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510(k) Data Aggregation
(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 <0.001% since 2019 (Implied as supporting safety/effectiveness comparable to predicate) | An analysis of adverse events was provided that showed less than 0.001% of adverse events were occurred since 2019. |
Missing Information for AI/ML-specific questions:
Given the nature of the device (a physical clear aligner), the following information typically found in AI/ML medical device submissions is not present in this document:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as this is not an AI/ML diagnostic device with a "test set" in that context. The "real-world data" mentioned for traction accessory effectiveness is not detailed enough to provide this.
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.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the effectiveness of the traction accessory, "real-world data" was used, which generally implies outcomes data from patient treatments. The exact nature of this data (e.g., direct measurement of tooth movement, patient satisfaction, clinical assessments) is not specified.
8. The sample size for the training set
- Not applicable. The "software" mentioned is for manufacturing and design, not an AI/ML algorithm that requires a training set in the diagnostic sense.
9. How the ground truth for the training set was established
- Not applicable.
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