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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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