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Rennou™ Varnish is indicated for the relief of tooth hypersensitivity through the mechanical occlusion of dentinal tubules.

Rennou™ Varnish is a cavity varnish intended for professional use as a topical application on prepared tooth surfaces. This fluoride-free varnish creates a rosin-based film that prevents penetration of restorative material into the dentinal tissue and provides relief of tooth hypersensitivity by occluding open dentinal tubules. Unit-dose varnish and applicator are packaged together in individual thin, sealed trays. Rennou™ Varnish is only applied by a professional clinician.

Rennou™ Varnish is a topically applied flavored (Spearmint, etc.) compound comprised of natural rosin, ethanol, xylitol, and Rennou™ (a combination of theobromine, calcium acetate, and sodium hydrogen phosphate). The major components are rosin and ethanol, which, when delivered together, efficiently promote a fast-drying film on the tooth surface. The varnish is sweetened with xylitol.

The provided document is an FDA 510(k) clearance letter for Rennou™ Varnish. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria in a quantitative manner typical of an AI/software device.

A 510(k) submission primarily shows that a new device is as safe and effective as a legally marketed predicate device. While "testing summary" is mentioned, it refers to laboratory studies, not a clinical trial with human subjects and specific performance metrics like sensitivity, specificity, or accuracy compared to ground truth.

Therefore, many of the requested elements for an AI/software device performance study are not applicable or cannot be extracted from this document, as Rennou™ Varnish is a physical medical device (cavity varnish), not an AI/software device.

Here's an analysis based on the information provided, highlighting the differences:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative "acceptance criteria" in the way an AI/software device would (e.g., minimum sensitivity of 90%). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device in terms of:

2. Sample Size for Test Set and Data Provenance

This information is not provided in the document. The "tests" mentioned are general laboratory studies ("Comprehensive laboratory studies evaluated Rennou™ Varnish for performance and biocompatibility. Enamel protection and dentinal hypersensitivity tests on molars and dentin specimens..."). There is no mention of a "test set" in the context of an AI/software device's performance evaluation against a defined ground truth.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a physical product, not an AI/software diagnostic or assistive tool where expert-established ground truth is typically used for performance evaluation.

4. Adjudication Method

Not applicable for a physical device.

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

Not applicable. This is not an AI/software device designed to assist human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical product, not an algorithm. The laboratory studies focused on the physical properties and biological interactions of the varnish itself.

7. Type of Ground Truth Used

For the laboratory studies:

• Physical/Biological Measurements: SEM analysis for tubule occlusion, deep penetration, smooth surface finish.
• Biocompatibility Standards: ISO 10993-5 and USP for cytotoxicity.
  These are objective measurements and established standards, rather than "ground truth" derived from expert consensus or pathology in the context of diagnostic AI.

8. Sample Size for Training Set

Not applicable for a physical medical device. There is no "training set" in the context of machine learning.

9. How Ground Truth for Training Set Was Established

Not applicable.

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To relieve dental hypersensitivity caused by bleaching procedures, cold, heat, acids, or sweets.

ReminGel is a convenient, premixed, ready-to-use, opaque aqueous-based gel. ReminGel consists of suspended hydroxyapatite and calcium and phosphate salts that help restore a tooth's hydroxyapatite structure through remineralization. This remineralization results in tubule occlusion and blocks fluid flow in dentinal tubules, thereby relieving dentinal sensitivity. ReminGel blocks nerve excitability through potassium release. ReminGel is packaged in a 3oz (90mL) tube. ReminGel is for prescription use (Rx) and over-the-counter (OTC) use. ReminGel can be applied to teeth using dental appliances (e.g. fluoride tray, whitening tray, periotray, etc.) or via a toothbrush.

