Quantium is a light-cured, radiopaque, universal composite. Quantium is designed to blend with the tooth structure when used alone or in the layering technique.

AI/ML Overview

The provided FDA 510(k) summary for the Quantium device (K242816) does not contain information typically associated with AI/ML device evaluations, such as specific acceptance criteria related to accuracy, sensitivity, specificity, or studies involving human readers or ground truth established by experts.

Instead, this document focuses on the nonclinical testing of a dental composite resin material against a predicate device and relevant ISO standards. Therefore, many of the standard questions regarding AI/ML device studies are not applicable.

Here's an analysis based on the provided text:

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

The document states that nonclinical testing of Quantium and the predicate device was selected from the "FDA Guidance Document, Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff, issued October 2005." The tests were conducted according to ISO 4049:2019.

Acceptance Criteria (Implied by adherence to ISO 4049:2019 and comparison to predicate):
The acceptance criteria are implicitly that Quantium must meet or exceed the requirements set forth in ISO 4049:2019 for the tested properties and perform equal to or better than the predicate device (TrusFIL Universal Composite Restorative, K202063).

Reported Device Performance:
"The nonclinical tests performed on Quantium and the predicate device showed Quantium performed equal to or better than the predicate. In addition, both devices meet the requirements set forth in ISO 4049:2019."

Test Parameter	Acceptance Criteria	Quantium Performance
Sensitivity to light	Meets ISO 4049:2019 and ≥ Predicate	Meets ISO 4049:2019 and ≥ Predicate
Depth of cure	Meets ISO 4049:2019 and ≥ Predicate	Meets ISO 4049:2019 and ≥ Predicate
Flexural strength	Meets ISO 4049:2019 and ≥ Predicate	Meets ISO 4049:2019 and ≥ Predicate
Water solubility	Meets ISO 4049:2019 and ≥ Predicate	Meets ISO 4049:2019 and ≥ Predicate
Shade/color stability	Meets ISO 4049:2019 and ≥ Predicate	Meets ISO 4049:2019 and ≥ Predicate
Radiopacity	Meets ISO 4049:2019 and ≥ Predicate	Meets ISO 4049:2019 and ≥ Predicate
Compressive strength	Comparable to Predicate	Performed equal to or better than predicate
Flexural modulus	Comparable to Predicate	Performed equal to or better than predicate
Hardness after cure	Comparable to Predicate	Performed equal to or better than predicate

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 describes nonclinical testing of material properties, not a clinical study involving patients or human data. Therefore, the concept of a "test set" and "data provenance" in the context of patient data is not applicable here. The sample sizes for each specific material test (e.g., number of specimens for flexural strength) are not detailed in this summary document. These details would typically be found in the full test reports, which are not provided.

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. This is a nonclinical material science study, not an AI/ML clinical study requiring expert ground truth for interpretation.

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

Not applicable, as this is a nonclinical material science study.

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. This is a nonclinical material science study.

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

No. This is a nonclinical material science study, not an AI/ML device.

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

The "ground truth" for this device is established by physical and chemical measurements conforming to ISO 4049:2019 standards and direct comparison to a legally marketed predicate device. This is a material science "ground truth," not a clinical ground truth.

8. The sample size for the training set

Not applicable. This is a nonclinical material science device, not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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December 17, 2024

Bisco. Inc. Jessica Berstein Global Regulatory Affairs Manager 1100 West Irving Park Road Schaumburg, Illinois 60193

Re: K242816

Trade/Device Name: Quantium Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: September 12, 2024 Received: September 18, 2024

Dear Jessica Berstein:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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-regulatory

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assistance/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).

Sincerely,

MICHAEL E. ADJODHA -S

Michael E. Adjodha, MChE, RAC, CQIA 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

Submission Number (if known)	K242816
Device Name	Quantum
Indications for Use (Describe)	Direct anterior and posterior restorationsCore build upsSplintingIndirect restorations including inlays, onlays, and veneers

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) #: K242816

510(k) Summary

Prepared on: 2024-09-18

Contact D

21 CFR 807.92(a)(1)

Applicant Name	Bisco, Inc.
Applicant Address	1100 West Irving Park Road Schaumburg IL 60193 United States
Applicant Contact Telephone	847-534-6034
Applicant Contact	Ms. Jessica Bernstein
Applicant Contact Email	jbernstein@bisco.com

21 CFR 807.92(a)(2)

Device Trade Name	Quantium
Common Name	Tooth shade resin material
Classification Name	Material, Tooth Shade, Resin
Regulation Number	872.3690
Product Code(s)	EBF

Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K202063	TrusFIL Universal Composite Restorative	EBF

Device Description Summary
21 CFR 807.92(a)(4)
Quantium is a light-cured, radiopaque, universal composite. Quantium is designed to blend with the tooth structure when used alone or in the layering technique.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
• Direct anterior and posterior restorations
• Core build ups
• Splinting
• Indirect restorations including inlays, onlays, and veneers
Indications for Use Comparison
21 CFR 807.92(a)(5)
The indications for use are similar. The additional text in the first indication of the predicate does not change the intended use; both the devices are indicated for direct anterior and posterior restorations.
Technological Comparison
21 CFR 807.92(a)(6)
Both Quantium and the predicate TrusFIL are methacrylate-based, radiopaque, light-cure pastes. Both also require the use of a dentalBoth Quantium and the predicate TrusFIL are methacrylate-based, radiopaque, light-cure pastes. Both also require the use of a dental adhesive and are available in a syringe and unit-dose capsule. The chemical composition of TrusFIL. All components of Quantium are based upon industry The difference in filler is Quantium's use of Ytterbium Fluoride, an industry standard filler, and is substantially equivalent in performance to TrusFIL's fillers.

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Nonclinical testing of Quantium and the predicate device was selected from the FDA Guidance Document, Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff, issued October 2005. Sensitivity to light, depth of cure, flexural strength, water solubility, shade/color stability, and radiopacity were tested according to ISO 4049:2019. Additionally, compressive strength, flexural modulus, and hardness after cure were also tested.

Clinical testing is Not Applicable.

The nonclinical tests performed on Quantium and the predicate device showed Quantium performed equal to or better than the predicate. In addition, both devices meet the requirements set forth in ISO 4049:2019. These results demonstrate that Quantium is as safe, as effective, and performs as well as the predicate.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.