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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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CeraClean is an extraoral cleaner of pre-treated ceramic, zirconia and metal restoration surfaces which have been contaminated during intraoral try-in.

CeraClean is used outside the mouth, as an extraoral cleaning gel suitable for non-abrasive cleaning of the bonding surfaces of prosthetic restorations after intraoral try-in. CeraClean is applied through a single-use tip or application to the prosthetic restorations and rinsed off prior to the application of a primer or cement for final placement of the restoration.

The provided text describes a 510(k) summary for the CeraClean device, which is an extraoral cleaner for dental restoration surfaces. The study presented aims to demonstrate substantial equivalence to a predicate device, Resolve 2.0.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a typical clinical study sense with quantitative thresholds for sensitivity, specificity, and so on. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data. The implicit acceptance criterion is that CeraClean's performance must be "substantially equivalent" to that of the predicate device, Resolve 2.0, across various relevant parameters.

Note on Differences: The document acknowledges differences in chemical composition (e.g., CeraClean is water-based gel with xanthum gum and potassium hydroxide vs. acrylate resin-based with silicate and chlorohexidine for Resolve 2.0; CeraClean is non-abrasive while Resolve 2.0 is abrasive). However, it argues these differences do not raise new questions of safety or effectiveness as both are water soluble, used outside the mouth, and rinsed off.

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

The document does not explicitly state the sample size for the test set. For the shear bond strength test based on modified ISO 29022:2013, it implies that the device was tested, but the number of samples or cases is not provided. Similarly, for water solubility, pH, and SEM EDX, specific sample sizes are not mentioned.

The data provenance is not specified. It's likely an in-house or contracted laboratory study, but the country of origin or whether it's retrospective or prospective data is not detailed. Given the nature of a 510(k) submission for a cleaning solution, this would typically involve laboratory testing rather than human subject data.

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

This information is not provided in the document. For a product like CeraClean, "ground truth" might refer to analytical chemistry results or physical property measurements rather than expert interpretations of images or clinical outcomes. The document relies on established ISO standards (ISO 29022:2013 for bond strength, ISO 7405:2008 and ISO 10993-1:2009 for biocompatibility) for its performance claims, implying that adherence to these standards constitutes the "ground truth" of performance evaluation.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method. Given that the tests are laboratory-based (shear bond strength, pH, water solubility, SEM EDX, biocompatibility), results would typically be quantitative and objectively measured, not requiring expert adjudication in the same way clinical imaging studies do.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human interpretation is involved. CeraClean is an extraoral cleaning solution, and its performance is evaluated through material science and biocompatibility tests.

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

The performance tests conducted (Shear Bond Strength, Water Solubility, pH, SEM EDX, Biocompatibility) are standalone laboratory tests of the device's physical and chemical properties. There is no "human-in-the-loop" component to these performance measurements as they assess the intrinsic properties and effectiveness of the cleaning solution itself.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation appears to be based on:

• Established material science standards and measurements: e.g., modified ISO 29022:2013 for shear bond strength, direct measurements for pH and water solubility, SEM EDX for residue removal.
• Biocompatibility standards: ISO 7405:2008 and ISO 10993-1:2009.

This is not expert consensus, pathology, or outcomes data in the clinical sense, but rather objective, repeatable measurements under controlled laboratory conditions referencing international standards.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device or study design. Training sets are used in machine learning or AI algorithm development. CeraClean is a physical cleaning solution, not a software algorithm.

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

As there is no training set, this question is not applicable.

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Resolve 2.0 is recommended for use on dental restorations, external to the mouth, prior to insertion into the mouth. After applying Resolve 2.0 to cleanse the restoration, the surface of the restoration should be washed thoroughly with water, and then air dried before placement in the mouth. For Use only by a Licensed Dentist. Rx Use Only. Non-sterile.

Resolve 2.0 is a thin, non-alcohol based gel containing chlorhexidine gluconate. This thin gel because of its water solubility, abrasive action and low viscosity when applied to dental restorations, acts as a cleaning agent. This gel is provided in easy to use syringes and floc-tipped applicator tips to precisely deliver the gel to the intended areas. For Use only by a Licensed Dentist. Rx Use Only. Non-sterile.

It appears the provided document is a 510(k) premarket notification for a dental device named "Resolve 2.0." This type of document is for demonstrating substantial equivalence to a predicate device, not for establishing novel acceptance criteria or conducting a comprehensive clinical study in the way one might for a new drug or a high-risk AI-powered diagnostic device.

Therefore, the requested information categories related to acceptance criteria, detailed study design, sample sizes for test/training sets, expert adjudication, MRMC studies, or specific ground truths for AI models do not directly apply to this document. This submission focuses on demonstrating similarity to an existing, legally marketed device.

However, I can extract the information relevant to the equivalence demonstration as presented in the document:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present "acceptance criteria" in the traditional sense of a performance study with defined thresholds. Instead, it compares the technological characteristics of Resolve 2.0 to its predicate device, Consepsis. The "acceptance" is based on demonstrating that these characteristics are equivalent.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not applicable/not provided in this type of 510(k) submission. The evaluation is based on physicochemical and biocompatibility testing, not clinical data sets in the AI sense.

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):

This information is not applicable/not provided as there is no "test set" and "ground truth" in the context of an AI device. The evaluation is based on laboratory testing and comparison to the predicate.

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

This information is not applicable/not provided.

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/not provided. This is not an AI-powered device.

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

This information is not applicable/not provided. This is not an algorithm.

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

For the properties evaluated (e.g., pH, water solubility, cleansing activity, biocompatibility), the "ground truth" would be established through laboratory testing and established scientific methods/standards (e.g., pH meter readings, solubility tests, accelerated aging protocols, ISO 10993-5 standard for biocompatibility).

8. The sample size for the training set:

This information is not applicable/not provided. This is not an AI device with a training set.

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

This information is not applicable/not provided.

Summary of the Study:

The document describes a benchtop and biocompatibility study to demonstrate that Resolve 2.0 is substantially equivalent to the predicate device, Consepsis. The study involved:

• Comparison of Technological Characteristics: Resolve 2.0 was compared to Consepsis across several physical and chemical properties including cleansing activity, active ingredient (chlorhexidine gluconate), water solubility, pH, presence of silicate (sand), consistency, pigmentation, and accelerated aging/shelf life.
• Biocompatibility Testing: Resolve 2.0 was evaluated per ISO 10993-5 "Biological Evaluation of Medical Devices" for cytotoxicity. The results were compared to those of Consepsis under the same standard. Both devices exhibited "Moderate" cytotoxicity, showing equivalence.

The conclusion drawn from this "study" (which is more accurately a set of comparative tests) is that Resolve 2.0 is substantially equivalent to Consepsis in design, composition, biocompatibility, performance, aging, limited intended uses, and safety and effectiveness. This equivalence allows the device to be marketed without requiring a full Premarket Approval (PMA) process.

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