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The Invisalign® System is intended for the orthodontic treatment of malocclusion in patients with primary, mixed (primary and permanent), or permanent dentition. The optional mandibular advancement feature(s) are indicated for the treatment of skeletal malocclusion in patients with mixed or permanent dentition.

The subject device Invisalign® System is a proposed modification to add integrated button, an optional feature into the predicate device, Invisalign System (K241412). The Invisalign® System consists of removable orthodontic appliances (aligners) and proprietary 3D treatment planning software. This submission adds an optional integrated button to aligners which is similar to the predicate device's precision cut feature that allows doctors to add orthodontic accessories such as elastics during treatment. The 3D treatment planning software allows the visualization and button placement on the aligners. The doctor still approves the treatment plan prior manufacturing, which is the same as that in the predicate.

Like the predicate device, the Invisalign® System consists of a series of doctor prescribed, customized, thin, clear plastic aligners that gently move the patient's teeth in small increments from their original state to a more optimal, treated state to address malocclusion. The optional MAF positions patients jaw forward to address skeletal malocclusion. The system is used in patients with primary, mixed, and permanent dentition. There are no changes introduced to the user workflow other than the addition of optional integrated button feature.

This FDA 510(k) clearance letter describes a modification to an existing medical device, the Invisalign System. It does not contain the detailed information typically found in a study report for proving device performance against acceptance criteria, especially for AI/software devices. The provided text primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device for an additional physical feature (integrated button) rather than a software-driven performance claim that would necessitate a rigorous clinical or performance study with acceptance criteria and specific test methodologies for AI.

Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted from this document because such a study, in the context of an AI/software device, does not appear to be the primary focus of this specific 510(k) submission as presented. The submission is for a physical device modification, not a new AI algorithm.

However, based on the information provided, here's what can be inferred or stated that such an approval did not involve:

Summary of Device Performance Study Based on Provided Text:

This 510(k) clearance letter for the Invisalign System (K252380) primarily concerns a modification to an existing device, specifically the addition of an "integrated button" feature to the aligners. The regulatory pathway is based on substantial equivalence to a predicate device (Invisalign System, K241412). The "study" described is a set of non-clinical tests to demonstrate that this physical modification does not negatively impact the device's safety and effectiveness. It does not present a study proving the performance of an AI/software component against acceptance criteria in the typical sense of a diagnostic or therapeutic AI device.

Therefore, most of the requested information regarding AI algorithm performance (e.g., sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, training set details) is not applicable or not provided in this document.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The subject device, Invisalign® System underwent a complete set of functional and performance testing, including durability, shear bond, retention, and biocompatibility testing. All testing passed acceptance criteria and demonstrated the device modification does not affect the safety and effectiveness of Invisalign® System and does not raise any new questions of safety and effectiveness."

However, the specific quantitative acceptance criteria and the corresponding reported performance values for these tests (durability, shear bond, retention, biocompatibility) are not detailed in this 510(k) summary. These are typically listed in an internal test report, not the public-facing FDA clearance letter.

2. Sample Sizes Used for the Test Set and Data Provenance:

• Sample Size: Not specified.
• Data Provenance: Not specified (since the tests are physical and chemical, not clinical data for an AI algorithm).
• Retrospective/Prospective: Not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not Applicable. The described tests (durability, shear bond, retention, biocompatibility) are laboratory-based engineering and materials tests, not clinical evaluations requiring expert consensus on a test set of patient data as would be the case for an AI diagnostic device.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This document does not mention an MRMC study. The device modification is a physical feature (integrated button) and its impact on human readers or clinical interpretation in an AI-assisted workflow is not discussed.

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

• No, not in the context of AI algorithm performance. The "Invisalign System" does include "proprietary 3D treatment planning software," and this submission notes the software allows "visualization and button placement on the aligners." However, the 510(k) focuses on the physical button's safety and effectiveness, not a new or modified AI algorithm's standalone performance. The software's role is described as "the doctor still approves the treatment plan prior manufacturing," indicating a human-in-the-loop scenario. No standalone algorithm performance evaluation is detailed.

7. The Type of Ground Truth Used:

• For the physical tests (durability, shear bond, retention, biocompatibility): The ground truth would be established through scientific measurement standards and validated laboratory methodologies (e.g., ISO standards for materials testing).
• For any software component related to the new feature: The ground truth for software functionality (e.g., correct button placement visualization, accurate manufacturing instructions) would internally be established through testing against design specifications and requirements. This is not detailed in the document.

8. The Sample Size for the Training Set:

• Not Applicable/Not Specified. This document does not describe the development or training of a new AI algorithm. If the "proprietary 3D treatment planning software" utilizes machine learning, its training set details are not provided as part of this specific 510(k) for a physical modification.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable/Not Specified. See point 8.

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