(379 days)
The Hsiner NIPPV masks provide a patient interface for application of noninvasive ventilation with ventilators with adequate alarms and safety systems to protect the patient in the event for ventilator failure. These masks are intended for use with spontaneously breathing adult patients (> 30 kg) with respiratory insufficiency or respiratory failure suitable for nominvasive pressure support ventilation treatment in the hospital/institutional environment (including but not limited to moderate.or severe dyspnea; elevated respiratory rates, labored breathing; or paradoxical breathing).
Hsiner's NIPPV Masks are intended to provide a patient interface between a conventional mechanical ventilator system and the patient for applications of non-invasive ventilation. The comection to the ventilator utilizes standard 22mm conical connections complying with ISO 5356-1. The interface with the patient's facial contours utilizes a soft, pliable seal that ensures that a good seal is achieved to deliver the pressurized gasses with minimal unintentional leakage, Unintentional gas leak around the face is minimized by the mask base to improve the closeness of fit to the skin. Soft, clastic headgear insures a tight comfortable fit against the face.
The Esiner NIPPY Masks are modifications to their CPAP/VPAP Masks (K063268). These masks differ from the CPAP/VPAP mask only in that the vents and anti-asphyxiation valves have been removed.
The provided document is a 510(k) summary for A Hsiner Company NIPPV Masks. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information (like sample size for test/training set, number of experts, adjudication method, MRMC study, how ground truth was established, effect size with/without AI assistance) is not applicable or cannot be extracted from this document as no clinical test was performed.
Here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from FDA guidance & standards) | Reported Device Performance (Hsiner NIPPV Masks vs. Predicate Devices) |
|---|---|
| Resistance to flow | Negligible difference between all masks (Hsiner NIPPV, Hsiner CPAP/VPAP, Fisher Paykel RT041). |
| Exhaust flow | Negligible differences at low pressure settings. Hsiner's NIPPV and CPAP/VPAP masks showed higher flows at higher pressure levels than the Fisher Paykel RT041. |
| CO2 Rebreathing | Negligible differences for Hsiner NIPPV and Fisher Paykel masks. Hsiner's CPAP/VPAP showed slightly lower EtCO2 levels. |
| Fraction of Inspired Oxygen (FIO2) | Slightly higher overall FIO2 percentages for Fisher Paykel masks. All FIO2 values significantly lower with added 20 LPM leaks. Decreasing therapeutic pressure resulted in higher FIO2. Increasing supplemental O2 flow rates resulted in significant increases in FIO2. |
| Swivel leakage | Notably higher for Hsiner NIPPV masks compared to the Fisher Paykel RT041 Mask. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No clinical test was performed for this device. The performance evaluation focused on bench testing the device and comparing its physical properties and in-vitro performance to predicate devices and established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No expert ground truth was established for a clinical test set as no clinical test was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method was used as no clinical test was performed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This document describes a medical device (NIPPV masks), not an AI algorithm. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the performance evaluation, "ground truth" was established by standardized laboratory measurements following protocols described in FDA's July 1995 guidance document "Draft Reviewer Guidance for Ventilators," ASTM 1100-90, and ISO 17510-2 (2007). These standards define acceptable ranges or methods for measuring parameters like resistance to flow, exhaust flow, CO2 rebreathing, FIO2, and swivel leakage.
8. The sample size for the training set
- Not applicable. No training set was used as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).