(138 days)
Perma Fiber / Perma Mesh is indicated for use as reinforcement for:
- · Manufacturing or repair of full or partial dentures, overdentures and orthodontic appliances
- · Temporary and/or permanent plastic/composite crowns and bridges
- · Custom splinting for immobilization of teeth
Perma Fiber / Perma Mesh glass fiber reinforcement material
This document is a 510(k) summary for the Perma Fiber / Perma Mesh dental reinforcement material. It primarily focuses on demonstrating substantial equivalence to a predicate device and obtaining marketing clearance. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or performance study would for a diagnostic or AI-driven device.
The provided text describes the administrative information, device name and classification, and intended use. The FDA letter confirms the substantial equivalence determination for marketing based on the information provided in the 510(k) submission.
Therefore, I cannot extract the requested information in the format provided because the document type does not typically elaborate on clinical study design, performance metrics, ground truth establishment, or multi-reader multi-case studies for this type of dental material.
In summary, the 510(k) process for a device like "Perma Fiber / Perma Mesh" primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves comparing material properties, design, and intended use, rather than extensive clinical studies with specific performance metrics and ground truth as would be seen for a diagnostic or AI device.
Therefore, many of the requested fields are not applicable or the information is not present in the provided 510(k) summary.
Here's how the information would be presented if it were available in this document:
1. A table of acceptance criteria and the reported device performance
- Not Applicable/Information Not Present in the Provided Document: For a dental material like Perma Fiber/Perma Mesh, acceptance criteria would typically relate to physical and mechanical properties (e.g., flexural strength, bond strength, wear resistance, biocompatibility) as measured in benchtop or in vitro studies. No specific acceptance criteria or corresponding device performance results are detailed in this 510(k) summary. The summary focuses on regulatory clearance based on substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Information Not Present: This document does not describe a "test set" in the context of clinical performance evaluation or data analysis for a diagnostic or AI device.
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/Information Not Present: Ground truth establishment by experts is typically relevant for diagnostic devices or AI applications. This document does not describe such a process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Information Not Present: Adjudication methods are relevant for resolving discrepancies in expert opinions for diagnostic ground truth. This is not applicable to this 510(k) summary.
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/Information Not Present: Perma Fiber / Perma Mesh is a physical reinforcement material, not a diagnostic tool or an AI-assisted device. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Information Not Present: This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Information Not Present: "Ground truth" as a concept for performance evaluation is not relevant for this material's 510(k) submission. For materials, the "truth" would be adherence to specified material properties and biocompatibility.
8. The sample size for the training set
- Not Applicable/Information Not Present: There is no "training set" as this is not an AI or machine learning device.
9. How the ground truth for the training set was established
- Not Applicable/Information Not Present: There is no "training set" or associated ground truth for this type of device.
§ 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.