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Inman Digital Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). The Inman Digital Clear Aligners position teeth by way of continuous gentle force.

The Inman Digital Clear Aligners consist of a series of dental-clinician prescribed customized clear plastic removable orthodontic aligner trays that are made from a clear, thin thermoformed polyurethane. A dental clinician prescribes the aligners based on an evaluation of the patient's teeth. Either intraoral scans or physical impressions of the patient's teeth are provided to Inman Orthodontic Lab by the dental clinician, along with the prescription. The series of plastic aligner trays are designed according to the prescription using standard dental software for planning the tooth alignments. The software used is 3Shape Ortho System (Reference device K152086). It is used for managing 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements and design of a variety of orthodontic appliances based on 3D scanned orthodontic models. After the plan is developed by Inman Orthodontic Lab, the prescribing dental clinician reviews and approves the model scheme before the molds are produced. Following approval, the customized aligner trays are fabricated by Inman Orthodontic Lab by press thermoforming of the material on the molds using standard thermoforming equipment. The trays are provided to the dental clinician who provides them to the patient assuring fit and function during the entire treatment period.

The provided document is a 510(k) summary for the Inman Digital Clear Aligners. It describes the device's indications for use, its description, and a comparison to a predicate device to establish substantial equivalence. The document details performance testing related to material properties, packaging, and manufacturing process validation, as well as biocompatibility testing.

However, this document does not contain information about a study that uses a test set, expert ground truth, or statistical measures of performance (like sensitivity, specificity, or AUC) for the Inman Digital Clear Aligners in the context of an AI/ML device.

The "Performance Testing" section (page 5) refers to:

• Laboratory Testing: Mechanical properties of the aligner material, moisture barrier properties of the packaging, and validation of design/manufacture processes. These tests are about the physical properties and manufacturing quality of the device, not its clinical diagnostic or treatment planning performance in a setting that would involve AI/ML output validation against expert consensus.
• Biocompatibility: Testing of the thermoplastic polyurethane material according to ISO 10993.

The document explicitly states: "Neither animal nor human testing are needed for this device because it is composed of the same materials, is designed similarly, and is manufactured by a similar method as the predicate device." This indicates that the 510(k) relies on substantial equivalence to a predicate device, rather than a de novo clinical performance study against specific acceptance criteria for a new and innovative AI/ML feature.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device. The device described is a physical medical device (clear aligners) and its regulatory submission focuses on material properties, manufacturing, and substantial equivalence to a predicate device.

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