(422 days)
Ceramic Bracket is indicated for orthodontic movement of natural teeth.
Ceramic bracket are designed to move teeth to improve their alignment. Ceramic bracket are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position. Ceramic bracket are intended for use in affixed to a tooth so that pressure can be exerted on the teeth. Use bonding supplies to bond the bracket on to a tooth. Use bonding supplies to bond the bracket on to a tooth. Ceramic bracket are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.
This is a 510(k) premarket notification for a medical device called "Ceramic Bracket." The document describes the device, its intended use, and argues for its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a numerical or pass/fail threshold manner, as might be seen for diagnostic device performance. Instead, it relies on demonstrating compliance with relevant ISO standards and comparability to the predicate device. The device is a physical orthodontic bracket, not a diagnostic algorithm.
Therefore, I will present the performance tests conducted and the general conclusion for device acceptance.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Compliance with ISO 27020 (General Orthodontic Brackets) | Device meets performance specifications of ISO 27020:2010 |
| Biocompatibility | Evaluated and tested according to ISO 10993 standards: |
- ISO 10993-3 (Genotoxicity, Carcinogenicity, Reproductive toxicity)
- ISO 10993-5 (In vitro cytotoxicity)
- ISO 10993-10 (Irritation and skin sensitization)
- ISO 10993-11 (Systemic toxicity)
- ISO 10993-12 (Sample preparation and reference materials) |
| Mechanical Function (Shear Bond Strength) | Tested, results compared to ISO 6872:2015, ISO 29022:2013, ISO 27020:2010, ISO 6474-2:2012, and clinical literature data. |
| Mechanical Function (Torque Strength) | Tested, results compared to ISO 6872:2015, ISO 29022:2013, ISO 27020:2010, ISO 6474-2:2012, and clinical literature data. |
| Structural Integrity | Tested, results compared to ISO 6872:2015, ISO 29022:2013, ISO 27020:2010, ISO 6474-2:2012, and clinical literature data. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample sizes used for each mechanical or biocompatibility test. It indicates that "Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use" and lists the types of tests.
- Data Provenance: Not specified in terms of country of origin. The testing was conducted to comply with international ISO standards, suggesting tests were performed in accordance with these globally recognized methodologies. The testing appears to be based on physical device samples rather than clinical data sets. It is a retrospective evaluation against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and study. The "ground truth" for a physical device like an orthodontic bracket is its physical and biological performance as measured against engineering and biocompatibility standards, not an expert-annotated dataset. The standards themselves are developed by expert consensus in the relevant fields (dentistry, materials science, biocompatibility).
4. Adjudication method for the test set
Not applicable. The "test set" here refers to physical samples of the device being evaluated through standardized laboratory tests, not a dataset requiring human adjudication.
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 device is an orthodontic bracket, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an orthodontic bracket, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance evaluation is established by:
- International Standards: Specific ISO standards (e.g., ISO 27020, ISO 6872, ISO 29022, ISO 6474-2 for mechanical properties; ISO 10993 series for biocompatibility).
- Clinical Literature Data: Used as a reference for comparison in mechanical testing.
Essentially, the device's characteristics are measured and compared against predefined thresholds and benchmarks set by these standards and literature, rather than against a human expert's "ground truth" for a case.
8. The sample size for the training set
Not applicable. Since this is a physical medical device and not an AI/algorithm, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.