(83 days)
Etching the enamel and dentine for adhesive restorations.
K-ETCHANT GEL is an etching agent consists of 40 % phosphoric acid aqueous solution and colloidal silica. It is classified into resin tooth honding agent, 21 CFR Section 872.3200, because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration.
This document is a 510(k) summary for K-ETCHANT GEL, an etching agent. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria. Therefore, most of the requested information cannot be found in the provided text.
Here is what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The 510(k) summary aims to demonstrate substantial equivalence, not to report specific performance metrics against pre-defined acceptance criteria from a study.
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 provided. The document mentions K-ETCHANT GEL has been a component of CLEARFIL PHOTO BOND and is now being marketed independently. It asserts that the applicant device is "essentially the same" as the K-ETCHANT GEL in CLEARFIL PHOTO BOND, implying prior established safety and effectiveness. No new test set data is presented for the independent device.
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 provided. As no specific test set study is detailed, there's no mention of experts or ground truth establishment in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is 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. The device is an etching agent, not an AI-powered diagnostic tool, so an MRMC study or AI assistance is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The device is a chemical etching agent, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided.
8. The sample size for the training set
This information is not applicable/not provided. The device is a chemical product, not a system that uses a training set for machine learning.
9. How the ground truth for the training set was established
This information is not applicable/not provided.
Summary based on the provided text:
The document is a 510(k) summary for K-ETCHANT GEL, an etching agent composed of 40% phosphoric acid aqueous solution and colloidal silica.
Overall Study Information:
The "study" presented is not a new clinical performance study but rather a demonstration of substantial equivalence to existing legally marketed predicate devices. The primary assertion is that K-ETCHANT GEL, when marketed independently, is essentially the same as its previous formulation within the CLEARFIL PHOTO BOND system and shares the same intended use.
Predicate Devices:
- CLEARFIL PHOTO BOND (510(k) Numbers: K943165, K012432 (modification))
- PULPDENT ETCH-RITE ROYALE (510(k) Number: K031915)
Claim of Substantial Equivalence:
The applicant states that the safety and effectiveness of the independent K-ETCHANT GEL are substantially equivalent to the K-ETCHANT GEL component in CLEARFIL PHOTO BOND and to other single-item etching agents like PULPDENT ETCH-RITE ROYALE. This means the existing evidence for the predicate devices and the prior use of K-ETCHANT GEL within CLEARFIL PHOTO BOND are being leveraged to support its independent marketing. No new clinical or performance data against specific acceptance criteria for the standalone device are detailed in this summary.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.