(313 days)
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
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (as per text) |
|---|---|
| Indications for Use: Alignment of permanent teeth during orthodontic treatment of malocclusion. | Smylio Nightwear Aligners: Indicated for the alignment of permanent teeth during orthodontic treatment of malocclusion. Predicate (iSMILE Aligners): Indicated for the alignment of teeth during orthodontic treatment of malocclusion. (Result: Same) |
| Technological Characteristics: Similar materials, design, manufacturing, and mode of action as predicate. | Smylio Nightwear Aligners: Thermoplastic Polymer, thermoformed, patient-specific, removable, delivers combination of minor forces for tooth movement. Predicate (iSMILE Aligners): Shares these characteristics. (Result: Same for all compared specifications including Regulation Number, Classification Name, Product Code, Classification, OTC or Rx, Material, Material Properties, Biocompatibility, Device Description, Anatomy Location, Size, Manufacturing Method, Patient Removable, Mode of Action.) |
| Material Properties (Non-clinical): Sufficient tensile strength, elasticity, ductility, chemical resistance, and clarity. | Material property testing performed to investigate elongation, tensile and flexural properties in accordance with ASTM D638 and ASTM D790. Demonstrated sufficient properties. |
| Manufacturing Process (Non-clinical): Robustness from 3D printing through thermoforming. | Internal manufacturing validation performed; robustness of process demonstrated. |
| Durability (Non-clinical): Suitable for prescribed period of use in real-world simulation. | Durability testing conducted; ensured suitability. |
| Biocompatibility (Non-clinical): Meets established standards for patient-contacting material. | Biocompatibility testing for aligner material performed in accordance with ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-11:2017. |
| Clinical Performance: Tooth alignment may occur under specified conditions (for mild malocclusions). | Study demonstrated that tooth alignment may occur for patients with at least 9 to 12 hours of wear time per day for one week prior to moving to the next aligner for patients with mild malocclusions. |
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.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.