(288 days)
The TOKUYAMA TISSUECARE denture relining, repairing, or rebasing resin material kit is a tissue conditioner and temporary liner for removable dentures. It is a prescription device intended for short-term use for conditioning of soft tissue distorted or damaged by the wearing of ill-fitting dentures, and for use as a temporary lining to make existing dentures more comfortable immediately after tooth extraction or oral surgery.
The main components of the TOKUYAMA TISSUECARE kit are:
- (1) powder (containing polyalkyl methacrylate and amorphous silica filler):
- (2) liquid (containing polvalkyl acrylate plasticizer and ethanol); and
- (3) adhesive (containing polyalkyl methacrylate and ethyl acetate).
The liner is formed by combining the powder and the liquid. The adhesive is used to bond the acrylic surface (it cannot be used to bond nylon, metal, or silicone surfaces). The TOKUYAMA TISSUECARE device utilizes a plasticizer that allows for continuous malleability and almost no surface roughness of the lining material when used in the short term.
This submission, K081554, is for a denture relining, repairing, or rebasing resin material kit (TOKUYAMA TISSUECARE). As a 510(k) premarket notification, it focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with acceptance criteria and performance metrics for a novel AI or diagnostic device.
Therefore, much of the requested information regarding acceptance criteria, study methodologies for AI/diagnostic performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to this type of medical device submission.
Here's a breakdown of what can be extracted and what is not applicable:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense. This submission is for a material, not a diagnostic or AI device with performance metrics like sensitivity, specificity, etc., that would be compared to acceptance criteria.
- What is mentioned: "The efficacy of the device has been shown to be substantially equivalent pursuant to ISO10139-1:1991, and all ingredients used in the TOKUYAMA TISSUECARE denture relining, repairing, or rebasing resin material kit are biocompatible." This indicates that the "acceptance criteria" were related to established standards for dental materials (ISO10139-1:1991 for efficacy and general biocompatibility requirements). The "reported device performance" is that it met these standards and was found substantially equivalent.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set in the context of diagnostic or AI performance is described. The "test" for this device involved demonstrating conformance to the ISO standard and biocompatibility.
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)
- Not Applicable. Ground truth in the context of diagnostic/AI performance is not relevant for this material submission. Expertise in verifying compliance with ISO standards and biocompatibility would have been internal or through a notified body.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No such adjudication method is described or required for this type of submission.
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 a material, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable in the diagnostic sense. The "ground truth" for this device refers to its compliance with material standards (ISO10139-1:1991) and biocompatibility requirements.
8. The sample size for the training set
- Not Applicable. No training set is involved as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. No training set is involved.
Summary based on the provided text:
This 510(k) summary for the TOKUYAMA TISSUECARE denture relining, repairing, or rebasing resin material kit demonstrates substantial equivalence to predicate devices based on:
- Technological Characteristics: Main components are powder (polyalkyl methacrylate, amorphous silica), liquid (polyalkyl acrylate plasticizer, ethanol), and adhesive (polyalkyl methacrylate, ethyl acetate).
- Performance: "The efficacy of the device has been shown to be substantially equivalent pursuant to ISO10139-1:1991." It also notes that "all ingredients used... are biocompatible."
- Predicate Device: Austenal's "Myerson's Permasoft Soft Reline Material" (K#933468).
The submission argues that "although the TOKUYAMA TISSUECARE denture relining, repairing, or rebasing resin material kit may have slightly different performance characteristics than the predicate devices, these differences do not raise new questions of safety or effectiveness." This implies that the performance characteristics, as measured by ISO10139-1:1991 and biocompatibility, were within an acceptable range to be considered substantially equivalent to the predicate.
§ 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.