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Angel Align System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.

The Angel Align System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. The Angel Align 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 set-up prior to approving it for aligner fabrication. Once the doctor approves the set-up, the series of custom-made aligners are manufactured, packaged, and shipped to the dental practitioner to be dispensed to the patient for treatment.

This FDA 510(k) summary focuses on demonstrating substantial equivalence of the "Angel Align System" to a predicate device (Invisalign - K143630), rather than a study proving the device meets acceptance criteria in the way a de novo or PMA would. Therefore, much of the requested information regarding specific acceptance criteria and detailed study designs for performance is not explicitly provided in this document.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are not defined in this 510(k) summary (which is typical for a substantial equivalence claim for a physical device like aligners), this table will describe the types of tests performed and their outcomes in relation to establishing equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated for specific non-clinical or clinical studies. The document only mentions "non-clinical performance tests" and "post market clinical data".
• Data Provenance: Not explicitly stated (e.g., country of origin). The clinical data is referred to as "post market clinical data," implying it would be collected after the predicate device was on the market and potentially includes data from various regions where the predicate was used. It is retrospective in the sense that data from an already marketed device (the predicate, or market data related to similar aligner use) was likely utilized to support the equivalence claim, but the specific nature of the clinical "study" is not detailed.

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

• This information is not provided in the document. For a 510(k) for a physical orthodontic aligner device, direct human expert ground truth establishment for a test set as one might see in an AI/imaging device is not typically detailed in this manner. The "ground truth" here is implied by the established orthodontic principles and the clinical outcomes observed in patients treated with similar devices.

4. Adjudication Method for the Test Set

• This information is not provided and is generally not applicable to this type of device and submission. Adjudication methods are more common in clinical trials evaluating specific endpoints with subjective interpretation, particularly relevant for AI/imaging device performance assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

• No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the context of this 510(k). The Angel Align System is a physical orthodontic aligner, and its accompanying software is for treatment planning and aligner design, not a diagnostic AI tool that would assist human "readers" (like radiologists interpreting images). Therefore, the concept of "human readers improve with AI" does not directly apply here. The software is a tool for the dental practitioner, not an interpretative aid that independently makes diagnoses requiring reader performance comparison.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• The 3D software component of the Angel Align System generates a provisional treated state and a series of intermediate teeth states, but it explicitly 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 set-up prior to approving it for aligner fabrication."
• This indicates that the software is not standalone in its clinical application; it operates with a human-in-the-loop (the dental practitioner) who reviews and approves the outputs before aligner fabrication. Therefore, a standalone performance study in the context of a fully autonomous AI system was not described or performed as the device requires human interaction and approval.

7. The Type of Ground Truth Used

• For the technical and performance characteristics, the "ground truth" is established by engineering and material science standards (ISO10993, software validation, design verification) relative to the predicate device.
• For clinical performance, the "ground truth" is based on clinical outcomes data from a "post market clinical study" which demonstrated safety and effectiveness for tooth movements, inferring successful orthodontic corrections in patients. This aligns with the accepted clinical efficacy for clear aligner systems.

8. The Sample Size for the Training Set

• This information is not provided. The software generates treatment plans based on a scan of the patient's teeth and likely relies on algorithms and biomechanical models, not necessarily a "training set" in the machine learning sense that would require a quantified sample size for training. If the software utilizes any machine learning component (which is not explicitly detailed but is common in 3D modeling), the training data details are not disclosed.

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

• This information is not provided as a "training set" in the typical AI sense is not explicitly mentioned with its ground truth establishment in this document. The software functions based on established principles of orthodontics and 3D modeling, with human oversight for approval.

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The Align System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Align System positions teeth by way of continuous gentle force.

Align Technology Inc. (Align) has developed the Align System, which is a series of clear plastic appliances (Aligners) that are intended to replace conventional wire and bracket technology for many orthodontic cases. The series of Aligners moves the patient's teeth in small increments from their original state to a final, treated state. The Align System will use a computer as a tool to assist in creating a series of Aligners that represent sequential movements to generate light and consistent forces on the patient's teeth.

