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NUPRO® Sensodyne® Prophylaxis Paste with NovaMin® is intended for cleaning and polishing procedures, including prior to and after scaling and root planing as part of a professionally administered dental prophylaxis treatment. Secondarily, NUPRO® Sensodyne® Prophylaxis Paste with NovaMin® can be used for the immediate relief of tooth sensitivity and for lasting sensitivity relief for up to 4 weeks (28 days) after just one application.

Device Description

NUPRO® Sensodyne® is a premium prophylaxis paste containing NovaMin®, a calcium sodium phosphosilicate. The dye-free formulations are available in fluoride and non-fluoride formulations, with two different grits to gently remove dental plaque and stains. The Polish Grit is ideal for prophy procedures requiring minimal tooth abrasion. The Stain Removal Grit is suitable for most cleaning procedures where a high level of polish is desired for stain removal.

AI/ML Overview

The provided text describes the NUPRO® Sensodyne® Prophylaxis Paste with NovaMin® and its substantial equivalence to a predicate device. However, it does not explicitly state acceptance criteria in a quantitative manner or present a table of acceptance criteria versus reported device performance against those specific criteria.

Instead, the submission focuses on demonstrating the device's safety and efficacy, particularly regarding its ability to reduce tooth hypersensitivity, to support an expanded indication for use.

Here's an analysis based on the provided text, addressing the requested information to the extent possible:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative acceptance criteria for cleaning, polishing, or sensitivity reduction. The study aims to demonstrate efficacy and safety, rather than meeting predefined numerical thresholds for device performance.

Acceptance Criteria (Inferred from study goals)	Reported Device Performance (as stated in the study findings)
Primary Goal: Efficacy in reducing tooth hypersensitivity immediately after application following dental scaling and root planing.	"NUPRO® Sensodyne® Prophy Paste with NovaMin® showed statistically significant reductions in hypersensitivity immediately after dental scaling and root planing."
Secondary Goal: Efficacy in reducing tooth hypersensitivity for lasting relief (up to 4 weeks).	"NUPRO® Sensodyne® Prophy Paste with NovaMin® showed statistically significant reductions in hypersensitivity... for 4 weeks (28 days) after just one application."
Safety: No relevant pathological conditions or adverse events associated with test product usage.	"During the entire trial period, there were no cases of relevant pathological conditions observed by the examiner associated with test product usage. No serious or non-serious adverse events occurred during the course of the study."
Cleaning and Polishing Ability: (Non-clinical, inferred)	"Non-clinical performance data includes testing to determine the cleaning ability of the NUPRO® Sensodyne® Prophylaxis Paste with NovaMin® to remove stain and stability testing." (Specific performance metrics not detailed)
Biocompatibility: (Non-clinical, inferred)	"Biocompatibility has been substantiated by human clinical studies." (Specific data not detailed)

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

Sample Size: 151 participants
Data Provenance:
- Country of Origin: Not explicitly stated, but the study was described as a "single site" study. Given the submission is to the US FDA, it's highly probable the study was conducted in the US, but this is not explicitly confirmed.
- Retrospective or Prospective: Prospective ("A single site, double-blind, randomized, three arm parallel group study to determine the efficacy...")

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

The text refers to "the examiner" for observing pathological conditions, but does not specify the number or qualifications of experts involved in establishing a formal "ground truth" for tooth hypersensitivity or other clinical outcomes beyond the study design itself. The judgment of hypersensitivity was based on qualifying responses to stimuli (tactile and air blast) from participants, which are direct patient responses, not expert consensus on an independent truth.

4. Adjudication Method for the Test Set

Not applicable. The study was a "double-blind, randomized, three arm parallel group study." The assessment of hypersensitivity was based on direct responses from participants to stimuli, and observations for adverse events by an "examiner." There is no mention of an adjudication panel or method for conflicting interpretations of objective data.

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 medical product (prophylaxis paste), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

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

Not applicable. This device is a medical product (prophylaxis paste) primarily intended for manual application by a dental professional, not an algorithm.

7. The Type of Ground Truth Used

For sensitivity reduction, the "ground truth" was based on patient-reported responses to standardized stimuli (tactile and air blast) at baseline and follow-up, which were qualified by specific criteria. For safety, it was based on direct clinical observation by an examiner for pathological conditions and adverse events.

8. The Sample Size for the Training Set

Not applicable. This device is a prophylaxis paste, not a machine learning model. Therefore, there is no "training set" in the context of an algorithm.

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

Not applicable, as there is no training set for an algorithm.

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