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510(k) Data Aggregation
(1 days)
Biocetec Co., Ltd
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.
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(184 days)
BIOCETEC CO., LTD
C-LineTM 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
C-Line ™ orthodontic ceramic brackets are intended to be bonded to a tooth to apply pressure to a tooth to alter its position. C-Line ™ orthodontic ceramic brackets consist of a translucent alumina body and a bonding base. The bracket's color marking and cords indicates the bracket positioning and facilitate bracket identification.
Here's an analysis of the provided text regarding the acceptance criteria and study details for the C-Line Orthodontic Ceramic Bracket, structured to answer your specific questions.
Important Note: The provided document is a 510(k) summary for a medical device (orthodontic ceramic bracket). It establishes substantial equivalence by comparing the new device to a predicate device, rather than proving a specific clinical performance. Therefore, sections related to AI performance, human reader improvement, and distinct ground truth for training/test sets are not applicable as this is not an AI/ML medical device.
Acceptance Criteria and Study Overview
The C-Line Orthodontic Ceramic Bracket K163467 sought to demonstrate substantial equivalence to a predicate device (Clarity Advanced Ceramic Bracket, K102803) by showing similar performance in non-clinical (bench) tests and comparable design characteristics and intended use. The "acceptance criteria" here are implied by the comparison to the predicate device, meaning the new device should perform similarly or better than the predicate in engineering tests without raising new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence determination based on non-clinical testing against a predicate, "acceptance criteria" are not explicitly defined as numerical thresholds. Instead, the performance of the applicant device (C-Line) is compared directly to the predicate device (Clarity Advanced) to demonstrate similarity.
| Performance Characteristic | Acceptance Criterion (Implied - Similar to Predicate) | Reported Device Performance (C-Line) |
|---|---|---|
| Mechanical Properties | "similar to the predicate device" | |
| Wire Slot Drag Test | Similar to predicate | Result of test data was similar for both brackets. |
| Wire Slot Torque Test | Similar to predicate | C-Line brackets had higher torque strength than Clarity Advanced brackets due to the higher in/out thickness of C-Line. (This difference was not flagged as raising new safety/effectiveness concerns). |
| Shear Test | Similar to predicate | Two brackets had a very similar shear strength. No fracture occurred during debonding. |
| Bracket Removal Test | Similar performance to predicate | C-Line brackets had a tendency to remain adhesive lower than Clarity Advanced because of the undercut pattern base, implying an acceptable debonding outcome. Most adhesive remained on enamel. |
| Biocompatibility | Compliance with ISO 10993 standards | All user directly contacting materials are compliance with ISO10993 requirements (Cytotoxicity, Sensitization, Oral Mucosal Irritation, Systemic Toxicity, Degradation Products from Ceramics). |
| Design Characteristics | Conforming to ISO 27020:2010 | Conforms to ISO 27020:2010. Slight differences in bracket in-out and torque angles were noted but deemed not to raise new safety/effectiveness questions. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for the "test set" for each individual bench test. It mentions "bench testing" was conducted on the C-Line device and the predicate device. The provenance is not specified, but the manufacturing company is based in the Republic of Korea, suggesting the testing was likely performed there or by a contract lab. The tests are "non-clinical," so "retrospective or prospective" data provenance is not applicable in the human data sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a non-clinical, bench testing study, not a study involving human expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. This is a non-clinical, bench testing study.
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 not an AI/ML device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests would be the established scientific and engineering principles and the performance of the legally marketed predicate device. For example:
- For mechanical properties (shear strength, torque strength), the "ground truth" is measured physical values and established material science expectations.
- For biocompatibility, the "ground truth" is established by adherence to recognized international standards (ISO 10993 series).
- For design characteristics, the "ground truth" is conforming to the referenced international standard (ISO 27020:2010).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
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