(168 days)
The Progressive Orthodontics App is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, which may be used for sequential aligner trays or retainers. These applications are based on 3D scans 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 the Progressive Orthodontics App 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.
The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software is for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients. Digital scans (3D) of a patient's dentition can be loaded into the software and the dental professional can then review different treatment plans and simulations for each individual patient and decide on the most appropriate treatment. This is a software only device. Physical outputs such as aligners are not included in the scope of the clearance.
The provided text is a 510(k) summary for the Progressive Orthodontics App. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific performance metrics against acceptance criteria. Therefore, several requested pieces of information are not explicitly detailed in this type of submission.
Here's an attempt to answer your questions based on the provided text, along with indications where the information is not present:
1. Table of acceptance criteria and reported device performance
The document does not explicitly state quantitative acceptance criteria or specific performance metrics in a table. It only states that "All test results met acceptance criteria" (Page 7) and "The software passed the testing and performed per its intended use" (Page 8) after verification and validation.
2. Sample size used for the test set and data provenance
This information is not present in the provided document. The 510(k) summary mentions "integration, verification, and validation testing" (Page 8) but does not detail the size of the dataset used for these tests, nor its provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and their qualifications
This information is not present. The document doesn't describe the process of establishing ground truth for any testing performed.
4. Adjudication method for the test set
This information is not present. No details are provided on how disagreements in ground truth (if experts were involved) were resolved.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
No, a multi-reader, multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done or at least not reported in this 510(k) summary. The document focuses on demonstrating substantial equivalence through software verification and validation, not on clinical comparative effectiveness.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document states, "The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software is for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients." (Page 4). It further states that "The use of the Progressive Orthodontics App 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." (Page 5). This strongly implies human-in-the-loop performance, as the software is a "front-end software tool" to assist professionals. While "standalone software module" is listed as a principle of operation (Page 6), this refers to the software existing independently, not necessarily operating without human interpretation or control. No "algorithm only" performance data is presented.
7. The type of ground truth used
The document does not specify the type of ground truth used for any testing. Since the product is a design and simulation tool, not a diagnostic one providing automated interpretations, the concept of "ground truth" for its performance evaluation (e.g., accuracy of measurements, validity of simulations) would likely involve comparison to established orthodontic principles, validated physical models, or expert consensus on design parameters, but this is not detailed.
8. The sample size for the training set
This information is not present. The 510(k) summary does not mention any "training set" for the software, suggesting that if machine learning or AI models are involved, their development and training details were not part of this specific submission summary. The product is described more as a design and simulation tool rather than an AI-driven image analysis or diagnostic tool.
9. How the ground truth for the training set was established
This information is not present, as no training set is mentioned in the document.
§ 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.