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Young Silver Fluoride Hypersensitivity Varnish is indicated for the treatment of dental hypersensitivity in adults. It is intended for professional use only.

Young Silver Fluoride Hypersensitivity Varnish is a formulation of silver, sodium fluoride, chitosan, acetic acid, and purified water intended for the treatment of dental hypersensitivity in adults. It is intended for professional use only.

Like other 510(k) cleared dental hypersensitivity varnishes including the predicate device, the proposed device works by physically occluding dentinal tubules through its silver and fluoride components. It contains small silver particles to facilitate their entry into the dentinal tubules, as well as chitosan and acetic acid to evenly disperse the solution. The product is supplied in a 10mL bottle with a dropper dispensing tip.

One to two drops of the varnish can treat up to 8 sites. If needed, a second application of the varnish may be administered after 1 week.

The provided text describes a 510(k) submission for a dental varnish. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical efficacy study with acceptance criteria often associated with AI/software medical devices. Therefore, the information needed to answer the questions about acceptance criteria for AI/software device performance is not present in this document.

The document discusses performance testing in a general product development sense (e.g., bench testing, biocompatibility, shelf life) to show the new device performs "as well or better than" the predicate, but these are not the quantitative acceptance criteria for AI model performance (e.g., sensitivity, specificity, AUC) that the prompt is looking for.

Specifically, there is no mention of:

1. Acceptance criteria table for AI performance: The document does not define specific metrics (e.g., sensitivity, specificity, accuracy) for an AI model.
2. Study proving device meets acceptance criteria: There is no clinical study described that evaluates an AI model's performance on a test set. The "study" mentioned refers to bench testing (dentinal occlusion, ion release) and biocompatibility for a physical dental varnish.
3. Sample size for a test set or data provenance: No test set of patient data for AI model evaluation is discussed.
4. Number of experts or qualifications for ground truth: No expert review for labeling images/data for AI training or testing is mentioned.
5. Adjudication method for a test set: Not applicable as there's no AI test set.
6. MRMC comparative effectiveness study: No study involving human readers with and without AI assistance is described.
7. Standalone (algorithm only) performance: Not applicable as it's not an AI algorithm.
8. Type of ground truth used: For a physical dental varnish, ground truth would relate to its physical and chemical properties, not diagnostic outcomes based on expert consensus or pathology data for an AI.
9. Sample size for training set, or how its ground truth was established: Not applicable as there's no AI training set.

In conclusion, the provided document does not contain the information requested because it pertains to a chemical dental product (varnish) and its 510(k) clearance based on substantial equivalence, not an AI/software medical device.

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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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