INVSENSOR00027 Fall Detection Clinical Performance Study

Not Applicable

Completed

Brief Summary: This study assesses INVSENSOR00027's clinical performance for fall detection.

Recruitment & Eligibility

Inclusion Criteria

18 to 45 years old
Physical status of ASA I or II
Subjects must be able to read and communicate in English
Has signed all necessary related documents, e.g. written informed consent, volunteer payment form, confidentiality agreement
Has completed Health Assessment Questionnaire and passed health assessment screening

Exclusion Criteria

Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this study
Inability to tolerate physical activities including jumping and fall simulation
Nursing female volunteers
Excluded at the Principal Investigator's discretion
Refusal to take the pregnancy test (for female subjects)
Positive pregnancy test for female subjects of child bearing potential. This is done for the safety of this population.
Refusal to shave hair (chest) off areas where sensors will be applied (male subjects)

Arm && Interventions

Group	Intervention	Description
INVSENSOR00027 Test group	INVSENSOR00027	The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.

Primary Outcome Measures

Name	Time	Method
Sensitivity of INVSENSOR00027's Fall Detection.	1-5 hours	For each subject's fall simulation, INVSENSOR00027 output will be computed. In order to calculate sensitivity of the device, true positives and false negatives need to be accounted for. For each event of fall, the sensor's output is observed. Fall that is correctly identified is marked as true positive (TP), whereas a missed detection is marked as false negative (FN). Combining the two, test sensitivity is computed by multiplying TP by 100 and dividing that over the sum of TP and FN.

Secondary Outcome Measures