A Dental Practitioner using the Align System diagnoses a patient, determines a treatment plan, and makes dental stone models of a patient's teeth. The Dental Practitioner then sends the molds, along with a prescription for treatment to Align. Align uses three-dimensional laser scanning technology to scan the mold into a computer. From this scanned image (which represents an untreated state) and following the Dental Practitioner's prescription, Align software generates the image of a final, treated state and then interpolates a series of images that represent intermediate teeth states. For each of these intermediate states, a rapid prototyping machine (such as a stereolithography machine) produces corresponding dental molds. In the final step, Align uses a conventional air pressure device (e.g., a Biostar) and commercially available retainer or positioner material (made by Raintree Essix or equivalent) to craft plastic Aligners to fit the developed teeth molds. The models with their corresponding Aligners are then mailed back to the Dental Practitioner. The total number of Aligners can vary from 1 to over 100 per patient, depending on the complexity of the case. The Aligners are individually identified and are dispensed to the patient by the Clinician with specific instructions for use (i.e., the Aligners are to be worn in a prescribed sequence).

This document is a 510(k) premarket notification for the "Align System" (later known as Invisalign). It describes the device and claims substantial equivalence to existing predicate devices. However, it does not provide a study to prove the device meets specific acceptance criteria in the way you've outlined.

Here's a breakdown based on the provided text, highlighting what's missing and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document is a 510(k) submission, which focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than establishing and meeting novel performance acceptance criteria through clinical trials. Therefore, explicit, quantified acceptance criteria and specific performance metrics designed to meet them are not present in this filing.

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

• Sample Size: Not applicable. No "test set" in the context of controlled clinical efficacy studies is described.
• Data Provenance: Not applicable. The submission relies on the concept of substantial equivalence, stating that "sufficient information available from the scientific literature" supports the safety and effectiveness of preformed tooth positioners in general. There is no specific original test data presented in this document.

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

• Number of Experts: Not applicable. No test set requiring expert ground truth establishment is described.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No test set requiring adjudication is described.

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

• MRMC Study: No. This device is a physical orthodontic appliance, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant here.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. While the Align System "will use a computer as a tool to assist in creating a series of Aligners," the device itself is the physical aligner, and its performance is assessed by its ability to move teeth, not as a standalone diagnostic algorithm. The computer is described as a "tool to assist" in the design process, not as a standalone diagnostic or treatment algorithm.

7. The type of ground truth used

• No specific ground truth data for a novel study is presented. The "ground truth" implicitly relies on:
  • The known mechanisms of action for orthodontic forces.
  • The established clinical effectiveness of predicate preformed tooth positioners.
  • The "Dental Practitioner's prescription" which guides the desired final state of the teeth.
  • The "scientific literature" mentioned for general assurance of safety and effectiveness of the device type.

8. The sample size for the training set

• Sample Size: Not applicable. The document does not describe a "training set" in the context of machine learning or AI development for the device's performance evaluation. The "Align System" itself is the series of physical aligners. While their software generates images, there's no mention of a training set for an AI model that diagnoses or predicts treatment outcomes in a general sense.

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

• Ground Truth Establishment: Not applicable. No training set is described.

Summary of Device and Evidence Presented:

This 510(k) submission for the Align System (Aligners) describes a series of clear plastic appliances intended to treat malocclusion. The key to its regulatory clearance is the claim of substantial equivalence to existing, legally marketed preformed tooth positioners (e.g., those from Great Lakes Orthodontics, TP Orthodontics, and Ortho-Tain).

The evidence provided to support this claim focuses on:

• Technological Characteristics: Stating that "The Aligners are equivalent to the currently marketed predicate devices."
• Intended Use: The Align System's intended use ("treatment of tooth malocclusion in patients with permanent dentition...positions teeth by way of continuous gentle force") is aligned with that of predicate devices.
• Performance Data: The document explicitly states: "Bench testing of the Aligners has not been performed due to the difficulty in evaluating this type of dental device in a laboratory setting. However, there is sufficient information available from the scientific literature to demonstrate that the preformed tooth positioner provides reasonable assurance of safety and effectiveness."

In essence, the "study" proving the device meets criteria is the argument for substantial equivalence, relying on the established history and scientific understanding of its predicate devices, rather than new, primary clinical or bench studies for this specific product.

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