Search Results

The STR8 Clear Aligner is indicated for the aligment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

STR8 Clear Aligners are thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning.

STR8 Clear Aligners are designed from digital scans of a patient's dentition. Using the scan, specialized orthodontic CAD/CAM software will be used to develop the treatment plans that consist of sequential dental models wherein the teeth are gradually realigned with each step. For this 510(k), ArchForm Treatment Planning System (K213916) will be used for this application. ArchForm is approved for use in the management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options. The specialized orthodontic treatment planning software has a 510k clearance for the intended use under FDA Classification Product Code PNN, regulation 872.5470.

Once the treatment plan is reviewed and approved by a STR8 Oral Care dental health professional, each 3D model from the treatment plan is manufactured. The aligner trays are then manufactured by thermoforming a dental thermoplastic sheet over each model. The aligners are then provided to the patient by the prescribing dental professional group.

This document is a 510(k) premarket notification for a medical device called "STR8 Clear Aligners." It is a regulatory submission demonstrating substantial equivalence to a predicate device, not a study showcasing AI model performance.

Therefore, the document does not contain the specific information required to answer your questions about acceptance criteria for an AI model, the study proving it meets those criteria, sample sizes, expert adjudication, MRMC studies, standalone performance, or ground truth establishment.

The document discusses the following:

• Device Description: STR8 Clear Aligners are thermoformed plastic aligners for orthodontic treatment.
• Comparison to Predicate Device: The document extensively compares the STR8 Clear Aligners to a predicate device (uLab Systems Dental Aligner Kit, K211510) across various specifications like regulation, classification, materials, indications for use, and manufacturing process. The goal is to show the new device is "substantially equivalent."
• Non-Clinical Performance Testing: This section mentions durability testing and an internal manufacturing validation to ensure dimensional accuracy (measurements within 0.3 mm of target).
• Biocompatibility Testing: Conducted according to ISO 10993-1 and ISO 10993-5.
• Clinical Performance Testing: States that no clinical studies were deemed necessary because of the similarities to the predicate device.

To directly answer your questions based only on the provided text, the answer for almost all points is that this information is not present or not applicable to an AI model evaluation.

Here's why, addressing each of your points:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria for the 510(k) process: The primary acceptance criterion here is "substantial equivalence" to a legally marketed predicate device. This is demonstrated by showing similar indications for use, technological characteristics, and materials.
   • Reported Device Performance: The document reports that for non-clinical performance testing, "All measurements were within 0.3 mm of the target input value" for manufacturing accuracy, and "no performance, cosmetic, or other detectable issues were identified" during qualitative assessment. Biocompatibility testing was also conducted and presumably met relevant standards.
   • No AI-specific acceptance criteria or performance metrics are provided.

2. Sample sized used for the test set and the data provenance: Not applicable. This document describes a 510(k) submission for a physical aligner, not an AI test set. The manufacturing validation involved assessing intraoral scans, digital models, 3D printed molds, and thermoformed aligners, but specific sample sizes for this internal validation are not detailed beyond "All measurements."

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. "Ground truth" in the context of an AI model assessment is not relevant to this submission. The "ground truth" for the device's function is its ability to align teeth as prescribed, which is assumed to be similar to the predicate based on design and materials.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human expert review/adjudication of an AI model's output is mentioned.

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: Not applicable. This submission does not involve an AI assistant for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm. The device relies on a "specialized orthodontic CAD/CAM software" (ArchForm Treatment Planning System, K213916) for treatment planning, which itself has a 510(k) clearance, but this document does not evaluate its standalone performance, only its use as a tool in the aligner's manufacturing process.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the manufacturing validation, the "ground truth" was the "target input value" from the digital treatment plan. For the overall device, the implicit "ground truth" for showing substantial equivalence is the established safety and effectiveness of the predicate device (uLab Systems Dental Aligner Kit).

8. The sample size for the training set: Not applicable. This is not an AI model requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a regulatory filing for a physical medical device (clear aligners) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information related to the rigorous testing and validation of an AI model.

Ask a specific question about this device