(78 days)
Dentistry traditionally uses Resilient Liners to treat denture wearing patients with:
- Ridge atrophy Ridge resorption Bony undercuts Bruxing tendancies Congenital or acquired defects Xerstomia Dentures opposing natural dentition
Kerr Resilient Denture Liner consists of two Polvinylsiloxane resin based paste components which interact and polymerize to produce a gingivally characterized elastomer. It is supplied in two 50 ml double barrel cartridges containing 25 ml. each of both the catalyst and base pastes. These cartridges are designed to be used with the Kerr Extruder Mixing Gun ( Sold seperately - Covered in 510 ( k ) No. K940379 ). The cartridges attach to disposable static mixing tips which mix the catalyst and base pastes by forces exerted by the Kerr Extruder prior to application of the soft liner material.
This document describes a 510(k) summary for the Kerr Resilient Denture Liner. However, it does not contain the acceptance criteria or a detailed study that proves the device meets specific performance criteria in a measurable, quantitative way as typically
expected for demonstrating safety and effectiveness of a medical device against pre-defined metrics. Instead, it broadly states that:
- Safety was demonstrated through biocompatibility tests as recommended by ISO 10993 (Ames Mutagenicity Assay, Cytotoxicity Study, Implantation Test).
- Effectiveness was demonstrated by "a combination of in-house testing and side by side test comparisons to predicate devices currently on the market," concluding that it "performs as well or better than Molloplast-B and Coe Supersoft."
Given the information provided in the input, it is not possible to complete the requested table and answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies. The document focuses on demonstrating substantial equivalence to predicate devices based on general performance and biocompatibility, rather than providing detailed quantitative performance metrics against pre-defined acceptance criteria.
Therefore, many sections of your request cannot be fulfilled from the provided text.
Here's an attempt to fill in what can be inferred or explicitly stated, with clear indications where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred/Broadly Stated) | Reported Device Performance |
|---|---|
| Safety: | Safety: |
| Non-mutagenic | Passed Ames Mutagenicity Assay (no evidence of mutagenicity implied by "demonstrated by subjecting... to various types of biocompatibility tests as recommended in the ISO 10993... These tests include: 1. Ames Mutagenicity Assay"). |
| Non-cytotoxic | Passed Cytotoxicity Study (Agarose Overlay) (no evidence of cytotoxicity implied). |
| Non-sensitizing/Non-irritating | Passed Implantation Test (Tissue Sensitization) (no evidence of sensitization/irritation implied). |
| Effectiveness: | Effectiveness: |
| Performs as well as or better than predicates | Bench testing results "indicates that Kerr Resilient Denture Liner performs as well or better than Molloplast-B and Coe Supersoft, two predicate devices currently on the market." (Specific metrics for "performs as well or better" are not provided). |
| Maintains resiliency over extended time | (Implied by the background discussion of resilient liners needing to maintain resiliency, but "extended time" is not quantified nor is the performance against this criterion specified for the Kerr device). |
| Bond failure resistance | (Implied by the background discussion of existing resilient materials suffering bond failure, but no specific performance data for the Kerr device in this regard is provided). |
| Resistance to fouling by oral environment | (Implied by the background discussion, but no specific performance data for the Kerr device in this regard is provided). |
Additional Requested Information (Where Possible to Infer or State):
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: Not specified. The document only mentions "cured samples of the material" for biocompatibility and "side by side test comparisons" for effectiveness without giving specific numbers of samples or tests.
- Data Provenance:
- Biocompatibility tests were "conducted by an independent laboratory." Country of origin is not specified.
- Effectiveness testing involved "in-house testing" and "side by side test comparisons." The location of "in-house" is not specified (presumably the manufacturer, Kerr).
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. The ground truth for biocompatibility tests is established by a laboratory according to ISO standards, not by an expert consensus process in the medical imaging sense. For effectiveness, the "ground truth" seems to be the comparative performance against predicate devices in bench tests, not clinical observation requiring expert review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As no expert review or human interpretation of results is mentioned for the test set to establish ground truth or adjudicate findings, an adjudication method 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
- No. This is a device for dental materials (resilient denture liner), not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical dental material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For Biocompatibility: The ground truth is the chemical and biological reaction of the material based on standardized laboratory assays (Ames, Cytotoxicity, Implantation) according to ISO 10993 guidance.
- For Effectiveness: The ground truth for effectiveness appears to be established by the performance characteristics of the predicate devices (Molloplast-B and Coe Supersoft) in bench tests, and the ability of the Kerr device to meet or exceed those characteristics. No clinical outcomes data is mentioned.
8. The sample size for the training set
- Not Applicable. This is a conventional medical device (dental material), not an AI/machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set mentioned, this question is not relevant.
§ 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.