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The OGL is intended to be used by emergency response personnel in military and commercial applications to produce emergency source of 93% USP liquid oxygen (LOX) which will be transferred into portable LOX systems. The portable LOX systems are used as an emergency source of supplemental oxygen for patient(s) while being transported for a crisis situation to a health care facility. This medical device is for supplemental oxygen and is not intended to sustain or support life.

The OGL is a device that generates 93% USP oxygen gaseous, liquefy it into LOX and store up to 40 liters of LOX. It OGL is a single module that weighs approximately 730 LBS empty or 830 full of LOX. The system is 52" long, 33" wide and 48" tall if the wheels are deployed). The system has to forklift pockets to allow the system to be moved by a forklift. The system also has retractable wheels that allows for one or two persons to easily move the device on a flat smooth surface.

The OGL requires only 200-240 VAC, 50/60 Hz 30 amp single phase power supply for operation. The system is very simple to operate. The control panel has a mode switch that allows the user to make liquid oxygen (LOX), generate gaseous oxygen for the oxygen gas port or transfer the liquid oxygen to a separate device. The control panel also has fault indicators if there is a problem with the system, emergency stop button, hour meter, Dewar pressure gauge and LOX quantity gauge.

1. Acceptance Criteria and Reported Device Performance:

The OGL is largely compared to its predicate device (PTOCS K022684) based on a variety of functional and environmental parameters. The acceptance criteria are implicitly defined by the predicate device's characteristics. The OGL's reported performance is then compared to these, demonstrating both similarities and some differences that the manufacturer argues are insignificant for safety and effectiveness.

2. Sample Size and Data Provenance for Test Set:
The document does not explicitly mention a "test set" in the context of a clinical study or a labeled dataset for AI model evaluation. Instead, the performance evaluation relies on bench testing of the OGL device itself, comparing its physical and functional specifications against those of the predicate device.

• Sample Size: Not applicable in the typical sense of a data sample for AI training/testing. The "sample" is the manufactured OGL device itself.
• Data Provenance: The data comes from the internal bench tests conducted by Essex Industries, Inc. d/b/a Essex Cryogenics of MO as described in their Qualification Test Report (OTR-50C-0103-5 .- 7). The country of origin for this testing is presumably the United States, given the company's location in St. Louis, Missouri. The testing is prospective in the sense that it evaluates the device's performance post-manufacture according to predefined specifications.

3. Number of Experts and Qualifications for Test Set Ground Truth:
Not applicable. The ground truth for the device's technical specifications and performance characteristics (e.g., oxygen purity, flow rate, environmental tolerances) is established through instrumentation and measurement according to engineering and quality assurance standards, not by human expert consensus or interpretation of images/data.

4. Adjudication Method for Test Set:
Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The testing involves objective measurements and functional verification against established engineering specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic or screening devices where human reader performance is a key metric. The OGL is a medical device for oxygen generation and liquefaction, and its evaluation focuses on its technical and functional performance, not its impact on human reader accuracy.

6. Standalone (Algorithm Only) Performance:
Not applicable. The OGL is a physical medical device; it is not an algorithm that performs a standalone function (e.g., image analysis) without human interaction. While it contains software with a microprocessor, its "performance" is evaluated as an integrated system, not as a standalone algorithm in the AI sense.

7. Type of Ground Truth Used:
The ground truth used for evaluating the OGL's performance is based on engineering specifications, objective physical measurements, and functional tests to ensure compliance with design requirements and comparability to the predicate device. For example:

• Oxygen Purity: Measured by a purity analyzer.
• Dimensional Examination: Measured with appropriate tools.
• Weight: Measured on a scale.
• Operating Temperature/Humidity: Tested under controlled environmental conditions.
• Functional Testing: Verifying delivery rates, pressure, normal evaporation rate, liquid transfer, and fault indicator operation.

8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML system that utilizes a training set of data. Its design and manufacturing are based on engineering principles and established medical device regulations, not machine learning.

9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this device.

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The BMOS is intended to be used by emergency response personnel in military and commercial fields to provide an emergency source of supplemental oxygen for one patient while being transported from a crisis situation to a health care facility. The BMOS is not intended to be a life sustaining or a life-supporting device.

The BMOS is a portable thermally insulated container that provides, when filled with liquid oxygen (LOX), an uninterrupted supply of supplemental oxygen gas to be inhaled by the patient. BMOS is operated by trained emergency response to administer patients with variable amounts of gaseous oxygen in doses measured in liters per minute (LPM).