Here's a breakdown of the acceptance criteria and study information for ReminGel, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Tubule Occlusion Testing: Resected human teeth were used. The exact sample size ("N") is not specified.
   • Biocompatibility Testing (Cytotoxicity, Irritation, Sensitization): Not specified in terms of human subjects or teeth. These are in vitro and in vivo tests, typically performed on cell cultures or animal models for initial screening (as per ISO 10993 standards listed). The document does not provide details on the specific samples used for these tests.
   • Shelf-Life Testing: Not specified.
   • Transit Testing: Not specified.
   • Data Provenance: Not explicitly stated, but based on the in vitro nature of the tubule occlusion study on "resected human teeth," it implies laboratory testing rather than a clinical trial in patients. The biocompatibility tests are also laboratory-based. It is retrospective in the sense that the results were gathered and submitted as part of the 510(k) submission, not a prospective clinical trial.

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

   • Not applicable/Not specified. The studies cited are non-clinical (laboratory/bench testing). For tubule occlusion, the "ground truth" would be the visible occlusion as observed through microscopy, which doesn't directly involve multiple expert adjudicators for "truth" establishment in the way clinical images would.

3. Adjudication method for the test set:

   • Not applicable. As the studies are non-clinical, there is no expert adjudication method like 2+1 or 3+1 typically used for clinical image interpretation.

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:

   • No MRMC study was conducted. This device (ReminGel) is a medical product (cavity varnish) and not an AI/software-as-a-medical-device that would typically involve human readers and AI assistance for interpretation.

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

   • Not applicable. This is not an algorithm or AI device.

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

   • Tubule Occlusion: Visual observation of dentinal tubule occlusion (likely microscopic evaluation).
   • Shelf-Life: Measured physical and chemical properties over time.
   • Transit, Cytotoxicity, Irritation, Sensitization: Results from standardized laboratory test methods (e.g., ISO 10993 series).

7. The sample size for the training set:

   • Not applicable. This is a medical product, not a machine learning/AI model that requires a training set.

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

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

Overall Context: The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Super Seal) and a reference device (Senzzzz Away) through non-clinical performance and biocompatibility testing, rather than extensive clinical efficacy trials. Clinical performance was explicitly "not deemed necessary" for this submission, likely due to the established mechanism of action and similarity to legally marketed devices.

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Indicated for relief of discomfort from dentin sensitivity.

CrystLCare™ PRO Biorestorative, Fluoride-Plus is a flavored dental strip which contains calcium, phosphate, and fluoride which are stabilized with a modified starch. The single-use strip is topically applied to the outer surface of a tooth or teeth that are experiencing dental sensitivity. The strip dissolves in salivator elease these minerals which then will precipitate crystals that form a layer over the tooth surfaces. This physically occludes exposed dentinal tubules and enamel porosities to relieve discomfort. The modified starch helps to stabilize the calcium, phosphate, and fluoride mineral components so that they can persity into the dentinal tubules.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CrystLCare™ PRO Biorestorative, Fluoride-Plus device.

Observation: The provided text is a 510(k) summary for a medical device (CrystLCare™ PRO Biorestorative, Fluoride-Plus) and does not describe acceptance criteria for a study that proves the device meets those criteria. Instead, it describes non-clinical tests used to demonstrate substantial equivalence to a predicate device, which is the basis for 510(k) clearance.

The typical structure of a 510(k) submission means that detailed acceptance criteria and study methodologies, as one might find in a clinical trial report, are usually not fully disclosed in this summary document. The information provided focuses on demonstrating equivalence to an existing device rather than establishing new performance criteria.

Therefore, I will extract the information that is present and note where the specific details requested are not available in this document.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria (e.g., target occlusion percentage) are not explicitly stated for the non-clinical tests. Instead, the performance is described in terms of equivalence to the predicate device.

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

• Test Set (Non-clinical):
  • Sample Size: Not explicitly stated. The text mentions "dentin samples" and "micrographs of dentin samples." The exact number of samples or experimental replicates is not provided in this summary.
  • Data Provenance: Not specified. This was a non-clinical, in-vitro study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Ground Truth for Non-Clinical Tests: Given that the study involves Scanning Electron Microscopy, EDX, and XRD analysis, the "ground truth" would be established by the results of these analytical techniques, interpreted by experts in materials science, microscopy, and potentially dentistry.
  • Number of Experts: Not specified. It's likely that internal experts or contracted lab personnel conducted and interpreted these analyses.
  • Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified. For non-clinical, analytical studies like SEM, EDX, and XRD, interpretation relies on the technical expert performing and validating the analysis, rather than a consensus-based adjudication method typical of human-reader studies for medical imaging.

