(59 days)
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
| Acceptance Criteria Category | Specific Test/Criterion | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-cytotoxic | TRUBYTE® SOFT RELINE MATERIAL: Non-cytotoxic. BONDER: Non-cytotoxic. |
| Non-irritant | TRUBYTE® SOFT RELINE MATERIAL: Non-irritant. | |
| Non-mutagenic | TRUBYTE® SOFT RELINE MATERIAL: Non-mutagenic. | |
| Non-sensitizer | TRUBYTE® SOFT RELINE MATERIAL: Non-sensitizer. |
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.
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510(k) SUMMA DFC - 6 1996
Page 1 of 2
NAME & ADDRESS:
DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 7171845-7511 Fax 17171 854-2343 P. J. Lehn Telefax
CONTACT : P. Jeffery Lehn DATE PREPARED:
September 26, 1996
TRUBYTE® SOFT RELINE SYSTEM TRADE NAME:
CLASSIFICATION NAME: Relining, repairing or rebasing denture base resin
PREDICATE DEVICES: New Per-Fit Improved K901621 Molloplast B Unknown PermaSoft K933468
The TRUBYTE® SOFT RELINE SYSTEM consists of three DEVICE DESCRIPTION: TRUBYTE® Soft Reline Material, TRUBYTE® Soft Reline Bonder, and components: 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.
The TRUBYTE® SOFT RELINE SYSTEM is for use as a long-term INTENDED USE: resilient lining material for removable dentures.
TECHNOLOGICAL CHARACTERISTICS: All of the components of the TRUBYTE® SOFT RELINE SYSTEM have been used in DENTSPLY predicate devices: Triad DuaLine™ Material (K926406), Lucitone® 199 Denture Base (Pre-1976 Device), Precise™ Denture Base (K952351), and Kadon (Pre-1976 Device).
LI
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TRADE NAME: TRUBYTE® SOFT RELINE SYSTEM
TRUBYTE® SOFT RELINE MATERIAL was evaluated and found to be non-cytotoxic, a non-irritant, non-mutagenic and a non-sensitizer. The following tests were performed on the MATERIAL: Cytotoxicity Elution Test, Primary Skin Irritation Study, Salmonella Mutagenicity Test, FHSA Regulation Acute Mucosal, and Kligman Maximization Study. The BONDER, used with the cured MATERIAL and Lucitone® 199 Denture Base, was tested by the Cytotoxicity Elution Test and found to be non-cytotoxic.
We believe that the prior use of the TRUBYTE™ SOFT RELINE SYSTEM's components in predicate devices, the performance data presented, and the results of toxicity and sensitization testing support the safety and effectiveness of TRUBYTE® SOFT RELINE SYSTEM for the intended use.
000014
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.