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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 Precision Medical, Inc. Easy Mate 6 + 6 are intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. These patients would normally receive the oxygen via a nasal cannula. The systems delivers 100% oxygen at different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home.

The Precision Medical, Inc. Easy Mate 6+6 consists of a Vacuum insulated cryogenic container that includes a pressure relief valve and a pneumatic conserver. The vacuum insulated container allows oxygen to be stored in a liquid state under pressure. When the control valve is positioned to deliver, liquid oxygen inside the container is warmed and changes to gaseous state. The gas is than allowed to be released to the patient at the set rate. The device is intended to be used with a larger stationary liquid Oxygen reservoir, where it is filled by a connection that allows the portable Device to be filled by the larger reservoir. The Precision Medical Inc Easy Mate 6+6 Is a mechanical device containing no electrical components.

The provided document is a 510(k) summary for the Precision Medical, Inc. Easy Mate 6+6, a portable liquid oxygen unit. It does not contain the detailed performance study information typically associated with AI/ML-based medical devices or diagnostic tools that would have "acceptance criteria" and "reported device performance" in the way an AI model would be evaluated.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (Precision Medical 2200 liquid oxygen system K041122) and the results of general performance and mechanical/climatic testing.

Therefore, I cannot directly provide answers to all the requested categories, as they are not applicable to the type of device and submission described. However, I can extract the relevant information from the document as it pertains to the device's validation.

Here's a breakdown of what can be extracted and what cannot:

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

• The document states: "The Precision Medical, Inc. Easy Mate 6+6 has successfully passed tests in the following areas; Mechanical / Climatic, Device Performance."
• It does not provide a table with specific quantitative acceptance criteria (e.g., specific thresholds for flow rate accuracy, duration of oxygen delivery under certain conditions) or corresponding measured performance values. This type of detail is usually found in the full 510(k) submission, not the summary.
• Acceptance Criteria (General): The device functions as intended to deliver supplemental oxygen at set rates.
• Reported Device Performance (General): The device successfully passed mechanical/climatic and device performance tests.
• Specifics of Acceptance Criteria/Performance: Not provided in this summary.

Applicability of other questions for this type of device:

The remaining questions (2-9) are typical for the evaluation of AI/ML algorithms or diagnostic devices where "ground truth" establishment, expert review, and statistical analysis of performance against a reference standard are critical. For a purely mechanical device like a portable liquid oxygen unit, these concepts are not directly applicable in the same way.

• No "test set" in the context of images or patient data for AI.
• No "experts" establishing ground truth for disease presence.
• No "adjudication method."
• No "multi-reader multi-case (MRMC) comparative effectiveness study" as there's no human interpretation component to be assisted by AI.
• No "standalone" algorithm performance study.
• No "ground truth" in the diagnostic sense (pathology, outcomes data). The "ground truth" for this device would be its ability to physically deliver oxygen accurately and safely, validated through engineering and functional tests.
• No "training set" as this is a mechanical device, not an AI model.

Summary based on the provided text for a general medical device, not an AI/ML device:

The document describes the Precision Medical, Inc. Easy Mate 6+6, a portable liquid oxygen unit.

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

(Note: Specific quantitative values for criteria and performance are not included in this 510(k) summary.)

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

• Not applicable / Not provided. This device undergoes engineering and functional testing, not a clinical "test set" in the diagnostic data sense. Details on the number of units tested are not in this summary.

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 applicable. The "ground truth" for this mechanical device is established through engineering specifications and verified by technical testing, not through expert interpretation of data.

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

• Not applicable. No expert adjudication process is described for this type of device validation.

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 a mechanical device, not an AI-assisted diagnostic tool for human interpretation.

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

• Not applicable. There is no algorithm or AI component in this mechanical device.

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

• Engineering/Functional Specifications: The "ground truth" for this device would be its adherence to established engineering specifications for oxygen production, flow rates, pressure regulation, and mechanical durability. This is verified through direct measurement and physical testing.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI model. There is no concept of a "training set."

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

• Not applicable. See point 8.

