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510(k) Data Aggregation
(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 | <30mL/min for leakage, 13.2kPa for pressure |
| Liquid Overflow | BS EN ISO 8185:2009 | Not explicitly stated, assumed met |
| Compliance | Comparable to predicate (5.54 mL/kPa) & BS EN ISO 8185:2009, BS EN ISO 5367:2014 | 6.23 mL/kPa |
| Compressible Volume | Comparable to predicate (255 mL) | 245 mL |
| Accessible Surface Temperature | BS EN ISO 8185:2009, IEC 60601-1:2005 | Not explicitly stated, assumed met |
| Steady State Noise | BS EN ISO 8185:2009, IEC 60601-1:2005 | Not explicitly stated, assumed met |
| Shelf Life/Accelerated Aging | N/A (Predicate not published) | 24 months |
| End-use Simulation/Duration of Use | N/A | 14 days (Comparable to predicate) |
| Biocompatibility | AAMI/ANSI/ISO 10993 series | Tests performed for cytotoxicity, sensitization, irritation, muscle implantation, genotoxicity, extractables/leachables. (Assumed met) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as this is a physical device and the tests are for its physical and functional characteristics, not an AI algorithm. There is no "test set" in the sense of a dataset for an algorithm. The "tests" refer to laboratory evaluations of the device's physical properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The "ground truth" for a physical medical device typically refers to engineering specifications, performance standards, and the capabilities of a predicate device, not expert consensus on interpretations of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human adjudication of results from an AI algorithm.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered device or a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on established medical device standards (e.g., ISO, IEC) and the performance characteristics of a legally marketed predicate device (MR290 Humidification Chamber).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI algorithm.
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