(82 days)
Damon 3 Modified is a polycarbonate bracket system intended to aid in the movement of patient's teeth during orthodontic treatment.
The device is a polycarbonate orthodontic bracket which will encompass maxillary and mandibular brackets from second bicuspid to second bicuspid. The Damon 3 Modified mandroum orders stemic and self-ligating qualities. The Damon 3 Modified bracket was appliance has bour acthe reinforcement of the metal assembly to the molded plastic body, to enhance the strength of the bracket against the over-travel of the metal slide and to improve the ease of its opening and closing mechanisms.
This looks like a 510(k) summary for a medical device (orthodontic bracket), which typically does NOT include detailed performance studies or acceptance criteria in the same way an AI/software device would. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel performance data.
Therefore, for your request, much of the information you've asked for is not present in the provided text, as it's not a performance study report for a new device, but rather a regulatory submission for equivalence.
However, I can extract the relevant information and explicitly state what is missing based on the document.
Acceptance Criteria and Device Performance Study (Based on Provided Text)
This 510(k) submission for the Damon 3 Modified orthodontic bracket does not present a performance study with detailed acceptance criteria and quantitative performance metrics. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (Ormco Corporation's Damon 3).
The primary "acceptance criterion" for this type of submission is the FDA's determination that the new device is substantially equivalent to a predicate device, meaning it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Summary of Equivalence Claims) |
|---|---|
| Intended Use Equivalence: Same intended use as the predicate device. | Intended Use: "The intended use of Damon 3 Modified is as a plastic orthodontic bracket that is designed for the movement of teeth during orthodontic treatment." This is stated to be "identical to" the original Damon 3 bracket. |
| Technological Characteristics Equivalence: Similar materials, design, mechanism of action. | Device Description: "The device is a polycarbonate orthodontic bracket which will encompass maxillary and mandibular brackets from second bicuspid to second bicuspid. The Damon 3 Modified appliance has four reinforcement of the metal assembly to the molded plastic body, to enhance the strength of the bracket against the over-travel of the metal slide and to improve the ease of its opening and closing mechanisms." The device "functions in a manner identical to" the original Damon 3. |
| Safety and Effectiveness: Differences in technological characteristics do not raise new questions of safety or effectiveness. | The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This implies the FDA found no new questions of safety or effectiveness. |
Detailed Information Not Applicable/Present in this 510(k) Summary:
Due to the nature of a 510(k) for substantial equivalence of a physical medical device (orthodontic bracket), the following points are generally not part of the submission in the way they would be for an AI/software device performance study:
2. Sample size used for the test set and the data provenance:
- Not applicable/Not provided for a performance study. This submission relies on equivalence to an existing device, not a new clinical performance trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Ground truth establishment for a test set is specific to performance studies, especially for diagnostic or analytical devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. This refers to methods for resolving discrepancies in expert opinions on a test set, which is not relevant here.
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/Not provided. This is highly specific to AI-assisted diagnostic or interpretation devices and does not apply to a physical orthodontic bracket.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not provided. This refers to AI algorithm performance in isolation, not a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided. Ground truth definition is for performance studies, not for demonstrating substantial equivalence of a physical device.
8. The sample size for the training set:
- Not applicable/Not provided. Training sets are for machine learning algorithms, not for the regulatory submission of a physical medical device.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As above, related to machine learning, not this type of device submission.
In summary, the provided text is a 510(k) premarket notification for an orthodontic bracket, which primarily demonstrates substantial equivalence to a predicate device. It does not contain the detailed performance study information (acceptance criteria, sample sizes, ground truth establishment, MRMC studies) typically found for AI/software-as-a-medical-device (SaMD) or novel diagnostic device submissions.
§ 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.