(50 days)
· Single crowns
· Bridges with a maximum of one pontic between two crowns
· Inlays, onlays, and veneers
XP202 zirconia blanks are used for the fabrication of esthetic zirconia restorations. The blanks are available in various heights and shades based on the Vita™ Classical shade guide. After sintering, restorations display a gradient shading and inherent fluorescence. The restorations are designed using dental CAD software and the data is converted into milling paths by CAM software. The blanks can be processed in milling units suitable for pre-sintered zirconia. Milled restorations must be final sintered in a furnace suitable for zirconia per the cycle designated for XP202.
The provided text pertains to the 510(k) premarket notification for the device XP202, a porcelain powder for clinical use (zirconia blanks for dental restorations). The document focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed clinical study with human readers or a specific acceptance criteria table for performance metrics like sensitivity/specificity.
Therefore, much of the requested information regarding clinical study design, human reader performance, and detailed statistical analysis of AI performance is not available in the provided text. The evaluation is primarily based on in vitro testing and comparison to recognized standards and predicate devices' properties.
Here's the information that can be extracted or inferred from the document:
1. A table of acceptance criteria and the reported device performance
The document states that in vitro testing was conducted to show that XP202 fulfills the requirements of FDA recognized standard ISO 6872: "Dentistry Ceramic materials" and compares its performance (flexural strength, chemical solubility, linear thermal expansion) to predicate devices. It concludes that "The results of XP202 are similar to Katana STML. The difference between XP202 and Lava Plus are their flexural strength and is addressed by limiting the indications to three unit bridges according ISO 6872."
Since a specific table of acceptance criteria with numerical values is not explicitly presented in the document, here's a conceptual representation based on the text:
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Standards Compliance | Fulfills requirements of ISO 6872: Dentistry Ceramic materials | Fulfilled |
| Flexural Strength | Similar to predicate device Katana STML; Meets requirements for indicated uses per ISO 6872 | Similar to Katana STML; Differences from Lava Plus addressed by limiting indications to 3-unit bridges per ISO 6872 |
| Chemical Solubility | Similar to predicate device Katana STML | Similar to Katana STML |
| Linear Thermal Expansion | Similar to predicate device Katana STML | Similar to Katana STML |
| Biocompatibility | Meets recommendations from FDA guidance and international standards (ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 7405) | Assessed by board-certified toxicologist; concluded safe for intended use |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for the in vitro tests. The document mentions "in vitro testing", but not the number of samples or items tested.
- Data Provenance: The tests are "in vitro testing", meaning conducted in a laboratory setting. The origin of the raw materials (zirconia blanks) would be from 3M Deutschland GmbH, Germany.
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 as the 'ground truth' for this device is established through in vitro measurements against recognized material standards (ISO 6872), not through expert interpretation of clinical images or data with human-in-the-loop.
- For biocompatibility, a "board-certified toxicologist" assessed the product, implicitly establishing "ground truth" for safety from a toxicological perspective.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as this refers to adjudication of discrepancies in expert readings, which is not part of the described in vitro material testing.
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
- No, an MRMC comparative effectiveness study was not done. This device is a material (porcelain powder/zirconia blank) used for dental restorations, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not relevant. The device is a material, not an algorithm. Its performance is evaluated through material properties in a laboratory setting, not through an algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the performance testing, the ground truth is established by physical and chemical measurements of material properties (flexural strength, chemical solubility, linear thermal expansion) as defined by the ISO 6872 standard for dentistry ceramic materials.
- For biocompatibility, the ground truth is established by compliance with ISO 10993 series standards and FDA guidance on biological evaluation of medical devices, assessed by a board-certified toxicologist.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm and therefore does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
§ 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.