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SDF Pro is intended to be used by dental professionals to treat tooth hypersensitivity. For use in adults over the age of 21.

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This FDA 510(k) clearance letter for the SDF Pro device does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

The letter's primary purpose is to confirm substantial equivalence of the SDF Pro to a legally marketed predicate device, allowing it to be marketed. It details:

• Device Name: SDF Pro
• Applicant: Belport Company, Inc., Gingi-Pak
• Regulation Number and Name: 21 CFR 872.3260, Cavity Varnish
• Regulatory Class: Class II
• Product Code: PHR
• Indications for Use: Intended to be used by dental professionals to treat tooth hypersensitivity in adults over the age of 21.

Therefore, it is impossible to provide the requested information based on the provided text.

The document is a clearance letter, not a summary of the technical or clinical performance data submitted for the clearance. Clinical study data, including acceptance criteria, performance metrics, sample sizes, ground truth establishment, and expert qualifications, would typically be found in the original 510(k) submission document itself, which is not provided here.

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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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Treatment of dentinal hypersensitivity. For use in adults over the age of 21.

FAgamin® is a professional treatment for dentin hypersensitivity. It is indicated for adults over 21 years of age.

FAgamin® is presented in a 5 ml black dropper bottle and contains a 38% w/v solution of diamine silver fluoride. Its design includes a secure screw cap and labeled container.

The provided document is a 510(k) Summary for the medical device FAgamin®, a cavity varnish for the treatment of dentinal hypersensitivity. It does not describe a study involving an AI/ML algorithm or its performance. The document focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than a clinical study proving device effectiveness against acceptance criteria in the context of AI.

Therefore, most of the requested information regarding acceptance criteria, study design for AI/ML, human expert involvement, and AI performance metrics cannot be found in this document.

However, I can extract information about the non-clinical tests performed and their criteria, which act as "acceptance criteria" for demonstrating substantial equivalence based on non-clinical performance.

Here's the information that can be extracted from the provided document:

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

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 does not specify a "test set" in the context of an AI/ML study.
• For the non-clinical tests, specific sample sizes (e.g., number of dentin samples, number of packages) are not provided in this summary.
• Data provenance (country of origin, retrospective/prospective) for these non-clinical tests is not detailed, though the applicant is from Argentina.

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 document does not describe an AI/ML study requiring expert ground truth for image interpretation or diagnosis. The non-clinical tests are laboratory-based.

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

• Not applicable. This document does not describe an AI/ML 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

• Not applicable. This document describes a medical device (cavity varnish), not an AI/ML software. No MRMC study was performed.

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

• Not applicable. This document describes a medical device, not an AI/ML algorithm.

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

• For the non-clinical tests, the "ground truth" refers to the established scientific and engineering criteria and measurements (e.g., chemical composition analysis, physical properties, biological assays, comparison to predicate device).

8. The sample size for the training set

• Not applicable. This document describes a medical device, not an AI/ML algorithm. No training set was used.

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

• Not applicable. This document describes a medical device, not an AI/ML algorithm. No training set was used.

Summary of the Study Performed (Non-Clinical for Substantial Equivalence):

The studies conducted for the FAgamin® device were non-clinical laboratory tests designed to demonstrate its substantial equivalence to a legally marketed predicate device (Silver Dental Arrest, K102973). The purpose was to show that FAgamin® is as safe and effective, and performs as well as or better than the predicate device.

The non-clinical tests covered:

• Physical and Chemical Properties: Appearance, color, odor, pH, density, silver ion concentration, silver diamine fluoride concentration, and fluoride ion concentration. These were compared against internal specifications and the predicate device's known properties.
• Stability: To ensure a 2-year shelf life.
• Efficacy surrogates:
  • Dentin Hydraulic Conductance: Measured to demonstrate the device's ability to desensitize by reducing dentin permeability, with a criterion of no significant difference from the predicate device.
  • Fluoride Release: Compared to the predicate device to ensure similar fluoride ion release, expected to contribute to its mechanism of action. The criterion was no significant difference.
  • SEM-EDS Analysis: Used to observe the formation of deposits and obliteration of dentinal tubules, confirming a similar mechanism of action to the predicate. The criterion was similarity in effect and deposits.
• Biocompatibility: Tests according to ISO 10993 standards including cytotoxicity, sensitization, irritation, and systemic toxicity. Criteria were established based on standard biological safety assessments.
• Packaging Integrity: ISTA 3A test to ensure the packaging protects the contents during transport.