This document (K071581) is a 510(k) premarket notification for a medical device called the "Backpack Medical Oxygen System (BMOS)". It aims to demonstrate substantial equivalence to a predicate device, not to prove specific clinical performance criteria for diagnosis or treatment. Therefore, many of the requested categories for AI/clinical studies are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document states "Extensive capability, performance, and environmental testing have been accomplished," but does not provide details on the number of units tested, duration, or specific test configurations.
• Data Provenance: Not specified, but implied to be internal testing conducted by Essex Cryogenics of MO., Inc.

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

• Not applicable. This device is a hardware system, and the "ground truth" for its performance is derived from engineering and functional testing against specifications, not from expert interpretation of data like in an AI diagnostic device. The "ground truth" here is whether the device physically performs according to its design and regulatory requirements.

4. Adjudication Method for the Test Set

• Not applicable. See explanation for #3. Adjudication typically refers to resolving disagreements between human readers, which is not relevant for physical device testing.

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

• No. This is not an AI-assisted diagnostic or therapeutic device that requires human-in-the-loop performance evaluation.

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

• Partially applicable, but not for an "algorithm". The "Testing" section describes standalone performance of the device itself against its specifications, but there is no "algorithm" in the context of AI. The device functions purely mechanically/physically.

7. Type of Ground Truth Used

• Engineering and Functional Specifications / Predicate Device Performance. The ground truth for the BMOS's performance is its ability to meet documented engineering specifications (e.g., pressure, flow, capacity) and to demonstrate substantial equivalence to the legally marketed predicate device (NPTLOX) in terms of its operational characteristics and safety/efficacy profile.

8. Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI models, so there is no "training set."

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

• Not applicable. See explanation for #8.

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The NPILOX is intended to convert liguid oxygen to gaseous oxygen (99.9% based on medical grade liquid oxygen) for delivery at 50 psig nominal for military use settings only.

The NPTLOX is a portable, thermally insulated container designed to store liquid oxygen (99.9%) and convert the liquid oxygen to gaseous form, which provides therapeutic oxygen to patients. This equipment meets the Aero-medical mission requirements for gaseous oxygen to be delivered to patients in the three methods listed below.

• 1240 DISS Flow control valves and humidifier bottles
• Laerdal Silicone Adult Resuscitators with 2500 ml reservoirs
• Impact 754 Eagle Ventilators
  The NPTLOX has six outlet ports that are capable of delivering oxygen to a maximum of six ambulatory or litter patients according to one or more of these approved methods.
  The system will be filled by current liquid oxygen storage/filling systems used in the United States Military. The design of the NPTLOX is a modification to the existing predicate device, the Portable Therapeutic Liquid Oxygen (PTLOX) 510(k) K880183. The major modifications are an improvement in maximum oxygen delivery rate, increased number of patient outlets and increased oxygen capacity.
  The NPTLOX provides gaseous oxygen to patients through 6 outlet ports at an outlet pressure of 50 ± 5 psig. The 6 outlet ports have a maximum combined system outlet flow of 66 LPM. This continuous flow rate is based on a design standard of 11 LPM per outlet fitting. The system is capable of flowing at least 60 LPM to meet the ventilator peak flow requirement. The NPLTOX has an accessory kit that includes three of each of the following: medical hoses, 0-15 LPM flow control valves, and humidifier bottles. The LOX capacity of the system is 20 liters. Oxygen delivery pressure is displayed via a pressure gauge. The LOX quantity can be periodically displayed via a LOX quantity indicator that is powered by two 9 volt batteries. There is no other electronics or software in the NPTLOX.

The provided text describes a medical device, the Next Generation Portable Therapeutic Liquid Oxygen System (NPTLOX), and its clearance through a 510(k) submission. While it mentions "Testing: Extensive capability, performance, and environmental testing has been accomplished on the NPTLOX with no issues arising regarding its safety and efficiency," and that "The combined testing and analysis of resplits provides assurance that the device meets its specifications and is safe/and effective for its intended use," it does not explicitly detail specific acceptance criteria, the study design, or the performance outcomes in a quantitative manner that would allow for a direct fill of the requested table and detailed breakdown.

Therefore, I cannot provide a complete answer to all parts of your request based solely on the provided document. However, I can extract the information that is present and highlight what is missing.

Here's an attempt to answer based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information from the document:

• Specific quantitative acceptance criteria for "capability, performance, and environmental testing."
• Detailed performance results from these tests (e.g., actual evaporation rate, detailed LPM consistency across all ports under various conditions, specific safety margins).
• Any statistical analysis or detailed study reports.

Based on the provided text, the following information is NOT available or explicitly stated:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The document mentions "Extensive capability, performance, and environmental testing" but does not define the number of devices or test conditions used.
• Data Provenance: Not specified.

