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Nightwear Aligners are indicated for the alignment of permanent teeth during orthodontic treatment of malocclusion.

The Smylio Nightwear Aligners are thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn at least 9 to 12 hours a day and are to be removed for eating and for cleaning.

Smylio Nightwear Aligners are designed from digital scans of a patient's dentition submitted by a dental health professional (e.g., dentist or orthodontist). Using the scan, sequential dental models are designed and approved by the treating physician prior to manufacturing.

Once the treatment plan is reviewed and approved by a dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The aligners are shipped to the treating clinician's office where they are then distributed to the patient in sequential stages. The patients' dental health professional then monitors their treatment of the first aligner to the delivery of the final aligner.

Nightwear Aligners are a sequence of transparent aligners created from a digital orthodontic treatment plan. The Nightwear Aligners are fabricated of a transparent thermoformed polyurethane plastic. Each aligner delivers a unique combination of minor forces to create the planned tooth movement. The digital orthodontic treatment plan is created by a dental health professional. The Nightwear Aligners incorporate the use of attachments to create spaces and force points in order to cause minor tooth movement. These force points are located in specific areas and positioned in such a way that they provide a continuous force which slowly dissipates over time on the tooth to be moved for as long as the aligner is worn.

The provided text describes the Smylio Nightwear Aligners and its substantial equivalence to a predicate device (iSMILE Aligners K200908). However, it does not contain acceptance criteria or a study designed to explicitly prove the device meets specific performance acceptance criteria in terms of diagnostic accuracy or a quantitative measure of treatment effectiveness with a defined threshold.

Instead, the document focuses on demonstrating substantial equivalence for regulatory clearance based on:

• Similarities in Indications for Use: Both devices are indicated for the alignment of permanent teeth during orthodontic treatment of malocclusion.
• Similarities in Technological Characteristics: The device description, materials, manufacturing method, and mode of action are compared and found to be "Same" as the predicate device.
• Non-clinical performance testing: Durability testing, material property testing (ASTM D638, ASTM D790), and biocompatibility testing (ISO 10993 standards) were performed to ensure the material and manufacturing process are suitable.
• Clinical performance testing: An internal clinical study was conducted to demonstrate that tooth alignment may occur with the specified wear time for mild malocclusions. This is a descriptive finding rather than a performance metric against a predefined acceptance criterion.

Therefore, many of the requested items (acceptance criteria table, ground truth establishment, MRMC study, effect size) are not explicitly present or detailed in the provided text because the regulatory submission's goal was substantial equivalence, not necessarily a performance claim against specific quantitative targets.

However, I can extract the information that is present and note where the information is absent according to your request.

Description of Acceptance Criteria and Proving Study (Based on Provided Text)

The provided text focuses on establishing substantial equivalence to a predicate device (iSMILE Aligners, K200908) for regulatory purposes, rather than proving the device meets specific quantitative performance acceptance criteria in terms of treatment efficacy or diagnostic accuracy against a predefined threshold. The "acceptance criteria" can be inferred as successful demonstration of similar indications for use, technological characteristics, and safety and basic functional performance, which collectively support substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Clinical): 20 patients
• Data Provenance: The study was conducted internally under an FDA cleared IDE application (G200298). The country of origin is not specified but it is an internal clinical performance test. The study is prospective in nature as it is a "clinical performance testing" that "was conducted".

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

• Number of Experts: Not specified.
• Qualifications of Experts: The clinical performance was determined "as determined by the treating dentist." No further specific qualifications (e.g., years of experience, specialization) are provided for these dentists.

4. Adjudication method for the test set

• Adjudication Method: Not specified. The outcome was "as determined by the treating dentist," implying a single determination, not a consensus or adjudicated process among multiple experts.

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, an MRMC comparative effectiveness study was not performed. This device is an orthodontic aligner, not an AI-powered diagnostic tool, so such a study would not be applicable. The text does not mention AI assistance.

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

• Standalone Performance: Not applicable. This device is a physical orthodontic aligner, not an algorithm or AI system.

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" for the clinical performance was the observation that "tooth alignment may occur for patients with mild malocclusions as determined by the treating dentist." This appears to be a clinical assessment/outcome, not pathology, imaging, or universally accepted objective ground truth.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This refers to a physical medical device, not a machine learning algorithm that requires a training set. The "design" (digital models) is approved by the treating physician, but this is not a training set in the context of AI.

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

• Ground Truth for Training Set: Not applicable (as above, no training set for an algorithm). The device design process involves digital scans and sequential dental models designed and approved by the treating physician, which would be the "input" for manufacturing, not a training set with established ground truth for an algorithm.

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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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