Conclusion from Non-Clinical Testing:
The document concludes that "The conclusions drawn from the non-clinical testing demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K102973."

No clinical testing was performed in support of this submission. Therefore, all performance claims are based on these non-clinical comparative tests.

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Treatment of dentinal hypersensitivity For use in adults over the age of 21.

e-SDF is a single component liquid device made up of 38% silver diamine fluoride.Silver diamine fluoride solution is applied to the tooth, to reduce tooth sensitivity by physically occluding the open dentinal tubules. e-SDF is a liquid that is applied to the teeth using an applicator brush or similar application.

The provided text describes a 510(k) summary for a medical device called "e-SDF." This device is a liquid made of 38% silver diamine fluoride, intended to treat dentinal hypersensitivity by occluding open dentinal tubules. The submission aims to demonstrate substantial equivalence to a predicate device, "Silver Dental Arrest (Advantage arrest)" (K102973).

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a quantitative sense with pass/fail thresholds. Instead, it presents a comparison of technological characteristics between the subject device (e-SDF) and the predicate device, aiming to show substantial equivalence. The performance is assessed through non-clinical testing.

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

The document mentions a "Hydraulic Conductance study" and "Scanning electron microscope (SEM) images" as part of non-clinical performance testing. However, it does not specify the sample size used for these tests (e.g., number of teeth, dentin samples).

The data provenance is also not explicitly stated. It's non-clinical lab testing, so it likely occurred in a controlled laboratory environment, but the country of origin of the lab or whether it was prospective/retrospective is not mentioned.

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

This section is not applicable as the provided document describes non-clinical performance testing (a "Hydraulic Conductance study" and SEM imaging) rather than a clinical study requiring expert assessment for ground truth. The evaluation criteria for the Hydraulic Conductance study and SEM images would be based on scientific measurements and observations, not expert consensus on diagnoses.

4. Adjudication Method for the Test Set:

This section is not applicable for the same reason as point 3. There is no human interpretation or diagnostic ground truth being established in the non-clinical tests described.

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:

This is not applicable. The device e-SDF is a dental product (cavity varnish/tooth desensitizer), not an AI-powered diagnostic imaging tool. Therefore, an MRMC study or AI assistance is not relevant to its performance evaluation as described.

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

This is not applicable. As mentioned above, the device is a dental product, not an algorithm, so the concept of standalone algorithm performance does not apply.

7. The type of ground truth used:

For the non-clinical tests described:

• Hydraulic Conductance Study: The ground truth would be the measured reduction in fluid flow through dentin, quantifiable by established scientific methods.
• Scanning Electron Microscope (SEM) Images: The ground truth is the visual evidence of precipitate formation and occlusion of dentinal tubules, observed microscopically.

8. The sample size for the training set:

This is not applicable. The e-SDF is a physical dental product, not a machine learning model, so there is no concept of a "training set" for its development or evaluation in the context of this submission.

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

This is not applicable for the same reason as point 8.

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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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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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Treatment of dentinal hypersensitivity. For use in adults over the age of 21.

Riva Star is a two-component device made up of Riva Star Step 1, containing silver diamine fluoride liquid, and Riva Star Step 2, containing aqueous potassium iodide liquid. Riva Star Step 1 silver diamine fluoride solution is applied to the tooth, immediately followed by Riva Star Step 2 aqueous potassium iodide, which forms an immediate reaction precipitate of silver iodide, thereby reducing tooth sensitivity by physically occluding the open dentinal tubules. Riva Star as well as predicates are liquids or gels that are applied to the teeth using an applicator brush or similar application.

The provided text describes the performance and equivalency of the device "Riva Star" to predicate devices, primarily "Advantage Arrest" and "Super Seal," for the treatment of dentinal hypersensitivity. However, the text does not contain a formal table of "acceptance criteria" and subsequent "reported device performance" against those criteria in a structured format. Instead, it discusses comparability to predicate devices and results from various tests, which indirectly serve as evidence of the device's acceptable performance.

Based on the information provided, here's a structured response outlining the key aspects:

1. Table of Acceptance Criteria and Reported Device Performance

As there is no explicit table of quantitative acceptance criteria provided in the text, I will infer what appears to be the implicit acceptance criteria from the non-clinical and clinical performance testing sections and present the reported performance of Riva Star against those objectives. The primary objective is substantial equivalence to predicate devices.

