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Archworx is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Archworx is intended to position teeth by way of continuous gentle force.

Devices are intraoral thermoformed plastic aligner trays for tooth malocclusion correction.

The provided text describes the regulatory clearance of an orthodontic device called "Archworx." It details the device's intended use, manufacturing process, and comparison to a predicate device for substantial equivalence. However, the document does not contain information about the acceptance criteria and the results of a study (especially a clinical or AI-related study) that proves the device meets those criteria.

Specifically, the document mentions:

• Biocompatibility testing: "Biocompatibility testing was conducted...and that the device met the acceptance criteria for all tests." It does not specify what these criteria were or provide the results.
• Bench Performance Testing: "Physical properties testing was conducted, and testing information was obtained from the material manufacturer. All the physical properties testing met the pre-specified acceptance criteria." Again, the criteria and results are not detailed.
• Verification and Validation Testing: "Yes, Performed. For 3 different patient cases, aligners were evaluated at 3 different points through the sequence for each sequence point, 3 critical dimensions based on intended positions of these critical tooth structures. Testing indicated the aligner designed in the software meets the planned location, positions and all dimensions as expected; and as prescribed." This is the closest to study results, but it's very high-level and lacks specific quantitative data or acceptance criteria. It also doesn't fit the typical structure of an AI/human-in-the-loop study.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or details about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training sets, or how ground truth was established, as this information is not present in the provided text.

The information provided is largely for a 510(k) submission for a physical medical device (orthodontic aligners), not an AI/ML-driven device that would necessitate the study details inquired about. The only software mentioned is "3Shape Ortho System Software (K180941)" which is used for scanning and designing models, implying it's a tool used in the manufacturing process rather than an AI-driven component of the "Archworx" device itself that requires clinical performance validation as per the prompt's implied context (e.g., diagnostic AI).

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