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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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The GoLox -93 is intended to provide supplemental oxygen to patients who have difficulty extracting oxygen from the air that they breathe. The patients would normally receive oxygen via a nasal cannula. It is intended for ambulatory use inside and outside of the home. It is not intended to be life supporting or life sustaining. The device has no contraindications.

The GoLox-93 is a double walled vacuum insulated cryogenic vessel designed to hold approximately 1 pound of liquid oxygen at a pressure of 22 psig with heat exchange tubing, relief valves and a pneumatic conserving device housed in a plastic enclosure. Oxygen is stored under low pressure in its liquid state where the pressure is limited by the pressure relief valve. The liquid oxygen is converted to near ambient temperature gaseous oxygen through a system of tubes and warming coils for delivery to patients requiring supplemental oxygen by a single lumen cannula. The device is not intended as life support or life sustaining. The GoLox-93 is a mechanical device and does not contain any electronics or software. The GoLox-93 is designed to be refilled only from Respironics Home Liquefaction Systems.

The provided text describes a medical device, the Respironics GoLox-93, which is a portable liquid oxygen unit. It's a 510(k) premarket notification, indicating it's a modification of a previously cleared device. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria for a novel device.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, ground truth, and comparative effectiveness studies is not available in the provided text. The text confirms that this is a device modification submission, where the primary goal is to show the modified device is substantially equivalent to existing, legally marketed devices.

Here's what can be extracted based on the provided text:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The submission is for a device modification, and the focus is on showing similarity to predicate devices rather than establishing new acceptance criteria for a novel device. The document states:

• "The GoLox-93 is identical to the GoLox USP except for the fill connection."
• "Additional testing provided includes verification that the fill connector mates with liquefaction systems and not with stationary vessels."

While specific performance metrics are not given, the implied "acceptance criteria" for this modification would be:

• Fill Connection Compatibility: The new fill connector mates only with 93% liquid oxygen liquefaction systems.
• Fill Connection Incompatibility: The new fill connector does not mate with USP oxygen stationary vessels.

The "reported device performance" related to these implied criteria is simply that the "verification" testing was done and confirmed this functionality. No numerical performance data (e.g., error rates, success rates) is presented.

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

Not explicitly stated. The document mentions "Comprehensive testing was performed" for the predicate device (GoLox USP vs. PLOX) and "Additional testing provided includes verification that the fill connector mates with liquefaction systems and not with stationary vessels" for the GoLox-93 modification. However, no sample sizes (e.g., number of fill connectors tested, number of liquefaction systems/stationary vessels used) or data provenance (country, retrospective/prospective) are detailed.

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

Not applicable/Not stated. This type of study (e.g., expert-reviewed images for an AI algorithm) is not described in this submission. The "ground truth" for the fill connector modification would likely be a direct functional test, not expert consensus on data.

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

Not applicable/Not stated. Adjudication methods are typically used for interpreting subjective data (like medical images) where multiple experts might disagree. The testing described for the GoLox-93 (fill connector compatibility) is an objective functional test and would not require such 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:

Not applicable. This device is a mechanical portable liquid oxygen unit, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant.

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

Not applicable. This is a mechanical device, not an algorithm.

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

For the GoLox-93 fill connector modification, the "ground truth" would be direct functional testing and observation of whether the connector successfully mated with the intended (93% liquefaction systems) and failed to mate with the unintended (USP stationary vessels) connections.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not a machine learning algorithm that requires a training set.

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

Not applicable. As stated above, this is a mechanical device, not a machine learning algorithm.

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The Caire Spirit 300 will provide a source of supplemental oxygen for ambulatory healthcare patients by vaporizing medical grade liquid oxygen and then dispensing it to the patient via an integral electronic conserving device (digital oxygen conserving device-DOCD). The Spirit 300 is neither a life sustaining nor life supporting device.

