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Permanent root canal obturation

White ENDOSEAL MTA is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment. The sealer can be used either alone or in combination with gutta-percha obturating cones, injected gutta-percha material or core-carriers, master cones.

The provided text is a 510(k) summary for a medical device (White ENDOSEAL MTA), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This document does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device.

The document discusses:

• Device Description: A root canal sealer for permanent root canal obturation.
• Performance Testing (Non-Clinical): This section outlines physical and chemical tests (e.g., setting time, flow, radiopacity, solubility, cytotoxicity) conducted according to ISO standards.
• Substantial Equivalence: The primary purpose of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is done by comparing technological characteristics and performance data.

The document does NOT contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets acceptance criteria using human readers, ground truth, or AI performance metrics.

Specifically, the following information is NOT present in the provided text:

• Acceptance Criteria Table and Device Performance for specific clinical or AI metrics: The "performance testing" section refers to ISO standards for material properties, not clinical or AI performance.
• Sample size for a test set (clinical or AI): No clinical study with a test set is described.
• Data provenance (country of origin, retrospective/prospective): Not mentioned.
• Number of experts and their qualifications for ground truth: No expert review for ground truth is described.
• Adjudication method for a test set: Not mentioned.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or reported.
• Effect size of human reader improvement with AI assistance: Not applicable as it's not an AI device.
• Standalone (algorithm only) performance: Not applicable as it's not an AI device.
• Type of ground truth (expert consensus, pathology, outcomes data): No ground truth for clinical or AI performance is described.
• Sample size for the training set: Not applicable as it's not an AI device.
• How ground truth for the training set was established: Not applicable.

The document focuses on the physical and chemical properties of a dental material and its biocompatibility to demonstrate substantial equivalence to a predicate device, not on diagnostic performance or capabilities involving AI or human interpretation of images.

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