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Rhodia hydrophilic dental impression materials are intended for use with PUTTY set for second impression (impression of correction) in the technique of double impression.

Rhodia hydrophilic dental impression material is intended for use for making intra-oral impressions. The device is a two-part vinyl polysiloxane paste with an addition-cure reaction. The base and catalyst pastes are extruded from dual-barrel cartridges through a mixing tip onto the surfaces of the teeth or onto a tray. The material quickly cures into a rigid impression. The hydrophilic property of the dental impression material helps to capture and reproduce perfect detail even in a moist environment.

This document is a 510(k) summary for the Rhodia Hydrophilic Dental Impression Material. It does not contain the detailed study information generally required to describe acceptance criteria and device performance in the way you're requesting for a medical device that claims diagnostic or prognostic capabilities based on specific performance metrics like accuracy, sensitivity, or specificity.

Dental impression materials are typically evaluated against physical and chemical properties and their ability to accurately replicate oral structures. The provided text indicates the device has been tested according to the criteria established in the Guidance Document, "Dental Impression Materials-Premarket Notification". However, it does not list specific acceptance criteria or report device performance data in terms of those criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies related to diagnostic accuracy, as this information is not present in the provided 510(k) summary.

The 510(k) process for this type of device primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device based on its intended use, technological characteristics, and safety and effectiveness, often through adherence to recognized standards for materials.

Based on the provided text, the following information can be extracted:

• Device Name: Rhodia Hydrophilic Dental Impression Material
• Intended Use: For making intra-oral impressions, specifically for "PUTTY set for second impression (impression of correction) in the technique of double impression."
• Device Type: Two-part vinyl polysiloxane paste with an addition-cure reaction.

The following information cannot be extracted from the provided text, as it's not relevant to this type of device's 510(k) submission or is simply not present:

• A table of acceptance criteria and reported device performance (in terms of specific quantitative metrics like accuracy, sensitivity, etc., which are not typically defined for impression materials in a 510k summary).
• Sample sizes used for a "test set" in the context of diagnostic accuracy.
• Data provenance.
• Number of experts used to establish ground truth.
• Qualifications of experts.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study information.
• Standalone (algorithm only) performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Summary of what can be gleaned about the study/testing:

The submission states: "Rhodia dental impression material is substantially equivalent to preamendment vinyl polysiloxane dental impression materials and has been tested according to the criteria established in the Guidance Document, "Dental Impression Materials-Premarket Notification"."

This indicates that testing was performed to demonstrate compliance with a recognized guidance document for dental impression materials. This testing would typically involve evaluating physical and chemical properties relevant to impression materials (e.g., tear strength, dimensional stability, working time, setting time, contact angle for hydrophilicity), rather than diagnostic accuracy. The specific results of these tests and the acceptance criteria are not detailed in this 510(k) summary.

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