BlueCheck™ Caries Detection & Monitoring is a solution containing colored agents that, when applied to tooth surfaces following a dental prophylaxis procedure, binds to surface porosities utilizing natural hydroxyapatite-binding chemistry of the protein component of the device. This allows dental professionals to observe the visual change in tooth surface color as blue on accessible tooth surfaces. BlueCheck is intended to be used in routine dental examinations as a diagnostic tool that assists dental professionals to visualize and assess caries. BlueCheck is supplied as a liquid product in single use vials (in a pack of 10 vials).

AI/ML Overview

The provided text is a 510(k) summary for the BlueCheck™ Caries Detection & Monitoring device. It focuses on demonstrating substantial equivalence to a predicate device based on indications for use, technology, and performance data from non-clinical testing.

Crucially, this document does not contain information about the device's specific performance metrics against pre-defined acceptance criteria from a human-in-the-loop or standalone study using a clinical test set. It discusses non-clinical performance testing related to removal from tooth surface after rinsing and brushing, and risk assessments/viral inactivation studies.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and the study proving the device meets them in the format you've requested for the following reasons:

No Acceptance Criteria or Performance Data for Diagnostic Accuracy: The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, AUC) for the device's diagnostic performance in identifying carious lesions. It states "Performance studies were conducted to demonstrate that the subject device has been removed from the tooth surface after rinsing, brushing with toothpaste containing sodium lauryl sulfate (SLS) and action of saliva," which relates to device residue, not diagnostic accuracy.
No Clinical Study Details: There is no mention of a clinical test set, an MRMC study, standalone performance, the number of experts, adjudication methods, or how ground truth was established for diagnostic performance. The "Performance Data" section solely refers to non-clinical tests.
No Training Set Information: The document is a 510(k) summary for a device (a liquid solution with staining agents), not an AI algorithm. Therefore, there is no concept of a "training set" in the context of machine learning.

The 510(k) process for this type of device (a diagnostic staining solution) typically relies on demonstrating substantial equivalence through:

Similar Indications for Use: As shown in the Indications for Use sections.
Similar Technological Characteristics: Explained in the "EQUIVALENCE TO MARKETED DEVICES" table, comparing the subject device to the predicate and reference devices in terms of formulation, application, detection method, etc.
Acceptable Non-Clinical Performance & Safety: This includes things like biocompatibility, shelf-life, and in this case, the ability of the stain to be removed post-use.

In summary, the provided text describes the regulatory clearance process for a chemical diagnostic aid, not a software/AI-driven medical device that would have specific diagnostic accuracy metrics and associated clinical study details as per your request.

If this were an AI/software device, the information you requested would typically be found in a clinical performance study report, which is usually part of the 510(k) submission but not always fully detailed in the public 510(k) summary.

Summary

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May 16, 2023

Incisive Technologies Pty Ltd % Melissa Burbage Senior Regulatory Specialist PaxMed International, LLC 12264 EL Camino Real, Suite 400 San Diego, California 92130

Re: K222560

Trade/Device Name: BlueCheck™ Caries Detection & Monitoring Regulation Number: 21 CFR 872.1740 Regulation Name: Caries Detection Device Regulatory Class: Class II Product Code: LFC Dated: May 1, 2023 Received: May 3, 2023

Dear Melissa Burbage:

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.

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K222560

Device Name

BlueCheck™ Caries Detection & Monitoring

Indications for Use (Describe)

To aid the dental professional in the visualization of carious lesions.

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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510(k) Summary

K 222560

BlueCheck™ Caries Detection & Monitoring

Incisive Technologies Pty Ltd

May 1, 2023

ADMINISTRATIVE INFORMATION

Manufacturer Name	Incisive Technologies Pty LtdLevel 4, 71 Collins StreetMelbourne, Victoria, AustraliaTelephone: +61 (0)3 9653 3777
Official Contact	Kerry A. Hegarty, PhD; CEO
Representative/Consultant	Melissa Burbage, Senior Regulatory SpecialistKevin A. Thomas, PhD; Floyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone: +1 858-792-1235Fax: +1 858-792-1236Email: mburbage@paxmed.com kthomas@paxmed.com, flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Device Name	BlueCheck™ Caries Detection & Monitoring
Common Name	Device, Caries Detection
Regulation Number	21 CFR 872.1740
Regulatory Class	Class II
Product Code	LFC
Classification Panel	Dental
Reviewing Office	Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory,ENT and Dental Devices)
Reviewing Division	Division of Health Technology 1B (Dental and ENT Devices)

PREDICATE DEVICE INFORMATION

Primary Predicate Device: K200601, LumiCare™ Caries Detection Rinse, GreenMark Biomedical, Inc.

