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510(k) Data Aggregation
(392 days)
Vittra APS Unique Flow
- Base under direct restorations;
- Small, non-occlusal stress-bearing class I restorations according to minimally invasive filling therapy;
- Pit and fissure sealant;
- Tunnel-type preparation;
- Repair of small enamel defects;
- Bonding of tooth fragments;
- Composite resin repairs;
- Non-carious cervical lesions.
Vittra APS Unique Flow is a light-curing composite of low viscosity, with a single shade for all dental shades, suitable for minimally invasive cavity preparations, base/liner and minor repairs. The composite is radiopaque, with a total inorganic filler content of 58% to 62% by weight (56% to 60% by volume) and an average particle size between 1.7 and 1.9 micrometers. It does not contain Bis-GMA or Bis-EMA in its formulation, following the current trend of Bisphenol A (BPA) free products. The composite has the APS as a photoinitiator system, an acronym for Advanced Polymerization System, which consists of a combination of different photoinitiators that interact with each other, amplifying the curing capacity of the light emitted by the light-curing units. Added to different materials, the system provides several advantages. APS confers great polymerization power, which allows a greater degree of conversion, obtaining superior stability to ambient light and providing longer working time during restorations.
The provided document is a 510(k) summary for the device "Vittra APS Unique Flow", a tooth shade resin material. It describes the device, its intended use, comparison with a predicate device, and non-clinical testing results to demonstrate substantial equivalence.
Here's the requested information synthesized from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (from ISO 4049 unless specified) | Reported Device Performance (Vittra APS Unique Flow) |
|---|---|---|
| Color Stability | No more than a small color change (EN ISO 4049, ISO 7491) | Meets requirements, in accordance with ISO 4049 |
| Flexural Resistance | ≥ 80 MPa (EN ISO 4049) | 123.8 MPa |
| Mimicry | No more than a small color difference (ISO 7491, ISO 4049) | Meets requirements |
| Light Passage (Syringe) | No light passage through components | Syringe provides shelter from light |
| Light Passage (Resin after Storage) | No difference in homogeneity, consistency, applicability | Physically homogeneous (for ambient light sensitivity) |
| Depth of Cure | > 1.5 mm (ISO 4049) | 3.996 mm |
| Radiopacity | > 1.0 mm against aluminum scale (ISO 4049) | 1.825 mm |
| Sensitivity to Ambient Light | Physical homogeneity of the sample | Meets requirements of ISO 4049 |
| Water Sorption | ≤ 40 µg/mm³ (EN ISO 4049) | 26.834 µg/mm³ |
| Water Solubility | ≤ 7.5 µg/mm³ (EN ISO 4049) | 1.632 µg/mm³ |
| Accelerated Stability Studies | Not explicitly stated as a numerical value; aimed to determine shelf life | Guarantees 3 years shelf life (based on 274 days study) |
| Long-Term Stability (Shelf) | Not finalized, but aimed to confirm expiration/storage conditions | Analysis not yet finalized; product commercialized based on accelerated stability |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific non-clinical test. The tests were conducted according to recognized standards like ISO 4049, ISO 7491, and ISO 10993. The data provenance is internal testing performed by Dentscare LTDA (Brazil), as indicated by the company information and submission details. It is a retrospective study based on laboratory testing of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions "observers" attested to the color stability and mimicry. However, it does not specify the number of experts, their qualifications, or how they established ground truth for these subjective assessments. For other objective tests (e.g., flexural resistance, depth of cure), the ground truth is established by the specified ISO standards and measured values.
4. Adjudication method for the test set
Not applicable. The tests are primarily objective measurements against established international standards (e.g., ISO 4049) or subjective assessments (color stability, mimicry) by unnamed "observers". There is no mention of a formal adjudication method for these non-clinical tests.
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. This device is a dental material (tooth shade resin), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dental material; it does not involve an algorithm or AI.
7. The type of ground truth used
For most tests, the ground truth is defined by the numerical specifications and methodologies outlined in recognized international standards such as ISO 4049, ISO 7491, and those within the ISO 10993 series. For color stability and mimicry, it appears to be a form of expert observation/assessment by unnamed "observers" against acceptance criteria of "no more than a small color change/difference".
8. The sample size for the training set
Not applicable. This device is a physical product and does not involve machine learning algorithms that require a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set is relevant for this type of device.
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