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)

• This device is mechanical (a liquid oxygen system), not an AI or diagnostic imaging device. Therefore, the concept of "ground truth" derived from expert consensus in the typical sense (e.g., for image interpretation) does not apply. Testing would involve engineering, performance, and environmental validation against physical specifications. No expert consensus process for "ground truth" is mentioned or implied.

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

• Not applicable as this is not a diagnostic device involving human interpretation and adjudication of results.

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 is not an AI-assisted diagnostic or interpretation device.

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)

• The "ground truth" for a device like this would be its engineering specifications and validated performance against those specifications using calibrated measurement equipment and standardized test procedures (e.g., flow meters, pressure gauges, temperature sensors, etc.). The document states "device meets its specifications," implying that the specifications themselves serve as the ground truth for performance.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI model requiring a training set.

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

• Not applicable.

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Provides supplemental therapeutic oxygen to a patient in a military field hospital setting.

The Portable Therapeutic Oxygen Concentration System (PTOCS) has been designed to accommodate Military Personnel with a source of supplemental oxygen in a setting where liguid oxygen may be unavailable. Aeromedical Evacuation and ground based medical missions require medical support systems capable of providing therapeutic oxygen. The gaseous oxygen generator will also be required to provide oxygen at the prescribed flow rates and pressures required to operate the oxygen driven equipment included in the AFMS deployable medical assemblages. Requirements are based on the deployable oxygen system, operational requirements document that has been issued by the United States Air Force.

This system is based on the Pressure Swing Adsorption principle and uses a molecular sieve to separate gases from the filtered ambient air. The oxygen is stored and delivered to the patient(s) through one of three ports (1/2 to 15 lpm settings) with a maximum litre per minute flow of 45 total at 50 psig. The oxygen concentration purity level is at 93% minimum, with an oxygen purity level average of 95%. Included with the generator is a secured accessory kit consisting of 20 feet of medical grade oxygen hose and flow regulators for each outlet.

The provided text is a 510(k) summary for the Portable Therapeutic Oxygen Concentration System (PTOCS). This document focuses on establishing substantial equivalence to predicate devices based on non-clinical bench testing, rather than detailed clinical study data with acceptance criteria for a new AI/software device.

Therefore, many of the requested categories for AI/software device studies are not applicable to this submission. The submission is for a physical medical device (an oxygen concentrator) and relies on bench testing to demonstrate performance, not a study evaluating an algorithm's diagnostic performance against a ground truth with human readers.

Here's a breakdown of the information that can be extracted from the document based on your request, with a clear indication of what is not applicable:

Acceptance Criteria and Device Performance

The document states that the PTOCS has an "oxygen concentration purity level is at 93% minimum, with an oxygen purity level average of 95%." This can be inferred as a key performance criterion for the device.

Study Information (as applicable to this type of device submission)

1. 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 explicitly stated as a "test set" in the context of an AI/software study. The testing was "non-clinical bench testing," which implies testing of device units. The number of units tested is not specified.
   • Data Provenance: The bench testing was "conducted by Essex Cryogenics of MO., Inc." This indicates the testing was performed internally by the manufacturer in the USA. It is prospective testing of the manufactured device.

2. 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. This is a physical medical device submission, not an AI/software diagnostic device. Ground truth in this context would likely refer to calibrated measurement equipment used in bench testing, not expert consensus on diagnostic images.

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

   • Not Applicable. As above, this is for a physical device, and the testing described is non-clinical bench testing, not a clinical study involving human readers or expert adjudication.

4. 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 is not an AI-assisted diagnostic device. No MRMC study was conducted.

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

   • Not Applicable. This is not an algorithm-only device. The device itself (the oxygen concentrator) is the standalone entity. Its performance was evaluated through non-clinical bench testing.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the device's performance (e.g., oxygen purity, flow rates) would be established by calibrated measurement instruments in a laboratory setting during "non-clinical bench testing." The document does not provide details on the specific gold standard instruments used, but this is the typical "ground truth" for such physical device testing.

7. The sample size for the training set:

   • Not Applicable. This is a physical device, not an AI/software device that requires a training set.

8. How the ground truth for the training set was established:

   • Not Applicable. No training set for an AI/software device is mentioned.

Conclusion from the Document:

The 510(k) summary states: "Non-clinical bench testing conducted by Essex Cryogenics of MO., Inc. as provided is conclusive in establishing substantial equivalence of the PTOCS to the predicate devices on which SE is claimed." This indicates that the performance criteria listed above (oxygen purity, flow rates, pressure) were met during the bench testing, allowing the device to be deemed substantially equivalent to existing predicate oxygen concentrators.

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