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Oralief™ OTC Toothpaste for Sensitive Teeth is a fluoride-free daily use cleaning toothpaste that provides rapid and continual relief from tooth sensitivity due to cold, heat, acids, sweets or contact, through its action of the occlusion of dentin tubules

Oralief™ OTC Toothpaste for Sensitive Teeth is a daily-use, fluoride-free toothpaste device that incorporates NovaMin® (calcium sodium phosphosilicate) as its active ingredient. The non-aqueous formulation is designed to clean teeth as well as to physically occlude dentin tubules for the reduction of tooth sensitivity. When exposed to an aqueous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for Oralief™ OTC Toothpaste for Sensitive Teeth, structured to address your specific points:

Since this is a submission for a toothpaste (a medical device in this context), the "acceptance criteria" and "performance" are typically measured against established safety standards (like abrasivity limits) and functional claims (like tubule occlusion efficacy), rather than diagnostic accuracy metrics. There isn't a direct "acceptance criteria" table in the form you might expect for a diagnostic AI device, so I will synthesize it from the provided safety and performance data.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set:
  • Biocompatibility: Not specified. "Many different biocompatibility tests have been performed on NovaMin."
  • Dentin Tubule Occlusion (in vitro): Not specified.
  • Abrasivity (RDA): Not specified (implied to be standard for ADA procedure, but the exact number of samples or teeth is not given).
• Data Provenance:
  • Abrasivity (RDA): Evaluated at Indiana University School of Dentistry (USA). This suggests the study was conducted in the USA.
  • Biocompatibility & Tubule Occlusion: Location of testing and specific methodology are not detailed, so provenance is unclear beyond being part of the submission process by NovaMin Technology, Inc. (USA).
• Retrospective or Prospective: Unspecified for all studies. Given the nature of these tests (in vitro, lab testing), they are typically conducted as controlled prospective experiments.

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)

This section is not applicable in the context of this device. The device is a toothpaste (medical device), not an diagnostic AI system that requires expert interpretation for establishing ground truth on a test set of images or clinical cases. The "ground truth" here is based on objective scientific measurements and established laboratory procedures for biocompatibility, abrasivity, and physical occlusion.

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

This section is not applicable for this device submission. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among multiple human readers when establishing ground truth for diagnostic studies, especially in medical imaging. The studies described here are laboratory-based and measure physical properties or biological responses, not subjective interpretations.

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 section is not applicable. An MRMC study is relevant for comparing the diagnostic performance of human readers, typically with and without AI assistance, on a set of clinical cases. This device is a toothpaste, not a diagnostic AI tool, so such a study would not be performed.

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

This section is not applicable. A "standalone" performance study refers to the performance of an algorithm independently of human input or interpretation. As this is a toothpaste, not an algorithm, this concept does not apply. The device's "standalone" performance in this context would be its inherent physical and chemical properties as measured in the lab.

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

The ground truth for the studies performed is based on:

• Biocompatibility: Standardized in vitro and in vivo (though not explicitly detailed) tests designed to detect toxicity or adverse biological reactions. The "ground truth" is the observation of biological response (or lack thereof) against established safety thresholds.
• Dentin Tubule Occlusion: Objective microscopic observation and quantification of occluded tubules in an in vitro dentin block model. The "ground truth" is the measurable physical blockage.
• Abrasivity (RDA): Quantitative measurement of dentin wear using a standardized procedure (ADA recommended) involving radioactive dentin. The "ground truth" is the measured RDA value against a scientifically established safety limit.

8. The sample size for the training set

This section is not applicable. The concept of a "training set" is relevant for machine learning or AI models, where data is used to teach an algorithm. This device is a physical product (toothpaste), and its development does not involve machine learning in this documented context.

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

This section is not applicable, as there is no "training set" for this device.

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PerioSRP™ Tooth Root Conditioner with NovaMin® is a two-phase product intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin. Studies have shown that PerioSRP™ Tooth Root Conditioner with NovaMin® is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.

