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The GoLox -93 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-93 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-93 is a mechanical device and does not contain any electronics or software. The GoLox-93 is designed to be refilled only from Respironics Home Liquefaction Systems.

The provided text describes a medical device, the Respironics GoLox-93, which is a portable liquid oxygen unit. It's a 510(k) premarket notification, indicating it's a modification of a previously cleared device. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria for a novel device.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, ground truth, and comparative effectiveness studies is not available in the provided text. The text confirms that this is a device modification submission, where the primary goal is to show the modified device is substantially equivalent to existing, legally marketed devices.

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

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The submission is for a device modification, and the focus is on showing similarity to predicate devices rather than establishing new acceptance criteria for a novel device. The document states:

• "The GoLox-93 is identical to the GoLox USP except for the fill connection."
• "Additional testing provided includes verification that the fill connector mates with liquefaction systems and not with stationary vessels."

While specific performance metrics are not given, the implied "acceptance criteria" for this modification would be:

• Fill Connection Compatibility: The new fill connector mates only with 93% liquid oxygen liquefaction systems.
• Fill Connection Incompatibility: The new fill connector does not mate with USP oxygen stationary vessels.

The "reported device performance" related to these implied criteria is simply that the "verification" testing was done and confirmed this functionality. No numerical performance data (e.g., error rates, success rates) is presented.

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

Not explicitly stated. The document mentions "Comprehensive testing was performed" for the predicate device (GoLox USP vs. PLOX) and "Additional testing provided includes verification that the fill connector mates with liquefaction systems and not with stationary vessels" for the GoLox-93 modification. However, no sample sizes (e.g., number of fill connectors tested, number of liquefaction systems/stationary vessels used) or data provenance (country, retrospective/prospective) are detailed.

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

Not applicable/Not stated. This type of study (e.g., expert-reviewed images for an AI algorithm) is not described in this submission. The "ground truth" for the fill connector modification would likely be a direct functional test, not expert consensus on data.

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

Not applicable/Not stated. Adjudication methods are typically used for interpreting subjective data (like medical images) where multiple experts might disagree. The testing described for the GoLox-93 (fill connector compatibility) is an objective functional test and would not require such adjudication.

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 mechanical portable liquid oxygen unit, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant.

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

Not applicable. This is a mechanical device, not an algorithm.

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

For the GoLox-93 fill connector modification, the "ground truth" would be direct functional testing and observation of whether the connector successfully mated with the intended (93% liquefaction systems) and failed to mate with the unintended (USP stationary vessels) connections.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not a machine learning algorithm that requires a training set.

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

Not applicable. As stated above, this is a mechanical device, not a machine learning algorithm.

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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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