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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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