Not Found

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed predicate devices. It does not contain details about specific performance metrics, clinical study designs, or expert reviews as requested in your prompt.

The document discusses:

• The device name: PerioSRP™ Tooth Root Conditioner with NovaMin®
• Its intended use: rapid relief of hypersensitivity associated with exposed tooth root dentin, and its effectiveness at occluding exposed dentinal tubules.
• The FDA's determination of substantial equivalence and resulting market clearance.

Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, ground truth, or study methodologies.

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DenShield™ is intended for the rapid and continual relief of hypersensitivity associated with exposed tooth dentin. Studies have shown that Dentibitly is effective at occluding exposed dentinal tubules, which has been showmin the literature to be associated with a reduction in hypersensitivity.

Not Found

This is a 510(k) premarket notification for a dental device, DenShield™ Treatment for Sensitive Teeth, which is a cavity varnish. The document primarily focuses on regulatory approval and equivalence to predicate devices, rather than detailed performance studies or AI incorporation.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and AI performance is not available within the provided text.

Here's why and what information can be extracted:

Information NOT available in the provided text:

• A table of acceptance criteria and the reported device performance: The document states "Studies have shown that Dentibitly is effective at occluding exposed dentinal tubules..." but does not provide specific performance metrics or acceptance criteria.
• Sample sized used for the test set and the data provenance: No details on study sample size or origin are provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• 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 device is a cavity varnish, not an AI-powered diagnostic tool. This type of study is irrelevant.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: While "occluding exposed dentinal tubules" is mentioned as a mechanism for effectiveness, the specific ground truth for the "studies" is not described.
• The sample size for the training set: Not applicable for this type of device.
• How the ground truth for the training set was established: Not applicable for this type of device.

Information that can be extracted or inferred:

• Device Name: DenShield™ Treatment for Sensitive Teeth
• Device Type: Cavity Varnish
• Intended Use: Rapid and continual relief of hypersensitivity associated with exposed tooth dentin.
• Mechanism of Action (as stated): Effective at occluding exposed dentinal tubules.
• Regulatory Classification: Class II, Product Code: LBH, Regulation Number: 21 CFR 872.3260 (Cavity Varnish)
• Regulatory Decision: Substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
• Regulatory Body: Food and Drug Administration (FDA)
• Date of Approval: October 18, 2006 (OC) 1 8 2006)

This document is a regulatory approval letter, generally not the place where detailed scientific study results are presented. Those would typically be found in the 510(k) submission itself or in published scientific literature.

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Provides rapid and continual relief from tooth hypersensitivity-dueto cold, heat, acids, sweets, or contact through its action of the occlusion of dentin tubules.

Oralief™ Therapy for Sensitive Teeth incorporates NovaMin® as its active ingredient. The unique brushing regimen and NovaMin® -containing formulation provide rapid and continual relief from tooth sensitivity. NovaMin® (calcium sodium phosphosilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O). When exposed to an aqueous environment, NovaMin® rapidly releases mineral-building ions, allowing it to relieve from sensitivity by physically occluding dentin tubules. Within a short period of time, essentially all of the NovaMin® reacts to form a mineral layer which is chemically and structurally similar to natural tooth mineral.

The provided document describes the FDA 510(k) premarket notification for Oralief™ Therapy for Sensitive Teeth. This product is a dentifrice (toothpaste) containing NovaMin® as its active ingredient, intended to provide relief from tooth hypersensitivity by occluding dentin tubules.

Here's an analysis based on the provided text, addressing your questions:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of a predefined threshold for statistical metrics (e.g., sensitivity, specificity). Instead, the acceptance criterion for the device seems to be demonstrated efficacy in reducing tooth hypersensitivity compared to a placebo, and substantial equivalence to a legally marketed predicate device (Butler GUM® Prophylaxis Paste with NovaMin®).

