Search Results

RnD TE and RnD SE is an aqueous primer used to rewet and desensitize a tooth prior to bonding. Bonding to tooth structure presents many challenges including the determination of the proper conditions for starting the bonding protocol. The tooth can be left too wet or too dry which could lead to debonding or post-operative sensitivity. RnD TE and R&D SE have been designed to aid in reaching the appropriate moisture level to provide an initial surface that allows an adhesive to reach its full potential.

The subject device formulations also work to ensure the long term bond integrity by limiting the development of matrix metalloproteinases (MMP's) that have been cited as a contributor to bond degradation over time.

RnD TE and RnD SE will be sold as a kit contain a 3ml bottle of RnD along with a single cavity well and Mircobrush® applicators. RnD has been designed as a single use material and is non-sterile. The material is a single component material that is applied directly to the tooth with no other components added prior to use.

AI/ML Overview

This document describes a 510(k) submission for new dental materials, RnD TE and RnD SE, which are resin tooth bonding agents. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices.

Although the document is a 510(k) summary and not a detailed study report, we can extract information regarding acceptance criteria and performance data for these dental materials.

Here's an attempt to answer your questions based on the provided text, recognizing that this is a summary and likely doesn't contain all the granular detail of a full study report:

Table of acceptance criteria and the reported device performance

The document does not explicitly state pre-defined "acceptance criteria" as pass/fail thresholds for specific performance metrics. Instead, it compares the performance of the subject devices (RnD TE and RnD SE) against predicate devices to demonstrate "substantial equivalence." The implication is that if the subject devices perform comparably to or better than the predicate devices, they meet the criteria for substantial equivalence.

Acceptance Criteria (Implied: Comparable to Predicate)	Reported Device Performance (Mean (sd) [n])	Predicate Device Performance (Mean (sd) [n])
Indications for Use:
Desensitizing	Yes	Yes
Rewetting	Yes	Yes
Preventing/Improve Bond Degradation/Strength	Yes	Yes (Aqua Prep F does not explicitly mention bond degradation)
Bond Strengths to Dentin (MPa)	RnD TE: 36.2 (5.7) [5]	HEMA GLU: 31.7 (2.0) [5]
	RnD SE: 33.4 (4.7) [5]	Aqua Prep F: 29.1 (3.1) [5]
		Hemaseal & Cide: 36.9 (3.1) [5]
Bond Strengths to Enamel (MPa)	RnD TE: 32.1 (2.9) [5]	HEMA GLU: 32.3 (2.8) [5]
	RnD SE: 27.8 (3.9) [5]	Aqua Prep F: 27.2 (3.5) [5]
		Hemaseal & Cide: 37.1 (3.0) [5]
Film Thickness (microns)	4	HEMA GLU: 5
		Aqua Prep F: 4
		Hemaseal & Cide: 5
pH	Neutral	Neutral
Components	Aqueous primer with Glutaraldehyde, NaF, HEMA	Various combinations of these components and Chlorhexidine Gluconate

Sample size used for the test set and the data provenance
- Sample Size (Test Set): For bond strength tests to dentin and enamel, the sample size was n=5 for each subject device (RnD TE and RnD SE) and each predicate device.
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. It is a non-clinical in vitro test, so "retrospective" or "prospective" as typically applied to human studies is not directly applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This non-clinical study involves material property testing (bond strength, film thickness, pH). Ground truth is established by the measurement methodology (ISO 29022:2013 - Dentistry - notched edge shear bond strength test), not by expert consensus on interpretations of images or clinical outcomes. Therefore, the concept of "experts establishing ground truth" in the way it's used for AI or diagnostic studies does not apply here. The measurements are objective physical properties.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

There was no adjudication method as this was a non-clinical, in vitro measurement of physical properties.
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 MRMC study was performed. This is a non-clinical laboratory test of dental materials, not a diagnostic device involving human readers or AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a material science study, not an AI or algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the performance metrics (bond strength, film thickness, pH) was established through standardized, objective in vitro laboratory measurements based on the ISO 29022:2013 standard.
The sample size for the training set

Not applicable. There is no machine learning or AI component to this device or its evaluation that would require a "training set."
How the ground truth for the training set was established

Not applicable, as there is no training set.

Ask a Question

Ask a specific question about this device

Page 1 of 1