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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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Clearfil tri-S bond Single dose is indicated for the following applications:

1. Direct restorations using light cured composite resin
2. Cavity sealing as a pretreatment for indirect restorations
3. Treatment of exposed root surfaces
4. Core build-ups using light- or dual-cured composite resin

This device is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials. The ingredients and composition of this device are the same as that of Clearfil tri-S bond (K042913) and it only differs in that it is filled in single dose tips (disposable tips).

The provided document is a 510(k) premarket notification for a dental adhesive system, "Clearfil tri-S bond Single dose." It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with acceptance criteria and device performance in the way typically seen for AI/ML-based medical devices or diagnostic tools.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable as this document describes a traditional medical device (a resin tooth bonding agent) where performance is evaluated through material properties and mechanical tests rather than diagnostic accuracy or human-AI interaction.

Here's a breakdown of the available information:

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: Not specified quantitatively in this summary. The tests were performed "between bovine tooth and a composite resin" and "between bovine dentin and core build up composite resin."
• Data Provenance: Not specified, but given the manufacturer is in Japan, it's likely the testing was conducted in Japan. The study is akin to in vitro or ex vivo testing, not a clinical study on human subjects.

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)

• Not Applicable. This is a material testing study, not a diagnostic study requiring expert ground truth for interpretation. Performance is assessed through physical and mechanical properties.

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

• Not Applicable. Adjudication methods are relevant for clinical or diagnostic studies involving human interpretation. This summary describes material property testing.

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 is not an AI/ML device, nor is it a diagnostic tool that involves human readers or AI assistance.

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

• Not Applicable. This is not an algorithm or AI device.

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

• Direct measurement of material properties: "Bond strengths" and "marginal sealing" are direct measurements or observations of the material's physical performance, not a "ground truth" established by human experts in a diagnostic context. The "truth" is based on the quantifiable physical properties of the materials and their interaction.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

Summary of Study:

The study described is a comparison of the "Clearfil tri-S bond Single dose" device to its predicate device, "Clearfil tri-S bond (K042913)," focusing on material properties and performance. The primary findings are:

• Safety: The device is considered safe because its ingredients and composition are identical to the predicate device, with the only difference being the single-dose packaging.
• Effectiveness: The device demonstrates substantial equivalence to the predicate in effectiveness, as evidenced by comparable "bond strengths" (between bovine tooth/composite and bovine dentin/core build-up) and "marginal sealing."

The 510(k) summary asserts substantial equivalence based on these comparisons, indicating that the new device performs at least as well as the legally marketed predicate device for its intended uses. No quantitative results for bond strength or sealing are provided in this summary, only the statement of substantial equivalence.

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