The reported device performance is based on the clinical study described.

Study Details

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

   • Test set sample size: 20 patients were enrolled (10 in the NovaMin® group, 10 in the placebo group). A total of 48 sensitive teeth were measured in the NovaMin® group and 42 teeth in the placebo group.
   • Data provenance: The study was conducted at the Dental School of the University of Bologna, Italy. It was a prospective, double-blinded, two-arm parallel group study.

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

   • The "ground truth" here is the patient's subjective experience of pain/hypersensitivity, measured using a Visual Analogue Scale (VAS). This is patient-reported, not expert-established in the traditional sense of diagnostic imaging.
   • The study protocol was approved by the Ethics Committee at the Dental School of the University of Bologna, Italy, implying expert oversight of the study design and ethical conduct. However, experts did not "establish ground truth" for individual patient responses.

3. Adjudication method for the test set:

   • Not applicable in the context of this study. The primary endpoint (VAS score) is a patient-reported outcome. There was no independent adjudication of patient responses. Measures included a metered air blast and cold water, which are objective stimuli, but the response (VAS score) is subjective.

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, an MRMC comparative effectiveness study was not done. This device is a toothpaste for sensitive teeth, not an AI-assisted diagnostic tool for human readers.

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

   • Not applicable. This device is a therapeutic product, not an algorithm. Its performance is evaluated through its direct effect on patients.

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

   • The "ground truth" for efficacy was primarily patient-reported outcomes data (Visual Analogue Scale - VAS scores) in response to standardized stimuli (metered air blast and cold water).
   • Additionally, in vitro studies demonstrated tubule occlusion, supporting the mechanism of action.

7. The sample size for the training set:

   • Not applicable. This is a clinical trial for a therapeutic device, not a machine learning model. Therefore, there is no "training set" in that context. The "training" here refers to the development and formulation of the product.

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

   • Not applicable, as there is no training set in the machine learning sense. The development of the product would have involved extensive R&D, chemical analysis, in vitro testing, and potentially pre-clinical animal studies, but not a "ground truth" derived from patient data in a training set.

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Butler NuCare™ Prophylaxis Paste with NovaMin® is intended for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. Secondarily, Butler NuCare™ Prophylaxis Paste with NovaMin® can be used for the immediate relief of tooth sensitivity, post-scaling and root planing.

Butler NuCare™ Prophylaxis Paste with NovaMin® is a product that is intended for cleaning and polishing procedures as a part of a professionally administered dental prophylaxis treatment. Butler NuCare™ Prophylaxis Paste with NovaMin® is also designed to physically occlude dentinal tubules for the immediate relief of tooth sensitivity, post-scaling and root planing. NovaMin® (calcium sodium phosphosilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O). When exposed to an aqueous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.

Here's an analysis of the provided text, focusing on acceptance criteria, study details, and related information, formatted as requested.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the device's performance. Instead, it makes a general statement about efficacy.

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

• Sample Size for Test Set: Not specified. The text only mentions "a bovine table overalian block model" for the tubule occlusion efficacy study.
• Data Provenance: The tubule occlusion study used a bovine (cattle) model, not human data. The location or timeline (retrospective/prospective) of this study is not mentioned. The biocompatibility tests are also not described in terms of sample size or provenance.

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

This information is not provided in the document. The study described (tubule occlusion in a bovine model) does not appear to involve human expert ground truth for interpretation. Biocompatibility tests rely on laboratory standards and results rather than expert consensus on interpretation of device performance against ground truth in a clinical sense.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the in vitro (bovine block model) tubule occlusion study and biocompatibility tests, an adjudication method for human readings would not be applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The study described evaluated the device's performance (in vitro tubule occlusion) against controls, not in the context of human readers with or without AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a prophylactic paste, not an algorithm or AI system. Therefore, the concept of an "algorithm only" or "standalone" performance study in the context of AI is not applicable. The device's performance was evaluated for tubule occlusion and biocompatibility.

