(164 days)
The ARIA WiFi Smart Scale is a body analyzer that measures body weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat percentage in generally healthy individuals 10 years of age or older. It is intended for home use only.
ARIA is a body weight scale and a body fat analyzer that operates by using a low, safe, battery-generated electrical current through the body (using a bioelectrical impedance analysis technique) to provide body fat and body weight information. After the user registers their scale, the scale automatically recognizes the subject based on body weight and body fat readings. ARIA contains a WiFi module (802.11 module) that allows it to connect to the Internet in the user's home. The module provides a complementary interface to the Fitbit website. Body weight and body fat measurements are independent of internet communication after initial product registration.
The ARIA scale automatically measures body weight and body fat composition. The scale recognizes the user based on previous weight readings, and can accept up to eight (8) different users. The 16 most recent readings are kept in memory on the scale and readings are also transmitted to the user's optional fitbit.com personal account for trending. If users have similar weight, the proper identity can be selected by tapping the scale.
Here's a breakdown of the acceptance criteria and study information for the Fitbit ARIA WiFi Smart Scale, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ARIA WiFi Smart Scale are established not through explicit numerical thresholds but by demonstrating substantial equivalence to a predicate device (Withings Smart Body Scale K121971) and showing that its body fat measurements are not statistically different from the predicate, with variation within an acceptable range.
| Feature/Metric | Acceptance Criteria (Implied from Predicate/Study) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Demonstrates equivalence in technology, intended use, classification, product code, indication for use, device description, analysis method, operating parameters, number of electrodes, power source, IP connectivity, and measured parameters to the predicate device (Withings WBS01 Smart Body Scale K121971). | The ARIA WiFi Smart Scale is listed as substantially equivalent to the Withings Smart Body Scale (K121971) across all listed features. Differences noted (e.g., age range, specific power source type, minor IP connectivity details) are presented as not impacting substantial equivalence. |
| Body Fat Measurement | Body fat composition (%) measurements should not be statistically different (p>0.05) from the predicate device, and body fat measurements should vary by 0.05) and body fat measurements varied by |
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.