(114 days)
3Shape Ortho System™ for dental retainers 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 based on 3D models of the patient's dentition before the start of an orthodontic treatment.
The use of the Ortho System™ 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.
3Shape's Ortho System™ is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzinq, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models. Output includes Dental Retainers. All devices are to be fabricated from FDA cleared or listed materials currently available in the software.
The device has no patient contact.
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
The document provided is a 510(k) summary for the 3Shape Ortho System™ software. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
Key takeaway: This document does not describe a study that establishes acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) using a defined test set with human expert adjudicated ground truth. Instead, it focuses on demonstrating substantial equivalence to a predicate device through a comparison of features, technical characteristics, and intended use, along with software verification and validation.
Therefore, many of the requested points cannot be directly extracted from this document as the type of study described (e.g., clinical performance study with AI assistance, standalone algorithm performance) was not performed.
Here's how to address your specific points based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) in the way one would for an AI-driven diagnostic or measurement device. The "performance" demonstrated here is primarily about functional equivalence and safety/effectiveness relative to a predicate device.
The closest to "acceptance criteria" are implied by the comparison table of features and the statement "All test results have been reviewed and approved, showing the Ortho System™ to be substantially equivalent to the predicates."
Implied "Acceptance Criteria" (Substantial Equivalence to Predicate):
| Acceptance Criteria Category | Reported Device Performance (3Shape Ortho System™ K163677) |
|---|---|
| Intended Use | Same as predicate (K152086) - management of orthodontic models, systematic inspection, detailed analysis, treatment simulation, virtual appliance design. |
| Technical Characteristics | Generally same as predicate (K152086) across all listed features (managing patient data, study material collection/alignment/measurement/analysis, treatment simulation, virtual appliance design). |
| Supported Anatomic Areas | Same as predicate (Maxilla, Mandible). |
| Supported PC Formats | Same as predicate (Windows). |
| Device Output | Largely same as predicate, with the addition of "Dental Retainers" as an output, which is the specific focus of this 510(k) for "dental retainers." Other outputs (Custom Metal Bands, Export Models, Directly Printed Transfer Tray, Vacuum Pressed Transfer Media) are also same. |
| Safety and Effectiveness | Found to be as safe and effective as the predicate device based on comparison and nonclinical testing. |
| Software Verification & Validation | Performed in accordance with FDA Guidance, all test results reviewed and approved. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states "Clinical testing is not a requirement and has not been performed." Therefore, there is no specific test set of patient data used for performance evaluation in the context of diagnostic accuracy, sensitivity, etc.
- The nonclinical testing mentioned is "Software, hardware, and integration verification and validation testing," which refers to standard software quality assurance and testing procedures on the software itself, not on a dataset of patient cases.
- Data Provenance: Not applicable as a clinical test set based on patient data was not used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No clinical test set with ground truth established by experts was used for performance evaluation in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set.
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. The document explicitly states "Clinical testing is not a requirement and has not been performed." This type of study would fall under clinical testing.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This type of performance study was not conducted as "Clinical testing is not a requirement and has not been performed." The device is a software suite providing tools for orthodontists, implying a human-in-the-loop operation for diagnosis and planning.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. Since no clinical performance study was conducted on patient data to evaluate diagnostic or measurement accuracy, no "ground truth" for such purposes was established or used. The ground truth for the software testing would be the expected functional behavior and calculations according to the software requirements and design specifications.
8. The sample size for the training set
- Not applicable. The 3Shape Ortho System™ software, as described, appears to be a rule-based or calculative software tool for orthodontic planning, not a machine learning or AI model that requires a "training set" in the sense of a dataset of labeled patient examples to learn from. Its "scientific concept" is described as applying "digital imaging tools."
9. How the ground truth for the training set was established
- Not applicable. As it does not appear to be a machine learning model, there is no "training set" and therefore no need to establish ground truth for it.
§ 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.