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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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