(72 days)
x-tra fil is intended for light curing class I and class II posterior fillings and core build-up.
x-tra fil is a hybrid resin composite restorative material for use in filling posterior dental cavities. The restorative consists of a single paste that is visible/blue light cured.
This document is a 510(k) summary for a dental restorative material called "x-tra fil". It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission does not typically include detailed performance studies with acceptance criteria, sample sizes, or ground truth establishment in the way that, for example, an AI/ML medical device submission would.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for device performance is NOT available in this document.
Instead, this document focuses on demonstrating substantial equivalence based on:
- Technological Characteristics: Stating that all components of "x-tra fil" are found in legally marketed predicate devices (K 040144, K 994056, K 926458, K 040769, K 030914, K 912425).
- Prior Use: Arguing that the prior use of these components in legally marketed devices negates the need for additional cytotoxicity, mutagenicity, or biocompatibility studies.
- Intended Use: Clearly defining the intended use as "posterior Class I and Class II cavities and core build-up."
To address your prompt as much as possible with the provided text, here's a breakdown of what is and is not present:
1. A table of acceptance criteria and the reported device performance
- Not Applicable/Not Provided: This document does not present specific performance criteria or a table comparing them to reported device performance. It relies on substantial equivalence to predicate devices for its safety and effectiveness claims.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided: No test set or associated sample size is mentioned, nor is any clinical study data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable/Not Provided: No test set or ground truth establishment by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided: No test set or adjudication method is described.
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/Not Provided: This device is a dental restorative material, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Provided: As this is a physical dental material, there is no algorithm or standalone performance testing in the sense of AI/ML devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable/Not Provided: No specific ground truth methodology is mentioned for this type of device submission. The "truth" here is established primarily through the compositional similarity to previously approved materials.
8. The sample size for the training set
- Not Applicable/Not Provided: There is no "training set" in the context of an AI/ML device for this submission. The device's safety and effectiveness are established through its chemical composition and the history of its individual components in other marketed devices.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided: See explanation for point 8.
Summary of Device Rationale from the Document:
The manufacturer, VOCO GmbH, is asserting that "x-tra fil" is substantially equivalent to predicate devices. Their rationale is based on:
- Identical Components: All components of "x-tra fil" are already found in several legally marketed devices (K 040144, K 994056, K 926458, K 040769, K 030914, K 912425).
- Inference of Safety and Effectiveness: Because the components have a history of safe and effective use in other FDA-cleared devices, the manufacturer concludes that "additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary." They believe this prior use and the provided performance data (though not detailed here) support the safety and effectiveness for its intended use.
The FDA's response confirms that they have reviewed the 510(k) and found the device substantially equivalent to legally marketed predicate devices, allowing the manufacturer to market it, subject to general controls.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.