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The Invisalign system is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

The current Invisalign system is a series of clear plastic aligners that are used to replace traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original to their final treated position for improved dental alignment.

This 510(k) Premarket Notification is being submitted because Align Technology, Inc. is making labeling changes that affect the indications for use, contra-indications, and precautions of the currently-commercialized Invisalign system. The technological characteristics of the modified and currently-marketed predicate device, such as design, raw material, and chemical composition, and their manufacturing processes and related software, are identical.

The labeling modifications include:

• -Expansion of the indications of use to permit treatment of patients who present with malocclusion without the limitation of permanent dentition.

• II. Removal of certain contra-indications that excluded patients with certain complex malocclusions from getting treated with the Invisalign system. These patients may or may not need additional orthodontic procedures to achieve the desired treatment outcome, and this is captured in the added precautions.

• Addition of precautions corresponding to the removal of contra-111. indications.
  Thus, the modified Invisalign system with the proposed labeling changes will allow the treatment of patients with malocclusion, including, but not limited to, those with primary dentition present (including mixed dentition), as well as of patients with severe open bite, severe overjet, skeletally narrow jaw, dental prostheses/implants, and/or those who require surgical correction.

The provided text describes a 510(k) premarket notification for a Modified Invisalign® system. Crucially, this submission is solely for labeling changes and explicitly states that there are no changes in the technological characteristics, design, raw material, chemical composition, manufacturing processes, or software compared to the predicate device (the existing Invisalign system K981095).

Therefore, this document does not contain information about a study to prove the device meets specific acceptance criteria based on performance. The entire submission rests on the premise of substantial equivalence to the predicate device because the device itself hasn't changed.

Given this, I cannot fill out the requested table or answer the specific questions about a study on device performance, sample sizes, ground truth, experts, or MRMC studies, as no such study is described in the provided text.

Here's a summary of what is stated in relation to equivalence:

Acceptance Criteria and Device Performance (based on Substantial Equivalence to Predicate Device)

Regarding the study-specific questions:

1. A table of acceptance criteria and the reported device performance: See table above, which is based on the claim of substantial equivalence for an unchanged device. No quantitative performance metrics are provided as no new performance study was conducted.
2. Sample sizes used for the test set and the data provenance: Not applicable. No test set or performance data related to the modified device's performance is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a performance study is described.
4. Adjudication method: Not applicable.
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 device is not an AI-assisted diagnostic tool, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical orthodontic system, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. There is no mention of a training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

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