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AH® PLUS™ Root Canal Sealer is used for permanent sealing of root canals following established endodontic procedures. The predicate device, AH26® Root Canal Sealer has the same intended use.

AH® PLUS™ Root Canal Sealer is a two-component paste: paste root canal sealer based on epoxy-amine resin chemistry. This easy-to-mix sealer adapts closely to the walls of the prepared root canal and provides outstanding long-term dimensional stability with minimal shrinkage upon setting.

The final product consists of two components, the epoxy resin paste (Paste A) and the amine-containing paste (Paste B) portions which are mixed prior to insertion into the root canal.

The provided text describes a 510(k) summary for a medical device called AH® PLUS™ Root Canal Sealer. It focuses on demonstrating equivalence to a predicate device (AH26® Root Canal Sealer) based on material composition, physical properties, and biological testing.

However, the document does not contain the kind of detailed information requested in the prompt regarding acceptance criteria, study methodologies for AI/machine learning device performance, or human reader studies.

Specifically, the prompt asks for:

1. A table of acceptance criteria and reported device performance: The document states that the physical properties "meet or exceed those standards found in ISO Specification 6876 and ADA Specification 57" and that it's comparable to the predicate in "setting time, flow, shrinkage, and microleakage physical property values." However, it does not provide the specific numerical acceptance criteria or the reported device performance values in a table.
2. Sample size for test set and data provenance: Not mentioned.
3. Number of experts and qualifications for ground truth: Not mentioned, as this is not a study assessing expert performance or an AI’s ability to interpret data.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study, effect size: Not applicable, as this is not an AI-assisted diagnostic device.
6. Standalone performance study: Not applicable in the context of an AI device. The document does describe pre-clinical and biological testing of the sealer's components and mixed product.
7. Type of ground truth: Not applicable in the requested context. The "ground truth" here is the adherence to ISO/ADA standards and biological safety assessments.
8. Sample size for training set: Not applicable (not an AI device).
9. How ground truth for training set was established: Not applicable (not an AI device).

Based on the provided text, the device is a root canal sealer, not an AI or machine learning-based device that would typically have the acceptance criteria and study designs described in the prompt. The "testing" mentioned refers to chemical and biological safety assessments and physical property comparisons to established standards and a predicate device.

To directly answer your request based only on the provided text, here's what can be extracted, acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information (as per prompt's specific requirements, due to the nature of the device and document):

• Sample size used for the test set and the data provenance: Specific sample sizes for biological and physical tests are not provided in this summary. Data provenance (country, retrospective/prospective) is not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/diagnostic imaging study requiring expert adjudication of images/data.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (not an AI algorithm).
• The type of ground truth used: The "ground truth" in this context is adherence to established international standards (ISO, ADA), and results from standardized biological safety tests (Ames, Growth Inhibition, Sensitization, Implantation, Toxicity studies).
• The sample size for the training set: Not applicable (not an AI device).
• How the ground truth for the training set was established: Not applicable (not an AI device).

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