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Premier's MultiMatch Universal Chameleon Restorative Composite is a nano-hybrid dental restorative intended for direct placement in all cavity classes in anterior teeth. Additional indications include repair of enamel defects, repair of provisionals, and repair of porcelain restorations, minor occlusal build-ups, and incisal abrasions.

Premier's MultiMatch Universal Chameleon Restorative Composite is a light-cured, radiopaque, resin-based nanohybrid restorative composite. It is formulated for direct placement in any type of anterior and posterior cavity form. It is intended to be used with a dental bonding agent and can be sculpted prior to curing. Once light cured, the composite can be easily finished and polished to achieve a highly esthetic and durable restoration. Available in three chameleon shades, MultiMatch can be dispensed via a unit-dose capsule or syringe to provide a restoration with an excellent visual color match to the surrounding dentition.

This document is a 510(k) Summary for Premier's MultiMatch Universal Chameleon Restorative Composite. It seeks to demonstrate substantial equivalence to a predicate device, SimpliShade (K162257).

The document does not describe a study involving an AI/Machine Learning algorithm for medical image analysis or similar diagnostic purposes where an "acceptance criteria" for algorithm performance would be relevant in the way outlined in the prompt. Instead, it describes a dental restorative material and its performance testing as compared to a predicate device.

Therefore, the prompt asks for information that is not present or applicable to the provided document. The document focuses on:

• Device Description: A light-cured, radiopaque, resin-based nanohybrid restorative composite.
• Intended Use/Indications for Use: Direct placement in all cavity classes in anterior and posterior teeth, repair of enamel defects, provisionals, porcelain restorations, minor occlusal build-ups, core build-ups, and incisal abrasions.
• Technological Characteristics: Comparison of composition, curing mechanism, storage, etc., with a predicate device.
• Non-Clinical Performance Data: Mechanical strength (flexural strength, compressive strength), water sorption and solubility, depth of cure, light sensitivity, radiopacity, polymerization shrinkage, volumetric wear, and color stability, as well as biocompatibility testing.

Since this 510(k) is for a dental restorative material and not an AI-powered diagnostic device, there are no "acceptance criteria" related to AI performance metrics (like sensitivity, specificity, AUC), no "test set" of images, no "experts" establishing ground truth for AI, no "adjudication methods" for AI interpretations, no "MRMC studies," no "standalone algorithm performance," and no "training set" in the context of machine learning.

The "acceptance criteria" mentioned in the document relate to the physical and chemical properties of the composite material, tested against established ISO standards for dental materials, and comparison to the predicate device's performance.

To answer the prompt directly based on the provided text, it's necessary to state that the requested information (related to AI model acceptance criteria and study design) is not relevant to this specific premarket notification.

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