(55 days)
NEOLab Clear Aligners are indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). The NEOLab Clear Aligners position teeth through the use of continuous gentle force.
NEOLab Clear Aligners consist of a series of customized clear plastic removable aligners that are fabricated from a clear, thin thermoformed polyurethane-polyester resin, and are intended to be worn 22 hours a day. The aligners are designed to gradually move the patient's teeth incrementally, repositioning them from their original misalignment to a more aligned state.
The provided document (K203339) is a Special 510(k) summary for the NEOLab Clear Aligners. It focuses on demonstrating substantial equivalence to a predicate device (Ormco Spark Aligner System, K182826) by showing that the new device has the same intended use, similar technological characteristics, and meets material and manufacturing specifications.
However, this document does NOT describe the acceptance criteria and the study that proves a device (e.g., an AI-powered device or a diagnostic device) meets specific performance criteria through a clinical or algorithmic performance study.
The testing described in this document is primarily related to:
- Mechanical properties of the aligner material: Ensuring it meets specifications for shelf life.
- Validation of manufacturing processes: Confirming the custom aligner fabrication.
- Biocompatibility testing: According to ISO 10993 standards for the thermoplastic polyurethane-polyester resin and the finished aligner.
There is no mention of a study involving:
- A test set of data (e.g., medical images, patient records).
- Any form of algorithm performance evaluation (e.g., accuracy, sensitivity, specificity, AUC).
- Human expert readers establishing ground truth.
- Multi-reader multi-case (MRMC) studies.
- Effect sizes of human reader improvement with AI assistance.
- Stand-alone algorithm performance.
Therefore, I cannot populate the requested table and information based on the provided text, as the document does not contain the study details you are asking for.
The document states:
- "Test data were submitted to: Assure the aligner mechanical properties of the aligner material meet specifications for up to 5 years shelf life; Validate the processes used for the design and manufacture of the customized aligners."
- "Biocompatibility: The thermoplastic polyurethane-polyester resin used for making the aligner series has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993..."
- "This testing showed that the material and manufactured aligner met the acceptance criteria, passed the respective tests, and are safe and biocompatible for the stated intended use."
This indicates that acceptance criteria existed for the material properties and biocompatibility, but these are not performance metrics for a diagnostic or AI device that interacts with patient data in the way implied by your questions about ground truth, expert readers, and test sets.
To fulfill your request, the document would need to describe a study evaluating the performance of a device, for example, an AI algorithm that analyzes orthodontic scans, or a diagnostic tool. Since this is a 510(k) for physical clear aligners, the type of performance evaluation differs significantly.
§ 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.