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eCligner® is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). The eCligner® is intended for minor anterior tooth movement by way of continuous gentle force.

eCligner® is a transparent and removable orthodontic appliance. eCligner® is a digitally- made Clear Aligner by the 3DCAD/CAM system. By printing the completed setup data into a series of plastic models, eCligne® is produced by a simple stamping procedure (Vacuum forming). eCligner® is designed for orthodontic tooth movement. Each step for using orthodontic appliance, eCligner® consists of 3 weeks (1 week for soft, 1 week for medium and 1 week for hard) and wearing the appliance 17 hours a day for each sequence is required. * More than 3 weeks of wearing may be required per step depending on the direction of orthodontic treatment and dentist's instruction. * eCligner® -H is used for 3 weeks during Final process. During one individual step of treatment, three aligners of different layer thickness are worn in weekly intervals. The applied layer thicknesses are 0.5 mm (medium) and 0.75 mm (hard). Each individual step is consisting of three different thickness appliances as follows: 1. eCligner® -S (Soft) 2. eCligner® -M (Medium) 3. eCligner® -H (Hard) *eCligner® -UH (Ultra Hard, 1.00mm) is used only for the patient with Bruxism (Teeth Grinding) since the aligner can be broken while the patient grinds their teeth unintentionally.

This document (K143499) is a 510(k) premarket notification for the eCligner® orthodontic plastic bracket device. The document primarily focuses on establishing substantial equivalence to a predicate device (Invisalign® System, K081960). It does not contain information about acceptance criteria, detailed device performance, or a specific study proving the device meets acceptance criteria in the way typically expected for a medical device efficacy study.

Here's an analysis based on the provided text:

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

The document does not provide a table of acceptance criteria with corresponding device performance metrics (e.g., accuracy, sensitivity, specificity, or tooth movement outcomes). Instead, it focuses on demonstrating substantial equivalence based on similar design, materials, and mechanism of action to a legally marketed predicate device.

The "Performance Testing" section mentions:

• Biocompatibility tests: These were performed in accordance with ISO 10993. The document states "Biocompatibility tests such as cytotoxicity, irritation, and sensitization were performed," but it does not report the acceptance criteria or the results of these tests.
• Software validation test: This was performed for the CAD/CAM system used to fabricate the device, according to FDA guidance. The document states "A performance qualification of the available software utilized in the processing steps of the subject device has been included to support substantial equivalence," but it does not report specific acceptance criteria or results from this validation.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No information is provided regarding a "test set" in the context of clinical performance or a specific study designed to evaluate clinical outcomes. The document discusses "performance testing" related to biocompatibility and software validation, but these are not clinical studies with a test set of patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. The document does not describe a study involving expert-established ground truth for a test set of clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No such study or adjudication method 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:

Not applicable. This device is an orthodontic appliance, not an AI-assisted diagnostic tool for human readers. No MRMC study is described.

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

Not applicable in the sense of an algorithm. The device itself is the physical orthodontic appliance. While it relies on a CAD/CAM system, the "standalone performance" of the device would refer to its clinical effectiveness, which is not detailed here. The software validation is mentioned but without performance metrics.

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

Not applicable in the context of clinical efficacy studies. For biocompatibility, the ground truth would be accepted ISO standards. For software validation, it would be the software's ability to meet its intended specifications, as per FDA guidance. No clinical ground truth (e.g., actual tooth movement measured against planned movement) is presented.

8. The sample size for the training set:

Not applicable. There is no mention of an AI model being trained with a specific dataset. The CAD/CAM system likely has its own development and validation protocols, but these are not detailed as a "training set" in a machine learning context.

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

Not applicable as there is no mention of a "training set" for an AI model.

Summary of what the document does state regarding performance/testing:

The document for the eCligner® primarily relies on substantial equivalence to an existing predicate device (Invisalign® System, K081960). It supports this claim by:

• Indications for Use: Stating that the eCligner® is "a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition... intended for minor anterior tooth movement by way of continuous gentle force," which is compared to the predicate's "alignment of teeth during orthodontic treatment of malocclusion."
• Technological Characteristics: Highlighting similarities in "design, mechanism of action and materials" (thermoplastic, gentle continuous pressure on teeth). Both systems use a 3D CAD/CAM system for digital planning and vacuum forming for production.
• Performance Testing (Non-Clinical):
  • Biocompatibility tests: Performed in accordance with ISO 10993 (cytotoxicity, irritation, sensitization). No results or specific acceptance criteria are provided in this document.
  • Software validation test: For the CAD/CAM system, performed according to FDA guidance "Guidance for the content of premarket submissions for software contained in medical devices." A "performance qualification" was included, but no specific data, acceptance criteria, or results are detailed.

In essence, this 510(k) premarket notification establishes that the eCligner® is as safe and effective as the predicate device by demonstrating similar fundamental scientific technology and performance characteristics through non-clinical testing (biocompatibility, software validation) and comparison of intended use, design, and materials. It does not present a new clinical study with detailed acceptance criteria, patient sample sizes, or outcome measures to "prove" its efficacy beyond substantial equivalence.

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