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Permanent obturation of the root canal following root canal treatment.

Sonendo Material A is a single component injectable paste material intended for permanent obturation of the root canal following root canal treatment. The device is comprised of alginate and a calcium containing compound which crosslinks in the presence of water to form an insoluble polymer. The placement into the root canal can be accomplished with or without the use a root canal point. The material is radiopaque and has physical properties such that it is suitable for root canal obturation. The material is packaged in either a syringe with single use dispensing tips or in a single dose capsule.

The provided text describes Sonendo Material A, a root canal filling resin, and its FDA 510(k) clearance based on substantial equivalence to a predicate device, iRoot SP Root Canal Sealer (K080917).

However, the document does not contain any information about an AI/ML powered device, nor does it provide details about acceptance criteria for an AI/ML product, performance metrics typically associated with AI/ML (e.g., accuracy, sensitivity, specificity, AUC), or studies involving human readers or ground truth established by experts/pathology for an AI model.

The "Performance Data" section of the document refers to bench testing to demonstrate physical-chemical properties and biocompatibility, which are standard for medical devices like root canal filling resins, not AI/ML software.

Therefore, I cannot fulfill your request for information related to AI/ML device acceptance criteria and study details. The input document pertains to a traditional medical device (root canal filling resin) and its regulatory clearance process.

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