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The Intelli-OX is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for all other medical applications, the device is Rx only.

The Intelli-OX portable oxygen delivery system that supplies Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical aluminum cylinder with handle and shroud all integrated into a single unit. A range of user-selectable flow setting is available with the user being able to control the flow rate, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard high flow oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation. Intelli-OX is for emergency use only. For all other medical applications, the device is Rx only. Key specifications include hose barb connection, protective shroud, carrying handle, easy to read content gauge, indexed flow meter, and integrated valve-regulator. This design allows medical personnel the ability to provide patient care and treatment sooner without delays caused by the need to mount a conventional regulator. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla.

The provided text describes the 510(k) submission for the Intelli-OX, an integrated portable oxygen delivery system, specifically focusing on its MR Conditional status. However, the document does NOT contain information related to a study proving the device meets acceptance criteria for an AI/ML-driven medical device, nor does it involve human readers, ground truth establishment by experts, or training sets.

The information provided pertains to the regulatory submission of a physical medical device (oxygen delivery system) to the FDA, and its testing for MR compatibility.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size used for a test set or data provenance for an AI/ML device.
• Number of experts or their qualifications for establishing ground truth for an AI/ML device.
• Adjudication method for a test set for an AI/ML device.
• MRMC comparative effectiveness study or human reader improvement with AI assistance.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
• Sample size for the training set.
• How ground truth for the training set was established.

The document does mention "MRI performance testing" which was completed to support the substantial equivalence determination for its MR Conditional status. The acceptance criteria for this specific aspect are listed as compliance with:

• ASTM F2052-15: "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment"
• ISO TIR 10974, 2012, Clause 21: "Assessment of the Safety Magnetic Resonance Imaging for Patients with an Active Implantable Medical Device"

This is a physical performance test for MR compatibility, not a study of an AI/ML device's diagnostic or predictive performance.

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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 Medipure Oxygen-LC System is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to neonates, pediatrics, and adults. The device is intended for limited duration use, such as would be necessary during patient transport.

The Medipure Oxygen-LC System is an integrated medical gas delivery system. The Medipure Oxygen-LC System is comprised of the Cavagna MVA2 series oxygen Valve Integrated Pressure Regulator (VIPR) permanently mounted to a large steel cylinder, either K or T size, and protected by a plastic guard. The Medipure Oxygen-LC System is a result of a design modification to the previously cleared Praxair Grab 'n Go Plus System (K132778).

This document describes the Medipure Oxygen-LC System, an integrated medical gas delivery system, and its substantial equivalence to a predicate device (Grab 'n Go Plus System, K132778). The modification involves using a high-strength Cr Mo steel cylinder (K or T size) instead of an aluminum one, and a new plastic shroud.

The information provided focuses on demonstrating substantial equivalence rather than a detailed clinical effectiveness study with acceptance criteria and performance statistics of a novel medical device. The data presented is primarily non-clinical performance data to verify that the design changes do not negatively impact safety and effectiveness compared to the predicate.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with specific numerical targets and matching device performance statistics in the way a clinical study evaluating a novel diagnostic or therapeutic device would. Instead, it refers to compliance with established standards and specifications for medical gas delivery systems.

• 49 CFR §173.301(h)(3) DOT: "Cylinder valve protection" (Ensuring compliance with Department of Transportation regulations for cylinder valve protection). | The device "passed all testing" and is compliant with ISO 11117-2008 and DOT Title 49 CFR Part 173.301(h)(3). |
  | Functional/Gas Delivery | - ISO 10524-3: "Pressure regulators for use with medical gases -- Part 3: Pressure regulators integrated with cylinder valves" (Ensuring proper function, pressure regulation, and safety of the integrated valve pressure regulator).
• Product specifications of the Medipure Oxygen-LC System (equivalent to the predicate device). | The device "passed all testing". Internal verification and validation testing confirms that product specifications are met and are equivalent to the predicate device. |
  | Purity/Safety | - Total Suspended Particulate, Odor and Oxygen Analysis: (Ensuring the delivered oxygen is free from contaminants and meets purity standards). | The device "passed all testing". |

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

• Sample Size for Test Set: The document does not specify the number of units or cylinders tested. It refers to "verification testing of the Medipure Oxygen-LC System," implying a device-level testing approach rather than a population-based study.
• Data Provenance: The testing was "Internal verification and validation testing," which indicates it was conducted by the manufacturer (Praxair Distribution, Incorporated).
• Retrospective or Prospective: The testing described is prospective as it was conducted on the newly designed Medipure Oxygen-LC System.
• Country of Origin of the Data: Not explicitly stated, but given the manufacturer's location (Tonawanda, New York, U.S.A.) and the US regulatory context (FDA submission), it's highly likely the testing was conducted in the US or by facilities compliant with US standards.

