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

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.

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.

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.

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