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The Identium® Impression Materials are intended to:

• be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums;
• provide models for study and for production of restorative prosthetic devices.

Identium® Heavy (regular 1:1, fast 1:1) is to be used as a heavy-bodied impression material in one-step technique (double mix) for:

• Impressions for crowns/bridges, inlays/onlays and veneer preparations
• Functional impressions
• Impressions for full or partial dentures
• Implant impressions

Identium® Medium (regular 1:1, fast 1:1) is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for:

• Impressions for crowns/bridges, inlays/onlays and veneer preparations
• Functional impressions
• Fixation impressions
• Implant impressions

Identium® Scan Heavy (regular 1:5) is to be used as a heavy-bodied impression material in one-step technique (double mix) for:

• Impressions for crowns/bridges, inlays/onlays and veneer preparations
• Functional impressions
• Impressions for full or partial dentures
• Implant impressions

Identium® Scan Medium (regular 1:5) is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for:

• Impressions for crowns/bridges, inlays/onlays and veneer preparations
• Functional impressions
• Fixation impressions
• Implant impressions

Identium® Scan Light (regular 1:1) is to be used as a syringeable light-bodied impression material in one-step technique (double mix) for:

• Impressions for crowns/bridges, inlays/onlays and veneer preparations
• Reline impressions
• Impressions for full or partial dentures

Identium® Impression Materials are addition-curing, elastomeric materials. Identium® Impression Materials have excellent flow and hydrophilic properties, high shear strength, dimensional accuracy and resistance to permanent deformation. The Identium® Impression Materials include three different viscosities (heavy-bodied, medium-bodied, light-bodied), available in an assortment of delivery systems: Traditional 1:1 50 ml automix cartridge version and 5:1 362 ml foil bags for use in most automatic dispensing and mixing systems (heavy-bodied and medium-bodied versions only). Most of the Identium® Impression Materials are available in a regular-set and a fast-set version.

This looks like a 510(k) premarket notification for dental impression materials, not an AI/ML device. Therefore, the typical "acceptance criteria and study that proves the device meets the acceptance criteria" structure, especially concerning AI/ML performance metrics, ground truth, expert adjudication, MRMC studies, and training sets, does not apply here.

Instead, this document describes a traditional medical device submission where substantial equivalence is demonstrated through:

• Comparison to predicate devices: Showing the new device has similar intended use and technological characteristics to legally marketed devices.
• Performance testing to established standards: Demonstrating compliance with relevant industry and regulatory standards for non-AI devices.

Here's how I can address the request based on the provided document, adapting the categories where necessary:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is typically not included in a 510(k) summary for material performance testing. Standard ISO tests for dental materials use specific sample numbers as defined within the standard itself (e.g., a certain number of specimens for tensile strength, dimensional accuracy, etc.), but these details are not provided in this high-level summary. The data provenance would be laboratory testing conducted by or for the manufacturer (Kettenbach GmbH & Co. KG, Germany).

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

Not applicable for this type of device. "Ground truth" in the context of AI/ML refers to verified labels for image data, clinical diagnoses, etc. For material performance, the "truth" is determined by objective physical and chemical testing methods outlined in standards like ISO 4823, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. Material performance tests are quantitative measurements (e.g., measuring dimensional change, tear strength) and do not involve human adjudication in the sense of reviewing cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images with and without AI assistance. This document is for a dental impression material, which is a physical product, not a diagnostic imaging tool.

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

No, a standalone algorithm performance study was not applicable or performed. This device is a material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective laboratory measurements dictated by the test methods in ISO 4823. This includes quantifiable properties like dimensional stability, tear strength, elastic recovery, etc., measured against the defined acceptance limits within the standard. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

Not applicable. This device is a material, not a machine learning model; therefore, there is no "training set."

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

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

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