(68 days)
SA Flowable Composite is a self-adhesive, light-curing, flowable composite. SA Flowable Composite applications include:
- · Minor restorations of class I (without contact point)
- · Underfillings of classes I and II
- · Fissure sealing
- · Repairs of composite restorations
- · Modifications to temporaries and long-term temporaries
- Blocking out and filling of undercuts
SA Flowable Composite is a self-adhesive, light-curing, flowable composite with optimum consistency for the described indications. The radiopaque composite is immediately ready for use because the preparatory steps of etching, priming and bonding are unnecessary. The SA Flowable Composite will be supplied in convenient applicators.
This is a 510(k) summary for a dental resin material, not an AI/ML device. Therefore, many of the requested categories related to AI performance, ground truth, expert adjudication, and training/test sets are not applicable or cannot be extracted from this document.
However, I can provide information based on the safety and performance testing described:
1. Table of Acceptance Criteria and Reported Device Performance
The document references compliance with specific ISO standards for dental materials. These standards define the acceptance criteria, and the device is reported to meet them.
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry | The device complies with the requirements described in ISO 7405:2008. (This implies it met the biocompatibility criteria defined in the standard.) |
| ISO 4049:2009 Dentistry - Polymer-based filling, restorative and luting materials | Performance testing has been performed in accordance with ISO 4049:2009 to demonstrate that the SA Flowable Composite is equivalent to or better than the predicate devices in terms of several material properties including film thickness, depth of cure, flexural strength, water sorption and solubility. (This implies it met or exceeded the criteria/performance of the predicate for these properties as defined or implied by the standard.) |
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the document. The document refers to general "performance testing" according to ISO standards, but details regarding sample sizes or data provenance for these tests are not included in this summary.
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 as this is a dental material performance test, not a diagnostic device relying on expert interpretation of data. The "ground truth" here is established by standardized laboratory testing methods defined within the ISO standards.
4. Adjudication Method for the Test Set
This information is not applicable as there is no human interpretation or adjudication required for the physical and chemical property tests performed on a dental material.
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 is not applicable. This document describes a dental material, not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable. This document describes a dental material, not an AI/ML device.
7. The Type of Ground Truth Used
The ground truth used for proving the device meets acceptance criteria is based on standardized laboratory measurements and tests of physical and chemical properties of the dental material, as defined by ISO 7405:2008 (biocompatibility) and ISO 4049:2009 (material properties like film thickness, depth of cure, flexural strength, water sorption, and solubility).
8. The Sample Size for the Training Set
This information is not applicable. This document describes a dental material, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. This document describes a dental material, 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.