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• Treatment of perforations of root canal and furcation caused iatrogenically or by caries lesions
• Via canal treatment of root perforation due to internal resorption
• Surgical treatment of root perforation due to internal resorption
• Periapical surgery with reverse filling
• Pulp capping
• Pulpotomy (removal of affected coronal pulp to preserve vitality of remaining pulp tissue)
• Apexogenesis (induction of root development in vital teeth with an inflamed coronal pulp).
• Apexification (induction of formation of a mineralized barrier at the root tip of young permanent teeth with incomplete root development and a necrotic pulp)

MTA Angelus is a mineral trioxide aggregate cement used for root repair during endodontic treatment, combining the powder and liquid produces a colloidal gel that solidifies to form a barrier.

The provided text describes the 510(k) summary for MTA Angelus, a root canal filling resin, and its establishment of substantial equivalence to predicate devices. However, it does not contain the detailed information required to answer all parts of your request about acceptance criteria and a study proving device performance in the context of an AI/algorithm-based device.

The document is for a traditional medical device (a dental material), not an AI/algorithm-driven one. Therefore, the concept of "acceptance criteria" and "study proving the device meets the criteria" as you've framed it, usually referring to performance metrics like sensitivity, specificity, AUC for an algorithm, is not applicable here.

Instead, the "acceptance criteria" for MTA Angelus are based on demonstrating substantial equivalence to existing legally marketed devices (predicates) by showing similar intended use, technological characteristics, materials, and performing in vitro or bench testing according to existing standards.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

1. A table of acceptance criteria and the reported device performance

Study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria is performance testing conducted for setting time, solubility, radiopacity, and dimensional changes, which included methods described in ISO 6876 Dental Root Canal Sealing Materials. This testing was performed to "demonstrate substantial equivalence."

The following information CANNOT be extracted from the provided text, as it pertains to AI/algorithm-driven devices, which MTA Angelus is not:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
  • The document describes bench testing (in vitro) not clinical or algorithm testing on data sets.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
  • Not applicable for a materials science bench test.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
  • Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
  • Not applicable as it's not an AI device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
  • Not applicable as it's not an AI device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
  • Ground truth for materials testing is typically measured physical or chemical properties, referenced against a standard (like ISO 6876).
• 8. The sample size for the training set
  • Not applicable as it's not an AI device.
• 9. How the ground truth for the training set was established
  • Not applicable as it's not an AI device.

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