(154 days)
- Anterior and posterior restorations
- Core build-up
- Indirect restorations for inlays, onlays and veneers.
Any-Com is a composite resin material designed for use in anterior and posterior restorations. It is composed of an enhanced zirconia filler, and all shades of the material are radiopaque. It is conveniently packaged in a syringe with a wide caliber. Dentists can dispense the material using their own instruments and apply it to the tooth. The product offers a wide range of options with a total of 20 shades available. Dentists can select shades such as A1, A2, B1, B2, etc., based on the desired brightness, yellowness, and darkness that match the patient's natural teeth. After the appropriate tooth pretreatment process for the selected shade, Any-Com is applied to the teeth using suitable instruments and in the appropriate amount. Once applied, it is permanently bonded to the tooth structure by using a photopolymerizer owned by the dentist for photocuring.
The provided document describes the FDA's 510(k) clearance for the "Any-Com" dental filling material. It does not contain information about a study proving the device meets specific acceptance criteria in the manner of a clinical trial or performance study with defined metrics like sensitivity, specificity, and sample sizes for AI/ML devices.
Instead, the document details a non-clinical performance evaluation to establish substantial equivalence to a predicate device (3M Filtek Universal Restorative), which is a different type of assessment.
Therefore, many of the requested fields cannot be filled as the information is not present in the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
The document lists several non-clinical tests performed, implying these are the metrics considered for substantial equivalence. It states that the test results "support that the subject device is substantially equivalent to the predicate devices." No specific quantitative acceptance criteria or numerical reported performance values are provided in this document.
| Acceptance Criteria (Implied by tests performed) | Reported Device Performance |
|---|---|
| Appearance | Met (Implied by S.E.) |
| Capacity | Met (Implied by S.E.) |
| Package | Met (Implied by S.E.) |
| Sensitivity to Ambient Light | Met (Implied by S.E.) |
| Polymerization Depth | Met (Implied by S.E.) |
| Flexural Strength | Met (Implied by S.E.) |
| Water Absorption | Met (Implied by S.E.) |
| Solubility | Met (Implied by S.E.) |
| Color | Met (Implied by S.E.) |
| Color Stability | Met (Implied by S.E.) |
| Radioactive Impermeable | Met (Implied by S.E.) |
| Biocompatibility (ISO 10993) | Yes |
| Conformance to ISO 4049 | Conformed |
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The tests performed are non-clinical, likely laboratory-based material property tests, not a "test set" in the context of an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. This is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for material properties is typically established by standardized test methods.
4. Adjudication method for the test set:
This information is not applicable and not provided. Again, this relates to expert review for diagnostic devices, not material property testing.
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 and not provided. The device, Any-Com, is a dental filling material, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. This device is a material, not an algorithm.
7. The type of ground truth used:
For the non-clinical performance data, the "ground truth" would be established by the standardized test methods (e.g., ISO 4049 for dental polymer-based restorative materials, ISO 10993 for biocompatibility). These standards define how to measure specific properties.
8. The sample size for the training set:
This information is not applicable and not provided. This device is a material, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
This information is not applicable and not provided. There is no training set for this type of device.
§ 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.