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The ClearArch is indicated for use as an orthodontic archwire to aid in the movement of patient teeth during orthodontic treatment. ClearArch is intended for patients seeking esthetic orthodontic treatment; these are primarily patients being treated with ceramic or polycarbonate braces.

ClearArch is a polymer-based orthodontic archwire for maxillary and mandibular arches. The wire material 1) is more aesthetic than conventional metal wires, 2) can take different shapes, including round, rectangular and square cross-sections, 3) can be bent like TMA and 4) delivers orthodontic forces similar to nickel titanium archwires. This archwire is intended to be used during the first two phases of orthodontic treatment. Its stiffness and strength are similar to the properties of metal orthodontic archwires in order to aid in efficient tooth movement during orthodontic treatment. Therefore, orthodontists can use an esthetic archwire in lieu of a less esthetic metal version without compromising treatment mechanics.

The provided document is a 510(k) summary for the ClearArch orthodontic wire. It focuses on demonstrating substantial equivalence to a predicate device rather than describing a study with a test set, ground truth, or expert involvement in the way AI/ML device studies typically do. Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission.

Here's an analysis based on the available information:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical or performance study with defined thresholds for sensitivity, specificity, accuracy, etc. Instead, it describes characteristics that were evaluated for substantial equivalence.

Study that proves the device meets the acceptance criteria:

The "study" described is a bench testing comparing the ClearArch device to a predicate device (BioMers Translucent Orthodontic Wire) and biocompatibility studies. The purpose of these tests was to demonstrate substantial equivalence for regulatory approval, not to meet specific performance acceptance criteria for a novel clinical outcome in the way an AI/ML device would.

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 document. The studies were bench tests, so "sample size" would refer to the number of wire samples tested, not patient data. Data provenance (country of origin, retrospective/prospective) is not applicable to bench testing of material properties.

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 applicable to this type of device and study. The "ground truth" for material properties like flexural strength, tensile strength, friction, water absorption, and elongation is established by calibrated laboratory equipment and standardized testing methods, not by expert consensus.

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

This information is not applicable. Adjudication methods are typically used in clinical studies where human interpretation of data is required to establish ground truth or resolve discrepancies. Bench testing results are typically quantitative and objective.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially imaging) where human readers interpret medical images, and is not applicable to an orthodontic archwire.

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

No, this is not applicable. The ClearArch is a physical medical device (an orthodontic archwire), not an algorithm or software requiring performance evaluation in a standalone mode.

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

The "ground truth" for the bench testing was based on objective measurements derived from standardized material testing methods and laboratory equipment. For biocompatibility, the ground truth would be established through pre-defined toxicological and biological endpoints according to relevant standards (e.g., ISO 10993).

8. The sample size for the training set

This is not applicable. There is no "training set" for a physical medical device like an orthodontic archwire. Training sets are used in the development of AI/ML algorithms.

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

This is not applicable as there is no training set mentioned or implied for this device.

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