Search Results

The U-Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The U-aligner system repositions teeth by way of continuous gentle force.

The U-Aligner system is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.

A dental health professional (e.g. orthodontist or dentist), using a standard personal computer prescribes the U-Aligner system based on an assessment of the patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth and completes a prescription form. Universal Orthodontic Lab then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription using a standard dental software used for tooth alignment (Ortho System™, K180941). The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Universal Orthodontic Lab produces trays, which are formed of clear, thin, thermoformed plastic. The trays are sent back to the dental health care professional who then provides them to the patient, confirming fit and design. Over a period, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the designed position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.

The technology is essentially identical to that used by a number of sequential aligner systems, including the two predicate devices.

The provided text describes a 510(k) premarket notification for a medical device called "U-Aligner." This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving that the device meets specific acceptance criteria through a standalone study. The document primarily focuses on comparing the U-Aligner's characteristics (indications for use, materials, mode of action) to those of predicate devices.

Therefore, the requested information regarding detailed acceptance criteria, a specific study proving the device meets them, sample sizes for test/training sets, expert qualifications, and adjudication methods for a medical image analysis or diagnostic device is not applicable to this document.

Here's why and what information can be extracted or inferred:

• Type of Device: The U-Aligner is an orthodontic plastic bracket (sequential aligner), not an AI/ML-driven diagnostic or image analysis device. Its "performance" is largely related to its physical properties, manufacturing accuracy, and biocompatibility, not its ability to interpret data or make classifications.
• Purpose of Submission: A 510(k) is about demonstrating "substantial equivalence" to a predicate device, meaning it is as safe and effective as a device already on the market. It's not typically about establishing entirely new performance benchmarks through de novo clinical trials.

Information that is relevant or can be inferred from the document:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not applicable for typical test set definitions. This device is a physical orthodontic aligner.
• For the manufacturing validation, the sample size is not stated, nor is the provenance of the data points (which would likely be internal manufacturing measurements).
• For biocompatibility testing, the "sample size" would refer to the number of biological samples or subjects used in the in-vitro and in-vivo tests, which is not specified but implicitly met the requirements of ISO 10993-1.

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):

• Not applicable. There is no "ground truth" establishment in the context of image analysis or diagnostic performance as this is a physical device. The "truth" for biocompatibility is whether the material is toxic, sensitizing, or irritating, as measured by established biological tests. The "truth" for manufacturing accuracy is whether the physical output matches the digital design.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No adjudication on diagnostic findings is 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. This is not an AI-assisted diagnostic or imaging device, so such a study would not be performed. The device itself is the treatment tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This refers to AI algorithm performance. The U-Aligner is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For biocompatibility: Established laboratory testing protocols (e.g., ISO 10993-1 standards for cytotoxicity, sensitization, irritation).
• For manufacturing accuracy: Comparison of the physical aligner's dimensions to the digital design specifications (expected locations and positions of tooth structures).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of AI/ML or a clinical study. The "design" phase involves dental software (Ortho System™, K180941), which itself would have been validated, but the specifics of its training data are not part of this 510(k).

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set for the U-Aligner device itself.
  The "ground truth" for the overall process would be the desired tooth movement prescribed by a licensed dental professional (orthodontist or dentist), based on their assessment of the patient's teeth. The software then generates a series of aligners to achieve this target.

Ask a specific question about this device