(160 days)
Protraction Face Mask and Reverse Pull Face Mask are used as a treatment option for Class III malocclusions.
Not Found
The provided document is an FDA 510(k) clearance letter for a "Protraction Face Mask / Reverse Pull Face Mask." This document explicitly states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria.
Typically, acceptance criteria and study results are provided for devices that rely on new technology or algorithms where performance needs to be clinically validated, such as AI/ML-based diagnostic devices.
The Protraction Face Mask / Reverse Pull Face Mask is an "Extraoral Orthodontic Headgear" (Product Code: DZB). This type of device is a physical, mechanical appliance used in orthodontics. Its performance is generally evaluated based on mechanical properties (e.g., strength, durability, biocompatibility of materials) and clinical effectiveness in applying forces for orthodontic treatment, which would be established through a comparison to existing, similar devices (predicate devices) already on the market.
Therefore, I cannot extract the requested information from this document because it describes a traditional medical device clearance, not an AI/ML or novel technology device that would typically have specific "acceptance criteria" and a "study proving the device meets acceptance criteria" in the way implied by the prompt's structured questions.
No information regarding acceptance criteria or a performance study as outlined in your prompt can be found in the provided document.
§ 872.5500 Extraoral orthodontic headgear.
(a)
Identification. An extraoral orthodontic headgear is a device intended for use with an orthodontic appliance to exert pressure on the teeth from outside the mouth. The headgear has a strap intended to wrap around the patient's neck or head and an inner bow portion intended to be fastened to the orthodontic appliance in the patient's mouth.(b)
Classification. Class II.