(35 days)
SternVantage Varnish LC is a surface sealing and finishing material for use on polymerized composite surfaces, denture bases, and temporary crowns and bridges.
The Stern Vantage Varnish LC material is a single-component, acrylate-based, light-curing surface coating material for dental applications.
The provided PMA (Premarket Approval) documentation for SternVantage Varnish LC explicitly states that no performance or safety data was included in the premarket notification. Therefore, this device did not undergo a study to demonstrate it met acceptance criteria in the traditional sense of a clinical trial or performance validation study.
Instead, the device's approval was based solely on its substantial equivalence to a predicate device (Palaseal material marketed by Kulzer, Inc.) concerning its design and performance characteristics.
Given this, I cannot provide the requested information in the format for a device that underwent performance testing against acceptance criteria. However, I can explain why I cannot and what information is available based on the provided text.
Here's the breakdown of why the requested information cannot be fully provided:
- No Acceptance Criteria or Reported Device Performance: The document clearly states, "Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification." This means there were no defined acceptance criteria for a new study, and no performance metrics from a new study to report. The acceptance was based on the assumption that if the new device has similar characteristics to an already-approved predicate device, it meets an equivalent standard.
Therefore, many parts of your request for information about a study proving acceptance criteria cannot be fulfilled directly from this document.
However, I can extract the relevant information from the document to explain the approval context:
- Reason for Approval: Substantial Equivalence to a Predicate Device
- Predicate Device: Palaseal material marketed by Kulzer, Inc. (cleared for marketing by FDA in K892452).
Since no new study demonstrating performance against acceptance criteria was conducted for SternVantage Varnish LC as part of this 510(k) submission, the following information is not available in the provided documents:
- A table of acceptance criteria and the reported device performance: Not applicable, as no performance study was conducted.
- Sample sized used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 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 is a dental varnish, not an AI diagnostic device).
- 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 sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the Sterngold ImplaMed SternVantage Varnish LC was cleared for marketing based on its "substantial equivalence" to an existing, legally marketed predicate device, not on a new study demonstrating its performance against specific acceptance criteria.
§ 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.