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

This type of information is not applicable to the non-clinical performance and engineering validation tests described. Ground truth for these tests is established by objective measurements against engineering specifications and regulatory standards, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This is not applicable for the engineering and functional tests performed. Adjudication methods are typically used in clinical trials or studies where there are subjective interpretations of data (e.g., medical image reading).

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, an MRMC comparative effectiveness study was not done. The device is a medical gas delivery system, not an AI-powered diagnostic or assistive tool for human readers.

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

Not Applicable. The device is a physical integrated delivery system, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests was:

• Compliance with International Standards: ISO 11117:2008, ISO 10524-3.
• Compliance with Federal Regulations: 49 CFR §173.301(h)(3) DOT.
• Internal Product Specifications: The device's design specifications, which are stated to be equivalent to the previously cleared predicate device.
• Objective Measurements: Such as pressure regulation, particulate analysis, odor analysis, and oxygen analysis.

8. The Sample Size for the Training Set

Not Applicable. This is not a machine learning or AI device that requires a training set.

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

Not Applicable. As above, no training set was used.

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The Intelli-Ox is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for emergency use only. For all other medical applications, the device is Rx only.

The Intelli-Ox portable oxygen system is a solution for supplying Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical Oxygen aluminum cylinder with handle and shroud all integrated into a single unit. A range of user-selectable flow setting is available with the user being able to control the flow rate, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides high flow oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for emergency use only. For all other medical applications, the device is Rx only.

Key specifications include hose barb connection, protective shroud, carrying handle, easy to read digital content gauge, indexed flow meter, integrated valve-regulator and user instructions. This design allows medical personnel the ability to provide patient care and treatment sooner without delays caused by the need to mount a conventional regulator.

This document describes the regulatory submission for the Intelli-Ox portable oxygen delivery system, not a study evaluating its performance against acceptance criteria in the context of an AI/human-in-the-loop system. The document focuses on demonstrating substantial equivalence to a predicate device (EZ-OX Plus) for FDA clearance. Therefore, many of the requested categories related to AI/human performance studies and ground truth establishment are not applicable.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific acceptance criteria in the form of performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet, nor does it provide reported device performance in that sense. Instead, it relies on demonstrating substantial equivalence to a predicate device through technological characteristics and compliance with recognized industry standards. The key "performance" reported is compliance with these standards.

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

This is not applicable as the submission is for a medical device (oxygen delivery system) and not an AI algorithm evaluated on a typical "test set" of data. The "test" involved physical and engineering evaluations against standards and comparison to a predicate device. Data provenance (country of origin, retrospective/prospective) is not mentioned for such testing.

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

Not applicable. There is no concept of a "ground truth" established by experts in the context of an image or data interpretation for this device. The evaluation is based on engineering specifications and compliance with standards.

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-assisted device requiring a MRMC study.

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)

Not applicable. The "ground truth" in this context is adherence to validated engineering specifications and recognized industry standards.

8. The sample size for the training set

Not applicable. No training set is involved for this type of device submission.

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

Not applicable.

Summary of the Study and Device Clearance:

The provided document (K143060) is an FDA 510(k) premarket notification for the "Intelli-Ox" portable oxygen delivery system. The "study" described is a demonstration of substantial equivalence to a previously cleared predicate device, the "EZ-OX Plus" (K053117).

The basis for substantial equivalence is primarily through:

• Comparison of technological characteristics: The Intelli-Ox is described as "very similar" to the EZ-OX Plus, with the main modification being the replacement of an analog gauge with a digital gauge. Both gauges serve informational purposes and do not control flow. The submission details a table (page 5) comparing various parameters (e.g., low flow settings, filters, pressure design, materials, dimensions) and states that the technological characteristics are the same.
• Compliance with recognized voluntary standards: The Intelli-Ox system complies with a list of industry and international standards applicable to medical gas regulators (listed on page 6). These include standards for risk management (ISO 14971), quality management (ISO 13485), electrical safety (IEC 60513, 60601-1-2), electromagnetic compatibility (IEC 61326-2-6-2, ISO 21730, IEC 61000-6-4, ISO 10651-3), and others like the United Nations Manual of tests and Criteria, IP rating, and 21 CFR regulations.

