(197 days)
Sureclear™ aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition.
OraMetrix sureclear™ aligners are orthodontic aligners fabricated from a clear, thin thermoformed plastic in a sequential series, individually customized for each patient based on a doctor's prescription to progressively reposition the teeth via gentle, corrective forces in the upper and lower dental arches.
The patient's dentist or orthodontist will use a digital scanning system to capture the anatomy and locations of the patient's teeth, and then after evaluating those will fill out an electronic prescription form describing the treatment plan using OraMetrix's previously cleared Suresmile® System software (K002620). The digitally scanned tooth data and prescription form are sent electronically via the Suresmile System® to OraMetrix technicians, using the Suresmile® System, separate the tooth scan data into individual tooth models representing the patient's malocclusion.
Additional OraMetrix technicians, also using the Suresmile® System's software, interpret the doctor's instructions provided on the prescription form; produce a setup and a sequence of intermediate models corresponding to each stage of the patient's aligner therapy. The setup and the intermediate stages are sent, via the Suresmile® System, back to the doctor for review, modification or approval. Once the doctor is satisfied with the planned therapy, an order for the production, packaging and shipment of the aligners is made via the Suresmile® System.
Based on the provided text, the document is a 510(k) Premarket Notification for the OraMetrix Sureclear™ aligners. It focuses on demonstrating substantial equivalence to a predicate device (ClearCorrect System, K113618) rather than proving the device meets specific performance acceptance criteria through a clinical study.
Therefore, the requested information regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies cannot be extracted from this document, as such studies were explicitly stated as "Not required and not performed."
Here's why:
- Device Type: The device is an orthodontic aligner.
- Regulatory Pathway: The submission is a 510(k) premarket notification, which relies on demonstrating "substantial equivalence" to a legally marketed predicate device rather than requiring de novo clinical trials to establish safety and effectiveness.
- Explicit Statement: The document explicitly states under "5.10 Clinical Performance Data":
"The performance of sequential aligners in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. Therefore, there was no clinical testing required to support sureclear™ aligners, as the indications for use is equivalent to the predicate device, which was not subjected to any clinical testing. The substantial equivalence of the subject device to the ClearCorrect System is supported by the non-clinical testing that was performed, along with other supporting documentation, and presented in this submission."
The "Relevant Testing Performed" section also lists:
- Clinical Testing: "Not required and not performed."
- Animal Testing: "Not required and not performed."
Conclusion:
This document describes a 510(k) submission where the device's acceptable performance is proven by demonstrating substantial equivalence to a predicate device through non-clinical testing (biocompatibility, physical/mechanical properties, internal specifications, risk analysis) rather than through a dedicated clinical study with specific performance metrics and a test set of patient data as implied by the questions.
Therefore, most of the questions you asked are not applicable to the information contained within this 510(k) summary.
§ 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.