(213 days)
The Orchestrate 3D Orthodontic Software 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, including dental casts, which may be used for sequential aligner trays or retainers. These applications are 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 the Orchestrate 3D 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 Orchestrate 3D Orthodontic Software is an orthodontic appliance design and treatment simulation software. This software is for use by Dental professionals to diagnose and design solutions for patients. Digital scans (3D) of a patient denture can be loaded into the software and the dental professional can then create treatment plans for each individual patient and their needs. The system can be used to fabricate dental casts using standard stereolithographic (STL) files for use in 3D printers. Dental casts printed can then be used to manufacture sequential aligner trays and retainers.
The provided text describes the "Orchestrate 3D Orthodontic Software," which is an orthodontic appliance design and treatment simulation software. The document is an FDA 510(k) summary demonstrating substantial equivalence to a predicate device.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity). Instead, the performance is demonstrated through a comparative analysis with a predicate device and a general statement about software testing.
| Acceptance Criteria Category | Specific Criteria (Implicit/General) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Indicated for similar use cases | "The Orchestrate 3D Orthodontic Software 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..." This is deemed "Similar" to the predicate. |
| Technological Features | Possesses similar core features and capabilities | "Stand Alone Software Module," "Imports Digital Patient Scans," "Can be used to design Dental Casts," "Useful for Diagnosis, treatment planning, and CAD design," "Virtual Planning of tooth movement," "Supports STL Files." These are deemed "Same" as the predicate. |
| Hardware/Software Requirements | Compatible with standard computing environments | "OS: Windows 10 64-bit, RAM: 8 GB, Monitor Resolution: 1280 X 800, Video Card Memory: 1 GB, Hard Drive Space: 10 GB, CPU: Intel compatible 2.6 GHz/Dual or Quad core 2.6 GHz, Mouse: Any Mouse with scrolling wheel or button." These are deemed "Same" as the predicate. |
| Login Method | Secure user access | "None Required; Uses Windows 10 Log in Security for User ID." Deemed "Similar; No effect to the indication for use." |
| Software Validation/Performance | Software performs per its intended use and passes testing | "The software passed the testing and performed per its intended use." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not report any specific sample size for a test set used to evaluate the device's performance in terms of clinical or technical accuracy. The comparison provided is at a feature and functional level with a predicate device.
There is no mention of data provenance (e.g., country of origin, retrospective or prospective) for any test data, as no specific performance study on patient data is detailed.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not mention any experts or adjudication processes used to establish a ground truth for a test set. The review primarily focuses on software functionality and its comparison to a legally marketed predicate device.
4. Adjudication Method:
Since no test set evaluating clinical performance against a ground truth is described, no adjudication method (e.g., 2+1, 3+1, none) is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not mentioned or presented in the provided text. The document does not discuss human reader performance with or without AI assistance. The software is described as a "front-end software tool" for professionals, implying it aids existing clinical workflows rather than directly replacing or augmenting human diagnostic performance in a quantifiable, comparative manner in this submission.
6. Standalone Performance Study:
A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not explicitly described or presented in terms of clinical metrics. The document states that the "software passed the testing and performed per its intended use," but this refers to general software verification and validation, not a standalone clinical performance study on a dataset.
7. Type of Ground Truth Used:
No specific ground truth (expert consensus, pathology, outcomes data, etc.) was mentioned as being used to validate the performance of the Orchestrate 3D Orthodontic Software. The validation presented focuses on functional equivalence to a predicate device and general software testing.
8. Sample Size for the Training Set:
The document does not provide any information regarding the sample size for a training set. As a software tool for design and simulation, rather than an AI/ML algorithm that learns from data, the concept of a "training set" in the context of typical AI device submissions may not directly apply or is not detailed here.
9. How Ground Truth for the Training Set Was Established:
Since no training set is mentioned, there is no information on how its ground truth might have been established.
In summary, the provided FDA 510(k) summary for Orchestrate 3D focuses on establishing substantial equivalence to a predicate device (3Shape Ortho System) through a comparison of indications for use, technological features, and the results of general software verification and validation testing. It does not contain details about clinical performance studies with specific acceptance criteria, test sets, ground truth establishment, or expert evaluations commonly found in submissions for AI/ML-driven diagnostic devices.
§ 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.