(81 days)
As reinforcement for:
- Removable dentures
- Crown and bridge (Composite)
a. single units
b. multiple unit bridges
c. inlay bridges
d. Maryland Bridges - Provisional Crown and Bridge
a. single units
b. inlay bridges
c. multiple unit bridges
d. Maryland Bridges - Splint device reinforcement (Bruxism Appliance)
- Splinting of teeth
- Orthodontic Appliances
TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders are glass fiber reinforcement materials for composite and acrylic dental restorative materials. The TESCERA Fiber Bundles are loose fiber bundles. The TESCERA Fiber Mesh is a plain woven mesh. The TESCERA Fiber Cylinders are woven cylinders (sleeves) that come in several 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 is for a medical device called TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders. This device falls under the category of a Class II medical device, specifically 21 CFR 872.3760 Denture Relining, Repairing, or Rebasing Resin. The submission demonstrates substantial equivalence to "Ribbond-Triaxial from Ribbond, Inc, cleared under K013881".
The submission focuses primarily on claiming substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria based on pre-defined performance metrics. The data presented is purely descriptive and does not include numerical performance results, statistical analyses, or the detailed study design typically associated with a clinical or non-clinical performance study.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, there are no explicit, quantifiable acceptance criteria or reported device performance metrics given in a tabular format as would be expected for a detailed performance study. The submission relies on a qualitative comparison to a predicate device.
The "Technological Characteristics" section attempts to draw a parallel:
| Technological Characteristics | TESCERA Fiber Bundles, Fiber Mesh, and Fiber Cylinders | Ribbond-Triaxial |
|---|---|---|
| Intended use | Reinforcing Material | Reinforcing Material |
| Form | Fiber bundles, woven fiber mesh and woven fiber cylinders | Woven fiber ribbon |
| Physical/Mechanical Properties | Increases the Flexural Strength of dental materials | Increases the Flexural Strength of dental materials |
However, this table does not present acceptance criteria or specific performance values. It merely states that both the applicant device and the predicate device "increase the flexural strength of dental materials" without quantifying the increase, setting a minimum threshold, or comparing them numerically. The conclusion of substantial equivalence is drawn from "side by side comparisons" and "biocompatibility" testing, without detailing the results of these comparisons or tests.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. There is no mention of a specific "test set" in the context of performance evaluation, sample sizes used for any mechanical testing (e.g., flexural strength), or the provenance (country of origin, retrospective/prospective) of such data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable/not provided. The submission does not describe a study involving expert assessment to establish a "ground truth" for a test set. This type of assessment is typically relevant for diagnostic devices that rely on expert interpretation. This device is a material used for reinforcement.
4. Adjudication Method for the Test Set
This information is not applicable/not provided for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable/not done as per the provided text. MRMC studies are typically used for diagnostic imaging devices to assess the performance of humans with and without AI assistance. This device is a dental reinforcement material.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
This information is not applicable/not done. This device is a physical material, not an algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this submission.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable here. For this type of material device, the "truth" would be established through physical and mechanical testing (e.g., flexural strength, biocompatibility) rather than expert consensus on diagnostic images or pathology. The document indicates that the device was "tested for biocompatibility and they were found to be non-toxic" and that it "increases the Flexural Strength of dental materials," which implies these properties were measured, but the specific methodologies, results, and thresholds are not detailed.
8. Sample Size for the Training Set
This information is not applicable/not provided. There is no "training set" mentioned or implied, as this is a physical device, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as point 8.
§ 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.