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Treatment of Dental Hypersensitivity for use in adults over the age of 21.

The Centrix FluoroSilver is a professional tooth desensitizer that is composed of Aqueous Silver Diamine Fluoride, 38.3% to 43.2% w/v. The solution is composed of water, ammonia, fluoride, silver and a colorant. The device is provided in a single 5 ml squeezable dropper bottle or a multi-pack which includes three 5 ml squeezable dropper bottles. Each variation is packaged in a preformed trav and includes applicators and the Instructions for Use (IFU). The primary mode of action is to reduce dentinal hypersensitivity by occluding open dentin tubules by the formation of a precipitate.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (Centrix FluoroSilver Silver Diamine Fluoride 38%). This type of document is provided when a company seeks to demonstrate that their new device is substantially equivalent to a legally marketed predicate device. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to demonstrating substantial equivalence through various performance and material characteristic comparisons, rather than clinical efficacy trials with predefined clinical acceptance criteria as would be typical for a PMA.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are implicitly defined by the characteristics of the predicate device and relevant standards. The goal is to show the new device is "substantially equivalent."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a "test set" in the sense of a clinical trial for performance. Instead, it describes various laboratory and in vitro/in vivo (animal) studies for substantial equivalence.

• Cytotoxicity (ISO 10993-5): No specific sample size mentioned, likely standardized by the ISO method.
• Skin Sensitization (ISO 10993-10): No specific sample size mentioned, likely standardized by the ISO method (typically animal models).
• Irritation (ISO 10993-23): No specific sample size mentioned, likely standardized by the ISO method (typically animal models for oral mucosa).
• Acute Systemic Toxicity (ISO 10993-11): No specific sample size mentioned, likely standardized by the ISO method (typically animal models like rats or mice).
• SEM Analysis: "Human tooth samples" used. Number not specified.
• Fluoride Release Testing: "SDF treated tooth cross sections" used. Number not specified.
• Dentin Permeability: "Human molar teeth samples" used. Number not specified, but the results include standard deviations, implying a sample size greater than one.

Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given that these are bench and preclinical studies for a 510(k), they are generally prospective laboratory studies. "Human molar teeth samples" would typically be ethically sourced from dental extractions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This type of information is generally not applicable to a 510(k) submission for substantial equivalence based on bench/preclinical testing. There is no "ground truth" established by experts in the context of interpreting images or clinical outcomes data. The "ground truth" for the tests mentioned (e.g., cytotoxicity, fluoride release, dentin permeability) is determined by the objective measurements and protocols of the respective ISO standards or laboratory methodologies.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human readers or expert consensus on qualitative data (e.g., image interpretation, clinical diagnosis). The studies presented are objective, quantitative laboratory tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses the performance of human readers, typically in interpreting medical images, with and without AI assistance. The device in question (Centrix FluoroSilver Silver Diamine Fluoride 38%) is a chemical product for treating dental hypersensitivity, not an imaging or diagnostic AI device.

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

Not applicable. This device is a chemical substance, not a software algorithm or an AI device. The term "standalone performance" for an algorithm does not apply here. The performance of the substance itself was evaluated.

7. The Type of Ground Truth Used

The "ground truth" used for these substantial equivalence tests were objective, quantitative measurements and observations derived from standardized laboratory tests:

• Cytotoxicity: Observation of cellular response in vitro according to ISO 10993-5.
• Skin Sensitization: Dermal response in animal models according to ISO 10993-10.
• Irritation: Mucosal response in animal models according to ISO 10993-23.
• Acute Systemic Toxicity: Clinical observations and necropsy findings in animal models according to ISO 10993-11.
• SEM Analysis: Direct microscopic observation of silver deposition on tooth samples.
• Fluoride Release Testing: Quantitative measurement of fluoride concentration.
• Dentin Permeability: Quantitative measurement of water flow through dentin.
• Chemical Identity Testing: Mass Spectrometry data for chemical composition.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device where a "training set" would be used to develop an algorithm. The device is a chemical product.

9. How the Ground Truth for the Training Set was Established

Not applicable, for the same reason as above.

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StatStix is applied to control temporary bleeding caused by minor cuts and abrasions that may occur on gingival tissue during dental procedures.

StatStix is designed incorporating a hand-held polypropylene handle with a nylon polyamide applicator tip coated with a dried solution of 25% Aluminum Sulfate Hydrate Solution with Mint Flavor. The device is configured in two sizes to help control minor gingival bleeding intended for transient use by a dentist during dental restorative procedures.

The provided FDA document describes the premarket notification (510(k)) for the StatStix device (K200764). It details the device's intended use and compares its characteristics to a predicate device for substantial equivalence. However, it explicitly states that clinical testing has not been performed on this product. Therefore, a study proving the device meets acceptance criteria based on clinical performance in humans is not present in this document.