The spirit 300 is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum insulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure relief valves, a manifold, an electronic printed circuit board conserving device (digital) and a protective case. The dewar has a capacity and capability to store 0.3L of liquid oxygen. The economizer regulator either draws gas from the dewar head space, if the internal pressure is above 20 PSI. If the internal pressure is below the 20 PSI, the economizer regulator will draw liquid oxygen, from the bottom of the dewar, which must then have to pass through a long vaporizing coil. The economizer regulator assures a longer duration time for the unit, because it allows the gas in the dewar headspace to be used for oxygen delivery. The gas outlet of the economizer regulator connects with the manifold, dependent on the flow selection setting, the manifold either delivers the gas to the conserving device PCB or diverts a 2L PM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow selector. The conserving device has equivalent settings for 1, 1.5, 2, 3, 4 and 5 LPM prescriptions. At the various conserving device settings, the outlet gas is delivered in quick pulse dosage just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting.

This document is a 510(k) summary for the Caire Inc. Spirit 300 Portable Liquid Oxygen Unit. It describes the device, its indications for use, and confirms that modifications have not altered the fundamental scientific technology of the predicate device.

Based on the provided text, there is no acceptance criteria or study information that describes device performance in the way requested. This document is a regulatory submission summary for substantial equivalence, not a detailed technical report of performance testing against specific acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

Here's why:

• Type of Document: This is a 510(k) summary, primarily focused on demonstrating "substantial equivalence" to a predicate device for regulatory approval. It asserts that modifications haven't altered fundamental technology, but it doesn't present the detailed test results or the specific acceptance criteria for those tests.
• Focus on Equivalence: The core of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is often done by comparing technical characteristics and demonstrating that any differences don't raise new questions of safety or effectiveness. It's not typically about proving performance against a novel set of clinical acceptance criteria with detailed study results as one might find for a PMA or CE Mark submission.

The document states: "Caire Inc confirms that the modifications described here within have not altered the fundamental scientific technology of the predicate device (Spirit 300) cleared under 510(K) number K013251." This is the primary "proof" offered in this summary, not a new study.

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The GoLox USP is intended to provide supplemental oxygen to patients who have difficulty extracting oxygen from the air that they breathe. The patients would normally receive oxygen via a nasal cannula. It is intended for ambulatory use inside and outside of the home. It is not intended to be life supporting or life sustaining. The device has no contraindications.

The GoLox is a double walled vacuum insulated cryogenic vessel designed to hold approximately 1 pound of liquid oxygen at a pressure of 22 psig with heat exchange tubing, relief valves and a pneumatic conserving device housed in a plastic enclosure. Oxygen is stored under low pressure in its liquid state where the pressure is limited by the pressure relief valve. The liquid oxygen is converted to near ambient temperature gaseous oxygen through a system of tubes and warming coils for delivery to patients requiring supplemental oxygen by a single lumen cannula. The device is not intended as life support or life sustaining. The GoLox USP s designed to be refilled from industry standard liquid oxygen stationary units already cleared and in the marketplace.

The provided text describes a 510(k) premarket notification for the "GoLox USP" portable liquid oxygen unit. It asserts substantial equivalence to a predicate device, the "Respironics PLOX (K050414)", based on comprehensive testing. However, the document does not contain explicit acceptance criteria or a detailed study report with specific performance metrics for the GoLox USP device against such criteria.

Therefore, I cannot populate the table or answer most of the questions about acceptance criteria and detailed study design. The document focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific performance acceptance criteria.

Here's what can be extracted based on the provided text:

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

The document does not explicitly define acceptance criteria or provide specific numerical performance results for the GoLox USP. It states that "Comprehensive testing was performed to determine equivalence between the GoLox and PLOX (K050414). Testing included connection/disconnection of proprietary connector, purity and flowrates in stated environmental conditions." This implies that the GoLox USP's performance in these areas was deemed equivalent to the predicate device, but no specific values or thresholds are given.

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

Not mentioned in the document.

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 applicable. This is a medical device performance study, not one requiring expert interpretation of data to establish ground truth in the way AI/ML algorithms often do.

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

Not applicable.

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/ML device.

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

Not applicable. This is not an AI/ML device. The "comprehensive testing" would have involved the device itself performing to its intended specifications.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not explicitly stated. For a physical device like this, "ground truth" would likely refer to established engineering and performance standards for oxygen delivery units. The testing focused on "equivalence" to a predicate device, meaning its performance in areas like "purity and flowrates" demonstrated results comparable to or within acceptable limits of the previously cleared PLOX.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device.

