(109 days)
The device is intended for orthodontic movement of teeth. It is used temporarily and is removed affer orthodontic treatment has been completed. The devices are intended to be single used only.
The MACH BRACKETS are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire placement and removal through self-ligation and enhancing the bonding and debonding characteristics of the bracket. The MACH BRACKETS is produced using Al2O3, translucent polycrystalline aluminum oxide (99.99%). This MACH BRACKETS are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady, gentle produce desired tooth movement.
The document provided is a 510(k) premarket notification for an Orthodontic Ceramic Bracket (Mach Brackets, Bright Brackets). It details the device's description, intended use, technological characteristics, and performance testing for biocompatibility.
Here's an analysis of the acceptance criteria and study information based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Items | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| In vitro cytotoxicity | Expected to pass ISO10993-5 standards | Passed |
| Oral mucous membrane irritation test | Expected to pass ISO10993-10 standards | Passed |
| BrdU as a guideline for testing skin sensitization | Expected to pass ISO10993-10 standards | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench tests were performed" for biocompatibility. However, it does not provide any details regarding:
- The specific sample size used for any of the biocompatibility tests.
- The data provenance (e.g., country of origin, retrospective or prospective) for these tests. Biocompatibility tests are typically laboratory-based and not derived from clinical patient data in the same way clinical trials are.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Biocompatibility tests, as described, do not typically involve human expert establishment of ground truth in the same way clinical diagnostic studies do. The "ground truth" for these tests is defined by the standards (ISO10993-5, ISO10993-10) themselves and the methodologies executed by the testing laboratory.
The tests were performed by the "Dental Devices Testing & Evaluation Center, Yeonsei University, College of Dentistry." While this indicates a reputable institution, no information is provided on:
- The specific number of experts involved in analyzing the test results.
- The qualifications of those experts (e.g., toxicologists, material scientists, with specific years of experience).
4. Adjudication Method for the Test Set
As these are laboratory-based biocompatibility tests and not clinical studies requiring human interpretation of outcomes, no adjudication method (like 2+1 or 3+1 consensus) is mentioned or typically applicable. The results are objective measurements against defined standard criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document describes biocompatibility bench tests, not a clinical study involving human readers or cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is applicable to AI/ML devices. The Mach Brackets are physical orthodontic ceramic brackets, not an algorithm or software device. Therefore, a standalone performance study is not relevant or applicable in this context.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the biocompatibility tests:
- The "ground truth" is established by the international standards (ISO10993-5 and ISO10993-10) that define acceptable biological responses for medical devices.
- The test results (e.g., "Passed") indicate compliance with these predefined criteria.
8. The Sample Size for the Training Set
This question refers to the training data for AI/ML algorithms. Since the Mach Brackets are a physical medical device and not an AI/ML product, there is no training set in the context of machine learning. The device itself is manufactured; it does not "learn" from data in the AI sense.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no training set for this type of device. Therefore, the establishment of ground truth for a training set is not applicable.
§ 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.