Regulatory and Compliance

Installation

Kintsugi Voice (KV) Device is a machine learning software API for use in remote clinician-patient encounters to predict signals consistent with a current depressive episode in patients aged 22 years and older. Clinicians intended to use the tool include, but are not limited to primary care providers, general practitioners, and other providers involved in the screening diagnosis of depression. The patient environment includes but is not limited to their home environment and other self-selected private spaces. The clinician will utilize the tool in a clinical environment.

Technologically, the API interfaces electronically to receive only the patient channel of a channel-separated, audio-recorded voice sample as input. The device offers outputs: True, False, Additional Consideration Required. Remote platforms compatible with the API include but are not limited to telehealth, remote patient monitoring, and telephony mediums.

The KV Device is not for use for patients with any known history of neurodegenerative or Central Nervous System disorders, any known history of schizophrenia, psychosis, or severe cognitive deficits, any known presence of other disorders that may lead to a false signal of depression including (but not limited to) Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Parkinson’s Disease, Stroke, Traumatic Brain Injury, as well as patients with voice disorders that may impact vocal cords such as acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia, any known history of vocal cord injury or cerebrovascular accident or head trauma with residual dysarthria in the past year, past or active heavy smokers with impacted vocal cords, and patients with a known history of congenital deafness.

Indicated Use

The KV Device is a software API that analyzes voice samples to predict vocal characteristics consistent with a current depressive episode, which can indicate lifetime mood disorders, such as major depressive disorder. The API is intended to be used in computer-based applications for real-time or post hoc display of results. The tool is for English-speaking people aged 22-years and older and those without vocal and neurological conditions. The KV Device is an adjunctive screening tool for depression and is not to be used in place of a complete patient evaluation or relied upon to make or confirm the diagnosis of any mood disorders.

Patient Consent

Kintsugi understands the importance of protecting patient rights and welfare as outlined in HIPAA. As an additional layer of protection for your patients, we require authenticated users to call the API endpoint to confirm that the patient has provided consent to having their voice recorded and subsequently submitted to the KV endpoint for vocal depression prediction. Samples without patient consent do not run through the prediction endpoint. The specific elements of consent should be agreed upon within your institution and accepted by an ethical committee when appropriate. After data is submitted, we continue to ensure its protection. Our technology is SOC II compliant and undergoes regular audits to ensure your patients' data remains secure.