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The GoLox USP is intended to provide supplemental oxygen to patients who have difficulty extracting oxygen from the air that they breathe. The patients would normally receive oxygen via a nasal cannula. It is intended for ambulatory use inside and outside of the home. It is not intended to be life supporting or life sustaining. The device has no contraindications.

The GoLox is a double walled vacuum insulated cryogenic vessel designed to hold approximately 1 pound of liquid oxygen at a pressure of 22 psig with heat exchange tubing, relief valves and a pneumatic conserving device housed in a plastic enclosure. Oxygen is stored under low pressure in its liquid state where the pressure is limited by the pressure relief valve. The liquid oxygen is converted to near ambient temperature gaseous oxygen through a system of tubes and warming coils for delivery to patients requiring supplemental oxygen by a single lumen cannula. The device is not intended as life support or life sustaining. The GoLox USP s designed to be refilled from industry standard liquid oxygen stationary units already cleared and in the marketplace.

The provided text describes a 510(k) premarket notification for the "GoLox USP" portable liquid oxygen unit. It asserts substantial equivalence to a predicate device, the "Respironics PLOX (K050414)", based on comprehensive testing. However, the document does not contain explicit acceptance criteria or a detailed study report with specific performance metrics for the GoLox USP device against such criteria.

Therefore, I cannot populate the table or answer most of the questions about acceptance criteria and detailed study design. The document focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific performance acceptance criteria.

Here's what can be extracted based on the provided text:

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

The document does not explicitly define acceptance criteria or provide specific numerical performance results for the GoLox USP. It states that "Comprehensive testing was performed to determine equivalence between the GoLox and PLOX (K050414). Testing included connection/disconnection of proprietary connector, purity and flowrates in stated environmental conditions." This implies that the GoLox USP's performance in these areas was deemed equivalent to the predicate device, but no specific values or thresholds are given.

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

Not mentioned in the document.

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. This is a medical device performance study, not one requiring expert interpretation of data to establish ground truth in the way AI/ML algorithms often do.

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/ML device.

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

Not applicable. This is not an AI/ML device. The "comprehensive testing" would have involved the device itself performing to its intended specifications.

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

Not explicitly stated. For a physical device like this, "ground truth" would likely refer to established engineering and performance standards for oxygen delivery units. The testing focused on "equivalence" to a predicate device, meaning its performance in areas like "purity and flowrates" demonstrated results comparable to or within acceptable limits of the previously cleared PLOX.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device.

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