(47 days)
Fabrication of temporary crowns, bridges, inlays, onlays and veneers.
Fabrication of long-lasting temporary restorations. Lining material for prefabricated temporary crowns made of composite and metal.
TempXN28 is a temporary crown and bridge resin intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. Temporary crown and bridge resin is designated at 21 C.F.R § 872.3770 as a Class II device.
Like Protemp™ 3 Garant™, TempXN28 is available in the proven Garant™ mixing and dispensing system.
The provided text is a 510(k) Summary for a dental material (TempXN28) and not a study describing the performance of an AI/ML powered device. As such, the requested information pertaining to AI/ML device acceptance criteria, study design, and performance metrics (e.g., sample size for test set, ground truth establishment, MRMC studies, standalone performance) is not available in the given document.
The document discusses the safety and effectiveness of the dental material TempXN28 by demonstrating its substantial equivalence to predicate devices (Protemp™ 3 Garant™, Luxatemp Fluorescence, and Sinfony).
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics for a software/AI device. For this dental material, acceptance criteria would typically involve biocompatibility, mechanical properties (e.g., flexural strength, wear resistance), polishability, color stability, and ease of use, all within acceptable ranges or comparable to predicate devices.
- Reported Device Performance: The document generally states: "To provide evidence for safety biocompatibility testing was carried out. The results show that TempXN28 is a safe device. The comparison for chemistry, performance data and indications for use shows that TempXN28 is substantially equivalent to the predicate devices."
- No specific performance values (e.g., strength in MPa, fill rate, etc.) are provided in this summary.
| Acceptance Criteria (Implied for Dental Material Equivalence) | Reported Device Performance (Implicit from Summary) |
|---|---|
| Biocompatibility (Safety) | Biocompatibility testing carried out, results show TempXN28 is a safe device. |
| Performance Data (e.g., mechanical, chemical properties) | Comparison for chemistry and performance data shows substantial equivalence to predicates. |
| Indications for Use | Substantially equivalent to predicate devices for stated indications. |
The following questions cannot be answered from the provided text as they relate to AI/ML device evaluation, which is not the subject of this 510(k) summary:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.