Black Diamond is a two-part liquid intended as a treatment for dentin hypersensitivity, for use in adults over the age of 21. The product does not need light cured and will provide occlusion of dentinal tubules preventing or reducing dentin hypersensitivity.

The formula has two liquid steps, each provided in an individual dropper bottle. A drop of each product is placed in a mixing well/dappen dish and applied sequentially to the tooth using a standard flock tip applicator bush such as a microbrush. The mixing pad, and applicator may or may not be included in the product package. These are standard items in dental offices and numerous types of each will work.

AI/ML Overview

This document (K222323) is a 510(k) Premarket Notification from the FDA regarding "Black Diamond," a medical device intended for the treatment of dental hypersensitivity. It primarily focuses on demonstrating the substantial equivalence of Black Diamond to predicate devices based on intended use, technological characteristics, and safety information.

However, this document does NOT contain information about acceptance criteria for a study demonstrating device performance against specific metrics, nor does it detail a clinical study with human or even animal subjects that would typically be used to prove a device meets performance claims through clinical endpoints.

Instead, the document references physical tests and biocompatibility assessments to support the device's technical equivalence and safety.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies are not present in this document.

Here's an analysis of what is and is not available based on the provided text:

Based on the provided document (K222323), here's an attempt to address your request, highlighting the information that is not present as it's a 510(k) submission focused on substantial equivalence rather than a clinical trial report:

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

Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance in this 510(k) document. The document's acceptance criteria are implicit in demonstrating "substantial equivalence" to predicate devices based on similar indications for use, technological characteristics, and safety.
Reported Device Performance:
- Hydraulic Conductance Test: "A hydraulic conductance test was completed showing the efficacy of Black Diamond in occlusion of dentinal tubules in comparison to the predicate device." However, specific numerical results or the methodology for "efficacy" comparison (e.g., percentage reduction in conductance, statistical significance) are not provided.
- SEM Images: "Additionally, SEM images were taken of untreated dentin treated with the predicate and subject device to show dentin tubule occlusion, and no other effect on healthy dentin." This indicates qualitative visual evidence but no quantitative performance metric.

Metric (Implied, from physical tests)	Acceptance Criteria (Implicit: Comparable to predicate)	Reported Device Performance (Qualitative/Comparative)
Dentinal Tubule Occlusion	Show efficacy in occlusion comparable to predicate	"Showing the efficacy... in comparison to the predicate device."
No Effect on Healthy Dentin	Show no adverse effect on healthy dentin	"No other effect on healthy dentin."

2. Sample sizes used for the test set and the data provenance

Test Set Sample Size: Not specified for the hydraulic conductance test or SEM imaging. These are typically bench-top or in vitro tests, not clinical test sets in the traditional sense of patient data.
Data Provenance: The tests are described as completed by the company ("A hydraulic conductance test was completed... SEM images were taken..."). The document does not specify the country of origin of this test data or whether it was retrospective or prospective. Given these are bench tests often performed on extracted teeth, the concepts of "retrospective" or "prospective" as applied to clinical data are not relevant here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. For a device for hypersensitivity, clinical studies would involve patient reported outcomes or objective measurements by dental professionals. The tests described (hydraulic conductance, SEM) are physical/material characterization tests that do not typically involve human "experts" establishing a "ground truth" through consensus on images or clinical assessments in the way an AI-driven diagnostic device would.

4. Adjudication method for the test set

Not Applicable. This concept is relevant for clinical studies involving human interpretation or multi-reader reviews, not for the physical/bench tests mentioned.

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 document does not describe any MRMC study. Black Diamond is a physical dental product (cavity varnish), not an AI-assisted diagnostic or treatment planning software.

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

Not Applicable. Black Diamond is not an algorithm or software. It is a physical dental varnish applied by a human.

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

Proxy Ground Truth for Equivalence: For this 510(k), the "ground truth" for performance is effectively demonstrated through physical property testing (hydraulic conductance, SEM imaging) and comparison to the known performance/composition of legally marketed predicate devices. The ground truth for safety is based on biocompatibility testing (ISO 10993-1) and risk assessment (ISO 14971), as well as the long-standing safety history of its components.
For a device like this, clinical outcomes data (e.g., reduction in patient-reported hypersensitivity scores) would be the ultimate ground truth for clinical efficacy, but such clinical trial data is typically not required for a 510(k) submission seeking substantial equivalence based on established predicate devices and bench performance. The document only mentions "a significant safe history of use as well as a published body of literature" for the components.

8. The sample size for the training set

Not Applicable. This device is not an AI/ML product requiring a "training set."

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

Not Applicable. This device is not an AI/ML product.

