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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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