(27 days)
XENO® NM Light Cured Dental Adhesive is indicated for:
- Direct composite and compomer restorations for all cavity classes in anterior and posterior teeth
- Veneers
- Composite, ceramic and metal repairs
- Cavity varnish for use with fresh amalgam
The XENO® NM Light Cured Dental Adhesive is a one-component light cure self-etching and self-priming dental adhesive designed to bond composite materials and compomers to enamel and dentin as well as to metals and ceramic. XENO® NM Light Cured Dental Adhesive combines acid etching, priming and adhesive in a single bottle.
The XENO® NM Light Cured Dental Adhesive did not conduct a separate study with acceptance criteria and device performance as it is a predicate device. The information provided describes the device's characteristics and its substantial equivalence to previously marketed devices.
However, based on the provided text, we can infer some aspects related to its technological characteristics and the grounds for its acceptance.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
Since this is a predicate device applying for substantial equivalence, formal acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, specificity) against a predefined threshold are not explicitly stated for this 510(k) submission. Instead, the "acceptance" is based on its similarity to legally marketed predicate devices and established safety through biocompatibility testing.
| Acceptance Criteria (Inferred from 510(k) summary) | Reported Device Performance (Inferred from 510(k) summary) |
|---|---|
| Technological Characteristics: All components present in the device have been used in legally marketed devices. | All components found in XENO® NM Light Cured Dental Adhesive have been used in legally marketed devices. |
| Biocompatibility: Device found acceptable for genotoxicity, cytotoxicity, and sensitivity. | XENO® NM Light Cured Dental Adhesive final formulation was evaluated for biocompatibility for genotoxicity, cytotoxicity, and sensitivity and found acceptable. |
| Safety and Effectiveness: Supported by prior use of components, biocompatibility data, and performance data for indicated uses. | "We believe that the prior use of the components of XENO® NM Light Cured Dental Adhesive in legally marketed devices, the biocompatibility data provided, and the performance data provided support the safety and effectiveness of XENO® NM Light Cured Dental Adhesive for the indicated uses." |
| Intended Use: Consistent with predicate devices. | Intended uses are for direct composite and compomer restorations, veneers, composite/ceramic/metal repairs, and cavity varnish for fresh amalgam. These are consistent with those of similar dental adhesives. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The submission focuses on the composition of the adhesive and its biocompatibility, rather than clinical performance data from a specific test set.
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):
This information is not provided as a formal clinical study with ground truth established by experts was not detailed in this submission. The "ground truth" for the acceptance of the device's design and materials comes from prior regulatory approvals of similar components and the results of biocompatibility testing interpreted by qualified personnel (though not explicitly named or quantified).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. As no detailed clinical test set is described, there's no mention of an adjudication method.
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:
This information is not applicable as the device is a dental adhesive, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance comparison would have been performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a dental adhesive, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's acceptance is based on:
- Prior regulatory approval/history of components: The fact that all components have been used in legally marketed devices serves as a form of "ground truth" for material safety and efficacy in dental applications.
- Biocompatibility testing results: The device underwent standard genotoxicity, cytotoxicity, and sensitivity testing, with "acceptable" results serving as the ground truth for biological safety.
8. The sample size for the training set:
This information is not provided. As this is not an AI/machine learning device, there wouldn't be a "training set" in that context. The "training" for the device's design and development comes from existing knowledge of dental materials and their performance.
9. How the ground truth for the training set was established:
This information is not provided. Similar to point 8, the concept of a training set and its ground truth in the context of AI/machine learning does not apply to this type of medical device. The "ground truth" for its development is based on established dental material science and regulatory precedents.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.