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· Professional cleaning of teeth: Removal of subgingival and supragingival plaque-biofilm and stains

· Professional cleaning of teeth including patients with dentin hypersensitivity

· Treatment of dentin hypersensitivity by blockage of the dentin tubules

· Can also be used in the presence of fixed orthodontic devices (brackets), restorative and prosthetic materials, and implants

· For maintenance in periodontitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth

· For maintenance in perimplantitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth

Clean & More is classified as airbrush (21 C.F.R. § 872.6080) because it is a powder to be used with air polishing devices in the professional tooth cleaning.

Clean & More is a prophylactic powder for gentle and professional sub- and supragingival cleaning of teeth, including the removal of plaque-biofilm and stains, using commercially available air polishing devices.

Clean & More is a glycine based air polishing powder containing functionalized tri-calcium phosphate, a substance which blocks open dentin tubules on the tooth surface, thereby contributing to a reduction in dentin hypersensitivity.

Here's an analysis of the acceptance criteria and study information for the "Clean & More" device, based on the provided document:

The document (K151748) describes a 510(k) premarket notification for "Clean & More," a prophylactic powder for professional tooth cleaning. The primary purpose of the submission is to demonstrate substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria. Therefore, the "acceptance criteria" for the device are largely implied by its performance being equivalent to the predicate devices and demonstrating safety and efficacy for its stated Indications for Use.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary demonstrating substantial equivalence, formal, quantitative acceptance criteria are not explicitly stated in the same way they would be for a direct performance claim against a specific standard. Instead, the "acceptance criteria" are implied by the requirement for the new device to perform equivalently to its predicate devices in various aspects.

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

• Clinical Study Test Set:
  • Sample Size: A total of 40 subjects were enrolled.
  • Data Provenance: The document does not explicitly state the country of origin for the clinical study. It was conducted "according to ISO 14155:2011 - Good Clinical Practice (GCP)," which suggests international standards were followed. It is a prospective study, as subjects were enrolled, treated, and followed up at specific intervals (10 days, 4 weeks, 3 and 6 months).
• Non-Clinical (In vitro) Test Set:
  • Sample Materials: Bovine enamel, composite materials, bovine dentin, zirconia surfaces, and titanium surfaces.
  • Data Provenance: Not specified, but generally in vitro studies are conducted in a controlled lab environment. This data is prospective in the sense that the experiments were designed and executed to test the device.

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

• Clinical Study:
  • Dentin Hypersensitivity: Ground truth for hypersensitivity was "predetermined hypersensitivity on at least two teeth determined by air blast and tactile scoring." The document does not specify the number or qualifications of the experts (e.g., dentists, hygienists) who performed these initial assessments or subsequent evaluations.
• Non-Clinical (In vitro) Studies:
  • The "ground truth" for these studies is the experimental measurement and comparison to the predicate device's performance. Experts would include the researchers conducting the tests and analyzing the data, but no specific number or qualifications are provided.

4. Adjudication Method for the Test Set

• Clinical Study: Not explicitly stated. The determination of "predetermined hypersensitivity" and subsequent assessment of "incidence and degree of dentinal hypersensitivity" would imply a clinical evaluation, but no multi-reader adjudication method (like 2+1 or 3+1) is mentioned. "Air blast and tactile scoring" are common methods, and typically, the assessing clinician's findings serve as the "ground truth" for that individual.
• Non-Clinical (In vitro) Studies: Not applicable in the same way as clinical adjudication. Data analysis of measurements and observations (e.g., Keyence microscope observation, statistical evaluation) would be the method to determine "truth."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not explicitly done or mentioned.
  • The clinical study focused on the effectiveness of Clean & More in reducing dentin hypersensitivity in a cohort of patients. It describes the device's performance, not a comparison of human readers with and without AI assistance.
  • The non-clinical studies were direct comparisons of material properties and performance between the new device and its predicate, not involving human readers' diagnostic accuracy.

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

• Yes, in spirit, the clinical and non-clinical studies can be considered standalone performance for the device itself.
  • The in vitro tests directly assessed the physical and chemical performance of the Clean & More powder. This is an "algorithm only" type of test in the sense that it's the device's inherent performance being measured.
  • The clinical study evaluated the direct effect of the Clean & More treatment on patients' dentin hypersensitivity relief. This is the "standalone" performance of the therapeutic intervention itself; it's not assessing a diagnostic algorithm or a human reader's interpretation.

7. The Type of Ground Truth Used

• Clinical Study: The ground truth for dentin hypersensitivity was established by expert clinical assessment (air blast and tactile scoring) of pre-existing hypersensitivity and subsequent changes after treatment. This effectively represents a clinical outcome and patient-reported state (pain level).
• Non-Clinical (In vitro) Studies: The ground truth was based on objective laboratory measurements of physical properties (e.g., surface roughness, abrasion levels, plaque removal efficiency) using scientifically accepted methods and instrumentation.

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" because this product is a physical dental device (prophylactic powder), not a software algorithm that requires machine learning training data. The studies conducted are for performance validation, not for training an AI model.

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

• As there is no mention of a "training set" in the context of an AI/ML algorithm for this device, this question is not applicable. The device's formulation and design would be based on prior scientific research and development, not on a machine learning training process.

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