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The Swift FX Nano channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system. The Swift FX Nano is: to be used by patients (>66lb / >30kg) for whom positive airway pressure has been prescribed. intended for single patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.

Device Description

The Swift FX Nano provides an interface such that airflow from a positive pressure source is directed to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face. Swift FX Nano is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Swift FX Nano is a prescription device supplied non-sterile.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Swift FX Nano Traditional 510(k):

Swift FX Nano - Acceptance Criteria and Supporting Study

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, the device relies on substantial equivalence to predicate devices, particularly the Swift FX, Mirage FX, and Ultra Mirage II. The acceptance criteria are primarily defined by demonstrating equivalent performance to these predicates.

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Equivalence)	Reported Device Performance (as described in the 510(k))
Intended Use	Same intended use as predicate devices.	"it has the same intended use" - channels airflow noninvasively for positive airway pressure (CPAP/bilevel) for patients >66 lbs, single-patient home reuse, multipatient hospital/institutional reuse.
Technological Characteristics	Substantially similar to predicate devices, particularly the Swift FX and Mirage FX.	"it has identical technological characteristics to the predicate devices" - provides seal via silicone interface, cushion design (nasal vs. pillows for Swift FX), various sizes, vent holes for CO2 flush, connects to conventional air delivery hose, molded plastic/silicone/fabric components, materials deemed safe. Pressure-flow characteristics and flow impedance are "identical" to the predicate.
Safety - Material Biocompatibility	Materials contacting heated humidified gas pathway and permanent skin contact are biocompatible according to ISO 10993-series and FDA Guidance #G95-1.	Heated Humidified Gas Pathway: Successfully passed ISO 10993-3 Genotoxicity, ISO 10993-5 Cytotoxicity, ISO 10993-6 Implantation, and ISO 10993-10 Sensitization and Irritation.
Permanent Skin Contact: Successfully passed ISO 10993-5 Cytotoxicity and ISO 10993-10 Sensitization and Irritation.
Safety - CO2 Re-breathing	Equivalent CO2 performance to predicate Ultra Mirage II.	"The CO2 performance of the new device and the predicate device are substantially equivalent." (Implicitly meets the predicate's performance.)
Risk Management	Application of risk management processes.	"development of the Swift FX Nano device complies with ISO 14971:2007, Medical devices - Application of risk management to medical devices."
New Questions of Safety/Effectiveness	No new questions of safety or effectiveness raised compared to predicates.	"the new device did not raise any new questions of safety or effectiveness"
Overall Safety & Effectiveness	At least as safe and effective as predicate devices.	"The new Swift FX Nano is as safe and effective as the predicate devices" and "it is at least as safe and effective as the predicate devices."

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

The provided summary does not describe a clinical test set with a specific sample size, nor does it mention data provenance (e.g., country of origin, retrospective/prospective study). Instead, the submission relies on bench testing and comparison to predicate devices, coupled with the established safety and efficacy of CPAP/Bilevel therapy using vented nasal masks.

The statement "Bench testing is sufficient to demonstrate safety and efficacy of the new Swift FX Nano, as was the case with the predicate devices" indicates that direct patient testing for a "test set" was not performed or deemed necessary for this 510(k) submission.

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

This information is not applicable as there was no clinical test set described in the 510(k) summary that required expert-established ground truth. The "ground truth" for this submission is the established safety and efficacy of the predicate devices and the performance of the Swift FX Nano against known engineering standards and biocompatibility tests.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical test set described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of medical images or data. The Swift FX Nano is an interface device for CPAP/bilevel therapy, and its evaluation focuses on mechanical performance, safety, and biocompatibility, not diagnostic effectiveness.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

This question is not applicable in the context of the Swift FX Nano. This device is a physical medical device (a mask) and does not involve an algorithm. The performance evaluation is based on bench testing of the physical properties and biocompatibility of the mask itself.

7. The Type of Ground Truth Used

The ground truth used in this 510(k) submission is primarily:

Established performance and safety of legally marketed predicate devices.
International standards and FDA Guidance for biocompatibility (e.g., ISO 10993 series, FDA Guidance #G95-1).
Established scientific principles for mechanical performance (e.g., pressure-flow characteristics, CO2 flushing).
Risk management principles as per ISO 14971:2007.

The "clinical data" section explicitly states "Use of vented nasal masks with CPAP or Bilevel therapy is proven technology and is well accepted by the medical community," which implicitly uses the outcomes data and established efficacy of the general device category as part of its ground truth.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical device and not an AI/algorithm that requires a training set.

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

This information is not applicable for the same reasons as #8.

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