(63 days)
Titan Dental Design is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of Titan Dental Design requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
Titan Dental Design by ClearAdvance, LLC is an orthodontic appliance design and treatment planning software. This software is for use by dentists, orthodontists, and trained health care professionals to diagnose and design treatment solutions for patients. The Titan Dental Design software allows users to upload digital scans of patient's dentition to the system, manipulate and move teeth in the dentition scan to create treatment plans for malocclusion, and export or send treatment planning files for physical production of orthodontic appliances such as thermoplastic aligners with the use of 3D printers.
The provided text is a 510(k) summary for the "Titan Dental Design" software. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data from a specific study, especially not one that involves human readers or clinical outcomes.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and performance metrics (especially those related to AI assistance or standalone performance) are not present in this document.
This document describes a software device that provides tools for managing orthodontic models, systematic inspection, detailed analysis, treatment simulation, and virtual appliance design options. It is not an AI-assisted diagnostic tool in the sense of detecting or identifying conditions from medical images, which is typically where the detailed performance metrics you've asked for (e.g., sensitivity, specificity, MRMC studies) are most relevant. This software is more of a design and planning tool for orthodontists.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of quantitative acceptance criteria for performance metrics (such as sensitivity, specificity, or precision), nor does it report specific numerical performance data against these criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices by comparing indications for use, technological characteristics, and stating that software validation testing was successfully performed.
The "Summary of Performance Data and Substantial Equivalence" section states:
"Utilizing FDA Guidance document 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (issued May 11, 2015) the Proposed Device, Titan Dental Design underwent appropriate integration, verification, and validation testing. The software passed the testing and performed per its intended use."
This is the reported "performance" - a qualitative statement confirming it "passed testing" and "performed per its intended use," rather than specific quantitative metrics.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any test set or the provenance (e.g., country of origin, retrospective/prospective) of any data used for testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish a "ground truth" for a test set, as its validation appears to be primarily software-centric (integration, verification, validation) rather than based on a clinical performance study with human readers.
4. Adjudication method for the test set
Not applicable, as no clinical test set with human adjudication is described.
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
No such study is mentioned or implied. This device is described as a "medical front-end device providing tools for management... treatment simulation and virtual appliance design options," not an AI-assisted diagnostic tool that aids human readers in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document describes the device as "Stand Alone Software" under "Technological Features," but this refers to the software's operational independence (i.e., it doesn't require other specific hardware or software beyond OS/RAM/CPU) rather than a "standalone performance study" in the context of an AI algorithm's diagnostic accuracy. The entire device functions as "algorithm only" in the sense that it is software, but performance data like sensitivity/specificity are not provided.
7. The type of ground truth used
Not explicitly stated. The validation appears to be against functional requirements and intended use, rather than a clinical ground truth like pathology or outcomes data.
8. The sample size for the training set
The document does not mention a training set size, implying that this is not a machine learning model that requires a distinct "training set." It's more of a rule-based or calculational software tool for dental design.
9. How the ground truth for the training set was established
Not applicable, as no training set or machine learning components are detailed.
In summary, the provided FDA document is a 510(k) clearance letter and summary for a dental software device that functions as a design and planning tool, not an AI-driven diagnostic or assistive technology. Therefore, it does not contain the detailed performance study information typically found in submissions for AI/ML-based diagnostic devices, such as acceptance criteria based on accuracy metrics, test set characteristics, expert ground truthing, or MRMC study results.
§ 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.