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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.

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.

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.

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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The Swift FX Bella 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 Bella is:

• to be used by adult 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.

The Swift FX Bella is a modified variant of the previously cleared Swift FX. It 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 nasal nares.

Swift FX Bella is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.

Swift FX Bella is a prescription device supplied non-sterile.

The provided document is a 510(k) summary for a device modification (Swift FX Bella) and focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting a study with specific acceptance criteria and detailed performance measurements for the modified device. Therefore, much of the requested information cannot be extracted directly from this document.

However, based on the available text, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for the modified device as pass/fail thresholds in a quantitative table. Instead, it relies on demonstrating equivalence to predicate devices for various performance aspects.

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

The document mentions "Clinical studies confirmed that the Swift FX Bella met user requirements," but does not provide details on the sample size used for these clinical studies or the data provenance (e.g., country of origin, retrospective/prospective nature). It primarily relies on bench testing and comparison to predicate devices, stating "Bench testing is sufficient to demonstrate safety and efficacy of the modified Swift FX Bella, as was the case with the primary predicate Swift FX device."

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the document. Since the testing primarily involved bench testing and demonstrating equivalence to existing predicate devices, the concept of "experts establishing ground truth" in the context of diagnostic accuracy doesn't directly apply in the way it would for an AI algorithm interpreting medical images. The "clinical studies" mentioned for user comfort and stability would have involved users/patients, but details are absent.

4. Adjudication Method for the Test Set

This information is not provided.

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

A MRMC comparative effectiveness study was not conducted (or at least, not described in this document). The device is a physical nasal mask, not an AI-based diagnostic tool where human readers would improve with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the Swift FX Bella is a physical medical device (nasal mask), not an algorithm or AI.

7. Type of Ground Truth Used

For the aspects where "clinical studies" were vaguely mentioned (comfort and stability), the "ground truth" would be subjective user feedback. For other performance aspects (pressure-flow, CO2, reprocessing, biocompatibility), the "ground truth" was established through bench testing and comparison to established specifications or performance of predicate devices.

8. Sample Size for the Training Set

This is not applicable as the device is not an AI algorithm requiring a training set.

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

This is not applicable.

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The Swift FX channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system. The Swift FX is: to be used by adult patients (> 66 lb/30 kg) 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.

The Swift FX 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 is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Swift FX is a prescription device supplied nonsterile.

This document describes a 510(k) premarket notification for a medical device called Swift™ FX, a vented nasal mask. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study against specific acceptance criteria for a novel device. Therefore, many of the requested categories are not applicable or cannot be extracted directly from this type of regulatory submission.

Analysis of the Provided Text for Acceptance Criteria and Study Information:

The document is a 510(k) summary, which aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. It primarily relies on comparisons to existing devices and bench testing, rather than extensive clinical trials with specific acceptance criteria as might be seen for a novel, high-risk device.

Here's an breakdown based on your request, noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't outline specific, quantitative acceptance criteria in a table format with corresponding numerical performance results for the Swift™ FX. Instead, it asserts "substantial equivalence" based on various characteristics:

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

• The document states: "Bench testing is sufficient to demonstrate safety and efficacy of the Swift FX, as was the case with the predicate device."
• Sample Size: Not specified. "Bench testing" typically refers to laboratory simulations and does not involve human subjects in a "test set" in the way clinical studies do. The number of masks or components tested is not mentioned.
• Data Provenance: The data primarily comes from bench testing conducted by ResMed. There is no mention of country of origin for the data or whether it was retrospective or prospective in a clinical sense.

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

• Not applicable/Not provided. The "ground truth" in this context is established through engineering and performance specifications during bench testing by the manufacturer, comparing the new device against the known performance of predicate devices. There is no mention of independent "experts" adjudicating clinical data for a test set.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. Since there's no "test set" in the clinical sense needing adjudication, no adjudication method is described.

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

• No. This type of study (MRMC) is typically used for diagnostic imaging devices where human readers interpret medical images. The Swift™ FX is a respiratory mask, and its assessment does not involve human readers interpreting "cases" in this manner.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. The Swift™ FX is a physical medical device, not an algorithm, so the concept of "standalone algorithm performance" does not apply. Its performance is inherent in its design and physical characteristics.

7. The Type of Ground Truth Used:

• The "ground truth" for the Swift™ FX's performance is essentially the engineering specifications and established performance characteristics of the predicate devices (Swift LT and Ultra Mirage II). The new device is considered "safe and effective enough" if its bench test results are "substantially equivalent" to these known and accepted predicate devices. This falls under engineering/performance data comparison rather than pathology or outcomes data.

8. The Sample Size for the Training Set:

• Not applicable. As a physical medical device, the Swift™ FX does not involve "training sets" in the context of machine learning or AI algorithms. The design and manufacturing process are guided by engineering principles and quality management systems (ResMed's 21 CFR Part 820 compliant Quality Management System).

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

• Not applicable for the same reason as above.

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