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Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth

Orthodontic Ceramic bracket, "ABSOLUTE" is made of alumina single crystal (mono clean sapphire) intended to be placed on teeth to straighten teeth. ABSOLUTE ceramic bracket consists of 3 parts. The first part is slot part is a ABOOLOTE ocramic bracket sencond part is round groove part that is to hold a wire with elastic "O" ring. And, the third part is base part is to adhere to tooth surface. Also, it has a marking on fore surface to indicate a location.

The provided text is a 510(k) summary for a medical device called "Orthodontic Ceramic Bracket (ABSOLUTE)". However, it does not contain the detailed information necessary to fully address all parts of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Here's an analysis based on the information available:

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

The document states: "Testing was performed according to 'Harmonized Standard'. Test results support the conclusion that actual device performance satisfies the design intent."

This is a very general statement and does not provide specific acceptance criteria or detailed device performance metrics. It indicates that some testing was done to a standard, but the specifics are not included in this summary. Therefore, a table cannot be populated.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text.

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)

This information is not provided in the given text. The device is a physical bracket, not an AI diagnostic tool that would typically involve expert ground truth for a test set in the same way.

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

This information is not provided in the given text.

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

This information is not applicable or provided. This device is a physical orthodontic bracket, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant to this product.

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

This information is not applicable or provided. As above, this is a physical medical device, not an algorithm.

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

This information is not provided and is likely not relevant in the same way it would be for diagnostic AI. For a physical device, "ground truth" would typically relate to material properties, mechanical integrity, biocompatibility, and intended function verified against engineering standards or clinical benchmarks. The document only mentions "Harmonized Standard".

8. The sample size for the training set

This information is not provided. This device is a manufactured product, not an AI model that undergoes "training" in the same sense.

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

This information is not provided and is not applicable for a physical device in the same way it is for an AI model.

Summary of available information regarding acceptance criteria and study:

• Device Name: Orthodontic Ceramic Bracket (ABSOLUTE)
• Intended Use: Orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
• Comparison: Substantially equivalent to SAPPHIRE CERAMIC BRACKET (K073045) ORTHO TECHNOLOGY, INC.
• Testing Information: "Testing was performed according to 'Harmonized Standard'. Test results support the conclusion that actual device performance satisfies the design intent."

Conclusion:

The provided 510(k) summary only offers a very high-level statement about testing being performed according to a "Harmonized Standard" and that the device meets its "design intent." It lacks specific quantitative acceptance criteria, detailed study designs, sample sizes, expert qualifications, or adjudication methods that would be present in a comprehensive study report. This is typical for a 510(k) summary, which is meant to summarize equivalence, not to be a full clinical or engineering study report. For a physical device like an orthodontic bracket, "acceptance criteria" would primarily revolve around mechanical strength, biocompatibility, bond strength, and dimensional accuracy, likely assessed through bench testing and adherence to recognized standards (e.g., ISO standards for orthodontics).

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