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Once finalized into a suitable design, the n!ce® glass-ceramic blocks are indicated for use as inlays, onlays, veneers, partial crowns and crowns.

Straumann® n!ce™ glass ceramic is a proprietary lithium disilicate (Li2O-SiO2) glass ceramic material intended to be milled to produce prosthetic restorations for natural and endosseous dental implant abutment borne teeth. The material is suitable for use in inlays, onlays, veneers, copings and monolithic crown restorations. The mandrel bonded to the blocks is compatible with Planmill milling equipment.

This document is a 510(k) summary for a dental glass-ceramic material, n!ce for Planmill, which means it describes the device's equivalence to existing legally marketed devices, rather than a study proving its efficacy or performance against defined acceptance criteria in the conventional sense. The focus here is on demonstrating substantial equivalence to a predicate device, specifically the n!ce Glass Ceramic Blocks (K160262). Therefore, the "acceptance criteria" and "device performance" in this context refer to the criteria met to show substantial equivalence and the tests performed to support that claim.

Given the context of a 510(k) summary for a material intended for milling dental restorations, the "device" is the n!ce® glass-ceramic blocks, and its "performance" is assessed against established material standards and characteristics deemed equivalent to the predicate device.

Here's an interpretation of the information requested, tailored to the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" generally refer to the established standards or characteristics that the new device must meet or demonstrate equivalence to, compared to the predicate device. "Reported device performance" refers to the results of tests conducted on the new device to show it meets these criteria or is substantially equivalent.

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

The document does not explicitly state the specific sample sizes used for each individual material test (e.g., number of blocks tested for flexural strength, or specific number of samples for biocompatibility). It references ISO and ASTM standards, which typically specify minimum sample sizes for their respective tests.

• Test Set Description: The "test set" consists of the n!ce® for Planmill glass-ceramic blocks.
• Sample Sizes: Not explicitly stated in terms of exact numbers, but testing was conducted according to international standards (e.g., ISO 6872, ISO 7991, ISO 10993 series, ASTM F1980). These standards would dictate the minimum sample sizes required for statistically valid results.
• Data Provenance: The studies were conducted by Institut Straumann AG. The country of origin of the data is not specifically mentioned, but given the company's location (Switzerland), it is likely European. The studies are prospective in the sense that they were conducted specifically for this submission to evaluate the new device against established benchmarks and the predicate device.

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

This type of information is not applicable to this 510(k) submission. This device is a material, not an AI or diagnostic device that requires expert human interpretation of results to establish "ground truth" for a test set. The "ground truth" here is defined by objective material properties measured according to established scientific and engineering standards (e.g., chemical composition, mechanical strength, biocompatibility), not by expert consensus or interpretations of images as would be the case for a diagnostic AI.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or subjective clinical endpoints, often in the context of diagnostic performance or clinical trials. As this is a material science and engineering evaluation, such methods are not used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic imaging devices or AI algorithms that assist human readers in interpreting medical cases. The device in question is a dental material, not a diagnostic tool or AI.

6. Standalone Performance Study

Yes, a form of "standalone" performance was done, in the sense that the material itself was characterized and tested against various international standards and its own specifications. The performance data listed (e.g., ISO 6872, ISO 7991, ISO 10993 series, ASTM F1980, simulated use validation, mandrel-block adhesion) represent tests performed on the n!ce® for Planmill blocks to demonstrate their inherent properties and functionality. This is akin to standalone performance for a material device, showing it meets established technical and safety benchmarks.

7. Type of Ground Truth Used

The "ground truth" for this material device is based on objective scientific and engineering measurements of its physical, chemical, and biological properties, as defined by international standards (e.g., ISO, ASTM). This includes:

• Material properties: Chemical composition, crystallization state, dimensions, flexural strength, radioactivity, chemical solubility, CTE, glass transition temperature.
• Biocompatibility: Demonstrated through adherence to ISO 10993 series, which involves specific laboratory tests (e.g., cytotoxicity, chemical characterization).
• Functional performance: Machinability, mandrel-block adhesion, and resistance to environmental factors (transport, storage).

There is no reliance on expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or treatment efficacy studies. Comparisons were made against the properties of the predicate device (n!ce Glass Ceramic Blocks K160262), which itself would have had its "ground truth" established through similar objective measurements and standards.

8. Sample Size for the Training Set

This is not applicable. The concept of a "training set" refers to data used to train machine learning algorithms. The n!ce® for Planmill is a physical material, not an AI or software device that undergoes training.

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

This is not applicable for the reasons stated above (no training set for a physical material device).

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