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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.

iRoot SP Plus Root Canal Sealer (iRoot SP Plus) is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. iRoot SP Plus is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. iRoot SP Plus demonstrates substantially equivalent physical properties to iRoot SP. iRoot SP Plus is packaged in a pre-loaded syringe and is supplied with disposable Tips.

The provided text is a 510(k) summary for a dental device (iRoot SP Plus), specifically a root canal filling resin. It addresses the substantial equivalence to a predicate device based on non-clinical tests and the predicate device's clinical history.

However, the document does not contain information about acceptance criteria or a study proving that an AI/ML-based device meets acceptance criteria.

The request asks for information related to an AI/ML device's performance, such as:

1. A table of acceptance criteria and reported device performance (for an AI/ML device)
2. Sample sizes and data provenance for an AI/ML test set
3. Number and qualifications of experts for AI/ML ground truth
4. Adjudication method for AI/ML test set
5. MRMC study details and effect size for AI assistance
6. Standalone performance of an AI algorithm
7. Type of ground truth used for an AI/ML device
8. Sample size for AI/ML training set
9. How ground truth for AI/ML training set was established

Since the provided text is for a root canal filling resin and not an AI/ML device, none of the requested information regarding AI/ML device performance and testing is present. The document focuses on chemical composition, physical properties, and equivalence to existing root canal sealers.

Therefore, I cannot provide the requested details based on the given input.

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Well-Paste™ is a biocompatible root canal sealer used for the temporary filling of root canals after endodontic surgery. Well-Paste™ can be used on its own and for vital pulpectomies in deciduous teeth.

Well-Paste™ is a temporary root canal filling material after endodontic surgery as pulp capping, pulpotomy or apexification. It contains Calcium Hydroxide and Barium Sulfate mainly, so it shows excellent radiopacity. It also has high fluidity and excellent accessibility into the root canal. Well-Paste™ is premixed paste as a non-setting material and is very stable without any solidification or separation. And it is packaged in a convenient syringe with disposable tips, a plastic holder and disposable tip cap.

This document is a 510(k) summary for a dental device, specifically a root canal filling material, and does not contain information about an AI/ML powered medical device. Therefore, it is not possible to answer the questions about acceptance criteria, study details, and AI/ML specific performance metrics as requested.

The document describes the device, "Well-Paste™", its intended use, and its substantial equivalence to a predicate device ("Metapaste"). The review focuses on material characteristics (e.g., device design, appearance, main materials, physical properties like flow, film thickness, radiopacity, solubility, and disintegration) and biocompatibility, not on algorithm performance or clinical study outcomes involving human and AI comparison.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance related to AI.
2. Sample size for a test set, data provenance, or ground truth details.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results or effect size of AI improvement.
6. Standalone algorithm performance.
7. Type of ground truth used in an AI context.
8. Sample size for a training set.
9. How ground truth for a training set was established.

Ask a specific question about this device