(81 days)
This device is intended to be used for the prescribed treatment of malocclusions by dentists. This device is intended for single use only.
Affirm Smart Releasable Force Module and Trade Name: Compliance Science™
This document is a 510(k) clearance letter from the FDA for the "Affirm Smart Releasable Force Module" and "Compliance Science™," indicating that the device is substantially equivalent to a legally marketed predicate device.
Crucially, this document does not contain information about acceptance criteria or a study proving that the device meets such criteria. It is solely a regulatory approval based on demonstrating substantial equivalence, not performance against specific criteria.
Therefore, I cannot provide a detailed answer to your request based on the provided text. The document does not include information on:
- Acceptance criteria and reported device performance
- Sample sizes for test sets or training sets
- Data provenance
- Number or qualifications of experts for ground truth establishment
- Adjudication methods
- MRMC studies or effect sizes
- Standalone performance
- Type of ground truth used
- How ground truth was established for training data
To answer your request, you would need to refer to the actual 510(k) submission or supporting documentation that was reviewed by the FDA, as this clearance letter only summarizes their decision.
§ 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.