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To take dental impressions.

This 510(k) application is for a line of dental impression materials. Vinyl polysiloxane impression materials have been used in the dental field since 1973. There are presently at least twelve manufacturers worldwide of this type impression material and more than 30 companies selling impression products under private label. Based upon the total impression market, which would include all types of impression materials used, the vinyl addition products have gained the majority share according to current trade reports.

Clinical studies as well as scientific evaluations have shown that the handling characteristics and the physical properties of the vinyl polysiloxane impression materials are superior to all previous impression materials. With the many impression techniques that are used in dentistry today, the vinyl addition system manufacturers have developed a great variety of different materials to satisfy these diverse requirements.

To create these various viscosities and rheological changes in the vinyl system, the type of filler used is changed. Radiopacity can be added by using a small percentage of barium sulfate in the filler addition (K872745, July 1987). Thixotropy to overcome the uncontrolled flow of impression materials which can cause gagging can be accomplished by altering the filler system. Instead of using extending fillers, bulking fillers are used. Aeorsil is an example of such a filler.

Fillers generally are not involved in the chemical reaction between the polymer, crosslinker and platinum complex. The filler particles interspersed between the silicone rubber matrix can alter the viscosity and durometer as well as the elasticity and tear strength of the set material. The efficacy and safety of the product is not altered since the addition silicone reaction is not dependent on the fillers used. The excellent dimensional stability of the vinyl system is also unaffected.

The available fillers that can be used in formulating vinyl polysiloxane impression systems are numerous and each one has a specific characteristic For example, silica is available in several forms. The crystalline type, the amorphous type, the fumed type or the diatomaceous type all have different characteristics when used in system design. When more than one silica is used in a system the change in rheology can be as a result of the properties imparted by each filler.

A further filler that can be used is combining the fumed silica with magnesum silicate, creating a rheologically altered impression material that is very thixotropic, yet fluffy and nonflowing except when some external force is applied. The resultant material can be used for impressions without the inconvenience of uncontrolled flow, which in many instances cause gagging.

Vinyl addition silicone products are used in other health related fields such as rehabilitation and occupational therapy for scar control after primary wound healing and in hearing restoration with externally worn hearing aids by the use of impressions of the outer and part of the middle ear. To our knowledge no reports have been published indicating any untoward reactions when vinyl polysiloxane materials are used in any application including the high volume usage in the dental field.

When used intraorally in dentistry, the impression is contaminated with saliva and blood. Vinyl addition impressions can be disinfected with any hospital level disinfectant or aqueous sterilant to prevent the spread of pathogens from the dental office environment to the dental laboratory technician, thus eliminating possible cross contamination.

This 510(k) summary describes a dental impression material, Perfectim, and does not contain information about acceptance criteria or a study proving device performance against such criteria in the manner typically found for AI/ML-powered devices or diagnostic tools. The document focuses on demonstrating substantial equivalence to predicate devices based on technological, safety, and effectiveness characteristics.

Therefore, many of the requested categories related to algorithm performance, ground truth, expert review, and statistical studies are not applicable or cannot be extracted from this document.

Here's a breakdown of the information that can be extracted, and where the requested information is absent:

1. Table of acceptance criteria and the reported device performance:
   Not applicable. This document does not describe specific numerical acceptance criteria for performance measures like accuracy, sensitivity, or specificity, nor does it present a study with reported performance against such criteria. The "performance" discussed relates to physical properties and handling characteristics of impression materials, which are compared qualitatively to existing predicate devices.

2. Sample size used for the test set and the data provenance:
   Not applicable. There is no mention of a "test set" in the context of data for an algorithm. The document refers to "Clinical studies as well as scientific evaluations" of vinyl polysiloxane impression materials in general, but does not provide details about sample sizes, data provenance, or specific studies related to Perfectim's performance in a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. As there is no test set for an algorithm, there is no mention of experts establishing ground truth in this context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable. No test set or expert adjudication process is described.

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 device is a dental impression material, not an AI/ML diagnostic tool, so an MRMC study related to AI assistance is irrelevant.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable. The concept of "ground truth" for impression material generally relates to its physical properties (e.g., dimensional stability, tear strength) and clinical utility in taking accurate impressions, which are assessed through material science testing and clinical observation rather than a "ground truth" akin to diagnostic accuracy. The document mentions "Clinical studies as well as scientific evaluations" but no specific methodology for establishing ground truth for Perfectim itself.

8. The sample size for the training set:
   Not applicable. No algorithm or training set is discussed.

9. How the ground truth for the training set was established:
   Not applicable. No algorithm or training set is discussed.

Summary of Relevant Information from the Document:

The 510(k) focuses on demonstrating substantial equivalence. Key aspects highlighted include:

• Intended Use: To take dental impressions.
• Device Description: A line of vinyl polysiloxane dental impression materials.
• Technological Characteristics: Similar to predicate devices, with variations in filler types to achieve different viscosities, rheological properties, and thixotropy. Radiopacity can be added (mentioning K872745).
• Safety and Effectiveness: Stated that "Clinical studies as well as scientific evaluations have shown that the handling characteristics and the physical properties of the vinyl polysiloxane impression materials are superior to all previous impression materials." The document reiterates that the efficacy and safety are not altered by filler changes. It also mentions disinfection capabilities.
• Predicate Devices: A table is provided listing Perfectim products and their corresponding predicate devices, suggesting equivalence in composition, function, and safety profile.

In essence, this document is a regulatory submission for a medical device (impression material) based on substantial equivalence, not a performance study of an AI/ML diagnostic system.

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