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510(k) Data Aggregation
(238 days)
This Mei Ceramic Bracket is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only.
The proposed device, Mei Ceramic Bracket, consists of ceramic orthodontic brackets which are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontics wire, to alter the tooth position. The ceramic bracket is produced using Al203, translucent polycrystalline aluminum oxide (99.99%). The brackets are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady, gentle pressure to produce desired tooth movement.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Conducted | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dimension Test | Meet dimensions itemized in ISO 27020 | Mei Ceramic Bracket was inspected and met the dimensions itemized in ISO 27020. |
| Bracket Removal Test | Perform comparably to predicate devices | Testing analysis shows comparable performance to predicate devices. |
| Shear Bonding Test | Perform comparably to predicate devices | Testing analysis shows comparable performance to predicate devices. |
| Torque Test | Perform comparably to predicate devices | Testing analysis shows comparable performance to predicate devices. |
| Wire Drag Test | Perform comparably to predicate devices | Testing analysis shows comparable performance to predicate devices. |
| Biocompatibility | Biocompatible according to ISO 10993-1 | Biocompatibility assessment and testing was performed using standard risk assessment techniques and in consideration of FDA and internationally recognized guidance's. This implies it met the standard. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each non-clinical test (dimension, bracket removal, shear bonding, torque, and wire drag tests). It states "Non-clinical performance data included testing results for dimension, Bracket removal test, Shear bonding test, Torque test, and Wire drag test." and "The testing analysis shows that Mei Ceramic Bracket perform comparably to the predicate devices."
The data provenance is from Orthosun Co., Ltd., located in Incheon, Republic of Korea. The tests appear to be retrospective as they were conducted on the finished device to demonstrate substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an orthodontic ceramic bracket, and the testing described is non-clinical (mechanical and material property testing). Ground truth in the context of expert consensus or medical diagnosis is not relevant for these types of tests. The "ground truth" would be the established international standards (like ISO 27020 or ISO 10993-1) and the performance of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert review processes for diagnostic accuracy, which is not relevant here. The evaluation of non-clinical tests would usually involve direct measurement against a standard or comparison to a predicate, not expert adjudication in the traditional sense.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data both with and without AI assistance. This document describes a physical medical device (orthodontic bracket) and its non-clinical performance testing.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone (algorithm only) performance study was not done. This concept is applicable to AI/ML software as a medical device (SaMD). The Mei Ceramic Bracket is a physical medical device, and the described tests are non-clinical, evaluating its physical properties and mechanical performance.
7. Type of Ground Truth Used
The ground truth used for these non-clinical tests includes:
- Established International Standards: Specifically, ISO 27020 for dimensional specifications and ISO 10993-1 for biocompatibility.
- Performance of the Predicate Device: The document states that the testing analysis shows the Mei Ceramic Bracket performs "comparably to the predicate devices" for bracket removal, shear bonding, torque, and wire drag tests.
8. Sample Size for the Training Set
Not applicable. The Mei Ceramic Bracket is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
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