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510(k) Data Aggregation
(151 days)
The Hi-Ox® High FiO2 Mask is intended to deliver high inspired oxygen concentrations to patients who require elevated inspired oxygen.
The HI-Ox80 is an oxygen mask to enable patients to inhale high concentrations of oxygen at moderate flow rates of 8 -10 |pm. It is a simple device consisting of a central manifold section where the patient mask, oxygen tubing and an oxygen reservoir bag attach. The triple valving in the manifold directs the oxygen to the patient and acts as an anti-asphyxiation valve removing the need for ventilation holes in the mask itself, thus allowing for delivery of high FiO2's.
Oxygen from the supply is either delivered to the patient via a one-way valve (inhalation valve) or stored temporarily in the oxygen reservoir bag. During exhalation, expired gas is directed to the atmosphere via another one-way valve (exhalation valve). In the event the patient's minute ventilation exceeds the oxygen supply flow rate, a third sequential dilution valve allows ambient air to get drawn into the inspired limb of the manifold eliminating the potential for asphyxiation.
The inhalation and exhalation one way valves are designed to have very low flow resistance (less than 1,5 cmH,O, typically ~ 1.07 cmH2O at flow rates of 60 lpm) to minimize the work of breathing. The sequential dilution valve is specified to be less than 3 cmH2O/U/sec. The oxygen mask is made of a soft material for conformance to the patient's facial contours. Positioning of the manifold connection on the mask minimizes the effective deadspace.
Here's an analysis of the provided text regarding the Hi-Ox® High FiO2 Mask, focusing on acceptance criteria and the study used to demonstrate compliance.
Hi-Ox® High FiO2 Mask - Acceptance Criteria and Supporting Study
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| FiO2 (inspired oxygen concentration) | In excess of 90% and over 80% at all times. The device is intended to deliver "high inspired oxygen concentrations." The documented performance clearly meets this general goal with specific values. |
| Inhalation one-way valve flow resistance | Less than 1.5 cmH2O at 60 lpm. (Specified design target) |
| Typically ~1.07 cmH2O at 60 lpm. (Actual measurement) | |
| 0.025 cmH2O per lpm. (Calculated from typical pressure drop at 60 lpm) | |
| Exhalation one-way valve flow resistance | Less than 1.5 cmH2O at 60 lpm. (Specified design target) |
| Typically ~1.07 cmH2O at 60 lpm. (Actual measurement) | |
| 0.025 cmH2O per lpm. (Calculated from typical pressure drop at 60 lpm) | |
| Sequential dilution valve flow resistance | Less than 3 cmH2O/L/sec. (Specified) |
| Mask fit/seal | Better sealing due to dual straps, lower durometer material, foam, and metal strip at nose bridge. (Subjective description of design improvements) |
| Anti-asphyxiation capability | Triple valving in the manifold directs oxygen to the patient and acts as an anti-asphyxiation valve, removing the need for ventilation holes in the mask itself. (Design feature) |
| A third sequential dilution valve allows ambient air to get drawn in if patient's minute ventilation exceeds oxygen supply flow rate, eliminating potential for asphyxiation. (Design feature) | |
| Work of breathing | Subjective testing also confirms little or no effort required for breathing through the Hi-Ox® oxygen mask assembly. (Subjective assessment) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the tests performed. It mentions "experiments conducted using a SensorMedics 229 metabolic measurement system." It does not specify the number of subjects or runs.
The data provenance is not explicitly stated regarding country of origin. The company is SensorMedics Corporation, located in Yorba Linda, CA, USA. This suggests the tests were likely conducted in the USA. The study design appears to be prospective as it describes direct experimentation to measure product performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish a ground truth with regard to the performance metrics (FiO2, flow resistance). The measurements for these criteria seem to be objective, instrument-based readings. For the "work of breathing," subjective testing was performed, but the number or qualifications of individuals providing this feedback are not specified.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as the reported performance seems to be based on direct measurements and objective criteria, not on expert consensus or interpretation requiring adjudication.
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
This device is not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This device is a physical medical device (oxygen mask), not an algorithm or software. Therefore, a standalone algorithm-only performance study is not applicable and was not performed.
7. The Type of Ground Truth Used
The ground truth for the performance criteria (FiO2, flow resistance) was based on objective, instrument-based measurements. For the "work of breathing," it was based on subjective patient feedback.
8. The Sample Size for the Training Set
This device does not involve machine learning or AI, so there is no training set and therefore no sample size for such a set.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
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