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This device entitled: Nano-TiCrown ™ Titanium Metal Alloy Dental Device (aka: Nano-TiCrown ™ ) is a Titanium/Titanium Nitride based alloy intended for use as a base metal alloy in the making of single unit device porcelain-fused-to-metal (PFM) prosthetic dental materials and custom-made dental prosthetic devices, such as a porcelain-to-metal veneer for a tooth. The Nano-TiCrown ™ is intended to be used as a single unit coping device, i.e., a PFM dental restorative device is not intended for use on metal only or other non-ceramic porcelain restorations. Nano-TiCrown ™ is a Class II (non-exempt) medical device that is described within the Dental Products medical specialty panel of the U.S. Food and Drug Administration (FDA), under FDA Regulation Number 21 CFR 872.3710, and Product Code: EJH. The Nano-TiCrown ™ device is recommended for all anterior and posterior tooth dental crown restorations. This Titanium Nitride coping device (i.e., Nano-TiCrown ™) is to be used by dental laboratories in the fabrication of PFM dental crowns for dentists, This Nano-TiCrown ™ is intended to be marketed to medical professionals and for point-of-care use, and is not intended for sale over-the-counter in its current design. [Warning: This device should be used with caution where the patient has known metal allergies and specifically is not intended to be used where known patient allergies to Titanium exist].

The Nano-TiCrown ™ Titanium Nitride dental coping substructure for full fused porcelain to metal PFM devices, consists of a Titanium Nitride substructure. The Nano-TiCrown ™ device is intended to be used in single unit coping dental restorative devices with full porcelain to metal coverage for PFM devices.

Here's a summary of the acceptance criteria and study information for the Nano-TiCrown™ device, organized as requested:

Acceptance Criteria and Device Performance

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document does not specify a distinct "test set" in the sense of a clinical or imaging study with a defined number of cases. Instead, the "test set" refers to samples of the Nano-TiCrown™ material that underwent various laboratory tests. The number of samples for each test (e.g., chemical composition, biocompatibility, mechanical properties) is not explicitly stated, but the testing was performed on the device material itself.
   • Data Provenance: The data originates from laboratory testing performed according to international and national standards (ISO, ASTM, ADA/ANSI). The country of origin for the testing itself is not specified but is implicitly associated with the material fabrication and relevant testing facilities. The study is retrospective in the sense that data was collected from manufactured material, not from a prospective clinical trial.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is not applicable as the "ground truth" for material properties is established by adherence to recognized international and national consensus standards (e.g., ISO 9693:1999(E), ASTM B 265-02, ISO 10993:1997(E)). These standards define the methodologies and acceptable ranges for various material properties. The experts involved would be the certified laboratory personnel performing the tests and ensuring compliance with these standards, rather than clinical experts providing diagnostic ground truth.

3. Adjudication method for the test set:

   • Not applicable. The "adjudication" is compliance with the specified quantitative and qualitative parameters outlined in the referenced consensus standards. Test results either meet or do not meet these predefined criteria.

4. 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:

   • Not applicable. This device is a dental material (base metal alloy), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers or AI assistance are not relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable, as it is not an algorithm or AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Ground Truth: Adherence to established international and national consensus standards for dental materials and biocompatibility (e.g., ISO 9693:1999(E), ASTM B 265-02, ISO 10993-1:1997(E), ANSI/ADA Specification NO. 41). These standards define ideal material properties and acceptable performance ranges.
   • For chemical composition, the ground truth also references CRC publish composition data.

7. The sample size for the training set:

   • Not applicable. This is a material science and biocompatibility study, not a machine learning study requiring a training set. The "development" and "refinement" of the material would involve iterative testing of various compositions and manufacturing processes, but not in the context of a "training set" for an algorithm.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set mentioned in the context of this device's evaluation.

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