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

• Was an MRMC study done? No.
• Effect size of human readers with/without AI assistance: Not applicable. This device is a dental product (cavity varnish), not an AI-powered diagnostic imaging tool.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Not applicable. This is a physical dental device, not an algorithm or software. The "performance" described is the device's physical and chemical action (occlusion, mineral deposition).

7. Type of Ground Truth Used

• Ground Truth: For the non-clinical tests, the ground truth was established by:
  • Analytical Results: Direct observation via Scanning Electron Micrographs (SEM) for physical occlusion, and elemental/structural analysis via Electron Dispersive X-ray (EDX) and X-Ray Diffraction (XRD) for chemical composition and crystal formation.
  • Comparison to Predicate: The performance was assessed relative to a legally marketed predicate device, with the predicate's established performance serving as a benchmark for equivalence.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a material science product; there is no "training set" in the context of machine learning or AI.

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no training set.

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Jasmate® Toothpaste is prescription fluoride dentifrice for use in the prevention and treatment of dental sensitivity.

Jasmate® toothpaste is a dentist and dental professional prescribed, daily-use, fluoride dentifrice to be used in the prevention and treatment of dental sensitivity through the physical occlusion of dentin tubules.

Sodium fluoride is absorbed by the surface of hydroxyapatite crystals on the teeth, which are needed for mineralization. This makes the teeth more resistant to demineralization by changing the apatite crystal solubility. Sodium fluoride inhibits the demineralization of teeth in a pH-related manner. Sodium fluoride and hydroxyapatite are active ingredients. When exposed environment, it undergoes a rapid surface reaction to form fluorapatite, which is chemically and structurally similar to natural tooth mineral, allowing it to physically occlude tubules.

The provided text is a 510(k) Premarket Notification from the FDA for a new medical device, Jasmate® Toothpaste. It details the device's characteristics, intended use, and a comparison to a predicate device (BioMinF® Toothpaste) to establish substantial equivalence.

However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or software. The tests mentioned are for a physical product (toothpaste) and evaluate properties like density, pH, viscosity, spreadability, foaming power, relative dentin abrasion, enamel fluoride uptake, enamel solubility reduction, and tubule occlusion (via SEM). These are standard physical and chemical performance tests for a dentifrice, not evaluation of an AI system.

Therefore, I cannot fulfill the request as it pertains to AI/ML acceptance criteria and studies, because the provided input does not describe such a device or its evaluation. The request's template is designed for AI/ML product submissions, while the document describes a chemical/physical product.

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Papacarie Duo is a gel cleanser intended to clean the interior of a prepared cavity of a tooth prior to self-etch bonding procedures.

Papacarie Duo is a light blue colored gel cleanser dispensed from a prefilled, multi-use syringe storage system to a mixing pad, then applied to the interior of a prepared tooth cavity by dental professionals using a flocked tip brush or micro brush (not included). The tooth cavity is rinsed with water 60 seconds after application and prior to application of self-etch bonding material. The formula has a light blue color for easier visualization when it is applied on tooth surfaces. For single application prior to self-etch bonding procedure.

The provided text is a 510(k) summary for a medical device called "Papacarie Duo." This document is part of a submission to the FDA to demonstrate its substantial equivalence to previously cleared devices. It describes the device, its intended use, and compares it to predicate devices. However, it does not contain specific acceptance criteria, study details, or performance data in the structured format requested.

The summary mentions that "Non-clinical performance tests were conducted according to ISO 29022:2013 using Papacarie DUO to demonstrate substantial equivalence to the predicate device, and cleaning of prepared tooth surfaces prior to bonding of restorations." It also states, "Biocompatibility of Papacarie Duo was demonstrated and the data provided in this submission according to ISO 10993-1:2018."

These statements indicate that studies were performed, but the document does not provide the acceptance criteria or the reported performance data from these studies. Therefore, I cannot complete the requested tables and details based on the provided input.

