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The Essex MR Conditional CGA 870 pressure regulators are used with a portable oxygen delivery system intended to provide supplemental oxygen to adults in hospital, sub-acute care, and pre-hospital / ground transport settings. It is offered in models that are MR-conditional (per ASTM F2052-15), and may be used during MR imaging for static magnetic fields of 3.0 T or less.

The Essex MR Conditional CGA 870 pressure regulator is designed to be installed on a medical CGA 870 post valve cylinder, regulate high pressure oxygen from 500 to 2,000 psig nominal, deliver a specific amount of oxygen to an attached flow selector, and be ignition resistant.
The device consists of:

• A yoke style inlet fitting per CGA 870.
• A pressure regulator section is to reduce the pressure from 500-2,000 psig to 50 psig nominal.
• A flow selector valve to control the flow at the regulated pressure between 0 and 25 L/min.
• Made of materials which meet the MR Conditional requirements of ASTM F2052-15.
  This is identical to our Class I, exempt model CGA 870 except for different materials to allow for the device to meet the ASTM F2052-15 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.

This document is a 510(k) Pre-market Notification for a medical device called the "MR Conditional CGA 870" pressure regulator. The device is intended for use with portable oxygen delivery systems for adults in various healthcare settings, including during MRI imaging.

Here's an analysis of the acceptance criteria and supporting studies based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a single, clear format as would typically be found in a study report. Instead, it lists various non-clinical tests performed according to recognized standards. The "acceptance criteria" are implied by compliance with these standards, and the "reported device performance" is indicated by the statement that the device meets or is found to be substantially equivalent to these standards and the predicate device.

However, based on the Non-clinical Testing Summary and the Bench Testing sections, we can infer some criteria and the device's claimed performance:

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify exact sample sizes (e.g., number of devices tested) for the non-clinical tests performed. It generally states that "a number of tests appropriate for the proposed device" were performed.
• Data Provenance: The tests are "Non-clinical Testing" and "Bench Testing," implying they were conducted in a laboratory setting by the manufacturer (Essex Industries, Inc.). The data is prospective in the sense that it was generated specifically for this 510(k) submission. There is no mention of country of origin for the data other than the manufacturer being based in the U.S.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document describes non-clinical, bench testing of a hardware device. Ground truth, in the context of expert review, typically applies to studies involving interpretation (e.g., medical imaging, clinical assessments) where human experts determine a definitive diagnosis or finding. For hardware performance, the "ground truth" is typically defined by the test methods and acceptance criteria within the referenced engineering standards.

4. Adjudication Method for the Test Set

This is not applicable for the same reason as above. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human assessment to resolve discrepancies in expert opinions. The testing described here is objective measurement against established engineering standards.

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 is not applicable. An MRMC study is a type of clinical comparative effectiveness study, usually for diagnostic devices, that assesses the performance of human readers (e.g., radiologists) with and without the assistance of a new diagnostic tool (often AI). The "MR Conditional CGA 870" is a physical medical device (pressure regulator) and not an AI-powered diagnostic tool, nor does it involve human readers for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. This question pertains to the performance of artificial intelligence algorithms. The device described in the document is a mechanical pressure regulator.

7. The Type of Ground Truth Used

For this device, the "ground truth" for evaluating its performance is based on established engineering standards and specifications. The device's performance characteristics (e.g., pressure regulation, flow rates, mechanical resistance, ignition resistance, MR-conditionality) are measured directly against the quantifiable requirements outlined in standards like CGA E-4, CGA E-7, ISO 10524, EN 738-1, and ASTM F2052-15. Biocompatibility was assessed against relevant criteria (VOC and PM2.5).

8. The Sample Size for the Training Set

This is not applicable. The concept of a "training set" refers to data used to train machine learning models. This document describes the evaluation of a physical medical device.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above.

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The Walk-O2-Bout® is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults in hospital, sub-acute care, and pre-hospital / ground transport settings. It is offered in models that are MR-conditional (per ASTM F2052-15), and intended for use during MR imaging for static magnetic fields of 3.0 T or less. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.

The Walk-O2-Bout® regulator is designed to be installed on a medical grade aluminum cylinder having 0.750-16 UNF-2B threads; regulate high pressure oxygen from 300-2000 psig nominal; deliver a prescribed amount of oxygen; and be ignition fault resistant. The device consists of: A threaded fill fitting per CGA 540. It shall allow the regulator installed on a cylinder to be refilled to its service pressure. It also allows for the pulling of a vacuum on the system. A pressure regulator section to reduce the pressure from 300-2000 psig to 50 psig nominal. Options of flow selector valves to control the flow between 0 and 25 L/min, at the regulated pressure. A vinyl dipped handle for ease of carrying. A DISS 1240 check valve to deliver 50 psig of oxygen high flow rates of oxygen to ventilators. There are several models offered. In all cases the basic pressure regulator is identical for all models. The models are offered with the following options: Flow rate range of 0 4 L/min (Pediatric), 0 15 L/min and 0 25 L/min (adult) Check Valve Swivel or Fixed Barb Fitting Handle style MR Conditional.

