Search Results

The TRUBYTE® SOFT RELINE SYSTEM is for use as a long-term resilient lining material for removable dentures.

The TRUBYTE® SOFT RELINE SYSTEM consists of three components: TRUBYTE® Soft Reline Material, TRUBYTE® Soft Reline Bonder, and TRUBYTE® Adhesive Remover.

TRUBYTE® Soft Reline Material is a silicone putty that is heat polymerizable. It is a one-component material based on an elastomer and benzoyl peroxide.

TRUBYTE® Soft Reline Bonder is a heat polymerizable methacrylate monomer and methacrylate polymer blend liquid.

TRUBYTE® Adhesive Remover is D-Limonene, a liquid food-grade solvent, intended for use in removing impression material tray adhesives.

TRUBYTE™ Soft Reline Material is bonded to the denture with the TRUBYT® Soft Reline Bonder, packed and compressed, and then heat cured. TRUBYTE Adhesive Remover is used to clean an existing denture prior to relining. The Adhesive is completely eliminated prior to using Soft Reline Material and Bonder.

This document describes the TRUBYTE® SOFT RELINE SYSTEM, a dental device. The information provided is primarily focused on safety testing for biocompatibility and does not detail performance acceptance criteria in the typical sense for an AI/CAD-driven medical device. Therefore, many of the requested fields are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document confirms these safety aspects but does not provide quantitative metrics or specific thresholds for "acceptance" beyond simply stating "non-cytotoxic," etc. This is characteristic of biocompatibility testing rather than performance metrics for an AI algorithm.

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

Not applicable. The document describes biocompatibility tests performed on the material itself, not on a dataset of patient information for an AI algorithm.

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

Not applicable. Ground truth, in the context of AI, refers to annotated data for training and evaluating models. This document details material testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are used in AI studies to resolve discrepancies in ground truth labels, which is not relevant here.

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

Not applicable. This is not an AI-driven device, so an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the biocompatibility tests is the scientific methodology and established safety standards (e.g., ISO standards for cytotoxicity, irritation, etc.) for evaluating material safety. The results are based on direct experimental observation (e.g., cell culture reactions for cytotoxicity, animal responses for irritation).

8. The Sample Size for the Training Set

Not applicable. This device does not involve a training set for an AI algorithm. The components have "prior use in predicate devices," which implies historical clinical experience and material performance data, but this is not a "training set" in the AI sense.

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

Not applicable. There is no AI training set involved. The "ground truth" for the predicate devices' historical use would have been established through clinical observation, material science testing, and regulatory approval processes over time.

Ask a specific question about this device