Search Results

TP Orthodontics Clear Aligner System consists of a series of plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, TP Orthodontics Clear Aligner System sequentially positions teeth by way of continuous gentle force.

TP Orthodontics Clear Aligner System consists of a custom-made series of plastic aligners that apply gentle pressure to teeth, gradually moving them into alignment. A dentist or orthodontist assesses the patient to determine if the patient is a good candidate. Impressions are taken by the dental clinician and submitted to TP Orthodontics along with the physician's prescription. TP Orthodontics, using a standard dental software used for teeth alignment, designs a series of plastic aligners intended to gradually realign the patient's teeth in accordance to the doctor's prescription. The set-up and intermediate stages are sent back to the physician for review and approval. Once the doctor has approved the model scheme, the aligners are produced using a thermoplastic material and shipped to the dental practitioner. The doctor delivers the aligners to the patient in sequential stages, provides instructions for use (such as when to change aligners), and monitors the case progression and fit and function from the first aligner through the end of treatment through follow-up appointments. Aligners must be worn by the patient most of the day (20-22h), being removed only for eating, drinking and performing oral hygiene and should be replaced every 2-3 weeks as prescribed by the doctor.

This document describes the FDA's 510(k) clearance for the TP Orthodontics Clear Aligner System and its substantial equivalence to predicate devices, thus the information provided focuses on the regulatory submission rather than a detailed scientific study. Therefore, some of the requested information regarding a device's performance study might not be explicitly present if it deviates from what is typically required for a 510(k) submission.

Here's the summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of substantial equivalence to predicate devices. For this type of device (clear aligners), this primarily involves demonstrating equivalent indications for use, technological characteristics, and safety profiles.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "therefore there was no clinical testing to support this device." This means there was no specific test set of patients used for a clinical performance study of the TP Orthodontics Clear Aligner System. The device's clinical performance relies on the established performance of predicate devices.

For the non-clinical manufacturing validation, the sample size is not specified, nor is the data provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable as no specific clinical 'test set' was used for this device in a de novo study. The ground truth for the overall category of sequential aligners (NXC) would have been established through years of clinical practice and research by orthodontists and dental professionals, leading to the FDA's clearance of the first device in 1998.

4. Adjudication Method for the Test Set

Not applicable as no specific clinical 'test set' was used for a new study on this device.

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 a physical medical device (clear aligner system), not an AI-assisted diagnostic or treatment planning system that would involve human "readers" or AI assistance in the way typically discussed in a MRMC study. The software mentioned is for designing the aligners, not for diagnostic interpretation by human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable for a physical clear aligner device. The "software" mentioned passed its validations, which would imply standalone testing of the software's functionality, but this is not an "algorithm only" performance for diagnosis or treatment decision making in the typical sense.

7. The Type of Ground Truth Used

For the specific device, the ground truth for regulatory clearance was demonstration of substantial equivalence to predicate devices. This means that its design, materials, manufacturing, indications for use, and overall safety and effectiveness were compared against devices already legally marketed and proven effective.

For the manufacturing validation, the ground truth would be the software output specifications (i.e., the aligners were produced accurately according to the digital design).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set" in the computational sense. The design of the aligners is based on dental software that applies established biomechanical principles and clinician input, not a data-driven training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no computational "training set" was used for this device.

Ask a specific question about this device