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The COPD Partners Model 300P Liquid Oxygen Portable will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing medical grade liquid oxygen, and then dispensing it to the patient via an integral electronic conserving device. The Model 300P Liquid Oxygen Portable is neither a life-sustaining nor life-supporting device.

The COPD Partners' Model 300P is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum-insulated cryogenic Dewar, an economizer regulator, electronic printed circuit board (PCB), an oxygen conserving system, and a protective case.

The Dewar has a capacity and capability to store 0.33 liters of liquid oxygen. Dependant on the flow selection setting, the control system either delivers the oxygen to the conserving device or delivers a 2 LPM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow method selector. The conserving device has an equivalent setting for 1, 2, 3, 4, and 5 LPM prescriptions. At the various conserving device settings, the outlet oxygen gas is delivered in quick pulses beginning at the start of inhalation.

The device also has a provision to track the patient's breath rate and in the event of an increase in breath rate, will deliver an increased volume of oxygen. There are two levels of increased volume, one at 4 breath per minute (BPM) over normal breath rate and another at 8 BPM over normal breath rate. The device delivers an extra 16 cc at each of these two thresholds. The COPD Partners Model 300P is transfilled from a commercially available medical grade liquid oxygen source.

The provided text describes a 510(k) summary for a medical device, the COPD Partners Model 300P Liquid Oxygen Portable. This document primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing and compliance with electrical safety standards. It does not contain information about studies involving human readers, ground truth established by experts, or the specific details typically found in studies for AI/algorithm-driven diagnostic or prognostic devices.

Therefore, many of the requested categories cannot be filled from the provided text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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 for Test Set: Not applicable. The testing described is bench testing of the device's physical and electronic performance, not testing on a patient data set.
• Data Provenance: Not applicable.

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 applicable. Ground truth as typically understood for diagnostic/AI devices (e.g., expert consensus on medical images or pathology reports) is not relevant for this type of device and testing.

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

• Not applicable.

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 MRMC comparative effectiveness study was done. This device is a portable oxygen unit, not an AI-assisted diagnostic or prognostic tool.

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

• Stand-alone performance was assessed for the device's oxygen delivery mechanism and safety features through bench testing. The "algorithm" for adjusting oxygen delivery based on breath rate was tested as part of the device's overall function. No specific "algorithm-only" performance metrics are provided in isolation from the integrated device.

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

• The "ground truth" for this device's performance is based on engineering specifications and regulatory standards. For example, oxygen purity levels are compared against an acceptable standard, and delivery rates are compared against the intended programmed output (e.g., 16cc per breath increase).

8. The sample size for the training set

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

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

• Not applicable.

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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 Spirit 300 HAS will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing 93% liquid oxygen and then dispensing it to the patient via an integral electronic conserving device. The Spirit 300 HAS is intended to be transfilled only by the In-X Corporation's Home-Away System. The Spirit 300 HAS is neither a life sustaining nor life supporting device.

The Spirit 300 HAS is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum-insulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure safety relief valves, a manifold, an electronic printed circuit board conserving device and a protective case. The dewar has a capacity and capability to store 0.3 liters of liquid oxygen. The vaporizer coil warms the oxygen gas to a suitable temperature, as it exits the dewar. Dependant on the flow selection setting, the manifold either delivers the gas to the conserving device PCB or delivers a 2 LPM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow selector. The conserving device has equivalent setting for 1, 1.5, 2, 3, 4, and 5 LPM prescriptions. At the various conserving device settings, the outlet gas is delivered in quick pulse dosages just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting. The Spirit 300 HAS is filled from a concentrator liquefaction device.

The provided text is a 510(k) summary for the Spirit 300 HAS Portable Liquid Oxygen Unit. It describes the device and its intended use, but it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a regulatory submission for premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance criteria and validation study results in detail. While device performance in terms of flow settings is mentioned in the device description, specific acceptance criteria for these performances and the studies validating them are not provided in this summary.

Therefore, I cannot fulfill the request for information on acceptance criteria and the study that proves the device meets them based on the provided text.

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