Search Results

VET-PREP is used to re-wet dried dentin following acid etching and drying of the prepared cavity.

WET-PREP is an aqueous solution of hydroxyethyl methacrylate. Hence, it is an aqueous re-wetting agent (dentin conditioner) that is applied to acid etching tooth structure, by the dentist following prior to application of a hydrophilic dentin adhesive such as ALL-BOND 2. The purpose of WET-PREP is to keep the dental cavity preparation adequately moist before the dentist restores the lost tooth structure.

The provided text describes the WET-PREP™ device, its intended use, and scientific rationale, but it does not contain the specific information required to complete all sections of your request regarding acceptance criteria and the detailed study proving device performance in the format you've outlined.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices and generally doesn't include the granular details of a full clinical or performance study report.

However, I can extract the information that is present and indicate where the requested information is missing.

Here's an attempt to answer your questions based only on the provided text, with clear indications of missing 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 for the test set: Not specified in the provided text.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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 question is not applicable to the type of device and study described. The performance evaluation involved measuring shear bond strength, which is an objective measurement, not a subjective interpretation requiring expert consensus on "ground truth" in the way a diagnostic imaging study would.

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

• Not applicable. As noted above, the evaluation involved objective shear bond strength measurements.

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

• No. This is not an MRMC study. The device is a dental re-wetting agent, not an AI system or diagnostic tool for human readers.

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

• Not applicable. The device is a chemical solution, not an algorithm. The performance was measured as a standalone effect of the chemical solution on material properties (shear bond strength).

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

• The "ground truth" in this context is the objectively measured shear bond strength of the dental materials to the tooth structure. This is a direct physical measurement. The comparisons are against untreated teeth and teeth treated with a predicate device.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI context where "training sets" are used. The study involves laboratory testing of a chemical product.

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

• Not applicable, as there is no "training set" in the context of this device's evaluation. The ground truth (shear bond strength) for the performance evaluation was established by experimental measurement in a laboratory setting.

Ask a specific question about this device