Note: below is just an opinion from me a Garmin user!
In a different post ( Body Fat % on Index S2 Smart Scale Seems Inaccurate) I started a discussion if the Index S2 smart Scale should be classified as a medical device.
Therefore in order to give some more visibility to this discussion I initiated a new thread, so that we can have constructive and positive discussions.
- According to "Garmin Index S2 Smart Scale Owners Manual release date 2020 Appendix page 4 - Body Mass Index Nutritional Status and Body Fat Percentage Status". Is stated that: "this data is not intended to diagnose any medical condition. Always consult your health care provider".
- In: "Garmin´s Important Safety and Product Information release date April 2021, page 3 Declaration of Conformity". Is stated that:
- Measurements provided by this device are for reference only. Garmin® is not responsible for the consequences of erroneous information. This device is not intended to diagnose, treat, cure, or prevent any disease
- Garmin declares that this product is in compliance with the directive 2014/53/EU
So we have here multiple statements from Garmin.
Unfortunately the statements regarding compliance is solely related to Wideband transmissions, Short Range Devices, ElectroMagnetic Compatibility Etc. Where Directive 2014/53/EU main focus is also Radio Equipment. Not related to the obtained measuring results.
But what about the accuracy of the results? What are the statements related to that? Owners Manual states: "For best accuracy, ensure you use the device under the same circumstances and at approximately the same time of day each time you use the device. Activities that temporarily impact your body's weight, hydration, and distribution of water can impact the accuracy of measurements."
What does this mean? 80kg is only 80 Kg if it is measured under the same circumstances?
What is Garmin´s standpoint related to Accuracy vs Precision?
It is a fact that latest years biometric monitoring gained some importance in our lives. So why is Garmin still making vague claims as: for reference only? Does this mean that if something is for reference only, the data obtained is accepted to be NOT trustfully?
I would accept own responsibilities what I do with the data obtained from a Garmin device, as long the data is True/valid!
Some companies such as OMRON, states that : "Their scale is a Medical Device with Clinically Validated Accuracy of key parameters that allow you to better understand your heart's health (visceral fat, fat and skeletal muscle) and are proven to be predictive for cardiovascular events. With Accuracy You can Rely On. They claim clinically Validated device using Bio-electric Impedance (BIA) Analysis Technology to assess your body’s composition. It provides precise results confirmed by medically approved golden standard methods of analysis.
What is this approved golden standard method of analysis? I do not know, what did I liked to read by deep diving into the declaration of conformity of OMRON VIVA HBF-22T-EBK? They classified it as a Body Composition Analyzer and by MDD (Not yet MDR) as a Class I with measuring function (MDD article 9 Annex IX rule 12). Where they needed to comply with several medical devices ISO standards, which are on a routine basis assessed by Notified bodies and Health Agencies.
Is Omron setting here BEST IN CLASS!!! And is Garmin hiding behind vague claims as for reference only and other meaningless claims?
In the Netherlands this clinical validated Omron Viva costs around 70 euros, and my S2 was almost 200 euros. In no way I want to bash Garmin, but for this price, I would expect more from Garmin.
What I would like to ask you fellow users, shouldn't the S2 or any other Garmin product (including software) which provide some sort of biometric value/information be a classified as a medical device and include some sort of verification, analytical validation, clinical validation etc? Which is assessed and approved by a recognized independent agency such as; TUV, BSI, DEKRA, ANSM, FDA?
Otherwise a statement as: "for reference only", could be as well as: "our data is fictitious, non validated, unsure, uncertain, unreliable, for entertainment purposes only with NONE value at all"
Please share your thoughts?
Note:
Garmin please lead by example and "Beat Yesterday"! Try to do better, be best in class! Or at least try to be best in a class, even-though it is a class on your own.