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Temporary C&B composite is a fluorescent cold polymerising pastepaste system for the production of temporary crowns, bridges, inlays and onlays. Temporary C&B composite consists of base paste and catalyst paste.

Temporary C&B composite is a fluorescent cold polymerising pastepaste system for the production of temporary crowns, bridges, inlays and onlays. Temporary C&B composite consists of base paste and catalyst paste.

The provided text is a 510(k) clearance letter from the FDA for a dental product, "Temporary C&B Composite." It states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.

However, this document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, expert involvement, or any other specifics related to a study proving the device meets acceptance criteria.

The letter is an administrative document, confirming the device's clearance based on equivalence, not a summary of a performance study. Therefore, I cannot extract the requested information from the provided text.

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temporary.cold.v and self-cure dentine are temporary cold-curing indirect crowns & bridges materials, Poly-methyImethacrylate based. Powder and liquid.

Intended use:

• Construction of temporary crowns and bridges -
• Immediate crown brush-modeling
• For gypsum or silicone key pouring technique -
• For rapidly repairing acrylic crowns and bridges -

Temporary.cold.v and self-cure dentine are chemically activated poly(methylmethacrylate) based, crown and bridge materials for temporary dental prosthesis.

They can be used for:

• Construction of temporary crowns and bridges .
• . Immediate crown brush-modeling
• . For gypsum or silicone key pouring technique
• . For rapidly repairing acrylic crowns and bridges

Temporary.cold.v and self-cure dentine are self-curing acrylic resins composed of a poly-methylmethacrylate powder and a liquid consisting of methylmethacrylate and other ingredients solution.

Here's a breakdown of the acceptance criteria and the study information for the "temporary.cold.v and self-cure dentine" device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that "Temporary.cold.v and self-cure dentine have the same technological characteristics as the predicate devices since all the devices are complying with ISO 10477:1992." This indicates that the acceptance criteria are implicitly defined by compliance with ISO 10477:1992 and the performance of the predicate device (Trim® Plus by Harry J. Bosworth - K961199). The provided values for the device's technical data are presented as a direct comparison against the predicate, implying they meet the necessary performance characteristics.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document mentions "tests performed by NIOM Laboratory - Norway," but the specific number of samples tested for each metric (flexural strength, water absorption, water solubility) is not provided.
• Data Provenance:
  • Country of Origin: Norway (tests performed by NIOM Laboratory).
  • Retrospective or Prospective: Not explicitly stated. Given the nature of laboratory material testing, it would generally be considered prospective testing of manufactured product samples.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This type of information is not applicable to this submission. The "ground truth" for the material's physical properties (flexural strength, water absorption, water solubility) is established through standardized laboratory testing following ISO norms, not human expert consensus.

4. Adjudication Method for the Test Set

This type of information is not applicable to this submission. Adjudication methods like "2+1" or "3+1" are relevant for expert review of subjective data (e.g., medical image interpretation), not for standardized laboratory measurements of material properties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this submission. This type of study is relevant for diagnostic devices involving human interpretation, not for material properties.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

This is not applicable to this device. This device is a material (temporary crown and bridge resin), not an algorithm or AI system. Its performance is inherent to its physical and chemical properties and how it's used by a dental practitioner.

7. Type of Ground Truth Used

The ground truth used for evaluating the device's performance metrics (flexural strength, water absorption, water solubility) is based on standardized laboratory measurements according to established protocols (implied by compliance with ISO 10477:1992).

For the broader claim of safety and effectiveness, the document relies heavily on:

• Extensive scientific literature: "safety and effectiveness are well documented in the dental literature," "a large amount of literature has assessed the clinical liability of these product – types and their formulation."
• Historical clinical experience: "these product types and their formulation are universal in the last fifty years manufacturing and clinical experience," and the company's own 21 years of manufacturing experience "without any record of human incompatibility or clinical evidence of adverse effects."

8. Sample Size for the Training Set

This is not applicable as the device is a material, not an AI/ML algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as the device is a material, not an AI/ML algorithm.

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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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For cementation of Temporary Restorations

Not Found

This is a 510(k) clearance letter for a medical device (Temporary Cement). The provided document does not contain information regarding acceptance criteria, device performance studies, or details about training and test sets of AI algorithms.

The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It refers to general controls and FDA regulations but does not include any performance data or study design.

Therefore, I cannot extract the information required to answer your questions based on the provided text. This document is a regulatory approval, not a scientific study report.

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Temporary crown and bridge material

Not Found

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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The Temporary Cardiac Pacing Wire with wave is intended for use in temporary cardiac pacing or monitoring.

The Temporary Cardiac Pacing Wire with wave has the same intended use as predicate device Temporary Cardiac Pacing Wire (TPW).

The Temporary Cardiac Pacing Wire is intended for use in temporary cardiac pacing or monitoring.

The Temporary Cardiac Pacing Wire with wave is a lead that consists of an uninsulated multifilament stainless steel wire electrode and an insulated multifilament conductor coated with blue polyethylene attached to a straight Keith needle. There is no exposed wire at the point of the swage to the straight Keith needle. The Keith needle is scored eliminating the need to cut the needle. The Keith needle is connected to an external temporary cardiac pacing or monitoring device. A 'wave' is preformed into the uninsulated distal end, then attached to a curved needle.

The provided document K980503 is a 510(k) summary for a Temporary Cardiac Pacing Wire with wave. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to meet specific performance acceptance criteria in the way a new, novel device might. Therefore, the information requested regarding a study proving acceptance criteria is largely not applicable in the typical sense for this submission type.

However, I can extract the information that is present and explain why some of the requested points are not explicitly detailed in a 510(k) for a substantially equivalent device.

Here's the breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance

Explanation: For a 510(k) submission, the primary "acceptance criterion" is often substantial equivalence to a predicate device. This means the new device shares the same intended use and technological characteristics as the predicate, or if there are differences, they do not raise new questions of safety or effectiveness and can be demonstrated to be as safe and effective as the legally marketed predicate. Specific numerical acceptance criteria are typically not provided as they would be for a de novo or PMA submission.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Nonclinical laboratory testing was performed to determine pullout force after implantation." It does not specify the number of wires tested.
• Data Provenance: The testing appears to be nonclinical laboratory testing, likely performed by the manufacturer, ETHICON, Inc. The document does not specify country of origin for the data or whether it was retrospective or prospective. Given it's nonclinical lab testing, it's typically prospective testing.

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

• Not Applicable. For nonclinical laboratory testing like pullout force, "ground truth" is established by direct physical measurement using validated testing protocols, not through expert consensus or interpretation of clinical data. Therefore, no experts were involved in establishing ground truth for this specific lab test.

4. Adjudication method for the test set

• Not Applicable. As the "ground truth" for the pullout force test is a direct physical measurement, there is no need for adjudication by experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size

• No. This is not a diagnostic device that involves human interpretation of results, but rather a medical device for temporary cardiac pacing. Therefore, an MRMC study is not relevant or required for this type of device.

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

• Not Applicable. This is a physical medical device, not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.

7. The type of ground truth used

• For the reported performance data (pullout force), the ground truth was established by direct physical measurement during nonclinical laboratory testing.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not Applicable. See point 8.

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