INVSENSOR00027 Clinical Performance Study

Not Applicable

Completed

Brief Summary: This study assesses the investigational sensor's (INVSENSOR00027) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.

Recruitment & Eligibility

Inclusion Criteria

18 to 80 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 sitting still or minimal movement for at least 30 minutes
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 (neck, 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 Posture Change Detection	1-5 hours	For each subject's position detection, INVSENSOR00027 output will be compared against observer's notes at each turn of the subject. Correctly detected position changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's posture change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection)
Sensitivity of INVSENSOR00027's Activity Change Detection	1-5 hours	For each subject's activity (e.g., walking and upright) detection, INVSENSOR00027 output will be compared against observer's notes. Correctly detected activity changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's activity change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection).
Sensitivity of INVSENSOR00027's Fall Event Detection	1-5 hours

Secondary Outcome Measures

Name	Time	Method
Respiratory Rate Detection	1-5 hours	Accuracy will be determined by comparing the respiratory rate measurement of the INVSENSOR00027 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00027 RR measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value.