(86 days)
X-cera Pre-shaded Zirconia Blanks are Intended for use with CAD/CAM technology to produce all ceramic dental restorations as prescribed by a dentist. All blanks are processed through dental laboratories or by dental professionals
"X-cera Pre-shaded Zirconia Blanks" is derived from zirconia powder that has been processed through various molding and sintering techniques - into their final net shapes. These blanks are then further fabricated into various prosthetic dental devices intended for use in the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. The zirconia powder is composed of ZrO2+ Y2O3 + HfO2+ Fe2O3+ Er2O3+ Al2O3. The performance of formed zirconia dental blanks conforms to ISO 6872, Dentistry, Ceramic Materials.
"X-cera Pre-shaded Zirconia Blanks" is ceramic dental blanks designed for the manufacture of ceramic dental prosthetic devices. The dental prosthetic devices are fabricated by CAD/CAM machining processes. All prosthetic dental devices are intended for single use applications. At the dental lab, the blanks are held to the CAD/CAM machine which is used to machine to the final dental restoration. At the completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2 so that its final properties can be achieved.
"X-cera Pre-shaded Zirconia Blanks" is supplied in different shapes, such as blocks, discs, rods, or customer ordered shapes. It is also supplied in the combinations of forty nine different colors. The different colors are originated from the different constituent of color additives (such as Fe2O3, Er2O3).
The provided text describes a 510(k) premarket notification for "X-cera Pre-shaded Zirconia Blanks," a dental device. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing (physical and chemical properties) and biocompatibility testing. It does not describe an AI/ML-driven medical device, nor does it involve a study with human readers, ground truth derived from expert consensus/pathology, or the typical metrics (sensitivity, specificity, AUC) associated with such devices.
Therefore, many of the requested details for an AI/ML device (e.g., sample size for training/test sets, expert qualifications, HRMC studies, standalone performance with AI, effect size of human improvement with AI) are not applicable to this submission.
Here's a breakdown of the information that is applicable, based on the provided text, and an explanation of why other points are not.
Acceptance Criteria and Device Performance (based on provided text):
The acceptance criteria are generally "met specifications" and "met all relevant requirements in the test standard" (ISO 6872 for performance, ISO 10993 for biocompatibility). The performance is presented as a comparison to the predicate device, not in terms of specific numerical thresholds for each test, but rather that the results were "very similar" or "comparable."
| Criterion Type | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|
| Physical/Chemical Performance | Meets specifications per ISO 6872:2015 for dental ceramic materials | "All tests were verified to meet acceptance criteria." / "Test results on radioactivity, pre-sintered density, sintered density, and flexural strength of the subject device are very similar to the predicate device." |
| Biocompatibility | Meets requirements per ISO 10993 (various parts) | Cytotoxicity: No cytotoxicity effect (met acceptance criteria). |
| Irritation Oral Mucosa: Not a primary oral mucosa irritant (met acceptance criteria). | ||
| Sensitization: Not a sensitizer (met acceptance criteria). | ||
| Subacute/Subchronic Toxicity: No subchronic toxic effects observed (met acceptance criteria). | ||
| Genotoxicity: No genotoxic effects observed (met acceptance criteria). |
Information NOT Applicable/Available for this Device Type (AI/ML Context):
Most of the questions relate to studies for AI/ML devices, which are not relevant here. The "device" in this context is a physical material (zirconia blanks) used for dental restorations, not a software algorithm.
Here's why and what's explicitly not available or applicable:
- Sample sizes used for the test set and the data provenance: This refers to the number of cases or patients in a clinical image dataset for AI evaluation. For a physical material, "test set" would refer to the number of material samples tested. The document states "Bench testing was performed per ISO 6872:2015 and internal procedures." It does not specify the number of individual blanks or samples tested for each property (e.g., flexural strength). There is no "data provenance" in the sense of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is entirely irrelevant. "Ground truth" for this device's performance is established by physical and chemical laboratory tests (e.g., measuring flexural strength, chemical composition, performing biocompatibility assays), not human expert interpretation of medical images.
- Adjudication method for the test set: Not applicable. There is no human interpretation or "adjudication" of findings.
- 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 does not involve human readers interacting with AI.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on standardized laboratory measurements and chemical analysis as defined by ISO standards (ISO 6872 for performance, ISO 10993 for biocompatibility).
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary regarding the provided document's context:
The FDA 510(k) clearance process for a physical dental material like zirconia blanks focuses on demonstrating safety and effectiveness by showing that the material performs as intended (e.g., strength, durability) and is biocompatible, and that it is substantially equivalent to a legally marketed predicate device. This is done through well-established bench testing (physical property measurements) and biocompatibility studies, not through clinical studies involving patient data, expert readers, or AI performance metrics.
§ 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.