(27 days)
The Hi-Ox® High FiO2 Mask is intended to deliver high inspired oxygen concentrations to patients who require elevated inspired oxygen.
The Hi-Ox® is an oxygen mask to enable patients to inhale high concentrations of oxygen at moderate flow rates of 8 -10 lpm. 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 cmH,O at flow rates of 60 lpm) to minimize the work of breathing. The sequential dilution valve's resistance is specified to be less than 3 cmH2O/I/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.
The provided text describes the Hi-Ox® High FiO2 Mask and a 510(k) submission to the FDA. However, it does not contain information about acceptance criteria or a study designed to prove the device meets specific performance metrics in the way a clinical trial or a formal validation study for a software algorithm would.
Instead, the document details the design principles and bench testing of a physical medical device (an oxygen mask) to demonstrate its functionality and safety compared to existing devices. The "tests" mentioned are primarily engineering validations and performance measurements of the mask's components.
Therefore, I will extract what I can from the provided text, but many of the requested sections (e.g., sample size for test set, ground truth experts, MRMC, training set) are not applicable to the type of device and testing described.
Here's the information derived from the provided text, addressing the points as best as possible:
Acceptance Criteria and Device Performance for Hi-Ox® High FiO2 Mask
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Design Target) | Reported Device Performance |
|---|---|
| FiO2 values | In excess of 90% and over 80% at all times (monitored via sampling port) |
| Inhalation/Exhalation Valve Flow Resistance | Less than 1.5 cmH₂O at 60 lpm (0.025 cmH₂O per lpm) |
| Sequential Dilution Valve Resistance | Less than 3 cmH₂O/I/sec |
| Work of Breathing | Little to no effort (Subjective testing) |
| Valve Flow Resistance after extreme storage | Unchanged from room temperature |
| Seal to face | Improved seal due to dual straps, softer material, foam, and metal strip |
| Absence of holes | No holes in the mask |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for FiO2 testing. The text refers to "experiments conducted" but does not quantify the number of "users" or "tests" beyond indicating a sampling port was used directly in front of "a user's nose."
- Data Provenance: The tests appear to be laboratory bench tests and subjective evaluations conducted by SensorMedics. The text does not specify the country of origin for the data (beyond SensorMedics being a US company) or if it was retrospective or prospective in a clinical sense. Given the nature of the device (physical mask), it's likely a controlled lab environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable or mentioned. The "ground truth" for these tests relates to physical measurements (FiO2, flow resistance) and subjective reports ("little or no effort required for breathing"). These are direct measurements or user experiences, not expert consensus on interpretations.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The tests are based on physical measurements of device characteristics (e.g., FiO2, flow resistance) or direct subjective feedback. There is no mention of ambiguous cases requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- MRMC Study: No, this is not an MRMC study. MRMC studies are typically used for diagnostic imaging or AI systems where multiple human readers interpret cases. This document describes a physical oxygen mask.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical mask, not an algorithm. The performance measured is that of the physical device's characteristics (e.g., FiO2 delivery, valve resistance).
7. The type of ground truth used
- Ground Truth Type:
- Direct Measurement: For FiO2, it was measured using a "SensorMedics 229 metabolic measurement system" via a sampling port. For valve resistance, it was measured using specialized equipment.
- ASTM Standard: Valve flow resistance after extreme temperature exposure was validated using established ASTM F920 test protocols.
- Subjective Report: Work of breathing was assessed via "subjective testing" where users reported "little or no effort required for breathing."
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set. The design and validation are based on engineering principles and bench testing.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).