(287 days)
The Novidia™ Flowable Composite is indicated for:
- Class III and V restorations
- Restoration of minimally invasive cavity preparations (including small, non-stress bearing occlusal restorations)
- As base/liner under direct or indirect restorations
- Repair of small defects in esthetic indirect restorations
- Pit and fissure sealing
- Blocking out of undercuts
- Repair of resin and acrylic temporary materials
Novidia™ Flowable Composite is a low viscosity, visible light activated, radiopaque, flowable composite indicated for minimally invasive cavity preparations as well as various other indications. The resin matrix of the Novidia™ Flowable Composite contains Urethane dimethacrylate (UDMA), Bisphenol-a glycidyl dimethacrylate (Bis-GMA) and triethylene glycol dimethacrylate (TEGDMA). The inorganic filler of the Novidia™ Flowable Composite is a mix of particles of alumino-silicate-based glasses, silica dioxide and pigments. A small percentage of the silica-based filler particles are covalently bound to quaternary ammonium residues (OASi), added to maintain the integrity of the restoration. The Novidia™ Flowable Composite is provided in syringes (2 g) and in single-dose capsules (0.2 g) and is available in three shades (A1, A2 and A3).
The provided text describes a 510(k) submission for a dental device, the Novidia™ Flowable Composite. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study proving acceptance criteria for a new AI/medical image analysis device. Therefore, much of the requested information regarding acceptance criteria, study details, and AI-specific metrics is not available in the provided text.
However, I can extract and structure the available information regarding performance data, which in this case refers to non-clinical testing.
1. Table of acceptance criteria and the reported device performance:
The document outlines a series of non-clinical (bench) tests performed on the Novidia™ Flowable Composite. For several key physical properties, it states that the device was tested according to ISO 4049:2009 standards, which would implicitly define the acceptance criteria, as the statement of "performing as intended" implies meeting these standards. However, the specific numerical acceptance criteria (e.g., minimum flexural strength value) are not explicitly stated in the text, nor are the precise numerical results for the Novidia™ Flowable Composite.
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Implicitly Meets Standard) |
|---|---|
| Flexural Strength (ISO 4049:2009) | Tested and performs as intended |
| Elastic Modulus | Tested and performs as intended |
| Compression Strength | Tested and performs as intended |
| Shade and Color Stability | Tested and performs as intended |
| Polymerization Conversion Degree | Tested and performs as intended |
| Viscosity | Tested and performs as intended |
| Spontaneous Polymerization Sensitivity (Ambient Light) (ISO 4049:2009) | Tested and performs as intended |
| Water Solubility (ISO 4049:2009) | Tested and performs as intended |
| Water Sorption (ISO 4049:2009) | Tested and performs as intended |
| Depth of Cure (ISO 4049:2009) | Tested and performs as intended |
| Radio-opacity (ISO 4049:2009) | Tested and performs as intended |
| Knoop Hardness | Tested and performs as intended |
| Preservation of Surface Integrity (Resistant to microbial degradation) | Novidia Flowable Composite with 1.2% (wt/wt) QASi filler is resistant to microbial degradation evidenced by preserved surface roughness in presence of continuous microbial challenge. |
Biocompatibility Testing:
| Biocompatibility Test (Standard Reference) | Reported Device Performance (Implicitly Meets Standard) |
|---|---|
| Cytotoxicity (ISO 10993 and ISO 7405) | Biocompatible |
| Oral Mucosal Irritation Test (ISO 10993 and ISO 7405) | Biocompatible |
| Acute Systemic Toxicity (ISO 10993 and ISO 7405) | Biocompatible |
| Material Mediated Pyrogenicity (ISO 10993 and ISO 7405) | Biocompatible |
| Bacterial Reverse Mutation (ISO 10993 and ISO 7405) | Biocompatible |
| Mouse Lymphoma Assay (ISO 10993 and ISO 7405) | Biocompatible |
| Biological Risk Assessment (ISO 10993 and ISO 7405) | Biocompatible |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for any of the bench tests.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given these are bench tests rather than clinical studies, these terms are less applicable.
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. The data comes from physical/chemical bench testing, not expert interpretation of medical images or conditions.
4. Adjudication method for the test set:
- This information is not applicable and not provided. Adjudication is relevant for clinical or image-based studies where multiple readers interpret data.
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 is a dental material, not an AI or medical image analysis device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable and not provided. The device is a dental material, not an AI or algorithm.
7. The type of ground truth used:
- The "ground truth" for the non-clinical performance and biocompatibility data is established by objective measurements and standardized protocols (e.g., ISO 4049, ISO 10993, ISO 7405 benchmarks for material properties and biological responses). For the "Preservation of Surface Integrity" test, the ground truth was the measured surface roughness under microbial challenge.
8. The sample size for the training set:
- This information is not applicable and not provided. This is a material science submission, not an AI/machine learning submission, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
- This information is not applicable and not provided, as there is no training set mentioned or implied.
In summary, the provided document describes the substantial equivalence of a dental material based on its physical, chemical, and biological properties evaluated through non-clinical bench testing. It does not contain information relevant to AI/medical image analysis device evaluation criteria such as clinical study design, expert consensus, or reader performance metrics.
§ 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.