(59 days)
The Clevaligner software is intended for use as a medical device standalone software, providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, 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 Clevaligner Software requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.
Clevaligner Software imports patient 3-D digital scans and provides the orthodontic treatment planning of the patient under dental professional supervision.
The Clevaligner Software performs the automatic segmentation of the 3-D digital scans, achieves an automatic design of an ideal arch form, which is approved by orthodontists using a 2D software interface.
The Clevaligner Software provides an initial to ideal final stage treatment plan, with each step of the treatment plan path presented in the 3D software interface.
Every 3D digital model from the path treatment plan, generated by the Clevaligner Software, can be exported for fabrication of orthodontic appliances, either to an orthodontic laboratory or directly to orthodontic appliance manufacturers for further use in orthodontic treatment.
The provided text does not contain the detailed acceptance criteria and study results in the format requested. While it refers to "Software verification and validation testing" and states that "All test results met acceptance criteria," it does not specify what those acceptance criteria were or what the reported device performance was against those criteria.
Specifically, the document is a 510(k) summary for the Clevaligner Software (V1.0.0), a Class II orthodontic software. It focuses on demonstrating substantial equivalence to a predicate device (SoftSmile, Inc. Vision K212770).
Here's a breakdown of what can be extracted and what is missing based on your request:
Information Extracted from the Document:
- Device Name: Clevaligner Software (V1.0.0)
- Intended Use: "intended for use as a medical device standalone software, providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual design of a series of dental casts, which may be used for sequential aligner trays or retainers, 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." (Page 6)
- Type of Study (Non-Clinical): Software testing, including verification and validation, conducted in accordance with IEC 62304 and FDA Guidance Documents ("General Principles of Software Validation" and "Cybersecurity in Medical Devices"). An "aligner manufacturing validation" was also performed to demonstrate that the digital aligners planned by the software match the fabrication of aligner trays/retainers with an acceptable level of accuracy. (Page 10)
- Clinical Testing: "Clinical testing has not been performed and is not required since the proposed device, Clevaligner Software, is a stand-alone medical device software which is used without direct patient contact." (Page 10)
- Documentation Level: Basic Documentation level as per FDA Guidance for the Content of Premarket Submissions for Device Software Functions. (Page 10)
- Cybersecurity Analysis: Performed in accordance with FDA Guidance. (Page 10)
Missing Information (Crucial for your request):
- A table of acceptance criteria and the reported device performance: This is the most significant missing piece. The document merely states "All test results met acceptance criteria" (Page 10) but does not list them or the specific performance metrics achieved.
- Sample size used for the test set and the data provenance: Not specified for the software verification/validation tests. For the "aligner manufacturing validation," it mentions "digital aligners treatment planned" but no specific sample size or origin.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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 done, as it states clinical testing was not performed. The software is for "virtual design" and "treatment planning," not direct interpretation by humans that would be assisted by AI in the diagnostic sense.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, non-clinical software testing was done, but the specific metrics are not detailed. The "aligner manufacturing validation" also seems to be a standalone performance check.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified for the software testing. For the aligner manufacturing validation, the "ground truth" implicitly would be the physical accuracy of the 3D printed models compared to the software's digital design, but the method for assessing this "acceptable level of accuracy" isn't detailed.
- The sample size for the training set: Not mentioned. This device likely uses machine learning for features like "automatic segmentation" and "automatic design of an ideal arch form," but no details on training data are provided.
- How the ground truth for the training set was established: Not mentioned.
Conclusion:
The provided FDA 510(k) summary confirms the device's regulatory clearance based on substantial equivalence, but it does not provide the specific technical details of the acceptance criteria nor the performance data that would typically be found in a detailed study report. The document indicates that thorough non-clinical software testing and validation were performed, and all acceptance criteria were met, but the specific details of these criteria and the results are not included in this summary. The "aligner manufacturing validation" hints at a performance metric related to accuracy in aligner fabrication, but again, without specific numbers or methods.
§ 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.