(261 days)
Smart Moves Complete is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Smart Moves Complete positions teeth by way of continuous gentle force.
Smart Moves Complete consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners). The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. Smart Moves Complete is intended as an alternative to conventional bracket technology and fixed appliances for the treatment of patients with malocclusion.
The provided text describes a 510(k) premarket notification for "Smart Moves Complete," an orthodontic aligner system. It details the device's indications for use, design, manufacturing, and comparison to a legally marketed predicate device. The submission explicitly states that no clinical studies were performed to support the device as the indications for use are equivalent to the predicate device, and thus, no comparative effectiveness study (such as MRMC) was done, nor was there a standalone algorithm performance evaluation.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, specifically within the context of AI/algorithm performance evaluation, cannot be extracted from this document as it pertains to a medical device that does not incorporate AI and relies on equivalence to a predicate device through non-clinical performance data.
The relevant sections of the document state:
- "No clinical studies are included in the submission" (page 4)
- "Clinical Performance Data: There was no clinical testing performed to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence is supported by non-clinical testing and the comparative table, so this is not required." (page 9)
Given this, I cannot provide the detailed information requested about acceptance criteria and a study proving the device meets them, as it relates to AI/algorithm performance, because such a study was not conducted or presented in this 510(k) submission.
The document focuses on demonstrating substantial equivalence based on:
- Same intended use as the predicate device.
- Similar technological characteristics, with a detailed comparison table (pages 5-6) highlighting similarities in product code, regulation number, regulation name, indications for use, device description, mode of action, anatomy location, size, manufacturing method, biocompatibility, hardness, and dental tooth alignment software description.
- Non-clinical performance testing (page 8-9) for materials and manufacturing process, including biocompatibility, software verification and validation (though this refers to the design software for aligners, not an AI algorithm for diagnostic or treatment planning), tensile strength, elongation, tensile stress, modulus, load, water absorption, durometer, and process flow validation. These tests are about the physical properties and manufacturing consistency of the aligners, not AI performance.
§ 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.