(172 days)
This device is intended for the orthodonic movement of teeth. It is removed after orthodontic treatment has been completed. The devices are intended to be single use only
The proposed device, Luce Ceramic Bracket, consists of ceramic orthodontic brackets which are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontics wire, to alter the tooth position. The ceramic bracket is produced using AI203, translucent polycrystalline aluminum oxide (99.99%). The brackets are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady, gentle pressure to produce desired tooth movement.
The provided document is a 510(k) Summary for the Luce Ceramic Bracket, a Class II medical device. This document focuses on demonstrating the substantial equivalence of the new device to a legally marketed predicate device (Alpha Pure K163117), rather than proving that the device meets specific performance criteria through a study with a test set and ground truth.
Therefore, the document does not contain the information requested regarding acceptance criteria, study details (sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set details). The concept of "acceptance criteria" in this context refers to the FDA's "substantial equivalence" determination, which is based on demonstrating that the new device is as safe and effective as a predicate device, primarily through comparison of technological characteristics and intended use, rather than through de novo performance studies with a well-defined ground truth in the way one might evaluate an AI/ML diagnostic algorithm.
Specifically, the document states:
- "Non-Clinical Study Performance: Biocompatibility testing were conducted on the predicate devices, Alpha Pure(K166117). Since the materials, manufacturing process, packaging materials and methods are identical between the subject and predicate devices, the test reports can be leveraged for the subject device. Subject device and the predicate(K16117) are Identical." This indicates that no new performance studies were conducted for the Luce Ceramic Bracket because it is deemed identical to its predicate for performance relevant to safety and effectiveness (e.g., biocompatibility).
The 510(k) pathway often relies on demonstrating similarity to existing devices, reducing the need for extensive new clinical or performance studies if substantial equivalence can be established through design, material, and manufacturing comparisons.
In summary, none of the requested information about acceptance criteria for a new performance study or details of such a study are present in this 510(k) summary. The document's purpose is to show substantial equivalence through direct comparison of features and leveraging prior testing on the predicate device.
§ 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.