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AirFit F20 Mask System:

The AirFit F20 mask has two product variants:

• AirFit F20 mask is intended for single-patent reuse in the home environment.
• AirFit F20 SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.

Both masks are intended for patients weighing more than 66lb (30kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocesssed if reused between patients.

AirFit F20 NM Mask System:

The AirFit F20 Non Magnetic mask has two product variants:

• The AirFit F20 Non Magnetic variant is intended for single-patient reuse in the home environment.
• The AirFit F20 Non Magnetic SLM (Sleep Lab Mask) variant is intended for multi-patient reuse in the hospital/institutional environment.

This mask is for patients weighing more than 66 lb (30 kg), who have been prescribed non-invasive CPAP or bi-level positive airway pressure (PAP) therapy. The Sleep Lab Mask is the only variant that is validated and intended for multi-patient reprocessing and must be reprocessed if reused between patients.

The AirFit F20 and AirFit F20 NM Mask Systems are both full-face masks intended for use with Continuous Positive Airway Pressure (CPAP) and/or Bi-Level devices. CPAP & Bi-Level devices are used for the treatment of Obstructive Sleep Apnea (OSA) and/or ventilatory support. Both treatments deliver pressurized air from a flow generator to the patient. Such delivery of pressurized air relies on the Patient Interface; commonly known as the mask. Full face masks are a common type of Patient Interface (Mask) and are known to efficaciously support the delivery of pressurized air by providing a seal around the patient's nose and mouth.

The AirFit F20 mask system has two product variants:

• AirFit F20 Mask: This is the home use variant that is intended for single patient re-use.
• AirFit F20 SLM (sleep lab mask): This is the variant that is intended for multi-patient re-use and must be reprocessed if reused between patients using the disinfection guide.

AirFit F20 (K170924) had a "For Her" variant which was cleared with aesthetic colour pops, the AirFit F20 Mask and AirFit F20 SLM also have the same "For Her" variant.

The AirFit F20 NM mask system has two product variants:

• AirFit F20 NM Mask: This is the home use variant that is intended for single patient re-use.
• AirFit F20 NM SLM (sleep lab mask): This is the variant that is intended for multi-patient re-use and must be reprocessed if reused between patients using the disinfection guide.

The AirFit F20 and AirFit F20 NM Mask Systems share a common design architecture as the predicate AirFit F20 (K170924), except that the AirFit F20 NM Mask System has non-magnetic clips.

The AirFit F20 and AirFit F20 NM mask systems are made up of the following four main component assemblies: cushion, elbow, frame, and headgear. The cushion and headgear are available in various sizes to allow for adequate mask fit over the intended patient population.

The AirFit F20 and AirFit F20 NM mask systems are prescription devices supplied non-sterile.

The provided FDA 510(k) clearance letter and associated summary pertain to the AirFit F20 Mask Systems, which are non-continuous ventilators (CPAP/Bi-Level masks). This type of device does not typically involve complex diagnostic algorithms or AI components that would necessitate the study structure outlined in your request (e.g., test sets, ground truth, expert adjudication, MRMC studies, standalone performance for AI).

Instead, the clearance is based on demonstrating substantial equivalence to a predicate device (AirFit F20, K170924) through non-clinical performance and safety testing, adherence to recognized standards, and biocompatibility evaluations.

Therefore, many of the specific questions you've asked cannot be directly answered from this document as they are not relevant to the type of device and clearance process involved.

Here's an attempt to extract the relevant information and address your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in a format typically used for diagnostic algorithm validation. Instead, it compares specific design parameters and performance characteristics of the new devices (AirFit F20 Mask System and AirFit F20 NM Mask System) against the predicate device (AirFit F20, K170924). The "Comments" column often indicates that the performance is "Equivalent" or "Identical," implying that the new devices meet or perform similarly to the established safety and performance profile of the predicate, which serves as the de facto acceptance benchmark.

Here's a summary derived from the comparison table (Pages 9-12 of the provided document):

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The AirFit F20 is a non-invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous pressure (CPAP) or bilevel system.

The AirFit F20 is:

• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure therapy has been prescribed
• intended for single-patient reuse in the home environment and multi-patient reuse in the hospital/institutional environment.

The AirFit F20 is an externally placed vented mask covering the mouth and the nose of the patient. It provides a seal such that pressure from a positive pressure source is directed to the patient's nose and/or mouth. The mask connects via a standard conical connector to a conventional air delivery hose, which in turn connects to the positive pressure source. The mask is held in place with an adjustable headgear that straps the mask to the face.

The AirFit F20 mask system comprises four subassemblies: cushion, frame, elbow and headgear. The elbow incorporates the vent array and anti-asphyxia valve safety features. The cushion and headgear are available in various sizes to fit a wide patient population.

AirFit F20 is a prescription device supplied non-sterile.

This document is an FDA 510(k) clearance letter for a medical device called AirFit F20, a non-invasive accessory for positive airway pressure (PAP) devices. It does not contain information about an AI/ML device or a study involving human readers and AI assistance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance using AI, as the provided text pertains to a traditional medical device submission and does not involve AI or ML.