7. The Type of Ground Truth Used

• For Tubule Occlusion Efficacy: The ground truth was established by comparing the device's ability to occlude tubules against "controls" in a bovine table overalian block model. This implies a quantitative measurement of tubule occlusion compared to a baseline or non-treated sample, rather than expert consensus, pathology, or outcomes data from human subjects.
• For Biocompatibility: The ground truth is based on standard biocompatibility test methodologies and thresholds, which determine whether there is "evidence of any hazardous effects."

8. The Sample Size for the Training Set

This information is not applicable as the device is a dental prophylaxis paste, not an AI or machine learning model that requires a training set.

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

This information is not applicable for the same reasons as in point 8.

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Oravive™ is a fluoride-free toothpaste product intended for cleaning the tooth surface on a daily basis. Clinical studies have shown that Oravive™ also provides relief from tooth sensitivity due to cold, heat, acids, sweets, or contact by the occlusion of dentin tubules.

Oravive™ is a daily-use, fluoride-free toothpaste device that incorporates NovaMin® as its active ingredient. The non-aqueous formulation is designed to clean your teeth as well as give your whole mouth a fresh feeling we call REVITALIZING! Oravive™ is also designed to physically occlude dentin tubules for the management of sensitive teeth. NovaMin® (calcium sodium phosphossilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O). When exposed to an aquoous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.

Here's a breakdown of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for clinical performance in a quantifiable, pre-defined manner. Instead, it describes findings that support the device's efficacy and safety compared to controls and a predicate device. The performance claims are primarily related to reduction in tooth sensitivity and abrasivity.

2. Sample Size and Data Provenance for the Test Set

• Sample Size:
  • Clinical Efficacy Study: A total of 75 patients were accepted into the study, with 25 in each of the three groups (Oravive™, placebo, and SrCl2 desensitizing toothpaste). 67 patients completed the six-week study.
  • In vitro tubule occlusion: Not specified, but mentioned results indicate statistical significance.
  • Abrasivity: Not specified, but performed according to ADA recommended procedure.
• Data Provenance:
  • Clinical Efficacy Study: Conducted in Wuhan University, Wuhan, China. The study was prospective (randomized, double-blind, placebo-controlled, six-week clinical trial).
  • Abrasivity Test: Conducted at Indiana University School of Dentistry.
  • Biocompatibility and In Vitro Tubule Occlusion: Location not specified.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not explicitly state the number or specific qualifications of experts used to establish "ground truth" for the clinical efficacy test set.

• Clinical Efficacy Study: The primary outcome measure was patient-reported tooth sensitivity using a Visual Analog Scale (VAS) after stimulation. While clinicians performed the stimulation, the "ground truth" here is the patient's subjective experience of pain, not an expert's diagnosis. The study was overseen by the Medical Ethics Committee of the School of Stomatology, Wuhan University.

4. Adjudication Method for the Test Set

• Clinical Efficacy Study: No explicit adjudication method (like 2+1 or 3+1 consensus) is described. The study was randomized, double-blind, and placebo-controlled. This design inherently aims to minimize bias in data collection and interpretation. The VAS scores were directly recorded from patients.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where multiple readers interpret cases with and without AI assistance. This device is a toothpaste where the primary outcome is patient-reported sensitivity.

6. Standalone (Algorithm Only) Performance

• Yes, a form of "standalone" performance was effectively evaluated for certain aspects.
  • In vitro tubule occlusion efficacy: This was an algorithm-only (device-only) test demonstrating its mechanical action.
  • Relative Dentin Abrasivity (RDA): This was a standalone test of the product's physical property.
  • Clinical Efficacy: While patients were involved, the study measured the effect of the device itself (Oravive™) compared to controls, rather than human interpretation aided by AI. This can be considered the "standalone" clinical performance of the product.

