(73 days)
As reinforcement for:
- Crown and Bridge (Composite)
a. Multiple unit bridges
b. Inlay Bridges - Provisional Crown and Bridge
a. Multiple unit bridge
b. Inlay bridges - Splint Device reinforcement (Bruxism Appliance)
- Splinting of teeth
- Orthodontic Appliances
TESCERA U-Bar and Barrel Fiber Reinforcement Materials are epoxy resin impregnated quartz fibers for reinforcing dental composite and acrylic restorative materials. The TESCERA U-Bar comes in a U Bar shape, and the TESCERA Barrels come in rod shapes with different size diameters They are designed to be used with the TESCERA indirect composite system but should be effective with other indirect and direct systems
This 510(k) submission for TESCERA U-Bar and Barrels does not describe specific acceptance criteria beyond "substantially equivalent" to its predicate device, everStick. The study that proves the device meets this "acceptance criteria" is a side-by-side comparison of the applicant device to the predicate device, demonstrating overall substantial equivalence.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (everStick) | "Side by side comparisons... clearly demonstrates that the applicant devices are substantially equivalent to the legally marked devices." Additionally, "TESCERA U-Bar and Barrels were tested for biocompatibility and they was found to be non-toxic. It is concluded that the information supplied in this submission has proven the safety and efficacy of TESCERA U-Bar and Barrels." |
| Biocompatibility | Found to be non-toxic. |
Note: The document does not specify quantitative performance metrics or specific thresholds for "substantial equivalence" beyond the general statements provided. This is typical for 510(k) submissions relying on substantial equivalence to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Side by side comparisons" and "tested for biocompatibility."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not mention the use of experts to establish ground truth for any test set or any qualifications of such experts. The evaluation appears to be based on direct comparison to the predicate device and biocompatibility testing.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for a test set.
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
Not Applicable. This device is a dental material (fiber reinforcement material), not an AI/software device. Therefore, no MRMC study involving human readers or AI assistance would be relevant or expected.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a dental material, not an algorithm or software device.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data) is not directly applicable to this type of dental material. The "truth" for this device's performance is established by demonstrating its material properties (biocompatibility) and functional equivalence (reinforcement capabilities) to a legally marketed predicate device. The document implies:
- Predicate Device Performance as a benchmark: The existing standard of performance set by the everStick device serves as the implicit "ground truth" for what constitutes acceptable "reinforcement material" performance.
- Biocompatibility testing results: The "non-toxic" finding from biocompatibility tests represents a measurable "ground truth" for safety.
8. The Sample Size for the Training Set
The document does not mention a "training set." This is a material-based device submission, not a machine learning or AI algorithm.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set mentioned, there is no ground truth established for it.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.