(295 days)
Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars).
The Clear Aligner 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 Clear Aligners are fabricated by thin thermoformed polyurethane or thermoformed multilayer copolyester and polyurethane composite (TPU +PETG) plastic. The corrective forces are generated via differences between current teeth arrangement and each step's aligner. They are designed to move the teeth to the target position and deliver desired clinical effect.
The traction accessory, also called "Angel Button", made of thermoplastic polyurethane can be selected and will be bonded to the outer surface of the aligner by adhesive made of acrylic polyurethane.
The provided text describes the regulatory clearance of a medical device, the "Clear Aligner," and summarizes the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device. However, it does not contain the detailed information requested regarding acceptance criteria and the study proving the device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, or accuracy, which are typical for studies involving diagnostic AI/ML devices.
The document focuses on:
- Biocompatibility testing
- Software validation & risk analysis
- Performance Testing of the traction accessory and shelf life
- Real-world data for the traction accessory's effectiveness and adverse event analysis.
Based on the provided text, I can only extract information related to the non-clinical tests and their general acceptance criteria. There is no mention of a device that requires performance metrics against specific acceptance criteria like sensitivity/specificity or accuracy in the way described in your request. The device in question is a clear aligner for orthodontic treatment, not an AI/ML-driven diagnostic tool.
Therefore, many of your specific numbered requests cannot be directly answered from this document.
Here's an attempt to answer based on the available information, noting where information is missing:
1. A table of acceptance criteria and the reported device performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Met requirements of study protocols; material considered non-cytotoxic, non-sensitizing, and not an intracutaneous irritant. | Results met the requirements of the study protocols; material is considered non-cytotoxic, non-sensitizing, and is not an intracutaneous irritant. (In compliance with ISO 10993) |
| Software Validation | Validated as per FDA Guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff". | The software system used in the process of clear aligner manufacturing has been verified and validated as per FDA Guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff". |
| Risk Analysis | Performed according to ISO 14971:2019. | A Risk Analysis was performed according to ISO 14971:2019. |
| Traction Accessory Strength | Met EA internal specifications and pre-defined acceptance criteria for shear and tensile strength. | The shear and tensile strength testing performed for the Angel button were tested according to EA internal specifications and the results passed the pre-defined acceptance criteria. |
| Shelf Life (Accelerated Aging) | Conformity with pre-established specifications and acceptance criteria for 3-year shelf life. | A 3-year shelf life accelerated aging testing were conducted and the test results showed conformity with the pre-established specifications and acceptance criteria. |
| Traction Accessory Effectiveness | Effective to aid the movement of teeth. (Implied, as based on "real-world data") | Real-world data was submitted to demonstrate that the traction accessory was effective to aid the movement of teeth. |
| Adverse Events | Low adverse event rate, specifically |
§ 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.