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BIJOU Orthodontic Ceramic bracket is indicated for orthodontic movement of natural teeth.

Orthodontic Ceramic bracket, BIJOU is composed of single crystal alumina and consists of three parts: the first part is the slot for the orthodontic wire; the second part is a round groove that is to hold a wire with an elastic "O" ring; the third part is the base that adheres to the tooth surface. A colored marking on wing part of bracket indicates orientation for placement.

The provided document describes the FDA 510(k) summary for the BIJOU Orthodontic Ceramic Bracket, indicating that no clinical performance testing was performed. Therefore, a study proving the device meets specific acceptance criteria as detailed in the request cannot be extracted from this document.

However, the document does list non-clinical performance data and states that the device is substantially equivalent to a predicate device based on these non-clinical tests and other characteristics.

Here's a breakdown of the available information based on your request, with "N/A" where the information is not provided because no clinical study was conducted:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence to a predicate device and no clinical data was performed, specific acceptance criteria for "device performance" in a clinical setting are not detailed. The non-clinical performance was evaluated against ISO standards.

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

• Sample Size (Test Set): N/A (No clinical test set was described)
• Data Provenance: N/A (No clinical data)

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

• N/A (No clinical test set or ground truth described)

4. Adjudication method for the test set

• N/A (No clinical test set 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

• N/A (No clinical study, and this device is a physical orthodontic bracket, not an AI-assisted diagnostic tool.)

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

• N/A (This is a physical medical device, not an algorithm.)

7. The type of ground truth used

• N/A (No clinical ground truth described. For non-clinical tests, "ground truth" would be defined by the specifications and measurement standards of the relevant ISO standards.)

8. The sample size for the training set

• N/A (No training set described for a clinical study or AI model.)

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

• N/A (No training set or ground truth described for a clinical study or AI model.)

Conclusion from document:

The BIJOU Orthodontic Ceramic Bracket received FDA 510(k) clearance based on its substantial equivalence to the PURE Sapphire bracket (K073045). This determination was made using a comparison of chemical composition, design, indications for use, and non-clinical performance testing (biocompatibility, design characteristics, adhesive strength, and in-house comparative tests). No clinical performance testing was performed or required for this 510(k) submission.

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