7. Type of Ground Truth Used

• Clinical Efficacy: Patient-reported outcomes (subjective pain perception via Visual Analog Scale - VAS) were the primary ground truth for tooth sensitivity.
• In vitro tubule occlusion: The ground truth was based on scientific observation and measurement of tubule occlusion in demin block models.
• Abrasivity: The ground truth was based on standardized laboratory measurement according to the ADA recommended procedure.
• Biocompatibility: Ground truth derived from laboratory test results indicating the absence of hazardous effects.

8. Sample Size for the Training Set

• The document describes a clinical trial for testing the device's efficacy, but it does not mention a separate "training set" as would be typical for machine learning algorithms. The studies described are for the evaluation of the finished product. If there was any optimization or formulation work that involved data, it's not detailed as a "training set" in the context of this submission.

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

• As no "training set" is described in the context of a machine learning algorithm, this question is not applicable based on the provided text. The studies mentioned are primarily for clinical validation and safety assessment of the developed product.

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Butler Nucare® Root Conditioner with NovaMin® is a two-phase product intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin. Studies have shown that Butler Nucare® Root Conditioner with NovaMin® is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.

Butler Nucare® Root Conditioner with NovaMin® is a biologically-compatible device designed to condition exposed tooth roots and to physically occlude dentin tubules for the management of sensitive teeth. Butler Nucare Root Conditioner with NovaMin® is an aqueous suspension of an inorganic particulate, NovaMin® (calcium sodium phosphosilicate), composed of elements that occur naturally in the body's hard tissues (Ca, Na, Si, P, and O). When exposed to an aqueous environment, NovaMin® undergoes a rapid surface reaction, allowing it to physically adhere to exposed root dentin and to physically occlude tubules. Within a short period of time, essentially all of the NovaMin® reacts to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.

The information provided describes a 510(k) premarket notification for a dental device, focusing on its substantial equivalence to a predicate device rather than a new clinical study establishing specific acceptance criteria and performance against those criteria. Therefore, much of the requested information regarding acceptance criteria, study design details, and performance metrics for a novel AI device is not available in the provided text.

Based on the provided information, here's what can be extracted and what is not available:

Acceptance Criteria and Reported Device Performance

The provided text does not present explicit numerical acceptance criteria for device performance as would be expected for a novel AI device. Instead, the focus is on demonstrating "substantial equivalence" to a predicate device and showing efficacy in specific in vitro tests.

Study Details (as far as available for this type of submission)

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

   • Biocompatibility Studies: Not specified, but standard in vivo and/or in vitro models would have been used for cytotoxicity, intracutaneous irritation, maximization, and acute systemic toxicity. Data provenance is not mentioned.
   • Tubule Occlusion Efficacy Study: An "in vitro dentin block model" was used. The number of dentin blocks or samples is not specified. Data provenance is not mentioned. This is an in vitro study, not typically subject to geographical provenance.

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

   • Not applicable to this type of submission. The studies described are laboratory-based (biocompatibility and in vitro efficacy), not involving expert-derived ground truth as in imaging or diagnostic AI.

3. Adjudication method for the test set:

   • Not applicable. The reported studies are experimental measurements (e.g., cell viability for cytotoxicity, physical measurements for tubule occlusion), not requiring human adjudication.

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. This is not an AI device, and no MRMC study was conducted.

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

   • Not applicable. This is not an AI algorithm. The performance studies evaluate the physical and biological effects of the product itself.

6. The type of ground truth used:

   • Biocompatibility: Measured biological endpoints (e.g., cell survival, skin reaction, systemic toxicity) based on established laboratory test methods.
   • Tubule Occlusion Efficacy: Direct measurement of tubule occlusion in an in vitro model (e.g., microscopy). The "ground truth" here is the objective physical state of the tubules after treatment.

7. The sample size for the training set:

   • Not applicable. This is not an AI device requiring a training set.

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

   • Not applicable.

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