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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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