(89 days)
The Ultramind Biofeedback System with de-STRESS Software is a biofeedback system designed to be used for relaxation training.
The Ultramind Biofeedback System comprises a sensor which transmits changes in the stress/relaxation levels to a receiver. In turn, the receiver feeds the information on line to a computer which, by means of the de-STRESS Software, is able to analyze, record, and select data as well as display instructions on how to use the system for the purpose of learning the art of relaxation.
The user wears on his/her finger a small plastic mold that contains two electrodes. The electrodes detect minute physiological changes, measured in terms of relative electro-dermal activity (EDA) or galvanic skin response (GSR), that reflect the user's conscious, subconscious or physical state. This information is transmitted by cordless link to a personal computer and is displayed in the form scientific graphs, or used to drive animation.
The animation depends on the user's state of mind, i.e., the user is able to change the animation by his/her thoughts or emotions. Through this "play", as the user learns to correlate between thoughts and emotions and the response of the computer game, he/she learns to control physiological responses - even in the realm of the autonomic nervous system.
After practice, the user retains the newly-learned capabilities, and can use them at will without the system. The learning process is accelerated through use of advance psychological techniques which enable the user to learn with both hemispheres of the brain, with the intellect and the subconscious.
This submission does not contain a study to prove the device meets acceptance criteria. The Ultramind Biofeedback System with de-STRESS Software is a modification of a previously cleared device (RelaxPlus™ System K951213) and claims substantial equivalence.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is the information that can be extracted:
Acceptance Criteria and Device Performance
Since no specific performance metrics or acceptance criteria are listed for the de-STRESS Software itself, and the device is claiming substantial equivalence based on minor modifications, the "performance" is implicitly considered to be equivalent to the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
Study Details
The provided document describes a 510(k) submission based on substantial equivalence to a predicate device, not a new performance study for the Ultramind Biofeedback System with de-STRESS Software. Therefore, the following information is not available:
- Sample size used for the test set and the data provenance: Not applicable as no new test set study is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a biofeedback device, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is for biofeedback with human interaction.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no new performance study is presented.
- The sample size for the training set: Not applicable as a new algorithm training study is not described.
- How the ground truth for the training set was established: Not applicable.
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.