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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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Major.Repair is a cold-curing polymer for dental prosthesis. Poly-methylmethacrylate based. For reparing and rebasing dentures. Powder and liquid. It is used to: - repair and rebase prosthesis - temporary prosthesis -

Major.repair is a cold-curing polymer for dental prosthesis. For reparing and rebasing dentures. Powder and liquid. It can be used to: - repair and rebase prosthesis . - temporary prosthesis . Major.repair is a self-curing polymer 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 major.repair device, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for major.repair are implicitly derived from the ISO 1567:1999 standard for "Dentistry – Polymer-based restorative materials," as the device is stated to comply with this standard. The reported performance data points from the NIOM Laboratory (Norway) are presented as direct measurements against relevant physical properties.

Note: The exact numerical acceptance values from ISO 1567:1999 are not explicitly stated in the document, but the fact that the device complies with the standard implies its performance meets or exceeds those values. The reported performance data for major.repair are the values determined from testing.

Study Information

The 510(k) summary for major.repair does not describe a new, standalone clinical study or comparative effectiveness study in the traditional sense, but rather relies on a literature review and historical data.

1. Sample size used for the test set and the data provenance:

   • Test set sample size: Not applicable in the context of a new, standalone study. The "test set" here refers to the samples used in the physical properties testing, but the sample size for those tests is not specified.
   • Data provenance: For the physical properties data, the testing was performed by NIOM Laboratory – Norway. For clinical aspects, the provenance is a vast body of existing dental literature, clinical experience with similar products, and the manufacturer's own historical sales data since 1966. This is a retrospective approach based on existing information and general scientific acceptance.

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

   • Not applicable as the "ground truth" for the physical properties was established through standardized laboratory testing (NIOM). For the broader clinical "ground truth," it relies on the consensus and findings published in the extensive dental literature cited (e.g., McKabe, Phillips, Graig, O' Brien) and decades of clinical experience. No specific individual experts are identified as establishing a ground truth for a new test set.

3. Adjudication method for the test set:

   • Not applicable. This type of adjudication (e.g., 2+1, 3+1) is typically used in clinical studies involving interpretation of medical images or patient outcomes, which is not the nature of the evidence provided for this dental material.

4. 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 MRMC comparative effectiveness study was mentioned or performed. This device is a dental material, not an AI-assisted diagnostic or treatment planning tool.

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

   • Not applicable. This is not an algorithm or AI device. The physical property tests are standalone measurements of the material itself.

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

   • For physical properties: Standardized laboratory measurements and compliance with ISO 1567:1999.
   • For clinical safety and effectiveness: Broad expert consensus from extensive dental literature, historical clinical experience with similar product types, and the manufacturer's long-term sales history with no reported adverse effects. This is a combination of expert consensus derived from literature and real-world outcomes data over a long period.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an AI/ML algorithm. The product's formulation and performance are based on established dental science and manufacturing processes.

8. How the ground truth for the training set was established:

   • Not applicable due to the absence of a "training set." The understanding of the material's properties and clinical behavior is derived from scientific principles, material characterization, and historical data as described above.

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Major.Base 20 is a denture base polymer for dental prosthesis. Poly-methylmethacrylate based. Heat-processed polymer. Powder and liquid. It is used for: - dental prosthesis - partial prosthesis - clasp prosthesis -

Major.base 20 is a denture base, poly(methyl methacrylate)-based polymers for dental prosthesis. It can be used for: - Total prosthesis . - Partial prosthesis . - Clasp dentures e Major base 20 is a heat cure denture base material composed of a poly-methylmethacrylate polymer powder and a liquid consisting of methylmethacrylate and other ingredients solution.

The provided document describes the 510(k) premarket notification for Major.base 20, a denture base material. The submission relies on substantial equivalence to predicate devices, rather than a de novo clinical study with specific acceptance criteria in the typical sense of a diagnostic or therapeutic device. Therefore, some of the requested information, particularly regarding a "study that proves the device meets the acceptance criteria" in the context of an algorithm or diagnostic performance, is not directly applicable or available in the provided text.

However, I can extract information related to the device's technical specifications and how its performance was assessed in the context of demonstrating substantial equivalence.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance (for Substantial Equivalence)

The acceptance criteria for Major.base 20 are implicitly defined by its substantial equivalence to predicate devices (Paladon® 65 and Probase Hot) and compliance with relevant ISO/ADA standards. The "device performance" reported is based on technical data of the polymerized material.

Study Information (Based on the 510(k) Submission)

For this type of device (denture base material), the "study" is primarily a nonclinical testing and comparison to existing, legally marketed predicate devices and reliance on extensive historical data and scientific literature.

1. Sample size 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 applicable in the context of a diagnostic AI study. The technical data provided (Flexural strength, modulus, water absorption, solubility, residual monomer) are physical properties measured on the material itself. The document does not specify the number of samples used for these tests.
   • Data Provenance: The technical tests were "performed by NIOM Laboratory - Norway." The broader "data" for substantial equivalence relies on a vast body of dental literature and historical clinical experience over 50 years worldwide ("universal in the last fifty years manufacturing and clinical experience").

2. 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)

   • Not applicable. This device is a material, not one requiring expert human interpretation for ground truth or diagnostic assessment. The "ground truth" for the material's properties would be defined by the standardized testing protocols themselves.

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

   • Not applicable. This is not a diagnostic interpretation scenario requiring adjudication.

4. 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-assisted diagnostic device.

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

   • Not applicable. This is not an algorithm or AI device.

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

   • The "ground truth" for the reported performance metrics (flexural strength, etc.) is the results of standardized laboratory physical property testing.
   • For the overall safety and effectiveness claim, the "ground truth" is established through extensive scientific literature, historical clinical experience (over 50 years with similar products), and compliance with international standards (ISO 1567:1999 / ADA/ANSI 12:2002), along with a lack of adverse event records from the manufacturer's long history.

7. The sample size for the training set

   • Not applicable. This is not a machine learning device that requires a "training set."

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

   • Not applicable. This is not a machine learning device.

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