(43 days)
The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
BruxZir® Shaded Blanks are used for the production of full-contour zirconia and zirconia-based substructures for crowns and bridges. Four (4) thicknesses (12 mm, 15 mm, 20 mm, 25 mm) and four (4) shades (100, 200, 300, 400) are available for milling into BruxZir full-contour crowns and substructures.
The provided document is a 510(k) summary for a dental device, BruxZir® Shaded. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not contain a detailed study proving the device meets specific acceptance criteria in the way typically required for AI/software-as-medical-device (SaMD) evaluations.
The "Acceptance Criteria" and "Study" described in this document are focused on the non-clinical performance and biocompatibility of a physical dental material, rather than the performance of an AI algorithm or a SaMD.
Here's an attempt to extract and interpret the information based on the provided text, while also explicitly stating what is not present given the context of AI/SaMD.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Description (Acceptance Criteria) | Reported Device Performance |
|---|---|
| Cytotoxicity Study (ISO 10993-5) | Pass (no reaction on cells) |
| Sensitization Study (ISO 10993-10) | Pass (no reaction on tested subject) |
| Irritation Study (ISO 10993-10) | Pass (no erythema or edema on test subject) |
| Mechanical Properties: Flexural Strength | Superior, claimed (not quantified against a specific benchmark in this section) |
| Mechanical Properties: Fracture Toughness (KIC) | Superior, claimed (not quantified against a specific benchmark in this section) |
| Mechanical Properties: Resistance to Thermal Shock | Great, claimed (not quantified against a specific benchmark in this section) |
| Esthetics: Color and Translucency | Most innovative, higher translucency (not quantified against a specific benchmark in this section) |
Note on "Acceptance Criteria": For the mechanical and esthetic properties, while "superior," "great," and "higher translucency" are stated, specific numerical acceptance criteria (e.g., minimum flexural strength in MPa) and corresponding numerical test results are not provided in this summary. The "Pass" for biocompatibility tests implies meeting the ISO standard requirements.
2. Sample size used for the test set and the data provenance
- Test Set (Biocompatibility): The document states "tested subject" for sensitization and irritation. The exact sample size (number of subjects/samples) for these biocompatibility tests is not specified in the provided text.
- Data Provenance: The tests are described as "Non-clinical test data" and "laboratory testing." The country of origin is not specified. The nature is retrospective or prospective is not specified but typically, such non-clinical lab tests are conducted prospectively on newly manufactured material samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the provided document. The "device" in this context is a physical dental material (zirconia blocks), not an AI system that requires expert-established ground truth for performance evaluation in an AI/SaMD context. The biocompatibility tests are based on standardized laboratory protocols (ISO 10993 series), not expert consensus on interpretations.
4. Adjudication method for the test set
This question is not applicable as it pertains to expert disagreement resolution in diagnostic or interpretive tasks, which is not relevant for the non-clinical material testing described.
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 question is not applicable. The device is a dental restoration material, not an AI system. Therefore, no MRMC study involving human readers or AI assistance would have been performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a dental restoration material, not an AI algorithm.
7. The type of ground truth used
- For Biocompatibility: The "ground truth" for the biocompatibility tests (Cytotoxicity, Sensitization, Irritation) is implicitly defined by the ISO 10993 standards (ISO 10993-5 and ISO 10993-10). A "Pass" result indicates that the material's reaction (or lack thereof) met the established criteria within these international standards, which serve as the reference or "ground truth" for biocompatibility.
- For Mechanical/Esthetic Properties: The document claims "superior microstructure and homogeneity," "higher translucency value," "superior mechanical properties," "high flexural strength," "high fracture toughness," and "great resistance to thermal shock." While these are performance claims, the specific "ground truth" against which these were measured (e.g., a specific reference material, a numerical threshold from a standard) is not explicitly detailed for each claim in this summary.
8. The sample size for the training set
This question is not applicable. The device is a dental restoration material; there is no AI algorithm being "trained."
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.