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The Invisalign System is indicated for the orthodontic treatment of malocclusion.

The Proposed Device is a minor change to the currently marketed Invisalign System (K143630) (hereafter referred to as "Predicate Device") to support repositioning of the mandible.

Invisalign System with Mandibular Advancement Feature consists of a series of doctor prescribed, customized, thin, clear plastic, removable orthodontic appliances (aligners) and proprietary ClinCheck 3-D software. The aligners gently move the patient's teeth in small increments and position the mandible forward from their original state to a more optimal, treated state. The Proposed Device treats patients with Class 1 and Class 2 malocclusion as well as patients with severe open bite, severe overiet, deep bite, skeletally narrow jaw, dental prostheses/implants. and/or those who require surgical correction. The Proposed Device includes two mandibular advancement features, also known as "precision wings", on each upper and lower aligner that function as mandibular repositioners, maintaining the lower jaw in the forward position.

The Proposed Device is made from the same material and utilizes the same manufacturing processes as the Predicate Device, Invisalign System (K143630). The software level of concern for the Predicate Device is moderate. Minor updates have been made to the proprietary ClinCheck 3-D software to enable placement of the mandibular advancement features on the aligners during the MA Phase of treatment. The software level of concern for the Proposed Device is determined to be the same as the Predicate Device: moderate.

I am sorry, but the provided text does not contain the specific information required to complete your request for acceptance criteria and the study details. The document is an FDA 510(k) summary for the Invisalign System with Mandibular Advancement Feature, which focuses on demonstrating substantial equivalence to a predicate device.

While it mentions performance testing and a clinical study, crucial details such as:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study (effect size with and without AI)
• Standalone algorithm-only performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How ground truth for the training set was established

are not present within the provided text. The document refers generally to "internal design specification and with the applicable performance standards" and states that "Test results obtained verified the safety and effectiveness of the Proposed Device per design specifications and applicable standards," but does not explicitly enumerate these criteria or their fulfillment in a detailed manner.

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