(191 days)
The MMOS is intended to convert liquid oxygen to gaseous oxygen for delivery to a patient and for delivery to rescue personnel to supplement environmental oxygen at high altitudes while mounted in rescue vehicles, e.g. HH-60 and HC-130 Guardian Angel (GA) rescue vehicles, at one-half (0.5) to fifteen (15) liters per minute (LPM) and fifty (50) pounds per square inch gauge (psig).
The MMOS, when filled with liquid oxygen, is used to provide medical treatment to injured isolated personnel and to supplement environmental oxygen during high altitude and parachuting operations. The MMOS is primarily employed on board the HH-60, HC-130, and Guardian Angel (GA) rescue Vehicle to treat 1-2 patients for durations of 4-8 hours. The MMOS contains a thermally insulated container of liquid oxygen (LOX) that is intended to supplement gases to be inhaled by a patient. The MMOS supports medical devices provided by the user including masks, cannulas, and Bag Valve Mask (BVM) being attached to the flow control patient outlets. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug. The MMOS is portable. The handle on top of the housing, as well as the handles on the left and right side of the front-angled user interface, make the MMOS portable. The MMOS can be carried onboard, tied down, transported and operationally perform on various aircraft and ground vehicles. The MMOS converts liquid oxygen from its insulated container through its heat exchanger into gaseous oxygen and finally the gaseous oxygen is available for distribution from an outlet port on the user interface. After connecting a tube assembly connector of a mask, cannula, and Bag Valve Mask (BVM) to an outlet port, masks, cannulas, and BVMs or other similar medical device (none of these devices is included in the MMOS) the patient can inhale the gaseous oxygen.
The provided text describes the Essex Cryogenics of Missouri, Inc. Mounted Medical Oxygen System (MMOS) and its substantial equivalence to a predicate device. It explicitly states device performance characteristics and refers to testing done, which can be interpreted as the study proving the device meets its acceptance criteria.
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from "Physical and performance characteristics") | Reported Device Performance (from "Physical and performance characteristics" and "Intended Use") |
|---|---|
| Supplies 93% oxygen concentration when filled from an OGS. | The MMOS supplies 93% oxygen concentration when filled from an Oxygen Generator System (OGS). |
| Capable of delivering gaseous oxygen to two patients at a combined maximum system flow rate of 22 Liters-Per-Minute (LPM) ambient. | The MMOS is capable of delivering gaseous oxygen to two patients at a combined maximum system flow rate of 22 Liters-Per-Minute (LPM) ambient. |
| Capable of delivering oxygen at a flow rate of 7 LPM for a minimum duration of 8 hours at one outlet. | The MMOS is capable of delivering oxygen at flow rate of 7 LPM for a minimum duration of 8 hours at one outlet. |
| Operating pressure is 50 ± 5 pounds per square inch gauge (psig). | The MMOS operating pressure is 50 ± 5 pounds per square inch gauge (psig). Also, it delivers oxygen at fifty (50) pounds per square inch gauge (psig). |
| Liquid oxygen (LOX) capacity is 4 liters. | The liquid oxygen (LOX) capacity is 4 liters. |
| Has two secondary accessory ports in addition to both patient ports. | The MMOS has two secondary accessory ports in addition to both patient ports. |
| Operates up to 14,000 Ft. MSL. | The MMOS operates up to 14,000 Ft. MSL. |
| Oxygen delivery pressure is monitored and displayed. | The oxygen delivery pressure is monitored and displayed. |
| Liquid oxygen quantity is monitored and displayed. | The liquid oxygen quantity is monitored and displayed. |
| Has a visual low quantity alarm that triggers when the liquid capacity is at or below 10%. | The MMOS has a visual low quantity alarm that triggers when the liquid capacity is at or below 10%. |
| Power required is a self-contained 9-volt lithium battery. | Power required by the MMOS is a self-contained 9-volt lithium battery. |
| Capability to be filled with LOX by standard Department of Defense (DoD) and North Atlantic Treaty Organization (NATO) servicing connectors. | The MMOS has the capability to be filled with LOX by standard Department of Defense (DoD) and North Atlantic Treaty Organization (NATO) servicing connectors. |
| Overall system weight (when filled with 4.0 liters of liquid oxygen) is 35 lbs. Empty weight is 25 lbs. | The overall system weight (when filled with 4.0 liters of liquid oxygen) is 35 lbs. Empty weight is 25 lbs. |
| Dimensions: 10.63 inches wide x 17.00 inches long x 8.75 inches wide within a tolerance of .06 inches in all directions. | The MMOS is 10.63 inches wide x 17.00 inches long x 8.75 inches wide within a tolerance of .06 inches in all directions. |
Study Proving Device Meets Acceptance Criteria:
The document briefly mentions a study, stating: "Essex Cryogenics of Missouri, Inc. Engineering personnel completed extensive MMOS capability, performance, and environmental testing with no issues arising regarding its safety and efficiency. The combined testing and analysis of results provides assurance that the device meets it specifications and is safe and effective for its intended use."
However, the provided text does not offer detailed information about the specific methodology, sample sizes, or expert involvement for this testing. It is a general statement about the completion of testing for the 510(k) submission. Therefore, much of the requested information cannot be extracted from this document directly.
Here's a breakdown of what can and cannot be answered from the provided text based on your specific requests:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The testing was conducted by "Essex Cryogenics of Missouri, Inc. Engineering personnel," suggesting it was internal testing, likely at their St. Louis, Missouri facilities (USA).
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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 specified. The document only mentions "Engineering personnel completed extensive MMOS capability, performance, and environmental testing." It does not detail specific experts or their qualifications for establishing a "ground truth" as might be relevant for clinical or diagnostic devices. For a durable medical equipment device like this, ground truth would typically be established by engineering specifications and physical measurements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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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:
- No. This is not applicable to a Portable Liquid Oxygen System. MRMC studies are typically for diagnostic imaging devices involving interpretation by multiple human readers comparing performance with and without AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "capability, performance, and environmental testing" would be a standalone evaluation of the device as an algorithm would be for a software product. The device itself performs its function (converting liquid oxygen to gas and delivering it) without constant human "in-the-loop" intervention in its core operational process, although it is operated by humans.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this type of device, the "ground truth" would be established by engineering specifications and direct physical measurements of its performance characteristics (e.g., oxygen concentration, flow rates, pressure, duration, capacity, weight, dimensions, alarm functionality).
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The sample size for the training set:
- Not applicable as this is a hardware medical device, not a machine learning/AI model.
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How the ground truth for the training set was established:
- Not applicable as this is a hardware medical device, not a machine learning/AI model.
§ 868.5655 Portable liquid oxygen unit.
(a)
Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.(b)
Classification. Class II (performance standards).