(102 days)
LuxaForm Plus is indicated for the following uses:
- As a matrix in the fabrication of provisional dental crowns and bridges .
- Mini "custom tray" for impressions .
- . Articulation of diagnostic molds
- Articulation of the working cast against the opposing arch .
- For fabrication of a maxillary bite guard, a maxillary anterior or posterior . bite plate or a maxillary anterior repositioning appliance
- Direct fabrication of Maxillary sports guard in the mouth without models ●
- Bite registration material either to be used directly or in combination with . three way trays (e.g. Triple Trays from Premier)
- Reinforcement of three way trays .
- For use in functional therapeutic cases as e.g. a Lucia Jig, anterior . repositioning splint etc.
- Guiding matrix to help recreate anatomic form .
The LuxaForm Plus is a detailed quick pre-impression matrix used in the fabrication of provisional crowns and bridges and can also be used as a bite registration material.
This document is a 510(k) Summary for the LuxaForm Plus, a temporary crown and bridge resin material. The document does not describe acceptance criteria, a study proving the device meets acceptance criteria, or any of the detailed information requested for AI/ML device studies.
Instead, it focuses on demonstrating substantial equivalence to predicate devices based on similarities in design, chemical composition, and performance specifications. This is a common regulatory pathway for medical devices that are not AI/ML based.
Therefore, I cannot extract the requested information as it is not present in the provided text.
Here's a breakdown of why each point cannot be fulfilled based on the given information:
- A table of acceptance criteria and the reported device performance: Not present. The document states "Substantial equivalence for this device was based on similarities in design, chemical composition and performance specifications as compared to predicate materials." It doesn't list specific acceptance criteria or performance metrics for LuxaForm Plus.
- Sample sized used for the test set and the data provenance: No test set or data provenance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no test set or ground truth described in the AI/ML sense.
- Adjudication method for the test set: Not applicable.
- 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 document pertains to a physical dental material, not an AI/ML system assisting human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable. The "ground truth" here is the chemical composition and performance of predicate devices, not clinical outcomes or expert labels.
- The sample size for the training set: Not applicable, as no training set for an AI/ML model is mentioned.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) premarket notification for a physical dental material and does not contain the information requested about acceptance criteria and studies for an AI/ML device.
§ 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.