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LED Curing Light is intended for use by trained dental professionals only for the purpose of light curing dental resins and composites.

LED Curing Light is classified as an Ultraviolet Activator for Polymerization (21 CFR 872.6070). It is used for polymerization of dental light cured materials by dental professionals. The device is based on blue LED (light emitting diode) technology. It has four curing modes. Using different modes gives dental professionals the flexibility to polymerize virtually dental resins and composites.

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Disposable Barrier Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

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The provided text is a 510(k) premarket notification letter from the FDA regarding "Disposable Barrier Sleeves." This document is a regulatory clearance for a physical medical device (barrier sleeves), not an AI/software as a medical device (SaMD).

Therefore, the document does not contain any of the information requested in your prompt regarding acceptance criteria and study details for an AI/SaMD. Specifically:

• No AI/SaMD Performance: The device is a physical barrier sleeve, completely unrelated to AI performance metrics.
• No Test Set/Ground Truth: There is no mention of a test set, data provenance, expert ground truth, adjudication, or MRMC studies because these concepts are not applicable to the clearance of a disposable physical barrier.
• No Training Set: Similarly, there is no training set for a physical product.

The document indicates that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its 510(k) clearance. The focus of the regulatory review for this product would have been on material safety, physical dimensions, intended use, and substantial equivalence to existing devices, not on algorithmic performance.

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