(62 days)
SIMPLICITY™ is a light cured (free radical polymerization), self-etching dental adhesive system, designed to provide a dentist with an increased ease of use that is less technique The bonding system combines both the etchant and primer applications into one sensitive. Thus, allowing for more predictable clinical results without sacrificing bond simple step. strength integrity.
SIMPLICITY™ is a universal adhesive system that when properly employed, can be used to seal enamel/dentin prior to restoring with light cured or self cured composite materials. Also, in situations of indirect restorations, the bonding system can be used to seal a preparation when using a light cured, self cured or dual cured composite cement or glass ionomer or resin-modified glass ionomer cement. In addition, the system allows the dentist to bond a post and core, along with the use to treat hypersensitive and/or exposed root surfaces.
SIMPLICITY™ is a light cured (free radical polymerization), self-etching dental adhesive system, designed to provide a dentist with an increased ease of use that is less technique The bonding system combines both the etchant and primer applications into one sensitive. Thus, allowing for more predictable clinical results without sacrificing bond simple step. strength integrity.
SIMPLICITY™ 2 is an acetone based adhesive that is dependent on the prepared surface of its conditioner (SIMPLICITY™ 1). This acidic conditioner application is a procedure that is very similar to the phosphoric acid etching process of dentin/enamel substrate in the ECLIPTOMER system. Applying the SIMPLICITY™ 2 (adhesive resin) directly to the conditioner prepared surface, assures proper moistness on the bonding interface, resulting in a reliable simplified bonding protocol.
Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) submission for SIMPLICITY™ Dental Materials:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Similar handling characteristics to predicate device. | "SIMPLICITY™ has similar handling to the ECLIPTOMER..." |
| Shear bond strength to dentin similar to predicate device. | "physical testing observations and analysis, including shear bond strength to dentin... suggest that SIMPLICITY™ is substantially equivalent to ECLIPTOMER." |
| Shear bond strength to enamel similar to predicate device. | "physical testing observations and analysis, including shear bond strength to... enamel, we suggest that SIMPLICITY™ is substantially equivalent to ECLIPTOMER." |
| Overall substantial equivalence to predicate device. | "From the physical testing observations and analysis... we suggest that SIMPLICITY™ is substantially equivalent to ECLIPTOMER (Bisco, Inc.)." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state a specific sample size for the "physical testing observations and analysis." It generally refers to "physical testing observations."
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of a 510(k) for a dental adhesive, this type of testing is typically prospective, conducted in a lab setting rather than on human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not mention the use of experts to establish ground truth for the physical testing. Instead, the ground truth is based on the measured physical properties (e.g., shear bond strength) and comparison to the predicate device.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" for this type of device is based on quantifiable physical and chemical properties, not expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. SIMPLICITY™ is a dental adhesive, and its performance is assessed through physical property testing, not human interpretation of cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. SIMPLICITY™ is a physical dental material, not an algorithm or AI system. Its performance is inherent to its material properties and chemical composition.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for SIMPLICITY™ is based on quantifiable physical and chemical properties, specifically "shear bond strength to dentin and enamel." The performance of the predicate device, ECLIPTOMER, serves as the benchmark against which the new device (SIMPLICITY™) is compared.
8. The Sample Size for the Training Set
- Not applicable. SIMPLICITY™ is a physical dental material and does not involve AI or machine learning algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As SIMPLICITY™ is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.