(183 days)
This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only.
The proposed device, Alpha Pure, consists of ceramic orthodontic brackets which are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontics wire, to alter the tooth position. The ceramic bracket is produced using Al203, translucent polycrystalline aluminum oxide (99.99%). The brackets are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady, gentle pressure to produce desired tooth movement.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Alpha Pure" device:
The provided document is a 510(k) summary for an orthodontic bracket, Alpha Pure. The entire document focuses on demonstrating substantial equivalence to a predicate device (Sapphire Ceramic Bracket, K073045), rather than establishing new performance acceptance criteria through clinical or comprehensive standalone studies.
Therefore, many of the requested sections (2-9, related to a standalone study or clinical trial) are not applicable or cannot be extracted directly from this type of regulatory submission. The "acceptance criteria" here are effectively the demonstration of comparable characteristics to a legally marketed device.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for "Alpha Pure" are implicitly defined by its ability to demonstrate substantial equivalence to the predicate device, "Sapphire Ceramic Bracket (K073045)", across various technological characteristics and indications for use. The reported "performance" for Alpha Pure reflects these characteristics.
| Acceptance Criteria (Demonstrates Equivalence to Predicate) | Reported Device Performance (Alpha Pure) | Predicate Device Performance (Sapphire Ceramic Bracket) |
|---|---|---|
| Indications for Use | "This device is indicated for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only." | "This device is indicated for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only." |
| Material | Aluminum Oxide | Aluminum Oxide |
| Biocompatibility | Meets the applicable requirement of ISO 10993 | Meets the applicable requirement of ISO 10993 |
| Maxillary Torque (mm) | -21 to +17 | -22 to +17 |
| Maxillary Angulation | 0 – 9 | 0 – 11 |
| Slot | 0.018", 0.022" | 0.018", 0.022" |
| Transparency | Half-transparency | Half-transparency |
| Color | White, same as tooth color | White, same as tooth color |
| Indication system | Colored-dot | Colored-dot |
| Design | Tie wings for ligature, Hook, Archwire Slot, Round home, base and identification marks for placement. Hooks for ligation, for additional tooth movement, Molded ceramic body with rounded corners and edges, Slot to hold orthodontic wires. | Tie wings for ligature, Hook, Archwire Slot, Round home, base and identification marks for placement. Hooks for ligation, for additional tooth movement, Molded ceramic body with rounded corners and edges, Slot to hold orthodontic wires. |
| Single Use | Yes | Yes |
| Non-Sterile Packaging | Yes | Yes |
Note on Differences: The document explicitly mentions slight differences in the range of Maxillary Torque and Maxillary Angulation. However, it concludes that "these differences are not expected to affect the overall performance of the device since they are still within the range of what is typically observed for orthodontic brackets."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the submission focuses on demonstrating substantial equivalence based on material properties, design, and intended use, rather than a clinical performance study with a test set of patient data.
3. 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)
This information is not applicable. Ground truth establishment by experts for a test set is not part of this type of 510(k) submission for an orthodontic bracket based on substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for studies involving subjective interpretation of data, which is not the primary focus of this submission.
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
This information is not applicable. MRMC studies are used for evaluating diagnostic image interpretation systems, typically AI-assisted tools. The Alpha Pure is an orthodontic bracket, a physical medical device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is an orthodontic bracket, not an algorithm, so the concept of standalone algorithm performance does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility study, the ground truth was based on the applicable requirements of ISO 10993 standards. These standards provide benchmarks and methods for evaluating biological responses to medical devices. No other "ground truth" (like pathology or outcomes data) in a clinical sense is mentioned for the device's functional performance, as substantial equivalence relies on comparison to an existing device.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of this 510(k) submission for a physical orthodontic bracket.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set, there is no ground truth established for it.
§ 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.