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OSW Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

The OSW Aligner System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3D software. The aligners progressively move the patient's teeth in small increments from their original state to a final treated state. The OSW Aligner System is intended as an alternative to conventional wire/bracket technology and fixed appliances for the treatment of patients with malocclusion. The 3D software generates the model of a provisional treated state and then creates a series of models that represent intermediate teeth states. The dental practitioner reviews these models to view, edit or approve the orthodontic treatment plan. The dental practitioner has the option to reject or request modifications to the setup prior to approving it for aligner fabrication. Once the doctor approves the setup, the series of custom-made aligners are manufactured, packaged, and shipped to the dental practitioner to be dispensed to the patient for treatment.

The OSW Aligner System is an orthodontic device. The provided text indicates that no clinical testing or bench testing was performed due to the established performance of sequential aligners and the difficulty of evaluating this device type in a lab.

Here's the information regarding acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not specify a separate "test set" in the context of clinical performance or data provenance from patient studies. The performance reported is from non-clinical performance tests for software verification and biocompatibility.

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

Not applicable. The reported tests are non-clinical and did not involve expert-established ground truth in the context of medical image analysis or clinical outcomes. The software verification tests would have their own internal verification process, but details on experts are not provided.

4. Adjudication method for the test set within a clinical context

Not applicable. No clinical test set or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. The device description does not position it as an AI-assisted diagnostic tool for human readers but rather as a system for generating aligners based on a practitioner's treatment plan.

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

The software verification tests represent a standalone evaluation of the software components (OSW OrthoSetup and OSWDP). The results indicate these components passed their respective verification criteria. The "algorithm" in this context is the 3D software that generates treatment plans and models for aligner fabrication. Its performance was verified, but specific metrics beyond "PASS" are not detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests:

• Software Verification: The "ground truth" would be established by following FDA Guidance for software verification and validation, ensuring the software performs as intended according to its specifications.
• Biocompatibility Testing: The "ground truth" is adherence to ISO standards (ISO 10993 series) for evaluating biological responses to medical devices.

8. The sample size for the training set

Not applicable. This document describes the clearance of a device that includes 3D software for orthodontic planning and aligner manufacturing, not a machine learning or AI model that requires a distinct "training set" in the conventional sense for medical image analysis. The software's development would involve internal testing and validation, but this is not typically referred to as a "training set" in this context.

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

Not applicable, as there is no mention of a "training set" as understood in machine learning/AI development in this document.

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