To answer your request, the following information would be needed from a more detailed study report, not present in this 510(k) summary:

• Specific acceptance criteria: What quantitative or qualitative targets did the device need to meet to be considered effective and safe?
• Reported device performance: The actual results from the tests (e.g., cleaning efficacy measurements, bond strength results, etc.).
• Study design details: Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, details of comparative effectiveness studies (if any), and standalone performance details for the "non-clinical performance tests conducted according to ISO 29022:2013."
• Details about biocompatibility testing according to ISO 10993-1:2018: While mentioned, the specific tests and their outcomes are not described here.

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Profisil® Fluoride Varnish is a 5 % sodium fluoride varnish which produces mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.

Profisil® Fluoride Varnish is designed to securely adhere to the tooth surface for several hours while releasing fluoride ions. The varnish contains 5 % sodium fluoride suspended in a mucosa-friendly, pleasantly flavored dimethicone gel. The varnish is available in following versions: mint, berry and unflavored.

The provided document describes a 510(k) premarket notification for a dental device, "Profisil Fluoride Varnish." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials for effectiveness. Therefore, the information typically requested about acceptance criteria and studies proving a device meets them for new effectiveness claims, especially those involving AI or comparative effectiveness with human readers, is not directly applicable to this specific submission.

However, the document does detail how the new device demonstrates equivalence to its predicate, focusing on non-clinical performance and biocompatibility. Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

For "Profisil® Fluoride Varnish," the acceptance criteria for non-clinical performance are based on the international standard EN ISO 17730:2020 "Dentistry - fluoride varnishes."

Biocompatibility Acceptance Criteria:

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

• Test set sample size: Not explicitly stated as this is a non-clinical device evaluation. The "test set" would refer to the samples of the Profisil® Fluoride Varnish subjected to the various physical and chemical tests (e.g., specific batches for pH, viscosity, fluoride release tests) and biocompatibility studies (e.g., cell cultures for cytotoxicity, animal models for sensitization/irritation). The exact number of samples tested for each property is not detailed in the summary.
• Data provenance: The standard EN ISO 17730:2020 is an international standard. Biocompatibility standards like ISO 10993 series are also international. The summary indicates these tests were performed to demonstrate compliance with these standards, suggesting laboratory testing specifically for the Profisil® product. There is no information on country of origin of data beyond the manufacturer being based in Germany. The data is prospective as it was generated to support the current submission.

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

This information is not applicable. The "ground truth" for this type of device comparison is based on established scientific and engineering principles codified in international standards (EN ISO 17730:2020 for dental fluoride varnishes) and biocompatibility standards (ISO 10993 series). The results are objectively measured physical and chemical properties and biological responses, not subjective interpretations by human experts in the sense of medical image analysis.

4. Adjudication Method for the Test Set

Not applicable, as the "test set" involves objective laboratory measurements against predefined standard requirements rather than subjective assessments requiring adjudication.

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 device is a dental fluoride varnish, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant to this submission.

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

Not applicable for the same reason as above; this is a physical dental material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the current device's performance evaluation is based on International Standards:

• EN ISO 17730:2020 "Dentistry - fluoride varnishes" for physical and chemical properties (pH, dynamic viscosity, fluoride release, SEM).
• ISO 10993 series for biocompatibility studies (cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity).

These standards define the acceptable range or nature of results for these properties, which serve as the objective "ground truth" for evaluation.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and therefore does not have a "training set."

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

Not applicable.

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The Dental Desensitizer is a colorless transparent gel that is applied to the sensitive part of the tooth to form a film, sealing the exposed dentin tubules and relieving dentin allergy. The product is used either by a dental professional in the dental office or provided to the patient for home treatment of dentin sensitivity.

Dental Desensitizer is a sustained release, 3% potassium nitrate and 0.11% weight fluoride ion, viscous gel. This product is designed to be used together with a custom-fabricated tray.

The provided text is a 510(k) Summary for a Dental Desensitizer. It outlines the premarket notification to the FDA for this device, claiming substantial equivalence to a predicate device, the UltraEZ Desensitizing Gel (K061438).

However, this document does not contain information about the acceptance criteria and study proving a software or AI/ML-based device meets acceptance criteria.

