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Accusil Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Accusil Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal models and dental implant restorative devices. Base and catalyst components are mixed in an equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.

The document describes the acceptance criteria and performance of Accusil Dental Impression Materials as part of a 510(k) premarket notification for FDA clearance.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that Accusil Dental Impression Materials were tested against specific ISO standards (ISO 4823 and ISO 48-4) and internal protocols. The "Acceptance Criteria" are implicitly derived from the requirements of these standards. The "Reported Device Performance" for Accusil is provided in the comparative table with predicate and reference devices.

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PRESIDENT The Original Xtra light body / light body / regular body:

• Correction material for the corrective impression technique
• Injection material for the double mix technique
• Injection material for the dual arch technique»
• Lining impression material

PRESIDENT The Original heavy body:

• Impression material for pick-up impression in the double mix technique
• Tray material for corrective impression technique
• Tray material for dual arch technique

PRESIDENT The Original System 360:

• Impression material for pick-up impression in the double mix technique
• Tray material for corrective impression technique
• Tray material for dual arch technique

PRESIDENT The Original putty / putty soft / putty super soft / fast putty soft

• Impression material for pick-up impression in the double mix technique
• Tray material for corrective impression technique

The subject device family is PRESIDENT The Original which consists of addition type silicone based dental impression materials. PRESIDENT The Original is the relaunch and improved version of the predecessor device PRESIDENT (K811767), which is on the market since 1981.

PRESIDENT The Original is a two base system consisting of base and catalyst that are mixed together before use. The product portfolio of the subject device PRESIDENT The Original can be broadly subdivided into tray materials and wash materials, according to their physical and chemical properties.

The tray materials have a higher tear strength and elasticity than the wash materials. PRESIDENT The Original System 360 devices are surface activated and thixotropic with fast pressure build up so that the wash material is driven into the clinically critical areas. PRESIDENT The Original putties are offered in three different end hardness` for each individual case.

PRESIDENT The Original wash materials are stable but also free-flowing under pressure to capture all details precisely. The hydrophilic properties are effected by surfactants in the material. In contact with moisture these additives move to the surface and decrease the surface tension, resulting in an improved wettability. Furthermore, new colors were added to provide a better contrast between wash and tray materials and to allow a more accurate detail readability.

PRESIDENT The Original family devices are addition type sillicone-based dental impression materials composed of polyvinylsiloxanes, addition type/surface silicone elastomers in various compositions to achieve different viscosities and flow properties depending on the intended use.

To start the curing process the base material needs to be mixed with the corresponding catalyst material. The setting occurs via an addition reaction. The base materials consist of polyvinylsiloxanes, inorganic silicon fillers and other additives (e.g. coloring pigments). In all PRESIDENT The Original family members, except the putty consistencies, surfactants are used to increase hydrophilicity of the impression material.

The document describes the acceptance criteria and the study conducted for the dental impression material, "PRESIDENT The Original," to demonstrate substantial equivalence to the predicate device, "Aquasil® Ultra+."

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states compliance with ISO 4823:2021, which sets forth the requirements and test methods for elastomeric impression materials. The specific acceptance criteria within this standard are not explicitly detailed in the provided text, nor are specific numerical performance values for each criterion. Instead, it states that the device "conforms with ISO 4823."

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

• Sample Size: Not specified in the provided text. The document states "extensive testing," but does not provide numbers for the test samples.
• Data Provenance: The testing was conducted by Coltène/Whaledent AG, based in Switzerland. The data is retrospective in the sense that the testing has already been completed to generate the submission data.

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

This information is not applicable to this type of device and study. The testing for dental impression materials is primarily objective, based on physical and mechanical properties measured in a laboratory setting according to international standards (ISO 4823). It does not involve human interpretation of images or clinical outcomes in the same way an AI diagnostic device would require experts to establish ground truth.

4. Adjudication method for the test set:

Not applicable, for the same reason as point 3. The performance is measured against standardized physical and mechanical properties.

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 device or a diagnostic device involving human readers. It is a dental impression material.

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

Not applicable. This is not an AI algorithm. The device performance is assessed directly through laboratory testing of its physical and mechanical properties.

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

The "ground truth" for this device's performance is defined by the objective, quantifiable physical and mechanical properties outlined in the international standard ISO 4823:2021, and biocompatibility standards (ISO 10993 series). These standards provide established methodologies and acceptance criteria for these properties.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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