(157 days)
The AirLife Autofill Humidification Chamber is intended to hold water required to humidify breathing gases delivered to any patient using a heated humidifier. The product is single use device, non-sterile and used in professional healthcare environments under a doctor's supervision and by skilled clinician. The Artofill Humidification Chamber is compatible with the Fisher and Paykel MR850 system.
The AirLife Autofill Humidification Chamber is intended to hold water required to humidify breathing gases delivered to patients.
The provided text describes a 510(k) premarket notification for the AirLife Autofill Humidification Chamber, comparing it to a predicate device (MR290 Humidification Chamber). The document focuses on demonstrating substantial equivalence rather than a study with acceptance criteria and a detailed performance evaluation of an AI-powered device.
Therefore, the requested information components related to AI/algorithm performance, such as sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are not applicable or available in this document.
The document primarily evaluates the physical and functional characteristics of a medical device (humidification chamber) against recognized standards and a predicate device.
Here's the closest representation of the requested table and related information based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly compliance with relevant medical device standards and demonstrating performance comparable to the predicate device. The "acceptance criteria" for each performance characteristic are often defined by the standard itself or by the performance of the predicate device.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate/Standard) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Humidity Output Invasive | Comparable to predicate (39.2 mg/L) & BS EN ISO 8185:2009 | 39.0 mg/L |
| Humidity Output Non-Invasive | Comparable to predicate (24.6 mg/L) & BS EN ISO 8185:2009 | 24.3 mg/L |
| Specific Enthalpy | Comparable to predicate (Max: 151 kJ/kg, Avg: 120 kJ/kg) & BS EN ISO 8185:2009 | Max: 156 kJ/kg, Avg: 117 kJ/kg |
| Hazardous Output | BS EN ISO 8185:2009 | Not explicitly stated, assumed met |
| Resistance to Flow @60L/min | Comparable to predicate (0.50 cmH2O) & BS EN ISO 5367:2014 | 0.40 cmH2O |
| Maximum Peak Flow | BS EN ISO 8185:2014 | Maximum continuous gas flow rate of 60 LPM in invasive mode and 120 LPM in non-Invasive mode (Comparable to predicate) |
| Leakage & Maximum Operating Pressure | Comparable to predicate (>100 mL/min for leakage, 13.2kPa for pressure) & BS EN ISO 8185:2009, BS EN ISO 5367:2014 |
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).