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The Invisalign® System is intended for the orthodontic treatment of malocclusion in patients with primary, mixed (primary and 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 modification to the predicate device, Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (K232233, cleared on September 26, 2023) to introduce an additional treatment planning workflow that does not require any Align Computer Aided Design (CAD) technician interaction. The Invisalign System consists of removable orthodontic appliances (aligners) and proprietary 3D treatment planning software. As part of this submission, there are no proposed design changes made to standard aligners or aligners with Mandibular Advancement Features (MAF) since the clearance of K232233. Further, there are no proposed changes to the proprietary 3D treatment planning software except for the non-significant changes that were implemented via Letter to File.

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.

The proposed modification in this premarket notification is to add a completely automated endto-end treatment planning workflow without CAD technician involvement. The subject device, Invisalign System, is the Invisalign System aligners produced with the additional treatment planning workflow.

There are no proposed design changes to the Invisalign System components as part of this submission.

The provided document is a 510(k) premarket notification summary for the Align Technology Invisalign System. It focuses on demonstrating substantial equivalence to a predicate device (K232233) for an updated version of the Invisalign System that includes an additional, fully automated treatment planning workflow.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

The document explicitly states that the submission is for a Special 510(k) notice to introduce an additional treatment planning workflow that does not require Align CAD technician interaction. It emphasizes that no proposed design changes were made to the standard aligners, aligners with Mandibular Advancement Features, or the proprietary 3D treatment planning software, except for non-significant changes previously implemented via Letter to File.

The core of the acceptance criteria and supporting study revolves around demonstrating that this new automated workflow achieves the same treatment plan and aligner output as existing workflows, and that this change does not affect the safety and effectiveness of the Invisalign System, nor does it raise any new questions of safety and effectiveness.

1. Table of acceptance criteria and the reported device performance:

Since this is a Special 510(k) for a workflow change, the acceptance criteria are not presented as numerical performance metrics in a typical table format for accuracy or sensitivity. Instead, they are framed as qualitative equivalency and safety/effectiveness assurances.

2. Sample sized used for the test set and the data provenance:

The document does not provide specific sample sizes for the test set used in the verification and validation (V&V) activities. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the data). This is typical for a Special 510(k) focused on a software workflow change for an established device, where the primary demonstration is of functional equivalence rather than clinical performance on patient cohorts.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not specify the number or qualifications of experts used to establish "ground truth" for the V&V of the automated workflow. Given the context, the "ground truth" for the automated workflow's output largely relates to its ability to replicate or achieve the same outcomes as an existing, human-in-the-loop workflow, which is already established by the predicate device's clearance. It's likely that internal engineers and potentially dental professionals (though not explicitly stated as "experts" for ground truth establishment in the V&V) were involved in comparing outputs.

4. Adjudication method for the test set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. This is consistent with a V&V study focused on functional equivalence of an automated workflow rather than a diagnostic performance study requiring expert consensus on subjective interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described. The nature of this submission (a Special 510(k) for an automated workflow addition to an existing device) does not typically require MRMC studies. The focus is on the functional equivalence of the new automated process to the existing, human-assisted process, not on improving human reader performance with AI assistance.

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

Yes, in the context of this submission, the "additional treatment planning workflow" is described as "completely automated end-to-end treatment planning workflow without CAD technician involvement." This implies a standalone (algorithm-only) performance was evaluated in terms of its ability to generate acceptable treatment plans and aligner outputs, which is then compared for equivalence to the human-in-the-loop processes. The V&V testing would have assessed this algorithm-only output against the established standards of the system.

7. The type of ground truth used:

The "ground truth" here is implied to be the established and accepted output of the predicate device's existing (manual or combined manual/automated) treatment planning workflows. The V&V compared the output of the new automated workflow to these established outputs, ensuring they were "the same treatment plan and aligners output." This is essentially a functional equivalence ground truth. It is not based on pathology, clinical outcomes data, or necessarily a new expert consensus on a novel diagnostic task, but rather on the consistency and correctness of the automated design process relative to the already-cleared, human-assisted process.

8. The sample size for the training set:

The document does not specify the sample size for the training set for the underlying proprietary 3D treatment planning software. This information is typically not provided in a 510(k) for a workflow modification if the core software algorithms (that would require training data) are not being substantially changed. The mention of an "automated end-to-end treatment planning workflow" suggests an AI/ML component, but details on its training are absent from this summary.

9. How the ground truth for the training set was established:

Since details on the training set are not provided, information on how its ground truth was established is also not available in this document.

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