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The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.

The ATOZ Mini-Screw is a temporary screw used as a fixing point for orthodontic treatment. The screw head has a round shape and has a cross groove in the middle so that it can be inserted and removed with a dental screwdriver. The ATOZ Mini-Screw has several models of the same design and diameter, only different lengths. The material of The ATOZ Mini-Screw is Titanium Alloy (ASTM F136). It is single-use only and may not be reused. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use.

The provided text is a 510(k) summary for the ATOZ Mini-Screw, an orthodontic anchor screw. It describes the device, its indications for use, and a comparison to predicate devices, along with non-clinical testing results. However, it explicitly states that clinical data was not required for this submission.

Therefore, many of the requested criteria cannot be extracted from this document, as they pertain to clinical studies and performance evaluation against a defined ground truth, which were not part of this 510(k) submission.

Here's a breakdown of what can be extracted and what cannot:

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

Since no clinical study was performed, there are no "acceptance criteria" related to diagnostic or evaluative performance against a medical condition, nor is there "reported device performance" in that context. The document refers to "bench test" results to demonstrate substantial equivalence to a predicate device, focusing on mechanical strength and biocompatibility.

Table of Bench Test Criteria and Performance (from "Summary of Non-Clinical Data")

2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used. The non-clinical tests would have their own sample sizes for material testing, but this is not specified in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set with human experts was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical test set was used.

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: Not applicable. The ATOZ Mini-Screw is a physical medical device (orthodontic anchor screw), not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The ATOZ Mini-Screw is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be established by adherence to recognized international standards (ISO, ASTM) for mechanical properties, biocompatibility, and sterilization, along with material specifications for the Titanium Alloy (ASTM F136).

8. The sample size for the training set: Not applicable as no machine learning training set was used.

9. How the ground truth for the training set was established: Not applicable as no machine learning training set was used.

In summary, the provided document is a 510(k) premarket notification that relied on non-clinical (bench) testing and comparison to predicate devices to demonstrate substantial equivalence, rather than clinical studies involving patient data or expert evaluations of diagnostic performance.

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