(60 days)
Provisional or temporary restorative materials are used in dentistry for treatment procedures not intended to be permanent or final. The purpose of the temporary material is to protect a prepared tooth surface during the interim period until the permanent restoration is available. An example of this interim period is the time that passes while porcelain or metal prosthetic devices are being fabricated in a dental laboratory. Another purpose of a temporary restoration is to provide an esthetically pleasing appearance for the patient during this interim period.
Kerr's TempFil F is designed to fulfill all of the requirements of a successful temporary restorative material. TempFil F is supplied in two formulations identified as Inlay and Onlay. The Inlay formula is slightly less filled and this lower viscosity paste will flow easily into the complex preparation configurations of the typical inlay type restoration. Conversely, the onlay formula, with its' higher filler loading, results in a stiffer paste more suited to the sculpting and packing associated with a typical onlay type restoration. These two formulations have also been adjusted to accomodate the different service conditions experienced by the two distinct types of restoration in the oral environment. The onlay paste contains an additional crosslinking monomer not found in the inlay material. This additional crosslinking results in a harder surfaced restoration which is better able to withstand forces exerted by opposing dentition. These forces are more prevalent in an onlay type restoration. The visible light activated curing characteristic of this no mix system is quicker and easier for the dentist to accomplish than the traditional chemically cured mixed catalyst and base systems. Both formulations contain a monomeric component that allows the cured material to maintain the degree of elasticity required for easy removal when the final restoration is available. This elasticity helps to prevent damage to prepared margins during removal. Both formulations contain a fluoride release agent to impart the benefits of fluoride even during temporary use. The kit contains a syringe of Relief, a water soluble gel that is designed to prevent adhesion to glass ionomer and composite resin based liners placed under the TempFil F restorative.
This document describes the safety and efficacy of a temporary dental restorative material called Kerr TempFil F. The information provided is for regulatory submission (510(k)) and focuses on comparisons to predicate devices and biocompatibility testing. It does not present acceptance criteria or a study design in the typical clinical trial sense with specified performance metrics, sample sizes, and ground truth establishment methods for a device that outputs a diagnostic or predictive result.
Therefore, I cannot populate the table and answer all the detailed questions as framed, because the provided text pertains to a material's safety and performance against existing similar materials, not an AI/diagnostic device's performance against specific acceptance criteria.
However, I can extract the relevant information and restructure it to highlight what is available.
Analysis of Kerr TempFil F Regulatory Submission (KA63786)
The provided text describes a temporary dental restorative material, Kerr TempFil F, and its safety and efficacy testing for a 510(k) submission. The "acceptance criteria" and "study" described here are related to material properties and biocompatibility, as opposed to performance metrics for a diagnostic or AI-driven device.
Key Findings from the Text:
- Device Type: Temporary dental restorative material.
- Purpose: To protect prepared tooth surfaces during the interim period until permanent restoration is available, and to provide an aesthetically pleasing appearance during this time.
- Efficacy Demonstration: A combination of in-house testing and side-by-side test comparisons to predicate devices.
- Safety Demonstration: Biocompatibility tests conducted by an independent laboratory as per ISO 10993 guidance.
1. Table of "Acceptance Criteria" and Reported "Device Performance" (Interpreted for a Dental Material)
Given the nature of the device (a restorative material), "acceptance criteria" are implied by the requirements for a successful temporary restorative material and by performing "as well or better than" predicate devices. "Performance" refers to the material's properties and how it fared in comparison.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| I. Functional Requirements for a Successful Temporary Restorative Material | |
| Ease of placement (flow into complex configurations) | TempFil F is supplied in two formulations: Inlay (lower viscosity, flows easily into inlay conformations) and Onlay (higher filler, stiffer paste for sculpting and packing onlays). |
| Ability to withstand forces (especially for onlays) | Onlay formula contains an additional crosslinking monomer resulting in a harder surfaced restoration, "better able to withstand forces exerted by opposing dentition" prevalent in onlay restorations. |
| Convenience (quick and easy curing) | Visible light activated curing (no mix system) is described as "quicker and easier for the dentist to accomplish than the traditional chemically cured mixed catalyst and base systems." |
| Ease of removal (without damaging prepared margins) | Both formulations contain a monomer allowing cured material to maintain elasticity "required for easy removal" and helps "prevent damage to prepared margins." |
| Fluoride release for patient benefit | Both formulations "contain a fluoride release agent to impart the benefits of fluoride even during temporary use." |
| Prevention of adhesion to liners | The kit includes "Relief," a water-soluble gel designed to prevent adhesion to glass ionomer and composite resin-based liners. |
| II. Biocompatibility (Safety) | |
| Non-mutagenic | Passed Ames Mutagenicity Assay. |
| Non-cytotoxic | Passed Cytotoxicity Study (Agarose Overlay). |
| Non-sensitizing (tissue) | Passed Kligman Maximization Study (Tissue Sensitization). |
| III. Comparative Effectiveness (Efficacy) | |
| Performance at least equivalent to predicate devices | "Results of this bench testing indicates that Kerr TempFil F Temporary Restorative Material performs as well or better than Fermit (Vivadent), E-Z Temp (Cosmedent), Clip (Voco), three predicate devices currently on the market." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified in the provided text. The "test set" here would refer to the samples of the material used for the biocompatibility tests and the in-house/side-by-side comparisons. Details on the number of material samples, teeth, or experimental units are not given.
- Data Provenance:
- Bench Testing: "In-house testing" (presumably Kerr's own laboratories) and "side by side test comparisons" to predicate devices.
- Biocompatibility Testing: Conducted by "an independent laboratory which specializes in safety and toxicity evaluation."
- Retrospective/Prospective: Primarily prospective testing was conducted for both safety and efficacy, as new samples of TempFil F were subjected to testing.
3. Number of Experts and Qualifications for Ground Truth
- Experts: Not applicable in the context of this material submission. Ground truth, in a diagnostic sense (e.g., diagnosis by radiologists), is not established for this type of device. The efficacy is based on material properties and comparison to predicate devices, and safety on standard biological assays.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no human interpretative "test set" requiring adjudication in the context of a dental material's performance testing described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This type of study is relevant for diagnostic or image-interpretation devices, not for a temporary restorative dental material. Therefore, an effect size of human readers' improvement with/without AI assistance is not applicable.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No. This term also pertains to AI/algorithm performance. The device is a physical material, not an algorithm.
7. Type of Ground Truth Used
- Ground Truth (Safety): Established through standardized in vitro and in vivo biological assays as recommended by ISO 10993 (Ames Mutagenicity, Cytotoxicity, Kligman Maximization).
- Ground Truth (Efficacy): Established through "in-house testing" (likely physical/mechanical property tests, handling characteristics) and comparative bench testing against established market predicate devices (Fermit, E-Z Temp, Clip). The predicate devices themselves serve as a form of "ground truth" or benchmark for acceptable performance.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This document describes the testing of a manufactured material, not the training of a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: Not applicable, as there is no training set for an AI/ML model for this device.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.