The document discusses the substantial equivalence of the AirFit F20 to a previously cleared predicate device (AirFit F20 (K153563)) based on:

• Intended Use: Same
• Operating Principle: Same
• Design and Materials: Similar
• Performance: Similar pressure-flow characteristics and flow impedance
• Operating Environments: Same (home and hospital/institution)
• Manufacturing Processes: Similar

The main differences from the predicate device relate to reprocessing claims for multi-patient reuse and material changes to certain components. Non-clinical data validation testing was conducted to demonstrate that these changes do not raise new questions of safety or effectiveness. This validation included:

• Bioburden efficacy tests
• Performance tests (visual inspection, total mask flow, AAV activation/deactivation, assembly integrity, mask-to-headgear connections) before and after reprocessing
• Residual toxicity tests
• Biocompatibility tests for material changes (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Acute systemic toxicity, Material-mediated Pyrogenicity, Implantation, Leachables testing)

In summary, the provided text describes a 510(k) clearance for a non-AI medical device and therefore does not contain the information needed to answer your specific questions about AI acceptance criteria and study details.

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The AirFit F20 is a non-invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous pressure (CPAP) or bilevel system.

The AirFit F20 is:
• to be used by patients weighing more than 66 lb (30 kg) for whom positive airway pressure therapy has been prescribed
• intended for single-patient reuse in the home environment and multi-patient reuse in the hospital/institutional environment.

The AirFit F20 is an externally placed vented mask covering the mouth and the nose of the patient. It provides a seal such that pressure from a positive pressure source is directed to the patient's nose and/or mouth. The mask connects via a standard conical connector to a conventional air delivery hose, which in turn connects to the positive pressure source. The mask is held in place with an adjustable headgear that straps the mask to the face. The AirFit F20 mask system comprises four subassemblies: cushion, frame, elbow and headgear. The elbow incorporates the vent array and anti-asphyxia valve safety features. The cushion and headgear are available in various sizes to fit a wide patient population.

AirFit F20 is a prescription device supplied non-sterile.

The provided document is a 510(k) summary for the ResMed AirFit F20, a non-invasive accessory for CPAP/bilevel systems. It focuses on demonstrating substantial equivalence to a predicate device (Quattro Air K123979) rather than presenting a study to prove acceptance criteria for a new, unique device performance. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable or not explicitly detailed as one might find in a study specifically designed to establish novel performance claims.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a direct table of specific acceptance criteria values alongside numerical performance results for the AirFit F20. Instead, it states that the device was designed and tested in accordance with ISO 17510-2: Sleep apnoea breathing therapy - Part 2: Masks and application accessories, and that testing confirmed the new device met "predetermined acceptance criteria" and its performance is "substantially equivalent" to the predicate.

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

• Sample Size for Test Set: Not explicitly stated. The testing appears to be primarily bench/non-clinical and biocompatibility. For bench testing of physical characteristics like flow, rebreathing, and resistance, samples would typically consist of a certain number of manufactured units of the AirFit F20. The specific number is not provided.
• Data Provenance: The testing was non-clinical (bench testing) and focused on material and functional performance. It does not involve human patient data in the context of clinical outcomes. The manufacturer, ResMed Ltd., is based in Australia, and the submission was made to the US FDA.

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

• This question is not applicable in the context of this 510(k) submission. The "ground truth" for the non-clinical tests (e.g., CO2 rebreathing, flow resistance) is established by measurement against predefined engineering specifications and international standards (like ISO 17510-2). These are objective physical measurements, not subjective expert interpretations that require "ground truth" establishment by multiple experts with specific qualifications like radiologists.

4. Adjudication Method for the Test Set

• Not applicable. Since the tests are objective physical measurements against standards and predicate performance, there is no need for expert adjudication.

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

• No. The document explicitly states: "Clinical data was not relied upon to demonstrate substantial equivalence to the predicate device. Bench testing demonstrates that the new AirFit F20 device performs in an equivalent manner and is as safe and as effective as the predicate device." MRMC studies apply to imaging or diagnostic devices where human readers interpret results, which is not the case for this device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance Study

• Yes, indirectly. The non-clinical data presented (CO2 rebreathing, AAV performance, total mask flow, flow resistance, through impedance, mechanical integrity, biocompatibility) represents testing of the device's inherent physical and functional performance, essentially "standalone" in a bench setting without human interaction influencing the core functional measurements. However, it's not an "algorithm" in the typical sense for AI, but rather the performance of the physical mask.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical tests is based on:
  • International Standards: Specifically, ISO 17510-2: Sleep apnoea breathing therapy - Part 2: Masks and application accessories.
  • Engineering Specifications: Predetermined acceptance criteria derived from the standard and design requirements.
  • Predicate Device Performance: Demonstrating substantial equivalence to the performance characteristics of the legally marketed predicate device (Quattro Air (K123979)).

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical device (mask), not an AI/algorithm-based diagnostic system that requires a "training set" in the machine learning sense.

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

• Not applicable. As above, there is no AI training set for this device.

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