Reference Device: K955445, Caries Finder, Danville Engineering, Inc.

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INDICATIONS FOR USE STATEMENT

To aid the dental professional in the visualization of carious lesions.

SUBJECT DEVICE DESCRIPTION

PERFORMANCE DATA

Non-clinical testing data submitted to demonstrate substantial equivalence included: shelf life testing, biocompatibility evaluation and testing according to ISO 10993-1, and performance testing compared to predicate and reference devices.

Performance studies were conducted to demonstrate that the subject device has been removed from the tooth surface after rinsing, brushing with toothpaste containing sodium lauryl sulfate (SLS) and action of saliva.

Risk assessments and viral inactivation studies were performed according to FDA's guidance Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) issued on March 15, 2019.

EQUIVALENCE TO MARKETED DEVICES

All devices use a stain in a liquid that is able to penetrate the subsurface of caries (active) lesions and bind either to the hydroxyapatite via electrostatic forces (subject device and primary predicate device) or to denatured collagen (reference device). Non-bound product is removed by rinsing with water. The remaining product is visible to the dental professional, as it contains a staining agent bound to a carious lesion. For the subject device, bound product is removed by brushing with a toothpaste containing SLS and by action of saliva.

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Characteristic	Subject Device	Predicate Device	Reference Device
	BlueCheck CariesDetection andMonitoringIncisiveTechnologies Pty Ltd	K200601LumiCare™Caries DiagnosticRinseGreenMarkBiomedical Inc.	K955445Caries FinderDanville Engineering,Inc.
Reason forPredicate/Reference	n/a	Similar indicationsPerformancecomparison	Similar indicationsPerformancecomparisonUse of color stainingagent
Product Code	LFC	LFC, EAQ	LFC
Regulation Number	872.1740	872.1740	872.1740
Identification	Caries DetectionDevice	Caries DetectionDevice	Caries Detection Device
Intended Use	Detection of dentalcaries	Detection of dentalcaries	Detection of dentalcaries
Indication for UseStatement	To aid the dentalprofessional in thedetection andmonitoring of dentalcaries.	To aid the dentalprofessional invisualization ofcarious lesions	A visual aid for thedetection of cariousdentin.
Indication forDisease	Dental caries	Dental caries	Dental caries
Indication forPatient Population	Adults and children	Adults andchildren	Not specified
Anatomic Sites	Directly visible toothsurfaces	Directly visibletooth surfaces	Directly visible toothsurfaces
Use Environment	Dental Operatory	Dental Operatory	Dental Operatory
Product Form	Liquid	Liquid	Liquid
Primary CarrierFluids	Phosphate BufferedSaline (PBS)	Water withPropylene Glycol	Water with PropyleneGlycol
Contains StainingAgent	Yes	Yes	Yes
Staining Agent	Deep-blue dye(Amido black)	Fluorescein	Red color: acid red 52Green color: FD&Cgreen
Carrier for StainingAgent	Submicron Protein(BovineHemoglobin)	Submicron StarchParticle (cationic)	None
Application	Product is applied toteeth with anapplicator/brush.	Product is pouredinto mouth andpatient instructedto rigorously swish	Product is applied toteeth with anapplicator/brush.
Detection Method	Areas of tooth decaytemporarily stain	Areas of toothdecay temporarilystain	Areas of tooth decaytemporarily stain
ViewingConditions	Ambient light/whitelight with the nakedeye or undermagnification	Blue light/orangefilter	Ambient light/whitelight with the naked eyeor under magnification
Characteristic	Subject Device	Predicate Device	Reference Device
	BlueCheck CariesDetection andMonitoringIncisiveTechnologies Pty Ltd	K200601LumiCare™Caries DiagnosticRinseGreenMarkBiomedical Inc.	K955445Caries FinderDanville Engineering,Inc.
Reason forPredicate/Reference	n/a	Similar indicationsPerformancecomparison	Similar indicationsPerformancecomparisonUse of color stainingagent
Stimulationwavelength	Visible light	Blue light (450-470 nm, peakvalue)	Visible light
Prescription/OTC	Prescription only	Prescription only	Prescription only
Usage	Single-patient,single-use	Single-patient,single-use	Single-patient, single-use

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CONCLUSION

Based on a comparison of the indications for use and technology, BlueCheck is substantially equivalent to LumiCare™ Caries Diagnostic Rinse, K200601.

Regulation Number and Section

§ 872.1740 Caries detection device.

(a)
Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.(b)
Classification. Class II.