Search Results

The ClearCorrect System is indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion.

The aligners of the ClearCorrect System are a sequential series of clear thermoformed orthodontic appliances that, when worn in the prescribed sequence and duration, progressively reposition the teeth. The aligner is an orthodontic appliance intended for intra-oral use. Individual devices will be used between 20 – 22 hours per day for a period ranging from one to three weeks. The corrective forces to align teeth are primarily generated by the difference between the starting tooth position and the planned tooth position defined by the appliance. Features can be added to the aligner that engage with composite resin tooth attachments to improve aligner retention and/or to apply forces in directions that cannot be achieved by engaging with tooth surfaces alone.

The provided FDA 510(k) summary (K220140) for ClearCorrect System does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.

Specifically, it lacks:

• A table of acceptance criteria and the reported device performance. While "Performance Data" is listed, it only mentions types of tests conducted (e.g., package integrity, biocompatibility, tensile performance, etc.) but does not provide specific acceptance criterion values or the results obtained from these tests.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
• If a standalone (algorithm only without human-in-the-loop performance) was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics (mode of action, materials, sterilization, use, packaging, and treatment planning software), and general performance data types. It states that performance data was generated but does not present the detailed results or the methodology in the way requested for a typical AI/medical imaging device submission.

It explicitly lists the following performance data categories:

• Package integrity via simulated transport test per ISTA 2A
• Validation of shelf life per ASTM F1980
• Biocompatibility per the ISO 10993 series standards
• Water absorption testing per ISO 62
• Tensile performance testing per ISO 527-3
• Flexural performance testing per ISO 178
• Impact performance testing per ISO 8256
• Tear resistance testing per ISO 6383-1
• Fatigue resistance testing per ASTM D7774
• Stress relaxation testing
• Dimensional stability per internal methods
• Usability testing per IEC 62366-1
• Software development per IEC 62304

However, for each of these, the specific acceptance criteria and the numerical results demonstrating that the device meets those criteria are not detailed in this summary.

Ask a specific question about this device