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BIOPURE™ MTAD™ ROOT CANAL CLEANSER is used to chemically clean the canal and disinfect the root canal system after endodontic instrumentation.

BIOPURE™ MTAD™ ROOT CANAL CLEANSER is a two-part liquid and powder product. Part A is the liquid and Part B is the powder. The mixed solution cleanses the root canal, removes the smear layer, and kills the bacteria in an instrumented root canal without harming the tooth structure or soft tissue.

The provided document is a 510(k) summary for the BIOPURE™ MTAD™ ROOT CANAL CLEANSER, a root canal cleanser. It states that the device is "substantially equivalent" to a predicate device (EndoPure™ Root Canal Cleanser, K032361) based on the prior use of components, performance data, and biocompatibility data. However, the document does not describe acceptance criteria for performance or a specific study that proves the device meets such criteria.

The 510(k) submission process for a Class I unclassified device like a root canal cleanser, especially in 2005, often relied on substantial equivalence based on material composition, intended use, and general safety and effectiveness, rather than rigorous comparative clinical performance studies with predefined acceptance criteria as might be expected for novel or higher-risk devices.

Therefore, many of the requested details about acceptance criteria and a performance study cannot be extracted from the provided text.

Here is a summary of what can and cannot be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not described in the provided text. The submission focuses on substantial equivalence to a predicate device rather than meeting specific quantifiable performance targets.
• Reported Device Performance: The document generally states that "the performance data provided" supports its safety and effectiveness, but it does not detail what that performance data is or what metrics were used.

2. Sample size used for the test set and the data provenance:

• Not described in the provided text. No specific "test set" in the context of a performance study is mentioned.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

• Not applicable/Not described. There is no mention of a ground truth established by experts for a test set.

4. Adjudication method for the test set:

• Not applicable/Not described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

• No, a multi-reader multi-case comparative effectiveness study is not mentioned. This type of study is more typically associated with imaging diagnostics or AI-assisted interpretation, not a chemical root canal cleanser.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a chemical cleanser, not an algorithm.

7. The type of ground truth used:

• Not applicable/Not described. The basis for safety and effectiveness is substantial equivalence to a predicate device, supported by component usage, performance data (undescribed), and biocompatibility data.

8. The sample size for the training set:

• Not applicable. This device is a chemical cleanser, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established:

• Not applicable.

In summary: The provided 510(k) summary for BIOPURE™ MTAD™ ROOT CANAL CLEANSER is a regulatory document focused on demonstrating substantial equivalence to a legally marketed predicate device. It does not contain the detailed information about specific performance acceptance criteria or a dedicated study with statistical endpoints, ground truth, or expert involvement that would be present for a medical device relying on such a performance study for approval. Instead, its approval hinges on the argument that its technological characteristics, intended use, and component safety are similar enough to existing products.

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