Search Results

Magic Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

Magic Clear Aligners consist of a series of custom-made removable plastic orthodontic appliances which sequentially reposition teeth by way of continuous gentle force. A digital or traditional mold impression of the patient's teeth is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data created of the patient's teeth, specialized orthodontic CAD/CAM software is used to develop treatment plans. Using the software, dental technicians design a series of intermediate models corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health professional's prescription. The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced. Once approved, the specialized orthodontic software is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. Voodoo Manufacturing produces the aligner trays by thermal forming a plastic sheet over each model in the treatment plan. The aligner trays are sent to the dental health professional who then delivers them to the patient, confirming fit and design. Over a period of time, additional trays are provided sequentially to the patient by the dental health professional to gradually move the teeth to the desired position. The dental health professional monitors treatment from the first aligner is delivered to when the final aligner is delivered and treatment complete. The aligners are held in place by pressure and can be removed by the patient at any time.

This document describes the premarket notification (510(k)) for "Magic Clear Aligners" by Voodoo Manufacturing, Inc. It does not concern an AI/ML medical device, but rather a physical orthodontic device manufactured using CAD/CAM software. Therefore, many of the requested criteria related to AI/ML device performance, such as MRMC studies, ground truth establishment for training sets, and expert adjudication, are not applicable.

However, I can extract information related to the device's acceptance criteria and the studies that prove it meets those criteria, focusing on the manufacturing process and biocompatibility, which are the relevant aspects for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Manufacturing Dimensional Accuracy: Not explicitly stated as a "test set" in the traditional sense of a clinical or AI study. The "test" involved assessing the accuracy of the manufacturing process. It stated that "Three critical aspects of the manufacturing process were assessed for accuracy: digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligners." The number of samples for each aspect (e.g., how many models, molds, or aligners were measured) is not quantified.
• Biocompatibility Testing: The sample sizes for each biological test (Cytotoxicity, Sensitization, Irritation, Subacute/SubChronic Toxicity, Genotoxicity) are not specified in the document.
• Data Provenance: Not applicable in the context of clinical data provenance for an AI/ML device as this is a manufacturing and biocompatibility study. The manufacturing validation was performed by Voodoo Manufacturing, Inc. The biocompatibility testing was conducted according to international standards (ISO 10993 series).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for manufacturing accuracy was the target input value in the CAD/CAM software. The "ground truth" for biocompatibility was compliance with international standards (ISO 10993).

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

• Not applicable as this is not an AI/ML device requiring human adjudication of results.

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 device is an orthodontic aligner and does not involve human readers or AI assistance in the diagnostic or interpretation process.

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

• Not applicable. While the device's design relies on CAD/CAM software, the "device" itself is the physical aligner. The software's performance is not being evaluated as a standalone diagnostic tool, rather its output is a component of the manufacturing process of the physical device. The document mentions the 3Shape A/S Ortho System software has a 510(k) clearance (K180941) under the PNN product code, indicating its own prior regulatory evaluation.

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

• Manufacturing Dimensional Accuracy: The "ground truth" was the target input value generated by the specialized orthodontic CAD/CAM software, representing the intended geometric specifications for the digital dentition models, 3D printed molds, and thermoformed aligners.
• Biocompatibility Testing: The "ground truth" was compliance with the pass/fail criteria defined by the relevant international standards (ISO 10993 series) for biological evaluation of medical devices.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set. The CAD/CAM software used for design and manufacturing is presumably a commercially available, previously validated tool.

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

• Not applicable. This is not an AI/ML device requiring a training set.

Ask a specific question about this device