• Ion Release: Riva Star released less fluoride and silver ions compared to primary predicate Advantage Arrest in a 7-day in vitro study, "demonstrating that Riva Star is as safe as Advantage Arrest."
• Biocompatibility: Passed Cytotoxicity (ISO Agarose, ISO Direct contact), Sensitisation (ISO Guinea Pig Maximization Sensitization), Oral Mucosal Irritation (Hamsters, collar method, 7 day), and Oral Acute Toxicity (Mice - 7 day) tests, providing "evidence of biocompatibility." Cytotoxicity results were "equivalent" to Advantage Arrest. |
  | 6. Shelf Life | Met: Stability testing established a shelf life of "25 months when stored between 2ºC (35ºF) to 8ºC (45ºF)." |
  | 7. Clinical Effectiveness in Reducing Dentinal Hypersensitivity | Met: A double-blind randomized clinical trial showed that "Riva Star was more effective than Super Seal in reducing dentine hypersensitivity after 7 days." This demonstrates clinical effectiveness, furthering the case for substantial equivalence. |

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

• Non-Clinical Hydraulic Conductance Study: Not explicitly stated how many dentin samples were used.
• Non-Clinical In Vitro Ion Release Study: Not explicitly stated how many samples of Riva Star and Advantage Arrest were tested.
• Biocompatibility Studies (Animals):
  • Sensitization: Guinea Pigs (sample size not specified)
  • Oral Mucosal Irritation: Hamsters (sample size not specified)
  • Oral Acute Toxicity: Mice (sample size not specified)
• Clinical Performance Testing:
  • Sample Size: Patients with "recognisable tooth sensitivity on both sides of their upper arch" (Exact number of patients/teeth not specified, but implied to be sufficient for a randomized clinical trial).
  • Data Provenance: The study was a "double blind randomised clinical trial on patients." The country of origin is not explicitly stated in the provided text.
  • Retrospective or Prospective: Prospective (clinical trial).

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

• Clinical Performance Testing: Ground truth (reduction in dentinal hypersensitivity) was established by patient responses recorded on a Visual Analogue Scale (VAS). This indicates self-reported patient pain levels, not expert consensus as the primary ground truth.
• Non-Clinical Studies: Ground truth for hydraulic conductance, SEM imaging, ion release, and biocompatibility was established through objective laboratory measurements and biological assays, not expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

• Clinical Performance Testing: The primary "ground truth" was patient-reported pain levels via Visual Analogue Scale (VAS). This is a self-adjudication method. The trial was "double blind randomized," suggesting measures were taken to prevent bias in data collection and interpretation. No external expert adjudication method (e.g., 2+1, 3+1) is mentioned for the clinical trial.
• Non-Clinical Studies: No adjudication method as these involved objective laboratory measurements.

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, an MRMC comparative effectiveness study involving human readers or AI assistance was not mentioned. The device, Riva Star, is a dental product (tooth desensitizer), not an imaging or diagnostic AI-powered device that would typically undergo such a study design.

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

• Not applicable. Riva Star is a physical product (liquid solution) applied by a clinician, not an algorithm.

7. The Type of Ground Truth Used

• Non-Clinical Studies (Hydraulic Conductance, SEM, Ion Release, Stability): Objective laboratory measurements and observations (e.g., fluid flow rate, microscopic images showing precipitate formation, ion concentrations, physical property measurements).
• Biocompatibility Studies: Biological assay results (e.g., cell viability, observed irritation/sensitization responses in animal models).
• Clinical Performance Testing: Patient-reported outcomes (self-reported pain levels) using a Visual Analogue Scale (VAS).

8. The Sample Size for the Training Set

• Not applicable. Riva Star is a physical medical device, not an AI/machine learning algorithm requiring a training set.

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

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

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Treatment of Dental Hypersensitivity.

Not Found

I apologize, but the provided text from the FDA 510(k) premarket notification letter for "Silver Dental Arrest" does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies for artificial intelligence or a medical device utilizing AI.

The document is a regulatory approval letter and an "Indications for Use" statement. It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It does not include the detailed technical study data that would be necessary to answer your questions regarding acceptance criteria and device performance.

Therefore, I cannot extract the requested information from the provided text.

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