(17 days)
Pre-Cemented Orthodontic Bracket System Extension II is indicated for use in bonding orthodontic appliances for orthodontic treatment.
The Pre-Cemented Orthodontic Bracket System Extension II is comprised of precemented ceramic and metal orthodontic brackets, transfer tray and adhesives.
The provided text is a 510(k) summary for the "Pre-Cemented Orthodontic Bracket System Extension II". It describes the device, its intended use, and its substantial equivalence to previously cleared devices.
Based on the information provided, here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness | The submission asserts that the device is safe and effective based on: |
- Prior use of components in legally marketed devices.
- Performance data provided (though specific metrics are not detailed in this summary).
- Previous biocompatibility data.
- The claim that shear bond strength testing, Failure Mode Effect Analysis (FMEA), and biocompatibility testing were not necessary due to no change in the super mesh base from predicate devices. |
| Substantial Equivalence | The device is deemed substantially equivalent to the predicate devices: - DENTSPLY International, Inc., Pre-Cemented Orthodontic Bracket System (K061252)
- DENTSPLY International, Inc., Pre-Cemented Orthodontic Bracket System Extension (K081291) |
| Technological Characteristics | The device represents an addition to K081291, and all its components have been used in legally marketed devices or found safe for dental use. No change in the super mesh base for metal and ceramic brackets. |
Study Information
-
Sample size used for the test set and the data provenance:
The provided 510(k) summary does not detail any specific clinical or performance study with a test set. It relies on the substantial equivalence to predicate devices and the prior use of components. It states that "performance data provided" but does not specify what this data entails or for which tests it was collected. Therefore, information regarding sample size, country of origin, or whether it was retrospective/prospective is not available. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No specific "test set" requiring ground truth established by experts is described in this summary. The submission is based on substantial equivalence and component history rather than a new performance study requiring expert adjudication of a test set. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As no specific "test set" is detailed, no adjudication method is mentioned. -
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 a physical orthodontic bracket system, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or mentioned. -
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. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not explicitly detailed. The "ground truth" for the device's safety and effectiveness appears to be derived from the established safety and performance of its predicate devices and the historical use of its components. There is no mention of specific new ground truth generation through e.g., pathology or new outcomes data specific to this device extension. The statement "performance data provided" is vague. -
The sample size for the training set:
Not applicable. As this is a physical device and not an AI/machine learning algorithm, there is no concept of a "training set." -
How the ground truth for the training set was established:
Not applicable. As there is no training set mentioned, this question is not relevant.
In summary, this 510(k) submission primarily leverages the concept of substantial equivalence to previously cleared devices. It does not present new, extensive clinical study data or a detailed performance study with a separate test set, training set, or expert adjudication as would be seen for a novel diagnostic device or AI algorithm.
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.