The ultimate conclusion is that "Based upon the performance testing and compliance with voluntary standards, the manufacturer believes that the Intelli-OX portable oxygen delivery system is substantially equivalent to the predicate device, and does not raise any new questions of safety and effectiveness."

This document does not describe a clinical trial or performance study against specific, quantified acceptance criteria in the manner one might find for a novel diagnostic or therapeutic device requiring clinical validation or an AI algorithm. Instead, it leverages the regulatory pathway of substantial equivalence based on established predicates and adherence to existing safety and performance standards for a well-understood type of medical device.

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For OxyTOTE Infinity:

"The OxyTOTE Infinity system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla and cannot be used directly in the MRI bore. The device is intended for limited duration use, such as would be necessary during patient transports. "

For Praxair Grab 'n Go Opti:

"The Grab 'n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla and cannot be used directly in the MRI bore. The device is intended for limited duration use, such as would be necessary during patient transports. "

The OxyTOTE Infinity and Praxair Grab 'n Go Opti series VIPR (Valve Integrated Pressure Regulator) Systems provide a package for those who need medical oxygen from portable cylinders. The oxygen regulator, analog pressure gauge, cylinder contents indicator and gas supply valve are combined, and permanently attached to the gas cylinder as one system. This design allows medical personnel the ability to provide patient care and treatment without the need to mount a conventional separate regulator.

The regulator reduces cylinder pressure and provides 10 user selectable flow rates (½, 1, 1½, 2, 3, 4, 6, 8, 15, 25 LPM) of USP oxygen that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides flow rates up to 100 LPM oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation, the device is for emergency use only. For all other medical applications, the device is Rx only.

Key features include; hose barb connection, protective shroud, carrying handle, cylinder content gauge, indexed flow meter, shutoff valve, and AUX (DISS-1240) connection.

The provided document is a 510(k) premarket notification for the OxyTOTE Infinity Series VIPR Systems and Praxair Grab 'n Go Opti Series VIPR systems. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing details of a study with acceptance criteria and a detailed breakdown of device performance in a clinical or imaging context.

Therefore, many of the requested sections about a study demonstrating the device meets acceptance criteria cannot be extracted from this document, as it describes a medical device for oxygen delivery, not an AI/algorithm-based diagnostic or prognostic device that would typically undergo such studies.

However, I can extract information regarding performance testing against established standards, which serve as acceptance criteria for this type of medical device.

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

For a traditional medical device like an oxygen delivery system, "acceptance criteria" are typically defined by compliance with recognized performance standards. The "device performance" is reported as having "passed" these standards.

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

This information is not provided in the document. The document describes engineering and physical performance testing of the device itself (e.g., ignition sensitivity, magnetic displacement force), not a study involving patient data or a "test set" in the context of an algorithm.

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 is not applicable as the document does not describe a study involving expert-established ground truth for a test set. The testing performed is against engineering and safety standards.

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

This is not applicable, as there is no "test set" requiring adjudication in the context of this device's performance evaluation as described.

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. The device is an oxygen delivery system, not an AI or algorithm-assisted diagnostic tool.

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

This is not applicable. The device is an oxygen delivery system, not an algorithm.

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

The "ground truth" for the performance testing described would be the defined parameters and limits set forth in the cited engineering and safety standards (e.g., maximum allowable magnetic displacement, ignition temperature limits). It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable as the device is not an AI/algorithm that requires a training set.

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

This is not applicable.

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The Grab 'n Go system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to neonates, pediatrics, and adults. The device is MR Conditional, and suitable for use during MR imaging for MRI systems up to 3.0 Tesla. The device is intended for limited duration use, such as would be necessary during patient transports.

The Grab 'n Go Plus / Grab 'n Go Digital (collectively referred to as the Grab 'n Go system) integrated delivery system supplies oxygen using a device comprising an integrated valve-regulator with pressure gauge, flow meter and oxygen gas cylinder with protective shroud all integrated into a single unit. The device is able to provide a range of user selectable flow settings, including low and high flows that may be clinically appropriate for certain classes of patients. An additional DISS connection provides standard 50-PSI oxygen gas delivery. The optional digital pressure gauge (Grab 'n Go Digital) provides both audible and visual low contents alerts and alarms as well as estimated time of use. The system must only be used by trained medical personnel.

Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the Praxair Grab 'n Go Plus / Grab 'n Go Digital device:

The provided document describes a medical gas delivery system, which is generally a mechanical device, not typically an AI/ML-driven software device. Therefore, many of the typical acceptance criteria and study elements associated with AI/ML devices (like sample sizes for test/training sets, expert consensus for ground truth, MRMC studies, or standalone algorithm performance) are not applicable or not explicitly detailed in this submission.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (LIV Portable Oxygen System) through non-clinical testing against established industry and international standards, and a single "end-user evaluation."

Let's break down what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on compliance with established safety and performance standards for medical gas regulators and MR-conditional devices, rather than specific numerical acceptance criteria with corresponding performance metrics from a dedicated clinical study as would be seen for a diagnostic AI device.

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

• Sample Size for Test Set: Not specified. The "end-user evaluation" indicates that "end-users" participated, implying a test set of human users interacting with the device. However, the number of users is not mentioned.
• Data Provenance: Not specified. The document does not indicate the country of origin for the end-user evaluation or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a physical device, it's highly likely this was a prospective evaluation conducted by the manufacturer for regulatory purposes.

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

• Not Applicable in the traditional sense for this device. The "ground truth" for this device's performance is adherence to engineering standards and a usability assessment. The "end-user evaluation" described seems to validate user interaction and understanding, rather than a diagnostic accuracy based on expert ground truth. Therefore, the document does not mention experts establishing "ground truth" for the test set.

4. Adjudication Method for the Test Set

• Not Applicable. Since there's no clinical diagnostic "test set" and no expert ground truth establishment, there is no mention of an adjudication method like 2+1 or 3+1. The end-user evaluation likely involved observing user interaction and collecting feedback, then comparing against predetermined usability criteria.

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

• No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret cases, and AI assistance might improve their performance. This device is a medical gas delivery system, which does not involve diagnostic interpretation by human readers.

6. Standalone (Algorithm Only) Performance Study

• No. This device is a hardware system; there is no standalone algorithm to evaluate. Its "performance" is assessed through engineering tests (compliance with standards) and a usability evaluation of the integrated system.

7. Type of Ground Truth Used

• For engineering performance: The "ground truth" is defined by the objective pass/fail criteria of the referenced industry and international standards (e.g., pressure output accuracy, leak rates, material compatibility, MR safety thresholds, alarm specifications).
• For end-user evaluation: The "ground truth" relates to predefined usability criteria, such as successfully operating the device, correctly interpreting alarms, and understanding the user manual. This is typically established by device design and human factors engineering principles.

8. Sample Size for the Training Set

• Not Applicable. This is a hardware device; there is no "training set" in the context of machine learning. The design and manufacturing processes are informed by engineering principles, predicate device evaluation, and standards, not data training.

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

• Not Applicable. As there is no training set, there is no ground truth established for it.

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The EZ-OX Plus Generation II is an integrated portable oxygen delivery system intended to provide supplemental oxygen to patients. When administered by properly trained personnel for oxygen deficiency and resuscitation, the EZ-OX Plus Generation II is for emergency use only. For all other medical applications, the device is Rx only.

The EZ-OX Plus Generation II portable oxygen system is a solution for supplying Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical D and E-Oxygen aluminum cylinder with handle and shroud all integrated into a single unit. A range of user-selectable flow setting is available with the user being able to control the flowrate, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 40 L/min oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation, the EZ-OX Plus Generation II is for emergency use only. For all other medical applications, the device is Rx only.

Key specifications include hose barb connection, protective shroud, carrying handle, easy to read content gauge, indexed flow meter, integrated valve-regulator and usage chart label with safety instructions. This design allows medical personnel the ability to provide patient care and treatment sooner without delays caused by the need to mount a conventional regulator.

Here's a breakdown of the acceptance criteria and study information for the EZ-OX Plus Generation II Portable Oxygen System, based on the provided document:

Acceptance Criteria and Device Performance

This device is not an AI/ML device, so many of the common fields for such devices (e.g., number of experts, adjudication methods, MRMC studies, ground truth for training data) are not applicable. The provided document details the testing performed to demonstrate the safety and effectiveness of the updated medical device in comparison to its predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Device: EZ-OX Plus Generation II Portable Oxygen System

Note: The document focuses on demonstrating that the updated device meets established safety and performance standards for portable oxygen systems, and also shows improvements over its predicate device.

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

• Test Set Sample Size: The document does not specify a distinct "test set" sample size in terms of number of devices tested or data points collected for the performance bench testing. It states that testing was "performed across the entire range of user configurable flow control settings."
• Data Provenance: Not explicitly stated (e.g., country of origin). The testing seems to be internal validation by Air Liquide Healthcare America Corporation. The document does not specify if the testing was retrospective or prospective, but as it's for a new device's 510(k) submission, it would inherently be prospective testing for this specific device.

