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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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