(64 days)
The device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only.
The Orthodontic Ceramic Brackets are bonded to teeth to apply forces to the tooth, transmitted through a flexible orthodontic wire , to alter the tooth position. The ceramic bracket has both, aesthetic and self ligating qualities. This aimed at facilitating easier orthodontic wire placement and removal through self- ligatation. The function and performance of the orthodontic ceramic brackets are equal to the predicate device. The Material was selected according the requirements of ISO 6474;1994. Ceramic materials based on High purity aluminia.
This medical device submission for the Bernhard Forster GmbH Orthodontic Ceramic Brackets is a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with performance metrics.
Therefore, the requested information cannot be fully provided in the format of a typical performance study. Instead, the "study" demonstrating acceptance is the comparison to the predicate device and the material testing conducted.
Here's how the provided information aligns with your request:
Acceptance Criteria and Device Performance (in the context of a 510(k) submission)
For a 510(k) submission, "acceptance criteria" are implicitly met by demonstrating substantial equivalence to an existing legally marketed device. Performance is primarily assessed through comparison.
Table of Acceptance Criteria and Reported Device Performance (based on substantial equivalence):
| Acceptance Criteria Category (Implicit in 510(k)) | Predicate Device Performance (Innovation C, K060837) | Bernhard Forster GmbH Device Performance (Orthodontic Ceramic Brackets) |
|---|---|---|
| Intended Use Equivalence | Intended for orthodontic movement of natural teeth. | Intended for orthodontic movement of teeth. Used temporarily and removed after orthodontic treatment. Single-use only. (Slightly broader, but determined substantially equivalent) |
| Material Equivalence | A12O3 | A12O3 (High purity alumina) |
| Design/Function Equivalence | Applies forces to teeth via orthodontic wire. Aesthetic and self-ligating qualities. | Applies forces to teeth via orthodontic wire. Aesthetic and self-ligating qualities facilitating easier wire placement/removal. Function and performance are equal to predicate device. |
| Single Use | YES | YES |
| Sterility | Non-sterile | Non-sterile |
| Biocompatibility/Safety | (Implicitly safe and effective due to prior marketing) | Material selected according to ISO 6474;1994 (Ceramic materials based on High purity alumina), implying meeting material safety standards. |
Detailed Breakdown of Study Information (as requested):
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A table of acceptance criteria and the reported device performance
- See table above. The "acceptance criteria" for a 510(k) are essentially demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "reported device performance" is the direct comparison point-by-point to the predicate device.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This is not a traditional "test set" study. The submission relies on material testing data for the device itself and comparison to the predicate device's established performance.
- Sample Size: Not explicitly stated as a clinical "test set" sample size. The material testing would involve specific numbers of brackets or material samples as per ISO 6474;1994, but these details are not provided in this summary.
- Data Provenance: The manufacturing company is Bernhard Forster GmbH, based in Pforzheim, Germany. Material testing would typically be conducted by the manufacturer or a certified lab. This would be considered "prospective" data for the new device's material properties, but it's not clinical human data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is not a study requiring expert readers or "ground truth" establishment in the sense of diagnostic accuracy. The "ground truth" for material properties is established by adherence to recognized international standards (ISO 6474;1994). The "ground truth" for substantial equivalence is the predicate device's established regulatory status and performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No "adjudication method" as this is not a diagnostic performance study involving multiple readers.
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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. No MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" (or basis of evidence) used for this 510(k) submission is:
- Predicate Device Equivalence: The legally marketed predicate device (Innovation C, K060837) serves as the primary "ground truth" for safety and effectiveness.
- Material Standards: Adherence to international material standards (ISO 6474;1994 for Ceramic materials based on High purity alumina) serves as "ground truth" for the material properties and biocompatibility.
- The "ground truth" (or basis of evidence) used for this 510(k) submission is:
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The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established
- Not applicable. This is not a machine learning or AI 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.