(151 days)
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.
| Acceptance Criterion (Implicit: Substantial Equivalence to Predicate) | Reported Device Performance (CeraClean) |
|---|---|
| Indications for Use: | |
| - Extraoral cleaner for dental restorations. | - Extraoral cleaner of pre-treated ceramic, zirconia, and metal restoration surfaces which have been contaminated during intraoral try-in. (Stated as substantially equivalent) |
| Chemical Composition: | |
| - Water Solubility | - Water Soluble (Explicitly stated as substantially equivalent to predicate) |
| - pH after rinsing (Neutral) | - pH = 7 (Predicate: pH = 7; Stated as substantially equivalent to predicate) |
| Physical/Mechanical Properties: | |
| - Shear Bond Strength (removes saliva contamination) | - Removes saliva contamination (Explicitly stated as substantially equivalent to predicate based on modified ISO 29022:2013) |
| - Water Solubility | - Water Soluble (Explicitly stated as substantially equivalent to predicate) |
| - Method of application (Syringe tip w/brush) | - Syringe tip or brush (Similar, within equivalence) |
| - Method of removal (Water spray & air dried) | - Water spray & air dried (Identical) |
| - Removal from substrate (SEM EDX) | - Demonstrates device is removed from substrate. |
| Biocompatibility: | |
| - Meets biocompatibility requirements. | - Met the requirements of the test (ISO 7405:2008 and ISO 10993-1:2009 cytotoxicity testing) |
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.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.