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CutterSil Activator Universal Plus paste and liquid are used as a catalyst to induce polymerization of the CutterSil base paste which is used for all inlay, crown and bridge, partial and edentulous impressions.

Device Description

Hardener Universal Plus (Liquid and Paste) (identical with Activator Universal Plus, Liquid and Paste) is the catalyst of the two component condensation curing silicone dental impression material Cuttersil (hardener and base paste and hardener are mixed before use according to the instruction of use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Hardener Universal Plus:

Device: Hardener Universal Plus (Liquid and Paste)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Properties:
Fulfils requirements of EN ISO 4823	The new D 890/3 hardener shows quite similar physical and handling properties in comparison to the old hardener. The new product also fulfils the requirements of EN ISO 4823. (Section 1) The physical data for the new D 890/3 hardener are in accordance with the functional specification for D 890/3 and the requirements of EN ISO 4823. (Section 4) The physical properties meet the requirements of the functional specification and EN ISO 4823. (Section 6)
Odor:
Less intensive than old hardener	The odour of the new hardener is less intensive compared with the old hardener. (Section 1)
Biocompatibility:
Verified in accordance with EN ISO 10993-1	The biocompatibility of the new D 890/3 Hardener Universal Plus prototype was verified in combination with base paste in accordance with the international standard The biocompatibility of D 890/3 Hardener Universal Plus in combination with base paste was documented in a Biological Evaluation Report. (Section 3)
Benefit overweighs possible risks	The benefit overweights the possible risks with the use of the new hardener. (Section 3 and 6)
Effectiveness (detailed dental impressions):
Effective for taking of detailed dental impressions	Based on the test data the new hardener it can be concluded is effective for taking of detailed dental impressions. (Section 4)
Clinical Performance & Safety:
Exhibit claimed technical performance	It is concluded that the product can be expected to exhibit the claimed technical performance. (Section 5 and 6)
Potential undesirable clinical effects and risks well controlled and acceptable	Potential undesirable clinical effects and risks seem well controlled and acceptable when weighted against their benefits in dentistry. (Section 5 and 6)
Risk Analysis (EN ISO 14971):
Acceptable risk when applied according to instructions	The risk analysis according to EN ISO 14971 was carried out for the new D 890/3 hardener and showed that the application of D 890/3 according to the manufacturer's instruction for use shows an acceptable risk. (Section 6)
Overall Regulatory Compliance:
Meets all relevant requirements for condensation curing silicone impression materials and Medical Device Directive 93/43/EWG	The new D 890/3 hardener meets all relevant requirements for condensation as an early wa rite new b osons hardoner moote and the Medical Device Directive 93/43/EWG SMCone Inforestion matomation. (Section 6, with some illegible text in the original)
Effective and safe when used according to manufacturer's instructions	Based on the actual facts D 890/3 and Trailonal Editipean Thousan "Chica" (c. be effective and safe when using it in accordance with the manufacturer's information for use. (Section 6, with some illegible text in the original)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for the test set regarding the physical properties or biocompatibility. It states that "test data" was used (Section 4) and that the biocompatibility was "verified" and "documented in a Biological Evaluation Report" (Section 3).

Data Provenance: The manufacturer, Heraeus Kulzer GmbH, is based in Dormagen, Germany. The evaluations mention compliance with European medical device legislation (Medical Device Directive 93/42/EWG) and international standards (EN ISO), suggesting the data originates from studies conducted or accepted within the European context. The document itself is a 510(k) Summary, which is a submission to the US FDA, so the data is being presented for US regulatory review. The type of data appears to be retrospective in the sense that the studies (biocompatibility, physical properties) were completed prior to this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Toxicological Expert Opinions: "In addition toxicological expert opinions are carried out to assess possible risks..." (Section 3). The number of experts is not specified, nor are their specific qualifications (e.g., years of experience, specific board certifications).
Clinical Evaluation Expert: "...expert stated for hardener D B90/3 that the benefits overweight the possible risks if the product is applied according to the instruction for use." (Section 5). The number of experts is referred to in the singular ("expert"), and no specific qualifications are provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for establishing ground truth from multiple expert opinions (e.g., 2+1, 3+1). It refers to "expert opinions" (plural) for toxicology and a singular "expert" for the clinical evaluation conclusion. This suggests a potential lack of formal adjudication for consensus if multiple individual opinions were initially present.

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

This section is not applicable. The device described is a dental impression material hardener. It is a material, not an AI-powered diagnostic or assistive device that would involve human "readers" or an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The device is a material, not an algorithm.

7. The Type of Ground Truth Used

Physical Properties: The ground truth for physical properties was established by testing against established international standards (EN ISO 4823) and functional specifications. These standards define measurable parameters and acceptable ranges.
Biocompatibility: The ground truth for biocompatibility was established by testing according to EN ISO 10993-1, which involves a series of standardized tests to assess biological responses.
Toxicological Evaluation: Ground truth was established through toxicological expert opinions and risk assessments.
Clinical Evaluation: Ground truth was established by an expert's conclusion based on evaluated data, clinical evaluation, and technical results, weighing benefits against risks. This leans towards expert consensus/opinion based on available evidence.

8. The Sample Size for the Training Set

This information is not provided and is likely not applicable in the typical sense of machine learning "training sets" as this is a material science and biocompatibility assessment, not an AI/algorithm development. The "training" in this context would refer to the development and formulation of the hardener itself, which is not quantified by a sample size in this document.

9. How the Ground Truth for the Training Set Was Established

As with point 8, this is not explicitly stated or readily applicable in the context of this device type. The "ground truth" for the development (or "training") of a material like this would involve iterative testing and refinement based on desired physical properties, handling characteristics, and biocompatibility, continuously measured against industry standards and internal specifications.

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