The document specifically states under section (9) "Clinical studies and tests performed": "Clinical studies and tests were not conducted."

Instead, the submission relies on non-clinical studies and tests, focusing on the physical, chemical, and biological properties of the dental desensitizer product itself, and its comparison to the predicate device.

Therefore, it is not possible to provide the requested information regarding AI/ML device acceptance criteria and study details based on the provided text.

The document details relate to a material/chemical product (a dental gel), not a software or AI/ML device. The questions in the prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance, training set details) are specific to the evaluation of AI/ML-based medical devices, which are not applicable here.

In summary, the provided context does not offer the necessary information to answer the questions about AI/ML device acceptance criteria and proving device performance.

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3MIM Clinpro™ Clear 2.1% Sodium Fluoride Treatment is indicated for the treatment of hypersensitive teeth.

3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment is an aqueous fluoride coating that is applied topically to the tooth surfaces for the treatment of hypersensitive teeth. The product is sweetened with xylitol and sucralose. Clinpro 2.1% Sodium Fluoride Treatment contains 9,500 ppm fluoride and added calcium and phosphate. 3M Clinpro Clear 2.1% Sodium Fluoride Treatment uses the L-Pop™ unit dose dispensing system designed by 3M. Each L-Pop contains 0.5 ml (0.5 grams) of the coating and is offered in mint and melon flavors and a flavorless version.

The provided document is a 510(k) premarket notification for a medical device called "3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a full clinical trial to prove efficacy and safety through detailed acceptance criteria and studies as one might see for novel high-risk devices.

Therefore, the information typically available for a detailed acceptance criteria and performance study (as requested in the prompt) such as prospective studies, ground truth establishment by multiple experts with adjudication, MRMC studies, or standalone algorithm performance, is not present in this type of FDA submission.

Instead, the document details bench testing to demonstrate that the subject device performs similarly to or better than its predicate devices based on certain physical properties and release characteristics. The acceptance criteria here are mainly "Pass/Fail" based on whether the device meets specific thresholds or shows comparable performance to the predicate devices in these bench tests.

Here's an attempt to extract and present the available information in the requested format, with the understanding that many aspects of your request (e.g., human-in-the-loop studies, multi-reader studies, detailed expert ground truth, training set information) are not applicable or not provided in a 510(k) submission for a dental varnish.

Acceptance Criteria and Device Performance Study for 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment

Note: This 510(k) submission primarily relies on demonstrating substantial equivalence through bench testing against predicate devices, rather than clinical efficacy studies with human subjects. Therefore, many of the requested details, particularly those related to human reader studies, multi-expert ground truth establishment, and training/test set specifics for AI/ML models, are not applicable or not provided in this type of regulatory document for a tooth varnish. The "acceptance criteria" here refer to the performance thresholds set for the bench tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of patient data or clinical images, as the evaluation is based on in-vitro bench testing of the device material. The sample size for each bench test (e.g., number of replicates, number of specimens) is typically detailed in the internal test reports, but not provided in this summary. The data provenance is from laboratory bench testing conducted by 3M, not from specific patient populations or countries.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The "ground truth" for this device's performance is established by standardized laboratory testing methods and physical measurements, not by human expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set

Not applicable. As the "test set" is material performance data from laboratory tests, no adjudication method is required.

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

No. This type of study (comparing human readers with and without AI assistance) is not applicable to a dental varnish product. This device is not an imaging AI or diagnostic tool.

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

Not applicable. This device is a physical product (dental varnish), not an algorithm or software. Its performance is evaluated through material science and physical property tests.

7. The Type of Ground Truth Used

The ground truth used is based on physical and chemical measurements and observations from in-vitro laboratory bench tests, conforming to established standards (e.g., ISO 17730-2020) or validated internal methods. For example, "visually occlude exposed dentin tubules" for SEM, or measurable fluoride release values.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not a machine learning model, so there is no "training set" in the context of data for model development.

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

Not applicable. See point 8.

