(61 days)
Sonata Micro Hybrid Composite is a dental restorative material intended for use to restore carious lesions or structural defects in teeth in combination of conditioners such as bonding, luting, etching agents commonly used in tooth restoration.
Sonata Micro Hybrid Composite is a dental restorative material intended for use to restore carious lesions or structural defects in teeth in combination of conditioners such as bonding, luting, etching agents commonly used in tooth restoration.
This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets them in the way typically expected for AI/software devices. The device, "Sonata Micro Hybrid Composite," is a dental restorative material, which is a physical product, not a software or AI device.
The provided text focuses on establishing substantial equivalence to existing predicate devices based on its intended use and material properties, rather than performance against specific acceptance criteria derived from a clinical or technical study as would be seen for AI/ML or diagnostic devices.
Therefore, I cannot extract the requested information from the provided text. The questions are designed for a different type of device and regulatory submission.
Specifically, for the reasons below, I cannot provide the requested table and details:
- No Acceptance Criteria or Performance Data: The document states the device is "substantially equivalent to Conquest Crystal, K932154 and other dental restorative resin composites on the market." This is the basis for its clearance, not a demonstration against predefined acceptance criteria from a specific study designed to measure performance metrics. The information is about the type of material and its intended use, not about a measurable performance outcome that could be compared to a benchmark.
- No "Study" in the AI/Software Sense: There is no mention of a study involving data sets, ground truth, experts, or statistical analysis of performance as would be relevant for an AI/ML device. The "study" here is implicitly a comparison of material properties and intended use to a predicate device.
- No AI/ML Component: The device is a physical dental composite. The questions regarding sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance are irrelevant to this type of product.
§ 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.