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

This question is not applicable to this type of medical device submission. The "ground truth" for a portable oxygen system's performance is established by objective engineering and safety standards (e.g., flow rate measurements, leakage tests, material strength), not by expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. As described above, the evaluation relies on objective measurements against engineering and safety standards. There is no subjective interpretation that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically for image-based diagnostic or prognostic AI/ML devices where reader performance is a key metric. This device is a mechanical portable oxygen system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this question is not applicable. The device is a physical medical device, not a software algorithm. Its performance is measured directly through bench testing.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Established Industry Standards: Specifically, ISO 10524-3:2005 for accuracy and EN 15996 and ASTM G175-03 for safety.
• USP (United States Pharmacopeia) and ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines: Supported standard deviation for precision.
• Engineering Specifications: Conformance to 49 CFR 178.46 for cylinders.

These standards and specifications define what constitutes acceptable "truth" in terms of device function and safety.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, and there is no "training set" in the context of machine learning or AI. The design modifications and improvements (e.g., excess flow device, brass orifice plate, vent holes, non-shuttling RPV) are based on traditional engineering design, analysis, and validation, not on a machine learning training process.

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

Not applicable, as there is no training set for this type of device. The improvements and design changes were driven by engineering analysis to increase safety and performance, address potential failure modes (even if not yet observed), and enhance user experience (e.g., eliminating audible vibration).

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The LIV is an inteqrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults.. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MR1 systems up to 3.0T. Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.

The Linde Integrated Valve® ("LIV") is a portable oxygen delivery system, consisting of a fully integrated cylinder, valve, requlator, flow meter, and shock-absorbing quard. A range of userselectable flow settings is available, inclúding low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 50 psig oxygen delivery, while an optional bed hanger allows the LV to be readily attached to a bed. The LV is suitable for use in all healthcare settings including, but not limited to, hospital, outpatient, imaging center, ambulatory, and home healthcare.

The provided document, K101792, describes a premarket notification for the "Linde Integrated Valve - LIV," a portable oxygen delivery system. However, the document does not contain a study that proves the device meets specific acceptance criteria in the manner requested.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Medcyl-E-lite K033897) based on technological characteristics and compliance with a series of recognized international and national standards for medical devices and gas cylinders. This type of submission (510(k)) primarily demonstrates that a new device is as safe and effective as a legally marketed predicate device, rather than providing detailed clinical study results with acceptance criteria.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted directly from this document. I will answer based on the information provided, explicitly stating when the requested information is not available.

Description of Acceptance Criteria and Proving Study

The Linde Integrated Valve (LIV) is a portable oxygen delivery system. The acceptance criteria for this device are primarily based on compliance with established safety and performance standards for similar medical devices and gas handling equipment. The "study" that proves the device meets these criteria is a series of non-clinical performance tests confirming adherence to these standards, as detailed in the "Non-Clinical Performance Summary" section of the 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for the test set: Not explicitly stated for each individual test or standard listed. The document indicates "safety and performance testing" in general. It is typical for compliance testing to involve a representative sample of devices, but the specific numbers are not provided in this summary.
• Data provenance: Non-clinical (laboratory/engineering) testing and design specifications. The country of origin for the data is not specified, but the standards are international (ISO, EN) and national (DOT, CFR, CE).

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

• Number of experts: Not applicable/not specified. The "ground truth" here is compliance with published, recognized standards and engineering specifications for device performance. These standards are developed by expert committees, but the individual tests themselves typically involve engineering or technical personnel rather than clinical experts establishing a "ground truth" in the diagnostic sense.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Adjudication method: Not applicable/not specified. Compliance testing generally involves objective measurements against predefined criteria in the standards, rather than expert adjudication of subjective findings.

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

• MRMC study: No. This document describes a medical device (portable oxygen delivery system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant and was not performed.

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

• Standalone performance: Not applicable. This is not an algorithm-based device. Performance testing for this device would assess its mechanical and functional specifications.

7. The type of ground truth used

• Type of ground truth: Predetermined performance parameters and established safety requirements outlined in recognized medical device and gas cylinder standards (e.g., ISO, DOT, EN, CE Mark Directive) and engineering specifications. For MR compatibility, adherence to ASTM standard 2503-05 serves as the ground truth.

8. The sample size for the training set

• Sample size for training set: Not applicable. This device is not an AI/machine learning product requiring a training set.