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APAPRO Desensitizer is a fluoride-free paste that is indicated to provide relief from tooth hypersensitivity resulting from cold, heat, acids, sweets, or contact, through its action of dentin tubule occlusion.

APAPRO Desensitizer is a fluoride-free tooth desensitizing paste that utilizes hydroxyapatite, the main component of teeth, as its active ingredient to relieve tooth sensitivity by physically occluding exposed dentin tubules. The hydroxyapatite deposited into dentin tubules by APAPRO Desensitizer then acts as a template for the further deposition of large amounts of calcium and phosphate ions, promoting crystal integrity and growth.

The provided text describes a 510(k) premarket notification for a dental device, Apapro Desensitizer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria related to a new device's performance metrics like sensitivity and specificity.

Therefore, the information requested about acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within the provided text.

The submission for Apapro Desensitizer (K220419) primarily relies on non-clinical tests comparing its mechanism of action and effectiveness in occluding dentin tubules to a predicate device, Oralief™ Therapy for Sensitive Teeth (K040858).

Here's what can be extracted based on your request, even if it highlights what's missing:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated as quantifiable performance metrics (e.g., specific percentages for sensitivity, specificity, or accuracy) in the context of a clinical trial. The "acceptance criteria" here implicitly refer to demonstrating substantial equivalence to the predicate device based on technological characteristics, intended use, indications for use, and a similar mechanism of action.
   • Reported Device Performance: The primary reported "performance" is that "APAPRO Desensitizer was shown to be as effective as the NovaMin® found in the predicate device in occluding dentin tubules."

   Trait	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (APAPRO Desensitizer)
   Indications for Use	Must be equivalent to the predicate device: Provides relief from tooth hypersensitivity resulting from cold, heat, acids, sweets, or contact, through its action of dentin tubule occlusion.	Provides relief from tooth hypersensitivity resulting from cold, heat, acids, sweets, or contact, through its action of dentin tubule occlusion. (Equivalent)
   Intended Use	Must be equivalent to the predicate device: For dental hypersensitivity relief, prescribed and applied by dental physicians for use in the Adult Population.	For dental hypersensitivity relief, prescribed and applied by dental physicians for use in the Adult Population. (Equivalent)
   Mechanism of Action	Must be equivalent or substantially similar to the predicate device: Formation of a hydroxyapatite layer to physically occlude dentin tubules.	Directly occludes dentin tubules by depositing a crystalline calcium phosphate layer (hydroxyapatite) on the tooth surface. (Equivalent in outcome, though different in active ingredient origin. Details in "Active Ingredient" and "Material Produced to Occlude Tubules").
   Performance (Dentin Tubule Occlusion)	Must demonstrate comparable effectiveness in occluding dentin tubules to the predicate device.	SEM micrographs showed similar occlusion of dentin tubules as NovaMin-treated samples. "APAPRO Desensitizer was shown to be as effective as the NovaMin® found in the predicate device in occluding dentin tubules."
   Biocompatibility	Must be biocompatible and non-antigenic, conforming to ISO 10993 standards.	Biocompatible, non-antigenic. Biocompatibility tests in accordance with ISO 10993 performed, and a biological risk assessment indicates no hazardous effects when used as directed in the Adult Population. (Equivalent)

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

   • Sample Size: Not specified. The "test set" in this context refers to dentin samples used for SEM imaging, not human subjects in a clinical trial.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study was a "non-clinical test" involving dentin samples.

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

   • Not applicable as this was a non-clinical in vitro test using SEM micrographs, not a study requiring expert clinical interpretation for ground truth.

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

   • Not applicable. This was an in vitro comparison of SEM micrographs, not a human reader 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:

   • No, an MRMC comparative effectiveness study was not done. This device is not an AI-based diagnostic tool.

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

   • Not applicable. This is a material-based dental desensitizer, not an algorithm.

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

   • For the non-clinical test, the "ground truth" for demonstrating dentin tubule occlusion was established through Scanning Electron Microscopy (SEM) micrographs to visually confirm the physical occlusion by the deposited hydroxyapatite layer. This is an objective laboratory measure.

8. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" as this device is not an AI algorithm.

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

   • Not applicable. There is no training set mentioned.

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