(133 days)
The AirFit N20 channels airflow non-invasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device.
The AirFit N20 is:
- o to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure has been prescribed
- intended for single patient re-use in the home environment and multi-patient re-use in the ● hospital/institutional environment.
The ResMed AirFit N20 is a non-invasive vented respiratory mask that provides a silicone air seal around the patient's nose and upper lip. The mask is held in place with adjustable head straps. Air flow from a positive air pressure (PAP) source is directed to the patient's airway non-invasively. It connects to a conventional PAP device air delivery hose via a standard 22mm swivel.
The AirFit N20 comprises 4 subassemblies: headgear, frame, cushion and elbow/short tube. The exhaust port is incorporated into the elbow/short tube assembly. For home use, the mask may be cleaned in warm soapy water.
The AirFit N20 is a prescription device supplied non-sterile.
The provided document is a 510(k) summary for the ResMed AirFit N20, a vented nasal mask. It primarily focuses on demonstrating substantial equivalence to a predicate device (AirFit N10) rather than presenting a detailed study proving the device meets specific performance acceptance criteria for a novel AI or diagnostic algorithm.
Therefore, many of the requested items, particularly those related to a study proving new device performance against acceptance criteria for an AI or diagnostic algorithm, are not present in this document. The document describes non-clinical testing for performance characteristics rather than a study with a test set, ground truth, experts, or a comparison to human readers.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of quantitative acceptance criteria alongside actual reported performance values for each criterion. It broadly states that "Testing confirmed that the new device met the predetermined acceptance criteria."
However, it lists the types of non-clinical testing conducted, which imply the areas where performance was assessed:
- CO2 rebreathing
- Total mask flow
- Flow resistance
- Through impedance
- Mechanical integrity (simulated normal use and reasonable abuse, home cleaning, multi-patient reprocessing, transportation, storage)
- Biocompatibility
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable or provided in the context of this 510(k) summary for a respiratory mask. The "test set" here refers to the physical devices undergoing engineering and biocompatibility testing, not a dataset for an algorithm. There is no mention of data provenance in the sense of patient data.
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)
This is not applicable as the document describes non-clinical engineering and biocompatibility testing of a physical medical device, not an AI or diagnostic algorithm requiring expert-established ground truth from images or patient records.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the type of testing described (engineering and biocompatibility of a respiratory mask).
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
No such study was done or is mentioned. This document pertains to a physical medical device (mask), not an AI-assisted diagnostic or an algorithm that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a respiratory mask, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" or reference for performance would be established engineering standards (e.g., ISO 17510-2, ISO 10993 series) and design specifications. For example, CO2 rebreathing would be measured against limits defined by standards, and biocompatibility would be assessed against the requirements of ISO 10993.
8. The sample size for the training set
This is not applicable as the document describes a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).