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BruxZir Steel™ can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading and to produce a strong prosthesis with a porcelain-like finish. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.

BruxZir Steel™ is a Coloring Liquid used to produce a natural whitening effect while increasing the flexural strength and fracture toughness of 4.6 - 4.9 mol% yttriastabilized zirconia (YSZ). The product increases the shade esthetics of the restoration while maintaining the translucency. Application of the zirconia substrate prior to sintering provides enhanced shade characteristics and improved flexural strength and fracture toughness.

This document pertains to the 510(k) premarket notification for BruxZir Steel™, a dental coloring liquid. The submission focuses on demonstrating substantial equivalence to a predicate device, DMAX Coloring Liquid (K173769), and referencing ZirBlank®-FS (K070045) for certain features.

Based on the provided text, the device is a Class II dental device (Regulation Number: 21 CFR 872.6660, Product Code: EIH). The evaluation presented is primarily a non-clinical study to demonstrate performance characteristics and biocompatibility. As such, the concept of "acceptance criteria" and "device performance" relating to clinical outcomes, AI assistance, or human reader studies is not applicable here. Similarly, ground truth establishment would refer to laboratory testing standards rather than expert consensus on medical images.

Here's an analysis of the provided information within the context of this specific device's evaluation:

1. Table of Acceptance Criteria and Reported Device Performance

For this non-clinical submission, the "acceptance criteria" are based on meeting established standards for dental materials and demonstrating properties comparable to or exceeding those of predicate/reference devices.

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

The document does not specify exact sample sizes for each non-clinical test (e.g., number of samples for flexural strength, number of animals for biocompatibility). However, it indicates that testing was performed according to the specified ISO standards (ISO 10993-5:2009, ISO 10993-10:2010, ISO 6872:2015, ISO 11664-4:2019). These standards typically define minimum sample sizes for reliable results.

• Data Provenance: The studies are non-clinical, laboratory-based tests conducted by the manufacturer, Prismatik Dentalcraft, Inc. The country of origin of the data is not explicitly stated but is implied to be in the USA, where the company is located (Irvine, California). The studies are prospective in nature, as they were conducted specifically to support this FDA submission.

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

This section is not applicable in the traditional sense of medical imaging or clinical diagnostic studies. For non-clinical performance and biocompatibility testing, "ground truth" is established by adherence to validated international standards and protocols. The "experts" would be the chemists, material scientists, and laboratory technicians performing the tests, whose qualifications are implicit in their ability to conduct such highly technical and standardized evaluations. There is no mention of a panel of human experts reviewing test results for "ground truth" adjudication.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving reader interpretations. For non-clinical laboratory tests, the results are quantitative measurements or qualitative assessments (e.g., pass/fail for biocompatibility) based on predefined criteria within the test standards, not on expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that are interpreted by multiple human readers (e.g., radiologists interpreting images) to assess the impact of a device (like AI assistance) on human performance. BruxZir Steel™ is a dental material, not a diagnostic imaging device, and its evaluation did not involve human readers interpreting cases.

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

Not Applicable. This concept applies to AI algorithms. BruxZir Steel™ is a physical dental material; it does not involve any AI algorithm or software.

7. The Type of Ground Truth Used

For this submission, the "ground truth" for the device's performance characteristics was based on:

• Established International Standards: ISO 10993 (Biocompatibility), ISO 6872 (Mechanical Properties), and ISO 11664-4 (Colorimetry). These standards dictate the methodologies and criteria for evaluating the material properties.
• Reference Devices: Performance criteria were also benchmarked against the properties of the ZirBlank®-FS (K070045) reference device for flexural strength, fracture toughness, and solubility.

8. The Sample Size for the Training Set

Not Applicable. This term refers to the data used to train machine learning models. BruxZir Steel™ is a physical medical device, not an AI/ML algorithm.

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

Not Applicable. As explained above, there is no AI/ML model or "training set" for this device.

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