(48 days)
Direct restorations of Black classes I V. ●
Direct composite veneers .
Shape corrections of teeth .
Temporary splinting of teeth loosened by trauma or periodontal disease .
. Indirect restorations (inlays, veneers)
. Restoration of primary teeth
Core build-up .
Temporary repairs of composite and ceramics (in combination with a suitable . repair system)
An improved light curing dental filling composite was developed within the scope of the project NEUN on the base of customary radical cross linking (meth)-acrylate monomers and dental glass fillers. The material is characterized by the following properties in detail:
- The material is a light curing nano hybride composite. .
- . The monomer matrix included is a particularly low-shrink mixture of polyether and urethane monomers preponderantly.
- A special TCD backbone monomer makes the excellent mechanical properties and the low . shrinkage possible. (TCD = tricyclodecane)
- . The composite material does not contain any Bis-GMA monomer making it toxicologically advantageous, as no Bisphenol-A can be released.
- The filler contained is a mixture of various particle size fractions of a customary, radiopaque dental . alass.
- The composite material contains non-agglomerated nano particles cross-linking to the polymer . network.
- . The material has a pasty consistency and can be applied plastically into the cavity. It is hardly sticky, packable, can be moulded, cured by blue light and polished with common systems.
- . Handling is comparable with customary light curing dental composite materials. For deeper cavities layering technique is recommended.
In its unpolymerized state, the composite material is plastically workable (pliable) similar to current products. Using a special initiator system reduced the sensitivity to ambient light. Cross-linking reaction is initiated with light curing devices (QTH, LED) customary in dental technology. Radical cross-linking of the (meth)- acrylate monomers occurs very fast, ensuring complete curing of a layer with a thickness of over 2 mm in an irradiation time of 20 seconds.
Thus, a highly cross-linked composite material results, fully complying with the mechanical requirements for a dental filling material in the Black classes I, II, III, IV and V according to the international standard EN ISO 4049.
The provided text describes a new dental filling composite named NEUN and its evaluation for regulatory clearance. Here's a breakdown of the acceptance criteria and the study performed, based only on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on established international standards for dental restorative materials.
| Acceptance Criterion (Standard/Property) | Reported Device Performance (NEUN) |
|---|---|
| Biocompatibility (EN ISO 10993-1) | Verified; did not show a significant toxicological reaction. Meets requirements of DIN EN ISO 10993 standard. Positive benefit/risk-relation. |
| Physical Properties (EN ISO 4049) | Fully complies with mechanical requirements for dental filling material in Black classes I, II, III, IV and V. Meets requirements of the harmonized standard for dental restorative materials of all cavity classes (type 1, class 2, group 1). Shows similar or better results compared to registered and commercially available products in in-vitro tests. |
| Clinical Effectiveness/Safety (MEDDEV 2.7.1) | Expected to exhibit claimed technical results. Potential undesirable clinical effects and risks seem well controlled and acceptable when weighed against benefits. Positive risks versus benefits ratio can be stated by the Expert. Application of NEUN considered safe based on risk analysis (DIN EN ISO 14971). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for any specific test set in the context of clinical or physical property evaluation. It refers to "in-vitro tests" for physical properties and "clinical studies" and a "clinical investigation report" for clinical evaluation.
- Physical Properties: "All important properties were proved with in-vitro tests." No sample size is given.
- Biocompatibility: "The biological compatibility... was verified in accordance with the international standard." "A certified laboratory has confirmed the prototype of NEUN meets the requirements of the DIN EN ISO 10993 standard." No specific sample size or data provenance (e.g., country of origin, retrospective/prospective) for the biocompatibility testing is provided, beyond the mention of a "laboratory prototype" and a "prototype from the production."
- Clinical Evaluation: "Based on the results of the clinical studies..." No sample size or data provenance is detailed for the clinical studies mentioned. The clinical evaluation followed MEDDEV 2.7.1.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Biocompatibility: The evaluation was conducted by a "certified laboratory." The "benefit/risk-relation has to be judged as positive" and was "discussed in a Biological Evaluation Report." No specific number or qualifications of experts involved in establishing ground truth for biocompatibility were explicitly stated, beyond the implicit expertise of a certified laboratory.
- Clinical Evaluation: "Therefore, a positive risks versus benefits ratio can be stated by the Expert for NEUN..." This indicates at least one "Expert" was involved in the clinical evaluation. No specific qualifications (e.g., "radiologist with 10 years of experience") are provided for this expert.
4. Adjudication Method for the Test Set
The document does not explicitly mention any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in any of the evaluations (biocompatibility, physical properties, or clinical evaluation).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, the document does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. The evaluation focuses on the performance of NEUN against established standards and competitor materials, not on human readers' improvement with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This device is a dental composite material, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply to this device. The physical and clinical evaluations are about the material itself.
7. The Type of Ground Truth Used
- Biocompatibility: Ground truth was established based on compliance with the DIN EN ISO 10993 standard and the toxicological assessment results from the certified laboratory.
- Physical Properties: Ground truth was established by compliance with the EN ISO 4049 standard and comparison with "best competitor materials" and "registered and commercially available products" via "in-vitro tests."
- Clinical Evaluation: Ground truth for clinical performance and safety was assessed through a "clinical evaluation in accordance with MEDDEV 2.7.1," which likely involved evaluating scientific data, clinical research, and technical results against established clinical benefits and potential risks, leading to an expert's conclusion on the benefit/risk ratio. This would typically be based on clinical outcomes and safety data and expert judgment.
8. The Sample Size for the Training Set
The document does not refer to a "training set" as this is a dental material, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as 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.