The provided text describes the 510(k) premarket notification for the Walk-O2-Bout®, a portable oxygen delivery system. However, it does not contain the detailed acceptance criteria and study results in the format requested. The document focuses on demonstrating substantial equivalence to a predicate device (K101792 – Linde – LIV Portable Oxygen System) rather than providing specifics of direct performance against pre-defined acceptance criteria with empirical data.

The "Acceptance Test Procedure" mentioned under "Non-clinical Testing Summary" suggests that such tests were performed, but the results and specific criteria are not detailed. Similarly, while "Flow accuracy: +/- 10%" is listed as a specification, the study proving the device meets this accuracy is not described.

Therefore, I cannot fulfill all parts of your request with the provided input. However, I can extract the available information as much as possible.

Here's a breakdown of what can be extracted and what information is missing from the provided document:

1. A table of acceptance criteria and the reported device performance

Based on the document, the acceptance criteria are generally implied by the specifications and compliance with standards. The specific reported device performance values against these criteria are not explicitly provided in a quantitative table within this document.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "a number of tests appropriate for the proposed device" were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The testing appears to be primarily engineering and bench testing, not involving expert interpretation or "ground truth" in the clinical sense.

4. Adjudication method for the test set

This information is not applicable and not provided. The testing appears to be primarily engineering and bench testing.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical gas pressure regulator, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used

The concept of "ground truth" as it applies to clinical diagnoses (e.g., pathology, outcomes data) is not relevant here. The ground truth for this device's performance would be established by physical measurement against engineering standards and specifications.

8. The sample size for the training set

This is not applicable as the device is a physical product and not an AI/machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable.

Summary of Study (Based on Provided Text):

The "study" described in this document is a series of non-clinical, bench-testing evaluations to demonstrate the physical and functional performance of the Walk-O2-Bout® device. The primary goal was to show substantial equivalence to a legally marketed predicate device (Linde – LIV Portable Oxygen System, K101792) and compliance with relevant industry standards (ISO, ASTM, CGA).

• Type of Study: Non-clinical bench testing.
• Purpose: To demonstrate the device's physical performance, safety (ignition, MR compatibility), and biocompatibility, and to support a claim of substantial equivalence to a predicate device.
• Key Tests Mentioned: Acceptance Test Procedure, Low/High temperature, Gas tightness, Flow regulation (Flow capacity), Outlet Flow vs. inlet pressure, Pressure regulation, Static increment, Pressure relief, Mechanical resistance, Endurance Inlet, Fill fitting endurance, Safety, Drop, Vibration and Shock, Proof pressure, Burst pressure, Ignition (ASTM G175), MR Conditional Testing (ASTM F2052-15, tested per ASTM F2052-06), Biocompatibility.
• Clinical Testing: "There was no clinical testing."

In conclusion, while the document confirms that various tests were performed to assess the device's performance against established standards and specifications, it does not provide the quantitative results or detailed acceptance criteria for each test in a manner that would fully answer your request. It mainly serves as a summary for a 510(k) submission, confirming adherence to regulatory requirements and substantial equivalence.

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The DMOS is intended to convert liquid oxygen to gaseous oxygen for delivery to a patient and/or for delivery to rescue personnel to supplement environmental oxygen at high altitudes while being carried by a rescue personnel at one-half (0.5) to fifteen (15) liters per minute (LPM) and fifty (50) pounds per square inch gauge (psig).

The DMOS, when filled with liquid oxygen, will be used to provide medical oxygen treatment to injured personnel or provide supplemental oxygen to operator during dismounted operations above 10,000 feet MSL. The DMOS provides for storing of 1.4 liters of liquid oxygen and converting this liquid into its gaseous state. The gaseous oxygen is capable of being delivered in controlled amounts to provide medical treatment to injured patients and uncontrolled amounts to drive respiratory medical devices or supplemental oxygen in high altitude. The DMOS is capable of being filled with liquid oxygen from the Oxygen Generator System (OGS) and with current liquid oxygen storage/ filling stations. The DMOS contains a thermally insulated container of liquid oxygen (LOX) that is intended to supplement gases to be inhaled by a patient. The DMOS supports medical devices provided by the user including masks, cannulas, and Bag Valve Mask (BVM) being attached to the flow control patient outlets. The DMOS is portable and can be carried onboard, tied down, transported and operationally perform on various aircraft and ground vehicles. The DMOS 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.