The document does, however, discuss non-clinical performance data and establishes acceptance criteria for those tests.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

2. Sample Size Used for the Test Set and Data Provenance:

• Clinical Test Set: Not applicable, as no clinical testing was performed for StatStix.
• Non-Clinical Test Set: Not specified for biocompatibility, physical properties, or shelf-life testing. The document states "standard laboratory benchtop practices" for physical properties and "consistent with ASTM F1980" for shelf-life, implying standard sample sizes for these types of tests would have been used, but specific numbers are not detailed.
• Data Provenance: Not explicitly stated, but assumed to be from Centrix Incorporated or their contracted laboratories given they are the submitter.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

• Clinical Test Set: Not applicable.
• Non-Clinical Test Set: Not specified. For non-clinical lab tests, "ground truth" is established by the methodologies and reference standards themselves, as opposed to expert human interpretation.

4. Adjudication Method for the Test Set:

• Clinical Test Set: Not applicable.
• Non-Clinical Test Set: Not applicable. Adjudication methods are typically relevant for subjective assessments or when multiple human readers/experts are involved in ground truth establishment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states, "Clinical testing has not been performed on this product." Therefore, there is no information on how much human readers improve with AI vs. without AI assistance. The StatStix device is a physical product (applicator with astringent), not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• No, a standalone performance study in the context of an algorithm or AI was not done. StatStix is a physical device, not an algorithm.

7. Type of Ground Truth Used:

• Clinical Ground Truth: Not applicable, as no clinical testing was performed.
• Non-Clinical Ground Truth: Established through standardized laboratory testing methodologies (e.g., ISO, ASTM, FTIR/pH/dosage weight analysis) where the outcomes are measurable and objective.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical product, not an AI/machine learning algorithm requiring a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no training set for this type of device.

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NoCord with astringent is a low viscosity vinyl polysiloxane impression material which is indicated for use as the wash material when the tray/wash technique is performed for indirect dental restorations. When applied as the wash material, NoCord

1. Retracts the gingival tissue to expose the sub-gingival margin
2. Controls gingival bleeding
3. Reproduces the structure of a patient's teeth and gums

NoCord is a low viscosity vinyl polysiloxane impression material.

I am sorry, but the provided text is a 510(k) clearance letter for a dental impression material without any information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the information requested in your prompt.

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Benda Wedge is an inter-proximal wedge coated with an astringent to be used in combination with other devices to temporarily retain composite or amalgam restorative material as well as to control gingival bleeding during dental restorations.

Benda Wedge is indicated for use as a temporary inter-proximal wedge during dental restorative procedures. Benda Wedge is similar in design to the Wedge Wand predicate device but includes a hemostatic agent to control gingival bleeding. Design features consist of the following: Available in four anatomically-shaped sizes for optimum placement in inter-proximal spaces. Use an injection-molded thermoplastic material which is then coated with a fixed amount of aluminum sulfate hexadecahydrate to help control gingival bleeding.

This document describes a medical device, the "Benda Wedge," which is a dental wedge coated with a hemostatic agent. The submission is a 510(k) premarket notification, indicating that the manufacturer is seeking to demonstrate substantial equivalence to previously cleared devices rather than providing extensive de novo clinical trial data.

Acceptance Criteria and Device Performance:

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., specific reduction in bleeding, retention strength, etc.). Instead, the entire submission is built around demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that it performs comparably to the predicate devices for its intended use, with the added benefit of a hemostatic agent.

Therefore, the table below reflects the primary claim of similarity rather than specific performance numbers.

1. Sample sizes used for the test set and data provenance:

• Test Set Sample Size: "Clinical testing has not been performed on this product." Therefore, there is no test set in the traditional sense, and thus no sample size for clinical performance evaluation. Non-clinical biocompatibility testing was performed, but sample sizes for this are not specified in the summary.
• Data Provenance: Not applicable, as no clinical testing was performed.

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

• Not applicable, as no clinical testing was performed and no ground truth for a test set was established.

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

• Not applicable, as no clinical testing was performed and no ground truth for a test set was established.

4. 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:

• Not applicable. This device is a physical dental wedge, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This device is a physical dental wedge, not an algorithm.

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

• Not applicable, as no clinical testing was performed. For the biocompatibility testing, the ground truth would typically be established by standardized laboratory tests and evaluations against ISO 10993-1 guidelines, with results interpreted by qualified toxicologists or materials scientists.

7. The sample size for the training set:

• Not applicable. This device is a physical dental wedge and does not involve AI or machine learning that would require a training set.

8. How the ground truth for the training set was established:

• Not applicable, as no training set was used.

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