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The cNEP Airway Management System is to be used as an aid for maintaining the patency of the upper airway in spontaneously breathing adults undergoing medical procedures less than 2 hours in duration, where the patient is intended to have mild to moderate sedation with non-propofol containing medications.

Device Description

The cNEP Airway Management System is a silicone rubber collar that is attached to the neck by a hydrogel and provides negative suction through a regulated vacuum source (see Figure 1). The vacuum suction allows the device to provide a patent airway during mild to moderate sedation.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance

Test	Purpose	Acceptance Criteria	Reported Device Performance
Biocompatibility
In Vitro Cytotoxicity	To assess the biological reactivity of device extracts	Non-cytotoxic	Non-cytotoxic
Sensitization	To assess the sensitization potential of device extracts	Non-sensitizing	Non-sensitizing
Irritation	To assess the irritation potential device extracts	Non-irritating	Non-irritating
Bench Testing
Collar Seal Maintenance	Demonstrate that the collar seal is not lost and maintained a seal during the procedure	Un-occluded reading gauge reading should equal occluded gauge reading	Pass
Patient Repositioning	Demonstrate the ability to reposition a patient while wearing the device	Device must remain on subject at operating vacuum.	Pass
Jaw Thrust	Demonstrate the ability for a caregiver to execute mandibular advancement (jaw thrust) while the device is applied	Ability to displace mandible forward.	Pass
Ability to Talk	Demonstrate the patient can talk with medical professionals while wearing the device	The subject must be able to speak during use.	Pass
Mouth Accessibility	Demonstrate medical professional can have full access to the patient's mouth while wearing the device	Device remains in place when patient opens their mouth.	Pass
Device Application on Side	Demonstrate the ability for a caregiver to apply the device to a patient while he/she is lying on their side	Device can be applied to subject.	Pass
Operational Testing at High and Low Temperature	Demonstrate accuracy of the operational vacuum zone cutoff boundary	Vacuum level within $40 \pm 2$ cm H2O	Pass
Drop Test	Demonstrate the device's ability to resist damage associated with inadvertent dropping	Device does not have damage and pass functional test	Pass
Low and High Temperature Storage	Demonstrate the device's ability to function properly after being stored in a hot/cold environment	No visual damage and pass functional test	Pass
Device Leakage	Demonstrate the device maintains vacuum	Vacuum level to be greater than 40 cmH2O	Pass
Clinical Study (5iS-009)
Primary Endpoint: Respiratory Impairment (RI) Incidents	The frequency of respiratory impairment (RI) events (decline in oxygenation or apneas > 15s) in the treatment (cNEP) group compared to the control group.	Statistically significant reduction in RI events in the cNEP group compared to control.	Mean RI events: Control = 3.5, cNEP = 1.92. Statistically significant difference for oxygen supplementation (p=0.01) and apnea events (p=0.0006).
Secondary Endpoint: Safety (Adverse Events)	The safety of cNEP Airway Management System as determined by adverse events reported by the investigators.	Acceptable safety profile with no serious device-related adverse events.	Cutaneous erythema in 41.3% of cNEP users, resolved within 20 minutes. No effect on heart rate or respiration.
Secondary Endpoint: Incidence of RI subjects	The incidence of subjects with one or more RI in the treatment group compared to the control group.	Reduction in incidence of subjects with one or more RI in the cNEP group.	Not explicitly reported as a separate number, but implied by the primary endpoint results.
Secondary Endpoint: Frequency of Interventions	The frequency of interventions to alleviate RI in the treatment group compared to the control group.	Reduction in interventions required to alleviate RI in the cNEP group.	10% in cNEP group required increased oxygen, 3% required jaw thrust. 42% in control group required increased oxygen.
Clinical Study (5iS-010 & 5iS-10B)
Primary Endpoint: Carotid Blood Flow	The change in common carotid blood flow measured at baseline and at the end of timed exposure to cNEP.	No statistically significant detrimental change in carotid blood flow.	No statistically significant difference in common carotid blood flow between control and cNEP treatment arm. Trivial overall increase in blood flow observed.
Secondary Endpoint: Safety (Adverse Events)	The safety of cNEP Airway Management System as determined by adverse events observed by the investigators.	Acceptable safety profile with no serious device-related adverse events.	No device-related adverse events reported.
Secondary Endpoint: Safety (Vital Signs)	The safety of cNEP Airway Management System as determined by assessing any change in vital signs measured at baseline and compared to while on cNEP.	No statistically significant detrimental changes in vital signs.	No statistically significant difference in vital signs (systolic BP, diastolic BP, heart rate, respiratory rate) between groups.

2. Sample Sizes and Data Provenance

Study 5iS-009:
- Test Set Sample Size: 54 subjects (24 control, 30 treatment).
- Data Provenance: Retrospective (implied by study design referring to "routine colonoscopy"), country of origin not specified.
Study 5iS-010:
- Test Set Sample Size: 8 subjects.
- Data Provenance: Not specified (implied prospective by protocol description), country of origin not specified.
Study 5iS-10B:
- Test Set Sample Size: 9 subjects.
- Data Provenance: Not specified (implied prospective by protocol description), country of origin not specified.

3. Number of Experts and Qualifications for Ground Truth of Test Set

The provided text does not mention the use of experts to establish ground truth for the clinical studies in the context of adjudication or independent review.
For Study 5iS-009, the "Primary Endpoint" definitions for respiratory impairment (decline in oxygenation by pulse oximetry and apneas defined by AASM Scoring Manual, 2007) and "Secondary Endpoints" such as "adverse events reported by the investigators" imply that these assessments were made by the investigators themselves, rather than a separate panel of experts for ground truth establishment.
For studies 5iS-010 and 5iS-10B, the "Primary Endpoint" refers to carotid blood flow by Doppler ultrasound, which is an objective measurement. "Adverse events observed by the investigators" again suggests investigator-based assessment.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (such as 2+1 or 3+1 consensus) for the clinical studies or the establishment of ground truth for the test sets. Assessments appear to be based on direct measurements (e.g., pulse oximetry, Doppler ultrasound) or investigator reports.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The studies described are clinical trials comparing the device to standard care or assessing its impact on physiological parameters, not studies evaluating human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The cNEP Airway Management System is a physical medical device, not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study was not conducted.

7. Type of Ground Truth Used

Study 5iS-009:
- Primary Endpoint: Objective physiological measurements (pulse oximetry for oxygenation decline, AASM 2007 criteria for apnea duration)
- Secondary Endpoints: Investigator-reported adverse events and observations (e.g., need for interventions).
Studies 5iS-010 & 5iS-10B:
- Primary Endpoint: Objective physiological measurements (Doppler ultrasound for common carotid blood flow).
- Secondary Endpoints: Investigator-observed adverse events and vital sign measurements.

8. Sample Size for the Training Set

Not applicable. As this is a physical device, there is no "training set" in the context of machine learning or AI.

9. How Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this physical device.

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