(90 days)
6MS Invisible Aligner is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars). The 6MS Invisible Aligner positions teeth by way of continuous gentle force.
6MS Invisible Aligner consists of a series of dental-clinician prescribed customized clear plastic removable orthodontic aligner trays that are made from a clear, thin thermoformed polyurethane-polyester composite. The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state. This occurs through forces applied by the appliance to the teeth over time until final correction, according to the dental clinician's prescription has been achieved. A dental clinician prescribes the 6MS Invisible Aligner based on an evaluation of the patient's teeth. Either intraoral scans or physical impressions of the patient's teeth are taken, after which the clinician determine course of treatment with the system. The clinician completes a prescription form using standard dental software used for tooth alignment. The series of plastic aligner trays are designed according to commercially available dental software for planning the tooth alignments. After the digital plan is developed and approved by the prescribing dental clinician, SMS OPCO produces the aligner trays. The customized aligner trays are then provided to the dental clinician who distributes them to the patient assuring fit and function.
The provided text is a 510(k) Summary for a medical device (6MS Invisible Aligner). It describes the device, its intended use, and lays out a comparison to a predicate device to demonstrate substantial equivalence. However, it does not contain information about an AI/Algorithm-powered device or a study involving human readers or AI assistance.
Therefore, I cannot fulfill your request for information related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI-powered device, MRMC studies, or standalone algorithm performance, as these concepts are not discussed in the provided document.
The "Device Testing Non-clinical Testing" section (Page 6) details conventional non-clinical tests for mechanical properties, packaging, and manufacturing process validation. It also mentions biocompatibility testing. The "Clinical Testing" section explicitly states that "Neither animal nor human testing are required for this product" because of its substantial equivalence to the predicate device in terms of materials, design, and manufacturing method.
In summary, the provided document does not support a response to your specific questions about AI/algorithm performance or MRMC studies.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.