(100 days)
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.
| Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Comfort and Stability (User Requirements) | Met user requirements. | "Clinical studies confirmed that the Swift FX Bella met user requirements of comfort and stability." |
| CPAP Seal Performance | Equivalent to the primary predicate device (Swift FX). | "The CPAP seal performance is equivalent to the primary predicate device." |
| Pressure-Flow Characteristics | Equivalent to the secondary predicate device (Mirage Swift, K042403) and identical to the primary predicate (Swift FX). | "The pressure-flow characteristics of the modified Swift FX Bella device is equivalent to the secondary predicate Mirage Swift (K042403)." |
| "The pressure-flow characteristics and flow impedance of both the modified device and the predicate device [Swift FX] are identical." | ||
| CO2 Performance | Equivalent to the secondary predicate device (Ultra Mirage II, K042403). | "The CO2 performance of the modified device is equivalent to the secondary predicate Ultra Mirage II (K042403)." |
| STERRAD 100S and STERRAD NX Reprocessing Performance | Equivalent to secondary predicates (Mirage Quattro, K063122; Mirage Liberty, K063011; Mirage Micro, K072940). | "The STERRAD 100S and STERRAD NX reuse reprocessing performance is equivalent to the secondary predicates Mirage Quattro (K063122), Mirage Liberty (K063011) and Mirage Micro (K072940)." |
| Biocompatibility (Silicone headgear material) | Equivalent to the secondary predicate device (Swift LT, K073638). | "Silicone headgear material biocompatibility of the modified device is equivalent to the secondary predicate Swift LT (K073638)." |
| Compatibility with Flow Generator Settings | Designed to operate on the same settings as the primary predicate (Swift FX). | "Both the modified Swift FX Bella device and the primary predicate Swift FX device (K090244) are designed to operate on the same flow generator settings as specified in the User Guide." |
| Materials Safety | All components fabricated using materials deemed safe (per ISO 10993-1). | "All the components of both masks are fabricated using materials deemed safe. (ref: ISO 10993-1)." |
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.
§ 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).