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Evadyne® is a light cured single-component material for the temporary restoration of crowns, bridges, or similar dental prostheses. Evadyne is intended for the general dental patient population.

NeoDental Chemical Products, Inc, (NeoDental) wishes to submit their Evadyne® Temporary Crown and Bridge Resin for 510(k) clearance. Evadyne®, (shown in Figure 1) is a yellowish translucent, light-cured temporary restoration material for direct filling. After curing, Evadyne can be removed in one piece when the permanent restoration is to be placed. Evadyne® is packaged as a multiple use syringe, with new tips being attached for each patient. The syringe can be used until empty. The syringe is kept capped between uses and is fitted with a new tip just prior to use. The syringe is cleaned with an alcohol wipe before and after use.

The provided document is a 510(k) Summary for a dental device called "Evadyne Temporary Crown and Bridge Resin". It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the format requested (e.g., diagnostic accuracy metrics like sensitivity, specificity, or AUC).

Instead, the document focuses on:

• Device Description and Intended Use: Explaining what the Evadyne resin is and how it's used.
• Substantial Equivalence to a Predicate Device: Comparing Evadyne to Fermit-N (K934978) based on intended use, indications, and technological characteristics. The argument for substantial equivalence relies on them having similar applications, mechanisms of polymerization, and general properties, while acknowledging some differences in composition, flow, and flexural strength.
• Non-Clinical Test Data (Biocompatibility): This section details the biocompatibility evaluation, primarily through referencing recognized consensus standards (ISO 10993-1) and listing specific biological tests conducted (Cytotoxicity, Sensitization, Genotoxicity, Irritation) in 2001-2002 by Covance Lab. It also mentions that the main ingredient (UDMA) and filler (fluoroaluminosilicate glass) are widely used and have a history of safe use, and that 76,000 units have been sold since 2005 without reported incidents.
• Claims of Equivalence, not Performance Targets: The document concludes that Evadyne is "substantially equivalent" to the predicate device, not that it meets specific quantitative performance targets or acceptance criteria in a comparative study against a pre-defined threshold.

Therefore, I cannot populate the requested table or answer most of the questions because the necessary information (acceptance criteria, device performance metrics, study design for accuracy, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance data) is not present in the provided text.

The closest information related to "acceptance criteria" is the device's conformance to biocompatibility requirements according to ISO 10993-1 and the fact that "Results were found to conform to requirements (see section 15)," but the specific numerical acceptance criteria for these biological tests are not detailed here. The "reported device performance" is simply the claim of being "substantially equivalent" and having an uneventful safety record over several years.

Summary of what cannot be provided from the text:

1. Table of acceptance criteria and reported device performance: Not available. The document discusses "substantially equivalent" to a predicate, and conformance to biocompatibility standards, but no quantitative performance metrics or specific acceptance criteria are listed.
2. Sample size for the test set and data provenance: Not applicable as it's not a performance study measuring accuracy. Biocompatibility tests would have their own sample sizes (e.g., guinea pigs for sensitization), but these are not for device performance against a diagnostic target.
3. Number of experts used to establish ground truth & qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not conducted or reported.
6. Standalone performance study: No such study described or reported.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable (no AI/ML involved).
9. How ground truth for the training set was established: Not applicable.

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Cavios® Cavity Liner is to be applied to the interior of a prepared cavity prior to the insertion of restorative materials. Cavity Liner is indicated for use in the general dental population.

Cavios®, (shown in Figure 1) is a light cured single-component yellow-white paste for use as a dentin liner and base. The product is preloaded into syringes and expressed via the syringe plunger through single-use disposable tips. Following the application, Cavios® is cured (polymerized) with a light source (approximately 470 nm). Following polymerization, the restorative materials, amalgam, etc., may be placed. Cavios® is packaged as a multiple use syringe, with new tips being attached for each patient. The syringe can be used until empty. The syringe is kept capped between uses and is fitted with a new tip just prior to use. The syringe is cleaned with an alcohol wipe before and after use.

The provided text does not contain information about acceptance criteria for a device's performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC). Instead, it focuses on the safety and material properties of the "Cavios Cavity Liner." The studies described are non-clinical (biocompatibility and bench testing) and do not involve a test set of patient data, ground truth establishment, or expert readers in the context of diagnostic performance.

Therefore, many of the requested sections about acceptance criteria, study design for diagnostic performance, ground truth, and expert involvement cannot be addressed from the given document.

Here's an analysis of the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here pertain to the biocompatibility and material characteristics established through recognized consensus standards rather than diagnostic performance.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable. The tests are for material properties and biocompatibility, not diagnostic performance on a patient data test set. Biological tests used laboratory samples (e.g., bacterial strains, rabbit whole blood, mouse fibroblast cells, guinea pigs).
• Data Provenance: The biocompatibility tests were conducted by Covance in 2002. The material properties tests are reported without specific lab or date, but under the context of "recognized consensus standards and other testing." This is non-clinical, laboratory-based data for materials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This information pertains to studies assessing diagnostic accuracy, which is not what is reported here. The "ground truth" for these tests are the established scientific methods and pass/fail criteria for material properties and biocompatibility.

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

• Not applicable. This information pertains to studies assessing diagnostic accuracy, which is not what is reported 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 medical device (cavity liner) and not an AI/diagnostic imaging product, so an MRMC study is not relevant or reported.

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

• No. The device is a physical material (cavity liner), not an algorithm.

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

• The "ground truth" for the non-clinical tests is based on the established scientific endpoints and methodologies of each specific test (e.g., whether bacterial growth is inhibited, percentage of hemolysis, cell viability, mechanical property measurements).

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of device material testing or safety assessments.

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

• Not applicable. As there is no training set, this question is not relevant.

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For use to stimulate the healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectomy, or for apexegenesis or apexification, and / or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.

Not Found

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental product called "Vitapex Pre-Loaded Dental Syringe" and "NeoDental Vitapex Paste". It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information.

The document does not contain any of the information requested in your prompt regarding:

• Acceptance criteria table and reported device performance
• Sample size and data provenance for a test set
• Number and qualifications of experts for ground truth
• Adjudication method for a test set
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone (algorithm only) performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

Therefore, I cannot fulfill your request based on the provided input.

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For use in the sealing of prepared root canals in adult or decidious teeth prior to final filling with gutta percha or other acceptable root canal filler. Used to promote healing effects and to help prevent bacterial contamination of the canal.

Endodontic Sealer

The provided text is a clearance letter from the FDA for a medical device called "Dentalis Kez Endodontic Sealer" (K971642). It states that the device is substantially equivalent to a predicate device and can be marketed. However, this document does not contain specific acceptance criteria, details of a study proving the device meets those criteria, or any information related to AI or algorithm performance.

Therefore, I cannot provide the requested information. The document is a regulatory clearance and not a study report or clinical trial summary.

To clarify, the information I cannot extract from the provided text includes:

1. A table of acceptance criteria and the reported device performance: This document only states the device is "substantially equivalent" for its indications for use. It does not list specific performance metrics or acceptance criteria.
2. Sample size used for the test set and the data provenance: No study details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No study details are provided.
4. Adjudication method for the test set: No study details are provided.
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: This is a physical dental sealer, not an AI or imaging device, so MRMC studies are not relevant. This document does not mention any AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an algorithm.
7. The type of ground truth used: No study details are provided.
8. The sample size for the training set: Not applicable as this is not an algorithm.
9. How the ground truth for the training set was established: Not applicable as this is not an algorithm.

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Ask a specific question about this device