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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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PURE CRYOGEN is indicated to be used as an accessory to Candela Corporation's Dynamic Cooling Device as a source of skin refrigerant fluid. The intended use of PURE CRYOGEN is (1) cooling of the skin prior to laser treatment, (2) reduction of pain during laser treatment, (3) allows for use of higher laser treatments, such as for hair removal and vascular lesions, and (4) reduces potential side effects of laser treatments, such as for hair removal and vascular lesions.

Air Liquide's PURE CRYOGEN consists of a disposable, non-refillable cylinder containing 1, 1,1,2-Tetrafluoroethane, commonly referred to as HFC-134a Low NAG gas ("134a gas"). The 134a gas cylinder is intended to be used as an accessory to Candela Corporation's Dynamic Cooling Device™ as a source of skin refrigerant fluid. The cylinder may be inserted into the Dynamic Cooling Device, which is then connected in line with Candela's laser device. Candela's laser controls the delivery of a pulsed spray of 134a gas just prior to the delivery of a laser pulsed spray of skin refrigerant cools the skin as it evaporates. Use of the 134a gas prior to laser treatment minizes thermal damage to skin during laser treatment and reduces pain associated with laser treatment.

The provided text describes a 510(k) premarket notification for a device called "PURE CRYOGEN". This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where the device meets acceptance criteria related to a specific performance metric (like diagnostic accuracy or efficacy improvement).

Therefore, many of the requested elements for describing an acceptance criteria study (e.g., sample size for test set, number of experts, adjudication method, MRMC study, sample size for training set, ground truth methods for training set) are not applicable or cannot be extracted directly from this type of regulatory submission. The document explicitly states "Non-clinical performance data" was used.

Below is an attempt to structure the available information per your request, with significant caveats where information is unavailable or not relevant to the document's purpose.

This document describes a 510(k) submission for the PURE CRYOGEN device, which is an accessory to laser surgical instruments for skin cooling. The submission aims to establish substantial equivalence to a legally marketed predicate device (Candela Dynamic Cooling Device™ (K001589)). The "study" described focuses on non-clinical performance and a comparison of technological characteristics between the PURE CRYOGEN device and its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this context refers to demonstrating that the PURE CRYOGEN device performs equivalently to the predicate device and does not raise new safety or effectiveness concerns, particularly regarding its compatibility and operation within the existing Dynamic Cooling Device (DCD) system.

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

• Sample Size: Not explicitly stated numerically for the compatibility and leak rate tests. The text mentions "multiple manual comparative insertions" and a "leak rate test." It's likely involved a small number of device units for physical comparisons and a statistically appropriate sample for the leak rate test, but specific counts are absent.
• Data Provenance: The data is non-clinical performance data generated by the device manufacturer, Air Liquide Healthcare America Corporation. The country of origin of the data is not specified but is implicitly associated with the manufacturer's testing facilities (likely in the US given the submission to the FDA). The data is generated from prospective testing of the PURE CRYOGEN device.

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

Not applicable. This was a non-clinical, comparative engineering/performance study, not a study requiring expert clinical ground truth evaluation. The "ground truth" was based on established engineering specifications, physical measurements, and the operational characteristics of the predicate device and DCD system.

4. Adjudication method for the test set

Not applicable. There was no clinical ground truth to adjudicate. Physical compatibility and leak rate tests typically involve direct measurement and observation against predefined engineering standards.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI-powered diagnostic tool, and no MRMC study was conducted.

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

Not applicable as this is not an AI algorithm. The device, PURE CRYOGEN, is an accessory that functions independently as a source of refrigerant fluid, but its intended use is as part of a system with a DCD and laser. The performance tests ("cylinder height, diameter, valve threads," "multiple manual comparative insertions," "leak rate test") are standalone tests for the accessory device's characteristics and its physical interaction with the DCD.

7. The type of ground truth used

The "ground truth" for this non-clinical performance data consisted of:

• Engineering specifications and measurements: For physical dimensions, valve threads, and gas pressure.
• Established operational parameters of the predicate device and DCD: To ensure compatibility and equivalent function within the system.
• Industry standards for leak rates: To assess shelf-life.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable. This device is not an AI algorithm.

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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 EZ-OX Plus is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults; a pressure requlator, flow meter and medical E-Oxygen cylinder with handle and shroud all integrated into a single, lightweight unit. Key specifications include hose barb connection, protective cap, carrying handle, easy to read content gauge, indexed flow meter, integrated regulator and usage chart label with safety instructions. Medical personnel can concentrate on providing patient care and treatment sooner without delays caused by the need to mount a regulator. With no assembly needed and the easy-to-use design, it is easy to operate.

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 stabilized or otherwise secured to prevent falling and rolling.

The EZ-OX Portable Oxygen System is a solution for supplying Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical E-Oxygen aluminum cylinder with handle and shroud all integrated into a single unit. 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.

The provided text describes a 510(k) summary for the EZ-OX Plus Portable Oxygen System, focusing on demonstrating its substantial equivalence to a predicate device rather than presenting a study proving it meets specific acceptance criteria based on clinical performance metrics. Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, how ground truth for training set was established) are not explicitly present in the document because it's a regulatory submission for device clearance, not a clinical trial report.

However, I can extract information related to performance data and safety testing, which act as a form of acceptance criteria for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are primarily defined by adherence to recognized standards and demonstrated performance in safety tests comparable to, or in some cases exceeding, those required for its classification and substantial equivalence to the predicate device.

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

Not applicable as this is not a clinical study involving a "test set" of patients or data in the typical sense. The "testing" refers to benchtop and component-level evaluations, not clinical data sets.

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 for this type of device (mechanical/electrical safety and performance) is established via recognized engineering standards and test protocols, not expert clinical consensus on a "test set."

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

Not applicable. Adjudication methods are relevant for clinical studies where subjective assessments might be made (e.g., by human readers of medical images). This document describes objective engineering tests.

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 portable oxygen delivery system, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or AI assistance.

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 system. Its performance is inherent to its mechanical design and function.

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

The "ground truth" for the device's performance is established by adherence to recognized international and national engineering/safety standards (e.g., 49 CFR 178.46, ISO 10524, EN-738-3) and successful completion of specified physical and mechanical tests outlined within those standards. This includes evaluating the regulator's resistance to ignition under specific pressure and temperature conditions.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of medical device clearance. The device is designed, manufactured, and tested to specifications, not "trained" like a machine learning model.

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

Not applicable, as there is no training set.

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