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K Clear aligners are indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars).

The K Line K Clear aligners are a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial position to a different end position using a softwaregenerated sequence of intermediate states. K Clear sequentially reposition teeth by way of continuous gentle force.

This submission describes the K Clear aligners, an orthodontic device intended for the alignment of teeth. The FDA has determined the device is substantially equivalent to a legally marketed predicate device (Smylio Invisible Clear Aligners, K212660).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the device's clinical performance in terms of treatment efficacy (e.g., specific tooth movement targets, reduction in malocclusion). Instead, the substantial equivalence decision is based on comparisons of design, materials, indications for use, and technological characteristics to a predicate device, along with performance data related to manufacturing and biocompatibility.

• Indications for Use: Highly similar. K Clear: "alignment of teeth during orthodontic treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars)." Smylio: "alignment of teeth during orthodontic treatment of tooth malocclusion."
• Technological Principles: Identical process to predicate and other sequential aligner systems.
• Regulation, Classification, Product Code, Class: Same as predicate.
• Mode of Action: Same (continuous gentle force).
• Method of Use: Same (worn 20-22 hours/day, removed for eating/cleaning, replaced sequentially).
• Material: Same (Thermoplastic polyurethane-polyester composite resin).
• Appliance Application: Same (Patient removable).
• Design: Same (Clear aligner).
• Biocompatible: Yes (Same as predicate).
• Prescription/OTC: Rx (Same as predicate).
• Sterile: Non-sterile (Same as predicate). |
  | Dimensional Accuracy (Manufacturing) | A manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing process for K Clear aligners. (No specific numerical acceptance criteria or results are provided in this summary). |
  | Performance as Intended (Manufacturing) | A qualification was performed to demonstrate the device is manufactured and performs as intended. |
  | Shelf-Life/Aging | A shelf-life/aging study was performed to support device labeling. (No specific acceptance criteria or results are provided). |
  | Biocompatibility | Evaluation and testing were conducted in accordance with ISO 10993-1. Specific tests performed:
• Cytotoxicity: ISO 10993-5:2009
• Sensitization: ISO 10993-10:2010
• Irritation: ISO 10993-10:2010
• Sub-chronic toxicity: ISO 10993-11:2017
• Genotoxicity: ISO 10993-3:2014
  (Implied acceptance is that the device passed these tests, indicating biocompatibility). No specific pass/fail criteria or results are provided. |

Regarding the device's ability to 'meet' clinical acceptance criteria, the document states: "The performance of sequential aligners in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. No clinical or animal testing data is included in this submission." This indicates reliance on the established clinical performance of the device type rather than novel clinical studies for K Clear.

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

No specific test set or clinical study was conducted for K Clear as part of this submission for direct patient outcomes. The submission relies on the established clinical effectiveness of the device type (sequential aligners under product code NXC) and "performance data" that includes manufacturing validation, qualification, shelf-life/aging study, and biocompatibility testing. These are not clinical test sets with patient data.

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

Not applicable, as no clinical test set using expert-established ground truth was part of this submission due to reliance on substantial equivalence and established clinical performance of the device type.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication was part of this submission.

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. The K Clear aligners are a physical orthodontic device, not an AI-assisted diagnostic or treatment planning software meant for human reader interpretation.

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

Not applicable. K Clear aligners are a physical device, not an algorithm. The aligners are used with a "software-generated sequence of intermediate states," but this software's performance as a standalone algorithm is not detailed, nor is it the central point of the device's regulatory review here.

7. The type of ground truth used

For the aspects for which data was presented:

• Manufacturing Validation, Qualification, Shelf-life/Aging: The "ground truth" would be the engineering specifications and quality control standards defined by the manufacturer and relevant to the manufacturing process for dimensional accuracy, intended performance, and material stability over time.
• Biocompatibility: The "ground truth" is defined by the standards listed (ISO 10993 series), which provide criteria for evaluating biological responses to medical devices. Meeting these standards serves as the ground truth for biocompatibility.
• Clinical Effectiveness: The "ground truth" for clinical effectiveness is considered to be the well-established performance of sequential aligners in the clinical environment since their first clearance in 1998. This is based on historical clinical use and published scientific literature for this class of devices, rather than a specific ground truth for K Clear itself.

8. The sample size for the training set

Not applicable in the context of a physical medical device. This term typically refers to machine learning models, which are not the subject of this submission in terms of clinical performance evaluation. The "software-generated sequence of intermediate states" implies some computational component, but details on its training data are not provided or required for this type of submission which focuses on substantial equivalence of the physical device.

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

Not applicable, as explained in point 8.

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