The furnished information describes the Dismounted Medical & Supplemental Oxygen System (DMOS), a portable liquid oxygen unit. It is being compared to a predicate device, the Backpack Medical Oxygen System (BMOS) (K071581).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate set of pass/fail metrics. Instead, it provides a comprehensive list of "Physical and performance characteristics" that the DMOS is designed to meet, and implicitly, these act as the acceptance criteria for the device's functionality and safety. The reported device performance is indicated by the fact that the device was deemed "substantially equivalent" to its predicate after "extensive DMOS capability, performance, and environmental testing." The table below merges the stated requirements with the implied "met" status based on the submission's conclusion.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "sample size" in terms of a number of devices tested in a statistically powered study, nor does it refer to a "test set" in the context of a dataset for algorithm validation. Instead, it states that "Essex Industries, Inc. Engineering personnel completed extensive DMOS capability, performance, and environmental testing." This implies testing of physical device prototypes.

The provenance of this testing data is prospective, as it refers to testing performed on the DMOS device itself. There is no explicit mention of the country of origin of the data, but given the company's address in St. Louis, Missouri, USA, and the reference to DoD and NATO standards, it is highly likely that testing was conducted in the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the device is a physical medical device (portable liquid oxygen unit), not an algorithm that requires expert annotation for ground truth. The "ground truth" for this device's performance is established through physical and environmental benchmark testing against defined engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

This is not applicable for the same reason as point 3. Testing involves objective measurements against engineering specifications rather than interpretative decisions requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. The device is a physical medical device, not an AI algorithm intended for diagnostic or assistive interpretation by human readers. Therefore, an MRMC study to measure improvement with AI assistance is irrelevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. The device is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth used for evaluating the DMOS is based on engineering specifications, direct physical measurements, and compliance with military standards (e.g., MIL-STD-810G, DOT-4L). For example:

• Oxygen concentration: Measured directly.
• Flow rates and pressures: Measured directly.
• Duration: Measured directly.
• Weight and capacity: Measured directly.
• Environmental tolerances (temperature, altitude, vibration, shock): Demonstrated through specific tests described in MIL-STD-810G.

8. Sample Size for the Training Set

This is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reason as point 8.

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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.

1. Table of Acceptance Criteria and Reported Device Performance:

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:

2. 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).

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 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.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not specified.

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:

   • 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.

6. 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.

7. 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).

8. The sample size for the training set:

   • Not applicable as this is a hardware medical device, not a machine learning/AI model.

9. 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.

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The MODS is intended to convert liquid oxygen to gaseous oxygen (99.9% based on medical grade liquid oxygen) for delivery to a patient at one-half (0.5) to fifteen (15) LPM and fifty (50) psig.

The MODS has a portable, thermally insulated container of liquid oxygen (LOX) that is intended to supplement gases to be inhaled by a patient, and is accompanied by tubing intended for connection to an oxygen mask.

The MODS is portable. The MODS houses the thermally insulated stainless steel container, which stores liquid oxygen, and is set on casters while the accompanying unit, the patient distribution kit, is encased with a handle. The MODS converts liquid oxygen (99.9% pure) from the insulated container through a heat exchanger into gaseous oxygen and finally the gaseous oxygen is distributed through the tubing in the accompanying interconnect hose or hose reel assembly and ultimately through the tubing in the accompanying patient distribution kit. After connecting the tube end to an oxygen mask, cannula, simulator ventilator, or other similar medical device (none of these devices is included in the MODS) the patient can inhale the gaseous oxygen.

The accompanying patient distribution kit has ten outlet ports that are capable of delivering oxygen to a maximum of ten patients. Multiple patient distribution kits can be used to deliver oxygen to more than patients.

The MODS has the capacity to store seventy-five (75) liters of LOX and convert it to a gaseous state. It can be filled using a fill harness and current commercially available LOX storage/filling systems such as a variable gas/liquid (VGL) cylinder. When using the MODS with external LOX cylinders, the system will run indefinitely under normal operating conditions (indoors at room temperature) as long as the LOX cylinders are rotated between each of two MODS external hookup ports. When filled with LOX, the MODS provides an uninterrupted supply of oxygen for delivery to patients at a maximum system flow rate of four hundred fifty (450) liters per minute (LPM) and, when connected to a patient distribution kit, at an individual patient flow rate of one-half (0.5) to fifteen (15) LPM. The nominal operating system pressure of the MODS is two hundred (200) psig and, when connected to a patient distribution kit, the individual hose pressure is fifty (50) psig.

This document describes a 510(k) Pre-market Notification for the Mass Oxygen Distribution System (MODS). The document DOES NOT contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria.

The provided text describes a medical device, the Mass Oxygen Distribution System (MODS), and its substantial equivalence to a predicate device (NPTLOX). It details the device's function, technical specifications, and intended use. The document explicitly states that "Essex Cryogenics of Missouri, Inc. engineering personnel completed extensive MODS capability, performance, and environmental testing with no issues arising regarding its safety and efficiency." However, it does not provide specific acceptance criteria or detailed study results that would allow for the completion of the requested table and information points about an AI device.

Therefore, I cannot fulfill the request as the provided text pertains to a liquid oxygen distribution system and does not mention any AI device, acceptance criteria or studies related to AI performance.

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