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Temporary CROWN AND BRIDGE Resin is indicated for use as a temporary restorative material for crown and bridge, inlay, and/or onlay restorations.

Cosmedent TEMPORARY CROWN AND BRIDGE RESIN is a self-cure composite resin fabricated from difunctional acrylic monomers and silicaceous fillers. These materials have sufficient physical properties to function in the oral cavity for up to 90 days and have esthetic qualities that mimic natural tooth appearance.

The provided text describes a 510(k) submission for a medical device, a Temporary Crown and Bridge Resin. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for proving new performance against acceptance criteria through a clinical study of the type usually associated with AI/software devices. Therefore, many of the requested points related to AI/software performance studies are not applicable to this document.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" in this context are the physical and mechanical properties of the predicate device (Luxatemp) that the applicant device (Cosmedent TEMPORARY C&B Filling Material) aims to be substantially equivalent to. The reported performance is the measured properties of the Cosmedent device.

2. Sample size used for the test set and the data provenance: Not applicable. This document pertains to material properties testing, not a clinical study with a "test set" in the context of AI/software or diagnostic performance. The testing would have been conducted in a laboratory setting. No information on the number of samples tested for the material properties is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties like compressive strength is established through standardized laboratory testing methods, not expert consensus.

4. Adjudication method for the test set: Not applicable. Material properties are measured objectively.

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 not an AI/software device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/software device.

7. The type of ground truth used: For the material properties (compressive strength, flexural strength, percent filler by weight, radiopacity), the ground truth is established through objective laboratory measurements following established standards for dental materials.

8. The sample size for the training set: Not applicable. This is not an AI/software device with a training set.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/software device.

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TEMPORARY CROWN AND BRIDGE MATERIAL is indicated for direct fabrication of TEMFORANT CROWN THD BRIDGE nlays, crowns or bridges used in indirect restorative procedures.

The TEMPORARY CROWN AND BRIDGE MATERIAL is a two-component, methacrylate-based material. The volume mix of this automixed material is a 1:1 ratio. The unit dose delivery system matchui. "The votential risks associated with asepsis and the need for disinfection.

I am sorry, but the provided text from the K060293 document primarily discusses the regulatory approval (510(k) summary) rather than a study detailing acceptance criteria and device performance. The document describes the device, its intended use, and technological characteristics, and then proceeds with the FDA's clearance letter.

There is no information within the provided text that describes:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or training set.
• Data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for a training set was established.

The document focuses on demonstrating substantial equivalence to a predicate device (Luxatemp Automix, K924830) based on material composition and intended use, rather than presenting a performance study with detailed statistical results against specific acceptance criteria.

Therefore, I cannot fulfill your request for details on acceptance criteria and a study proving the device meets them based on the provided input.

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Temporary crown and bridge material

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The provided document is a 510(k) premarket notification letter from the FDA for a "Temporary Crown and Bridge Material." This type of document is a regulatory approval for a medical device and does not contain information about acceptance criteria, study designs, sample sizes, or ground truth establishment for an AI/ML powered device.

Therefore, I cannot provide the requested information based on the given input. The document is for a traditional medical device, not an AI/ML one, and thus does not include the details of an AI/ML performance study.

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