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TempFil is a light-cured, single component temporary filling material intended to be used for filling of inlay and onlay preparations, implant screw and endodontic access openings, and for the emergency replacement of lost fillings.

TempFil is a light cured single component temporary filling material designed for fabrication of provisional inlays and onlays. TempFil contains a resin base, which provides a sculptable viscosity with non-sticky placement. Available in syringe and unidose delivery systems; TempFil sets to a permanent elastic phase which allows for easy removal even in the presence of preparation undercuts.

This document is a 510(k) premarket notification for a dental material, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific performance metrics (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance) is not applicable and cannot be extracted from this document.

The document describes the device, TempFil, as a light-cured single component temporary filling material for provisional inlays and onlays, implant screw and endodontic access openings, and emergency replacement of lost fillings. It claims substantial equivalence to another legally marketed device, TempFil F-2.

The FDA's review and determination of substantial equivalence are based on the comparison of the device's characteristics (e.g., composition, intended use, performance) to a predicate device, rather than a clinical study with detailed performance metrics as would be expected for an AI/ML diagnostic or prognostic tool.

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TempFil F - 2 is a light oured, single component temporary filling material intended l emplil F - Z is a light-successingle compensions in the go to be used for inlay and only preparations, implantserew-access openings andto be assurement of lost fillings for the emergency

The device is a visible light-cured, single component temponery filling material. It is specifically designed for temporary inlays and onlays. TempFil F - 2 has a permanent elastic phase which allows for easy removal even in the presence of preparation undercuts.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is primarily a 510(k) summary for a dental temporary restorative material called TempFil F-2. It describes the device, its intended use, and claims substantial equivalence to other legally marketed devices, but it does not detail any specific performance studies or acceptance criteria that would allow me to fill out the requested table and answer your questions.

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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 beriod 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.

TempFil C&B is supplied in a double barreled cartridge container which can be used with any of the currently available cartridge dispensers ( i.e. Kerr's Extrude mixer/extruder dispenser ) that will accept 1:1 mix ratio plungers. This allows the dentist to simultaneously mix and dispense the material directly into the impression or crown form.

The provided text describes a medical device, "Kerr TempFil C&B Temporary Restorative Material," and its safety and efficacy. However, it does not contain the specific information required to complete the table and answer all the questions. The document is a 510(k) summary from 1997 for a dental temporary restorative material.

Here's an analysis of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Ames Mutagenicity Assay
• Cytotoxicity Study (Agarose Overlay)
• Kligman Maximization Study (Tissue Sensitization) |
  | Efficacy/Suitability | Performed "as well or better than three predicate devices currently on the market" through in-house and side-by-side bench testing. |

Missing Information:
The document lists acceptance criteria for "ease of placement" and "convenience" by describing how the device meets them through its design. For "safety" and "efficacy," it states that tests were conducted and the device performed well or met standards, but does not provide specific quantitative acceptance criteria or detailed numerical performance results for these criteria. For example, it doesn't state "mutagenicity rate Y MPa."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document mentions "cured samples" for biocompatibility tests and "bench testing" but does not give sample numbers.
• Data Provenance (Country of Origin): Not specified.
• Retrospective or Prospective: Not applicable, as the tests described are bench (laboratory) tests and biocompatibility studies, not clinical studies involving patients over time.

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)

• Number of Experts: Not applicable. The "ground truth" here is established by standardized laboratory assays (biocompatibility) and direct physical/chemical measurements (bench testing for efficacy) against predicate devices, not by expert interpretation of patient data in the context of clinical imagery or pathology.
• Qualifications of Experts: The biocompatibility tests were "conducted by an independent laboratory which specializes in safety and toxicity evaluation." Specific qualifications of personnel are not given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. This concept typically applies to clinical studies where human readers/experts independently assess cases and discrepancies need resolution (e.g., in radiological reads). The tests described are laboratory-based.

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

• MRMC Study: No, an MRMC study was not done. This device is a dental material, not an AI-powered diagnostic or assistive tool, and the studies described are bench and biocompatibility tests.
• Effect Size of AI Improvement: Not applicable.

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

• Standalone Study: Not applicable. This device is a physical dental material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: For biocompatibility, the ground truth is established by the results of standardized biological assays (Ames, Cytotoxicity, Kligman) against pre-defined safety thresholds. For efficacy, the ground truth is established by direct physical/mechanical measurements and comparative performance against predicate devices in bench tests, presumably meeting certain performance specifications.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The development process would involve formulation, iterative testing, and optimization, but not a distinct "training set" in the AI sense.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable, as there is no training set in the AI sense.

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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.

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.

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