(142 days)
The Comfort Twin Nasal Mask is an accessory to a non-continuous ventilator (respirator), intended for use by adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy in hospital, clinic and home environments.
The Comfort Twin Nasal mask is a respiratory nasal mask using a dual cushion design with built-in bellows and an inner sealing flap for improving unintentional leak. It is a single patient use accessory for use with CPAP or bi-level devices. The Comfort Twin mask is strapped to the patient's face covering the nose, and connected to tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is then able to be applied to the lungs in a non-invasive way.
The provided text describes a 510(k) summary for the Comfort Twin Nasal Mask, which is a new device. The acceptance criteria and the study proving the device meets them are discussed in the context of demonstrating substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance within specification comparable to cited device predicates. | "All performance characteristics performed within specification and comparable to the cited device predicates." |
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "The new device was validated using bench data." This indicates that the testing was performed in a laboratory setting. The specific sample size for the test set is not provided. The provenance of the data is bench data, implying controlled experimental conditions rather than human or animal studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. Since the validation was performed using "bench data," there was no need for human experts to establish ground truth in the way it would be required for clinical image analysis or diagnostic studies. The ground truth would be defined by the technical specifications and measurements of the device components and its interaction with test equipment.
4. Adjudication Method for the Test Set:
Not applicable. As the validation was based on "bench data," an adjudication method for reconciling expert opinions is not relevant. The "adjudication" would involve comparing measurements against predefined technical specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study focused on demonstrating substantial equivalence through bench data, comparing the performance characteristics of the new device to predicate devices. There is no mention of human readers or AI assistance in this context.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):
Yes, in spirit, but not in the context of an algorithm. The study essentially evaluates the "standalone" performance of the physical device itself (the Comfort Twin Nasal Mask) in a controlled bench setting, without human intervention or interpretation that would typically be associated with an algorithm. It's an engineering performance evaluation, not an AI algorithm evaluation.
7. Type of Ground Truth Used:
The ground truth used was technical specifications and performance characteristics of the predicate devices (Respironics Reusable II Contour Nasal Mask and Resmed Mirage Activa), against which the new device's "bench data" was compared. The statement "All performance characteristics performed within specification and comparable to the cited device predicates" implies that the predicate devices' established performance benchmarks served as the ground truth for comparison.
8. Sample Size for the Training Set:
Not applicable. This device is a physical medical device (nasal mask), not an AI algorithm that requires a training set. The concept of a "training set" is not relevant to this type of product submission.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As a physical device, there is no training set in the context of machine learning.
§ 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).