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510(k) Data Aggregation
(329 days)
The InfinixTM Universal Composite is indicated for:
- · Restorations in the posterior region (Class I and II)
- · Anterior restorations (Class III, IV)
- · Class V restorations (cervical caries, root erosion, wedge-shaped defects)
- · Veneering of discolored anterior teeth
- · Splinting of mobile teeth
- · Extended fissure sealing in molars and premolars
- · Repair of composite/ceramic veneers
Infinix™ Universal Composite is a packable (high viscosity) dental composite filling material, intended for direct anterior and posterior restorations, class V restorations, veneering of discolored anterior teeth, and repair of composite/ceramic veneers. The resin matrix of the Infinix™ Universal Composite contains Urethane dimethacrylate (UDMA), Bisphenol-a glycidyl dimethacrylate (Bis-GMA) and triethylene glycol dimethacrylate (TEGDMA). The inorganic filler of the Infinix™ Universal 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 Infinix™ Universal Composite is provided in syringes (4 g) and in single-dose capsules (0.2 g) and is available in five shades (A1, A2, A3, B1 and translucent).
The provided document is a 510(k) Premarket Notification from the FDA for a dental resin material named "Infinix™ Universal Composite". This submission focuses on demonstrating substantial equivalence to a predicate device based on material properties and non-clinical testing. It does not describe a study involving algorithms, human readers, or image analysis for diagnostic purposes.
Therefore, most of the requested information regarding acceptance criteria, device performance in a diagnostic context, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document as it pertains to a different type of medical device and evaluation.
However, I can extract the non-clinical performance criteria and reported performance from the document.
1. A table of acceptance criteria and the reported device performance
The document lists various non-clinical tests performed on the Infinix™ Universal Composite to establish substantial equivalence to the predicate device, Tetric EvoCeram®, and compliance with ISO 4049 and FDA guidance. The acceptance criteria are implicitly those defined by these standards and guidance documents. The document states that the device "performs as intended based on the bench testing per ISO 4049 and FDA guidance document". Specific numerical results for "reported device performance" are not provided in this summary, but the general conclusion is that the device met these criteria.
| Acceptance Criteria (Implied by Standard/Guidance) | Infinix™ Universal Composite Performance (Reported) |
|---|---|
| Biocompatibility (ISO 10993, ISO 7405) | Biocompatible (based on assessment of Cytotoxicity, Oral Mucosal Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Bacterial Reverse Mutation, Mouse Lymphoma Assay, Biological Risk Assessment) |
| Flexural Strength (ISO 4049:2009) | Performed as intended (Met ISO 4049:2009 criteria) |
| Elastic Modulus | Performed as intended |
| Compression Strength | Performed as intended |
| Shade and Color Stability | Performed as intended |
| Polymerization Conversion Degree | Performed as intended |
| Viscosity | Performed as intended |
| Spontaneous Polymerization Sensitivity at Ambient Light (ISO 4049:2009) | Performed as intended (Met ISO 4049:2009 criteria) |
| Water Solubility (ISO 4049:2009) | Performed as intended (Met ISO 4049:2009 criteria) |
| Water Sorption (ISO 4049:2009) | Performed as intended (Met ISO 4049:2009 criteria) |
| Depth of Cure (ISO 4049:2009) | Performed as intended (Met ISO 4049:2009 criteria) |
| Radio-opacity (ISO 4049:2009) | Performed as intended (Met ISO 4049:2009 criteria) |
| Knoop Hardness | Performed as intended |
| Preservation of Surface Integrity | Performed as intended |
| Intensity for curing | $\geq550 \text{ mW/cm}^2$ |
| Wavelength for curing | $430-490 \text{ nm}$ |
| Curing time | $20 \text{ sec.}$ |
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 applicable and not provided. The study pertains to non-clinical bench testing and biocompatibility assessments of a dental material, not a diagnostic device with test sets of patient data.
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 applicable and not provided. Ground truth in the context of this device would relate to the physicochemical properties and biocompatibility of the material, not expert interpretation of diagnostic data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are relevant for expert review of human data, not for 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
No such study was done or is described. This device is a dental filling material, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No such study was done or is described. This device is a dental filling material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's evaluation is based on established scientific and regulatory standards for material properties and biocompatibility as outlined in ISO 4049, ISO 10993, ISO 7405, and FDA guidance for dental composite resin devices. It's objective, quantitative measurements against these standards.
8. The sample size for the training set
This information is not applicable and not provided. There is no "training set" in the context of material property evaluation for a dental composite.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the reasons stated above.
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