Summary of Device Performance Proof in this 510(k) Context:

For Black Diamond, demonstrating "substantial equivalence" is the primary means of "proving" it meets regulatory requirements for marketing. This is achieved by:

Similar Indications for Use: Directly compared and shown to be identical to the predicate and reference devices.
Similar Technological Characteristics: Contains silver and fluoride, similar two-part liquid application, and similar mechanism of action (silver deposition for tubule occlusion).
Bench Testing:
- Hydraulic Conductance Test: Used to show ability to occlude dentinal tubules, implying efficacy for hypersensitivity. (Details lacking on specific quantitative results).
- SEM Images: Visual confirmation of tubule occlusion.
Safety Assessments: Biocompatibility testing (ISO 10993-1), risk assessments (ISO 14971), and ion elution tests.
Long History of Use: Mention of commercial availability in other countries with a safe history for its components.

Summary

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June 23, 2023

Elevate Oral Care, LLC % Steve Pardue Elevate Oral Care 346 Pike Road Suite 5 West Palm Beach, Florida 33411

Re: K222323

Trade/Device Name: Black Diamond Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: PHR Dated: June 8, 2023 Received: June 8, 2023

Dear Steve Pardue:

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

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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 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-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).

Sincerely,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M. ChE., 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

510(k) Number (if known) K222323

Device Name Black Diamond

Indications for Use (Describe)

Black Diamond is intended as Treatment of Dental Hypersensitivity. For use in adults over the age of 21.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Elevate Oral Care. The logo consists of a blue globe-like icon on the left, followed by the word "elevate" in blue, and the words "ORAL CARE" in a smaller font size below it. The logo is simple and clean, with a focus on the company name and its connection to oral health.

510(k) Summary

Submitter:

346 Pike Road, Suite 5 · Vest Palm Beach, FL 33411 Phone: 877-866-9113 · Fax: 561-244-1927 www.elevateoralcare.com

K22323

Company:	Elevate Oral Care
Street:	346 Pike Road, Suite 5
City, State Zip:	West Palm Beach, FL 33411
Country:	USA
Estab. Registration #:	3009603151
Correspondent:	Steve PardueManaging Member
Phone:	877-866-9113
Fax:	561-244-1927
Email:	spardue@elevateoralcare.com
Date:	October 26, 2022

Name of Device

Proprietary Name:	Black Diamond™
Classification Name:	Silver Fluoride Dental Hypersensitivity Varnish21 CFR 872.3260 as Class II deviceProduct Code: PHR
Common Name:	Silver Fluoride Dental Hypersensitivity Varnish & Device

Predicate Devices

Primary Predicate Device	510(k)
Silver Dental Arrest	K102973

Reference Device
Riva Star	K172047

Description

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may not be included in the product package. These are standard items in dental offices and numerous types of each will work.

Indications for Use

. Black Diamond is a two-part liquid intended as a treatment for dentin hypersensitivity, for use in patients over the age of 21.

Comparison of the Intended Use of Black Diamond to the Predicate Device

Black Diamond Indication for Use	Silver Dental Arrest
Treatment of Dental Hypersensitivity. For usein adults over the age of 21.	Treatment of Dental Hypersensitivity. For usein adults over the age of 21.

Comparison of the Intended Use of Black Diamond to the Reference Device

Black DiamondIndication for Use	Riva Star
Treatment of DentalHypersensitivity. Foruse in adults over theage of 21.	Treatment of DentalHypersensitivity.For use in adultsover the age of 21.

Technological Characteristics

Black Diamond has similar composition and claims as the predicate device Silver Dental Arrest and reference product Riva Star (product codes PHR). All three devices contain silver and fluoride as the main functioning ingredient.

Black Diamond uses an aqueous solution of silver fluoride, followed by a second solution of Stannous Fluoride, a reducing agent, that causes the deposition of silver into open dentinal tubules which in turns reduces sensitivity and hydraulic conductance. This same silver deposition process is used by the predicate device as well as the reference device, both in product code PHR.

Black Diamond has been commercially available in various countries for many years with a significant safe history of use as well as a published body of literature.

Application of Black Diamond is similar to both other products in product code PHR.

Summary of Physical Tests

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A hydraulic conductance test was completed showing the efficacy of Black Diamond in occlusion of dentinal tubules in comparison to the predicate device. Additionally, SEM images were taken of untreated dentin treated with the predicate and subject device to show dentin tubule occlusion, and no other effect on healthy dentin.

It was concluded that Black Diamond is substantially equivalent to the predicate device, and reference device, and is a two-part liquid intended as a treatment for dentin hypersensitivity for use in patients over the age of 21.

Description of Safety and Substantial Equivalence

The chemical components in Black Diamond have been used extensively in dental devices and have significant toxicological profiles and safety history. Biocompatibility and Risk assessments have been completed on the product, ingredients, and combination of ingredients. Ion elution tests have been successfully completed. These facts support the compatibility of Black Diamond, and the safety of the applicant device is substantially equivalent to the predicate devices in properties, intended use and composition.

Information provided in this submission confirms the substantial equivalence to the predicate devices with common indications, and indication from the reference predicate devices. The data provided in this 510(k) submission also shows that the composition is safe for its intended use based on the biocompatibility assessment and risk assessment conducted according to ISO 10993-1 and ISO 14971.

Regulation Number and Section

§ 872.3260 Cavity varnish.

(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.