(1 days)
A-Line Advanced orthodontic ceramic bracket is intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.
This orthodontic bracket is made of polycrystalline ceramic and is used for the treatment of malocclusion. It is designed to be attached to the surface of patients' teeth and be connected to the orthodontic wire in order to apply physical pressure on the tooth movement. Each model differs in size and dimension, color identification as they are attached to the tooth surface corresponding to 20 of the 28 permanent teeth.
The provided text is a 510(k) summary for a medical device called "A-Line Advanced" (an orthodontic ceramic bracket). It does not describe a study involving an algorithm, AI, or human readers, so many of the requested items are not applicable.
Here's the information that can be extracted and a note for those that are not present:
1. A table of acceptance criteria and the reported device performance
The document provides the following performance characteristics and specifications, which serve as acceptance criteria for the device:
| Item | Reference Standards | Specification | Reported Performance (from testing) |
|---|---|---|---|
| Physical and Performance Characteristics | |||
| Dimension | ISO 27020(2019) | -. Torque(±3°) | |
| -. Angulation(±3°) | |||
| -. Offset (±3°) | |||
| -. Slot length(±0.1 mm) | |||
| -. Slot width(±0.1 mm) | |||
| -. Slot depth(±0.1 mm) | |||
| -. In-out(±0.1 mm) | Stated as passed | ||
| Corrosion | ISO 22674(2016) | ||
| ISO 10271(2020) | 1.642 ± 0.157 ug/cm² in 7 days | Stated as passed | |
| Hazardous elements | ISO 22674(2016) | -. Be : 0.00 wt % | |
| -. Cd : 0.00 wt % | |||
| -. Pb : 0.00 wt % | |||
| -. Ni : 36.59 wt % | Stated as passed | ||
| Adhesion Test to tooth | ISO 11405(2015) | -. Mean±SD : 7.22 ± 2.34 MPa | Stated as passed |
| Biocompatibility Testing | |||
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Non-cytotoxic |
| Mucosal Irritation | ISO 10993-23 | None Irritation | None Irritation |
| Skin Sensitization | ISO 10993-10 | Do not show any hypersensitivity | Do not show any hypersensitivity |
| Acute systemic toxicity | ISO 10993-11 | Do not show any acute systemic toxicity | Do not show any acute systemic toxicity |
| Comparative Performance (Bench Tests) | |||
| Wire Slot Torque strength | ISO 27020 | (Implicitly compared to predicate device) | Result demonstrates stability |
| Shear Bond Strength | ISO 11405 | (Implicitly compared to predicate device) | Showed bond strength |
| Bracket Removal Test | N/A | (Implicitly compared to predicate device) | Showed stability of de-bonding performance |
| Wire Slot Drag Strength | N/A | (Implicitly compared to predicate device) | Measured friction |
| Door Pull-Out Strength | N/A | (Implicitly compared to predicate device) | Measured tensile force at fracture |
| Adhesive Strength Bonding | ISO/TS 11405 | (Implicitly compared to predicate device) | Conducted to study bonding |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each test mentioned (e.g., how many brackets were tested for corrosion, how many teeth for adhesion, etc.). The provenance of the data is from non-clinical laboratory testing performed by "KTR (Korea Testing & Research Institute)" and "Seoul National University Dental Hospital Dental Material & Device Evaluation Center." These are non-clinical (bench) tests, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical device that does not involve expert image interpretation or ground truth establishment in the context of the requested AI/human reader study format. A "biological evaluation written by an expert [Seoul National University Dental Hospital Dental Material & Device Evaluation Center]" was used to justify not conducting certain biocompatibility tests. No specific number or individual qualifications are listed beyond "expert."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no human reading or adjudication process described.
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. This is a physical medical device (orthodontic bracket), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device would be defined by established engineering and biocompatibility standards (e.g., ISO standards) and the physical properties and performance characteristics of the device when subjected to these standardized tests. It does not involve expert consensus on medical images or pathology.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model.
§ 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.