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The CP Brackets are indicated for orthodontic movement of teeth.

The CP Brackets are ceramic orthodontic brackets will be used for a complete orthodontic treatment. The brackets are single-use devices.

The provided text is a 510(k) summary for the CP Bracket System, an orthodontic bracket. It describes the device, its intended use, and its technological characteristics. However, the text does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert adjudication as typically found in studies for AI/ML devices or studies directly comparing performance against specific metrics.

The submission focuses on establishing substantial equivalence to a predicate device (Mystique® Brackets) based on:

• Prior use of components in legally marketed devices.
• Biocompatibility testing.
• Market experience in Japan (20,000 units sold with only four user-error complaints).

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided document. The submission's approach is not based on a statistical performance study against defined acceptance criteria but rather on demonstrating equivalence and safety through material composition, biocompatibility, and limited market surveillance.

Here's a breakdown of what can be surmised or explicitly stated from the text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not applicable in the context of a prospective clinical or technical "test set" as defined for performance studies. The document mentions "Approximately 20,000 units of this bracket have been sold in Japan since 2003," which represents real-world usage data, not a controlled test set.
• Data Provenance: Japan (for the 20,000 units sold). Retrospective (market surveillance data).

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

• Not applicable. There was no explicit "ground truth" establishment by experts for a test set described in this submission. The 4 complaints received were "investigated" and attributed to user error, implying some form of review, but not a formal expert panel for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. No formal adjudication method for a test set is described.

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:

• No. This is a physical medical device (orthodontic bracket), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study involving AI assistance was performed.

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

• No. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the market surveillance data, the "ground truth" for the complaints was the result of an "investigation" which concluded "user failing to follow the adhesive manufacturer's instructions." This is an outcome of an internal investigation rather than an independent expert consensus or pathology.

8. The sample size for the training set:

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

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

• Not applicable.

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