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

Not Found

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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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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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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