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• [1] Cleaning of contaminated glass ceramic, zirconia, resin restorations, metal restorations and fiber post after intraoral try-in.
• [2] Cleaning for contaminated prepared tooth (cavity, root canal and tooth abutment), and implant abutment

This subject device is a dental cleaning agent suitable for non-abrasive cleaning of the bonding surfaces of prosthetic restorations after intraoral try-in.

It is also suitable for cleaning a contaminated prepared cavity, root canal, and tooth/ implant abutment. It is used in helping to achieve optimal adhesive results.

The provided text describes the regulatory clearance of a dental cleaning agent, KATANA Cleaner, by the FDA. It includes a 510(k) summary which details the device, its intended use, comparison to predicate and reference devices, and non-clinical performance testing.

Here's the breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Summary of Device Performance against Criteria:

• Appearance and Coating Property: The device met in-house standards, showing no difference from predicate and reference devices.
• Shear Bond Strength: The device demonstrated "good performance as cleaning agent," with shear bond strengths "equal to or greater than those of the predicate device and the reference device" after contamination with artificial saliva. Specifically, for "Just after prepared" and "for 3 weeks at 70 ℃/ 158 °F," the shear bond strength was equal to the "Positive control (Without contamination and applying the subject device)" and higher than the "Negative control (without the subject device)."
• pH (before rinse/after rinse): The pH value of the subject device was within the range of the predicate and reference devices and became neutral after rinsing, similar to the control.
• Water Solubility: The device was easily removed from the substrate, indicating good water solubility.
• SEM and EDX Surface Comparison: The peak area ratio of the subject device was the same as the control, predicate, and reference devices.
• Staining Test: The device was confirmed to be colored (purple), similar to the predicate and reference devices.

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: Not explicitly stated in the provided text for the individual bench tests. The text only mentions "Shear bond strength tests to the adherent surfaces were performed on this device..." and does not give the number of samples per test.
• Data Provenance: The studies were performance bench tests ("Non-Clinical Performance Testing"). There is no mention of country of origin of the data or whether it was retrospective or prospective, as these are in vitro laboratory tests. The submitter, Kuraray Noritake Dental Inc., is based in Japan.

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

• This information is not applicable as the evaluation involved non-clinical bench testing (material science / engineering properties) rather than human reader interpretation of medical images or clinical data. "Ground truth" in this context refers to the measured physical and chemical properties, not expert consensus.

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

• This information is not applicable as the evaluation involved non-clinical bench testing and not human interpretation or adjudication.

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 information is not applicable. This submission is for a dental cleaning agent, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance was not performed.

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

• This information is not applicable. This is a physical dental cleaning agent, not an algorithm.

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

• The "ground truth" for the non-clinical performance tests was established through measured physical and chemical properties, comparative analysis against controls (positive and negative), and comparison to predicate and reference devices. This includes:
  • Direct measurements of shear bond strength.
  • Visual inspection for appearance and coating property.
  • pH measurements.
  • Observation of water solubility.
  • Analytical techniques like Scanning Electron Microscopy (SEM) and Energy-Dispersive X-ray Spectroscopy (EDX) for surface comparison.
  • Biocompatibility testing according to ISO standards.

8. The sample size for the training set:

• This information is not applicable. This is a physical medical device, not a machine learning model; therefore, there is no "training set."

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

• This information is not applicable as there is no training set for this type of device submission.

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