecay. Canary Numbersbetween 21 - 70suggests the presence ofan early lesion or decayand treatment dependsupon location of thesesuspect areas and patientrisk factors.	tooth surface.Readings over 20suggest presence ofcaries into the dentin.Readings over 30suggest the presenceof caries into dentinrequiring restoration.	suggests healthy dentin.The stronger the red colourthe larger the suspiciousarea of caries.
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CRITERIA	The Canary System	DIAGNODent	SOPRO
Probe	Lenses and mirrors	Fiber Optic	Fiber Optic
Light source	660 nm <50 mW Laser,sinusoidally modulated at2Hz	655 nm <1 mw Laser	450 nm LED
Camera	CMOSResolution: 640 x 480pixels	N/A	1/2" CCD; Resolution(752x582) PAL; (768x494)NTSC
Returned light	AC or modulatedLuminescence + thermalinfraredPulsing the laser lightallow for measurement ofboth the luminescenceand changes in thermalproperties.	Fluorescence(DC luminescence)	Fluorescence(DC luminescence)
Detectors forReturned Light	• Photodiode for LUMand or ACFluorescence• Mid-IR detector forPTR• Visible Range CMOSCamera to track areascanned & visualsurface changes	Photodiode for DCfluorescence	Visible range CMOS camerafor DC fluorescence
Sterilization andDisinfection	Disposable, one-time useplastic sleeve and plastictip. The Canary Systemunit and cables can alsobe disinfected withalcohol-based solutions.	Probe tip only,autoclave	Probe autoclave
Medical DeviceClassification	II	II	II
User interface	Graphical, numericand audible tones	Numeric and audibletones LED numbers	Image with colours

Quantum Dental Technologies: 510(k) Summary for K112139

475

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KI12139

	Visual image of surface under examination and surface that was examined previously Reports generated for patients.
Patient & DentistReports	Reports generated for patients and dentistswhich can be printed orstored on The Canary forlater review	No printed reports	Reports stored on dentalpractice software wherebridging is available
Power source	100-120/200-240,50/60Hz	6- AA Alkaline battery	115-230V, 50-60Hz

The Canary System is substantially equivalent to other legally marketed devices in the United States. This conclusion is based on indications for use, bench, in vitro studies, as well as EMC, laser and electrical safety testing. Differences that exist between The Canary System and the nredicate devices relating to technical operation and performance do not affect the safety and effectiveness of the device.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.

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

OCT
26 2012

Ouantum Dental Technologies, Incorporated Josh Silvertown, Ph.D. M.B.A. Vice President, Corporate Development 748 Briar Hill Avenue Toronto, Ontario Canada M6B 1L3

Re: K112139

Trade/Device Name: The Canary System™ Regulation Number: 21 CFR 872.1745 Regulation Name: Laser Fluorescence Caries Detection Device Regulatory Class: II Product Code: NBL Dated: October 9, 2012 Received: October 10, 2012

Dear Dr. Silvertown:

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.

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Susan Luonne

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Page 1 of 1

Indications for Use

510(k) Number (if known): K112139

Device Name: The Canary System™

Indications for Use:

The Canary System is intended to be used by qualified dental professionals as an aid in the diagnosis of dental caries, and as an intra-oral camera to visualize and record anatomical details.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-counter Use NO (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Puuri

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

000010

Regulation Number and Section

§ 872.1745 Laser fluorescence caries detection device.

(a)
Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.(b)
Classification. Class II, subject to the following special controls:(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter;
(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and
(3) The labeling must include detailed use instructions with precautions that urge users to:
(i) Read and understand all directions before using the device,
(ii) Store probe tips under proper conditions,
(iii) Properly sterilize the emitter-detector handpick before each use, and
(iv) Properly maintain and handle the instrument in the specified manner and condition.