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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:
• 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 AirFit N20 is an externally placed vented respiratory mask covering the patient's nose. It provides a seal such that pressure from a positive air pressure (PAP) source is directed to the patient's airway non-invasively via the nose. The mask connects to the positive pressure source through a conventional air tubing via a standard conical connector. The mask is held in place with adjustable head straps.

The AirFit N20 comprises 4 subassemblies: headgear, frame, cushion and elbow/short tube. The exhaust port is incorporated into the elbow/short tube assembly. The cushion and headgear are available in various sizes to fit a wide patient population.

The AirFit N20 is a prescription device supplied non-sterile.

This document is a 510(k) premarket notification for the ResMed AirFit N20, a vented nasal mask, seeking clearance for expanded reprocessing claims. It is an FDA regulatory submission, not a study report describing an AI/ML device. Therefore, the requested information regarding acceptance criteria and a study proving an AI/ML device meets them cannot be provided as the document does not pertain to such a device.

The document discusses the substantial equivalence of the AirFit N20 with added reprocessing claims to a previously cleared predicate device. It details non-clinical testing performed to demonstrate that the expanded reprocessing claims do not affect the intended performance or raise new questions of safety or effectiveness.

Here's a breakdown of the non-clinical testing mentioned, which serves as the "study" demonstrating the device meets its expanded claims, though it is not an AI/ML study:

1. Table of Acceptance Criteria and Reported Device Performance:

• Mask Pressure-Flow tests per ISO 17510:2015.
• Relevant mask mechanical integrity tests: visual inspection, assembly integrity, headgear connection integrity, simulated body weight crush test, and free fall drop test. |
  | Residual Toxicity: Device must remain safe after reprocessing. | Demonstrated using appropriate Cytotoxicity biocompatibility tests, performed in accordance with ISO 10993-5:2009. |

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated in terms of number of devices/units tested. The document refers to "the subject device" implying a representative sample was used for the non-clinical tests.
• Data Provenance: The tests were conducted internally or by contracted labs as part of the regulatory submission process by ResMed Ltd. (Australia) for their device. This is prospective testing for regulatory clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

• This is not applicable as this is not an AI/ML device study. Ground truth in this context would refer to established standards and test methods (e.g., ISO standards, biocompatibility protocols) against which the physical device performance is measured. The "experts" would be the engineers, scientists, and technicians conducting and interpreting these non-clinical tests. Their specific numbers and qualifications are not provided in this regulatory summary.

4. Adjudication Method for the Test Set:

• Not applicable as this is not an AI/ML device study. Decisions are based on objective measurements against predefined acceptance criteria from international standards (e.g., ISO 17510:2015, ISO 10993-5:2009).

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/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used:

• Established
  standards and validated test methods:
  • Bioburden efficacy test protocols (implicitly following relevant standards for cleanliness and disinfection).
  • ISO 17510:2015 for Mask Pressure-Flow tests.
  • Specific mechanical integrity test protocols (visual inspection, assembly integrity, etc.).
  • ISO 10993-5:2009 for Cytotoxicity biocompatibility tests.
• The ground truth is the performance of the predicate device and the specified limits/requirements within the applicable standards.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device; there is no "training set."

9. How the Ground Truth for the Training Set was Established:

• Not applicable. This is not an AI/ML device.

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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:
• 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 modified 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 modified 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.

This document describes the regulatory submission for the ResMed AirFit N20, a non-invasive vented respiratory mask. The submission, K161978, is a modification of a previously cleared predicate device, AirFit N20 (K153673), aiming to demonstrate substantial equivalence.

Based on the provided information, the following can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state sample sizes for specific tests (e.g., number of masks tested for CO2 rebreathing, or number of cleaning/reprocessing cycles). It mentions "testing to simulated normal use and reasonable abuse scenarios," suggesting laboratory-based testing.

• Data Provenance: The testing was conducted by ResMed Ltd, an Australian company, for a device intended for international markets (indicated by FDA submission). The data is retrospective in the sense that it's bench testing and verification/validation conducted by the manufacturer, not a prospective clinical trial. There is no mention of data from human subjects in the testing phase beyond what is implicitly covered by biocompatibility standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This is a medical device submission primarily relying on bench testing and engineering verification/validation against international standards (e.g., ISO 17510:2015, ISO 10993 series) and comparison to a predicate device, rather than human expert-established ground truth for a diagnostic output. The "ground truth" here is the adherence to established engineering specifications and safety standards.

4. Adjudication Method for the Test Set

Not applicable for this type of submission. The evaluation is based on objective measurements against pre-defined engineering and performance criteria and adherence to recognized standards.

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

No. This document explicitly states: "Clinical data was not relied upon to demonstrate Substantial Equivalence to the predicate device. Bench testing demonstrates that the modified AirFit N20 mask device performs in an equivalent manner and is as safe and as effective as the previously cleared predicate AirFit N20 device (K153673)." Therefore, an MRMC study is not relevant to this submission.

6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance)

Yes, in the sense that the device's functional and mechanical performance was evaluated in isolation ("bench testing") against pre-defined specifications and standards. This is not an AI algorithm, but a physical medical device; its "standalone performance" refers to its intrinsic characteristics and operation.

7. Type of Ground Truth Used

The "ground truth" for this device, as described in the submission, is based on:

• International Standards: Primarily ISO 17510:2015 (Medical devices – Sleep apnoea breathing therapy Masks and application accessories) and ISO 10993 series for biocompatibility.
• Engineering Specifications: Predetermined acceptance criteria derived from the device's design requirements and performance characteristics of the legally marketed predicate device (K153673).
• Predicate Device Performance: The original AirFit N20 (K153673) serves as a benchmark for "similar performance."

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, there is no AI/ML training set.

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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.

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