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Permanent obturation of the root canal following vital pulp-extirpation.
Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and lateral condensation technique.

NRSP Injectable Root Canal Bioceramic Sealer is a convenient premixed ready-to-use, injectable white hydraulic bioceramic paste developed for permanent root canal filling and sealing applications. NRSP is an insoluble, radiopaque and aluminum-free material based on a strontium silicates composition, which requires the presence of water to set and harden. NRSP does not shrink during setting and demonstrates excellent physical properties. NRSP is packaged in a preloaded syringe and is supplied with disposable Intra Canal tips. NRSP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods. NRSP Injectable Root Canal Bioceramic Sealer is available in three preloaded syringe mode that provide different in specification in5g,3g,2g,1g and 0.5g. The only difference between the types are the net weight.
Root canal filling paste is a pre mixed paste material consisting of an inorganic powder system and an organic mixed liquid. It can solidify in a humoral environment, effectively seal the root tip, and has good biocompatibility; The curing time is stable and less affected by root canal moisture and humidity; It has excellent X-ray resistance, fluidity, antibacterial properties, non staining of teeth, and no irritation.

The provided document is a 510(k) premarket notification for a medical device called "Injectable Root Canal Bioceramic Sealer." It does not contain information about an AI/ML powered device or study results related to AI/ML performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI-powered device. The document primarily focuses on non-clinical bench testing and biocompatibility testing for a traditional medical device (root canal sealer) to demonstrate its substantial equivalence to a predicate device.

The tables and information presented are for the non-AI root canal sealer, for example:

• Table 1: Comparison to Predicate Device lists characteristics of the proposed device and its predicate, showing "Same" for many attributes like product code, regulation number, class, indications for use, chemical composition, and performance standard conformance.
• Table 2: Biocompatibility testing details various biocompatibility tests performed on the device (e.g., In Vitro Cytotoxicity, Skin sensitization, Ames test, Acute Systemic Toxicity Test, Bone implant test, Endodontic usage Test), all of which resulted in "Pass" for the "Proposed device."

Since the request is specifically about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML, and the document describes a non-AI medical device, I cannot fulfill the request as phrased.

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