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

• Ground truth for training set: Not applicable.

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The LIV is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MRI systems up to 3.0T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall! be rah Uized or otherwise secured to prevent falling and rolling.

The Linde Integrated Valve™ ("LIV") is a portable oxyqen delivery system, consisting of a fully integrated cylinder, valve, requlator, flow meter, and shock-absorbing quard. A range of user-selectable flow settings is available, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 50psig oxygen delivery, while an optional bed hanger allows the LIV to be readily attached to a bed. The LIV is suitable for use in all healthcare settings, including, but not limited to, hospital, outpatient, imaging center, ambulatory, and home healthcare.

The Linde Integrated Valve (LIV) is a portable oxygen delivery system. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way one might for a novel AI/software device.

Here's the breakdown based on the provided information, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the LIV primarily relies on demonstrating substantial equivalence to a predicate device (MEDICYL-E-Lite K033897) rather than setting specific quantitative acceptance criteria for novel performance, as one would for an AI/software device. The "acceptance criteria" here are implicitly met by showing the device's technical characteristics are substantially similar and that it conforms to relevant standards.

• Flowrate Selector and Flow Outlet (yes)
• Cylinder On/Off (yes)
• Filling Port (active; w/ non-return valve)
• Excess Flow Device (yes)
• Residual Pressure Valve (yes)
• Burst Disk (yes)
• Single stage piston style (yes)
• Guard (2 grip, Access Ports, green color)
• Cylinder Sizes (D, E)
• Materials/construction (Aluminum)
• MRI Compatibility (yes; tested up to 3.0T) |
  | Compliance with 21CFR49 § 178.46 | Aluminum cylinders conform to the requirements of 21CFR49 § 178.46, Specification SAL seamless aluminum cylinders. |
  | MRI Compatibility (ASTM standard 2503-05 and CDRH document) | Evaluated in accordance with the draft CDRH Magnetic Resonance Working Group document, "A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems," dated February 7, 1997.
  MR-conditional (per ASTM standard 2503-05). Intended for use during MR imaging for MRI systems up to 3.0T. |
  | Safety and Effectiveness (Implicit) | The manufacturer believes that the LIV is substantially equivalent to the predicate device and "does not raise any new questions of safety or effectiveness" based on safety and performance testing and compliance with voluntary standards. |
  | Intended Use Alignment with Predicate | Both devices are portable oxygen delivery systems. The LIV's indications for use: "integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MRI systems up to 3.0T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only." |
  | Additional Features (no new safety/effectiveness concerns) | The LIV includes features not in the predicate: Pressure Outlet (yes) and Contents Gauge (active), which are implicitly deemed not to raise new safety or effectiveness concerns. |

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

This is not applicable in the context of this 510(k) summary. This document does not describe a "test set" or data provenance in the way one would for a clinical study comparing AI performance against ground truth. The evaluation is primarily based on engineering design, materials, and compliance with standards, along with a comparison of technological characteristics to a predicate device.

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

Not applicable. This is a medical device (hardware) submission, not an AI/software device submission requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable for the same reasons as above.

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. The LIV is a hardware device for oxygen delivery, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. The "ground truth" for this type of device submission revolves around engineering specifications, material properties, and functionality meeting established standards and being comparable to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. No AI/machine learning training set is involved.

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

Not applicable. No AI/machine learning training set is involved.

In summary:

The provided document is a 510(k) summary for a physical medical device (an oxygen delivery system). It demonstrates the device's safety and effectiveness by establishing substantial equivalence to an already legally marketed predicate device, rather than through a standalone performance study with clinical endpoints or AI-specific validation metrics. The "study" implicitly referenced is the "safety and performance testing and compliance with voluntary standards" conducted by the manufacturer, which is deemed sufficient to demonstrate this equivalence. The "acceptance criteria" are met by matching or exceeding the predicate's characteristics and complying with relevant engineering and safety standards.

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The Ox-Sox is designed to fit over and clearly identify "E" Oxygen cylinders, both in healthcare facilities and for home use. The device is for use with gas cylinders containing oxygen.

The Ox-Sox is designed to fit over and clearly identify "E" Oxygen cylinders.

The provided text does not contain information about acceptance criteria, device performance, or any study details that would allow for the construction of such a table or the answering of the subsequent questions. The document is an FDA 510(k) clearance letter for the Ox-Sox device, indicating it is substantially equivalent to legally marketed predicate devices, and outlines its indications for use as a cover to identify "E" Oxygen cylinders. It does not include performance data or study results.

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