(87 days)
SonicFill 2 is indicated for direct placement in all cavity classes in anterior teeth. Additional indications include: base/liner material, repair of enamel defects, repair of povisionals, repair of porcelain restorations, minor occlusal build-ups, pit and fissure sealant, luting of composite/ceramic veneers, core build-ups and incisal abrasions.
SonicFill 2 is a light-cured, low-shrink, resin-based, dental restorative designed for direct placement. SonicFill 2 is used in combination with the SonicFill 2010 Handpiece (K091091), which activates the restorative sonically for delivery. Upon delivery the restorative drops in viscosity, allowing the composite to closely adapt to the cavity walls. When the cavity is filled and the SonicFill 2010 Handpiece (K091091) is deactivated, the restorative resin returns to its original viscosity. The composite in the cavity is then shaped and sculpted to the contours of the tooth. SonicFill 2 is designed to have a high depth of cure and low shrinkage stress allowing a cavity up to 5mm in depth to be filled and cured in a single bulk increment.
The provided text describes the regulatory submission for the dental restorative material, SonicFill 2. It does not contain information about a study based on acceptance criteria for an AI/ML powered device, or a standard clinical trial with outcomes, or an MRMC study.
However, it does detail non-clinical performance testing for SonicFill 2, comparing it to a predicate device (Metamorphosis K091023). Based on this information, I can construct a table for the non-clinical performance and extract relevant details.
Here's the information extracted from the document, tailored to your request as much as possible given the content:
Device: SonicFill 2 (Dental Restorative Material)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets for each parameter. Instead, it compares SonicFill 2's performance to established standards (e.g., ISO 4049, ISO 10993 series) and to its predicate device, Metamorphosis (K091023), often indicating "Pass" or "Equivalent to Predicate."
| Performance Characteristic | Acceptance Criteria (based on predicate/standards) | Reported Device Performance (SonicFill 2) |
|---|---|---|
| UV Color Stability (per ISO 4049) | Must Pass (as per predicate and standard) | Pass |
| Volumetric Shrinkage | Must Pass (as per predicate and standard) | Equivalent to Predicate |
| Shrinkage Stress | Must Pass (as per predicate and standard) | Equivalent to Predicate |
| Depth of Cure | Must Pass (as per predicate and standard) | Pass |
| Light Sensitivity (per ISO 4049) | Must Pass (as per predicate and standard) | Pass |
| Flexural Strength (per ISO 4049) | Must Pass (as per predicate and standard) | Pass |
| Radiopacity (per ISO 4049) | Must Pass (as per predicate and standard) | Pass |
| Translucency | Must Pass (as per predicate and standard) | Pass |
| Working Time | Must Pass (as per predicate and standard) | Pass |
| Water Sorption/Solubility (per ISO 4049) | Must Pass (as per predicate and standard) | Pass |
| Polishability | No comparable criterion for predicate (N/A) | Pass |
| Biocompatibility | Meets requirements (per predicate and ISO 10993 series) | Meets requirements |
| Shelf Life | 24 months based on real-time data (for predicate) | 24 months based on accelerated data |
2. Sample size used for the test set and the data provenance
The document specifies "non-clinical performance data included testing for mechanical strength, polishability, water sorption and solubility, flexural strength, depth of cure, light sensitivity, radiopacity, volumetric shrinkage, shrinkage stress, and color stability. Working Time testing, stability testing and biocompatibility testing were also performed." This indicates laboratory testing of the material itself.
- Sample Size for Test Set: Not explicitly stated in terms of number of samples for each test. The tests are laboratory-based material characterization tests.
- Data Provenance: The document does not specify a country of origin for the data or whether it's retrospective or prospective, as these terms are more typically applied to clinical studies. It describes internal laboratory testing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for material properties in this context is established by standardized testing methods (e.g., ISO standards), not by human expert consensus or interpretation.
4. Adjudication method for the test set
Not applicable. This is not a study involving human interpretation of data requiring adjudication.
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, an MRMC comparative effectiveness study was not done. This document pertains to a dental restorative material, not an AI-powered diagnostic or assistive device that would involve human readers. The document explicitly states: "Clinical performance testing has not been performed for SonicFill 2."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, this is not an AI/ML algorithm. It is a dental material.
7. The type of ground truth used
The ground truth is based on standardized laboratory testing and measurements of material properties as defined by international standards (e.g., ISO 4049, ISO 10993 series). The comparison is also made against the performance of a legally marketed predicate device (Metamorphosis K091023).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
§ 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.