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The Oxy-Serve II Oxygen Conserving Regulator is intended as an oxygen conserving pressure regulator for ambulatory patients. The Conserving Regulator delivers a prescribed flow of oxygen only during the inhalation cycle, conserving oxygen during the exhalation cycle.

The Oxy-Serve II Oxygen Conserving Regulator is a high pressure oxygen regulator integrated with a conserving device to deliver oxygen during the inhalation phase of a patients breathing cycle, thereby extending the useful life of an oxygen cylinder.

The Oxy-Serve II is constructed of aluminum with brass high pressure chamber components. The device is pneumatic and requires no electrical power source. An indexable control knob selects from 11 flow rates ranging from 1 to 6 LPM in .5 LPM increments. Two outlet ports are connectable using a dual lumen cannula. One port senses the inhalation of the patient thus initiating the selected flow to the patient during the full inhalation cycle. Flow ceases at the end of the inhalation cycle. The second port delivers the oxygen.

The device can operate as a conserving regulator, or as a standard continuous flow regulator operable by sliding a switch on the face of the regulator housing. In continuous mode the sensing diaphragm control component is bypassed and a continuous flow of oxygen is delivered at the flow selected by the indexable control knob through the outlet port.

The provided text describes a 510(k) premarket notification for the Oxy-Serve II Oxygen Conserving Regulator. It focuses on demonstrating substantial equivalence to a predicate device through performance, mechanical, and environmental testing. However, the document does not contain the specific details required to fully address your request in the format of acceptance criteria and the study that proves the device meets them.

Here's a breakdown of what can and cannot be answered based on the provided text:

Information Present in the Document:

• Device Name: Oxy-Serve II Oxygen Conserving Regulator
• Predicate Device: K010747 - OPC Oxygen Conserving Regulator - Western Medica, Corp.
• Performance Testing: The document states that "The Oxy-Serve II Oxygen Conserving Regulator has been subjected to performance, mechanical, and environmental testing to insure the device meets the performance criteria as intended." It also mentions "lab testing to have similar performance characteristics" and "passing extensive safety testing."
• Conclusion: The device is deemed "substantially equivalent to the legally marketed predicate device and is safe and effective for its intended use."

Information NOT Present in the Document (and therefore cannot be provided in the table or detailed answers):

• Specific Acceptance Criteria: The document mentions "performance criteria as intended" but does not define what those criteria are (e.g., flow rate accuracy, oxygen conservation percentage, pressure regulation ranges, environmental durability thresholds).
• Reported Device Performance: While it states testing was done, it doesn't provide any quantitative or qualitative results from these tests. It simply says the device meets the criteria and has similar performance to the predicate.
• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).
• Number of Experts Used: Not mentioned.
• Qualifications of Experts: Not mentioned.
• Adjudication Method: Not mentioned.
• Multi-Reader Multi-Case (MRMC) Study: This type of study is typically relevant for interpretative devices (like AI in imaging) and is not applicable to a mechanical oxygen conserving regulator. Therefore, it was not done and an effect size cannot be provided.
• Standalone Performance: Not explicitly detailed, though the "lab testing" implies an evaluation of the device itself.
• Type of Ground Truth: Not explicitly detailed beyond "performance, mechanical, and environmental testing." For a mechanical device, ground truth would usually be established by calibrated measurement instruments against specifications.
• Sample Size for Training Set: This is applicable to machine learning models, which this device is not.
• How Ground Truth for Training Set was Established: Not applicable for this device.

Based on the available information, here is the closest response I can provide:

The document states that performance, mechanical, and environmental testing were conducted to ensure the Oxy-Serve II Oxygen Conserving Regulator meets its intended performance criteria and is substantially equivalent to the predicate device (K010747 - OPC Oxygen Conserving Regulator - Western Medica, Corp.).

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

Note: Specific quantitative criteria and results are not provided in the submitted text. The acceptance criteria are inferred from the statement "to insure the device meets the performance criteria as intended."

2. Sample sized used for the test set and the data provenance

• Sample Size: Not specified in the document.
• Data Provenance: Not specified in the document. The testing was described as "lab testing."

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

• This information is not applicable and not mentioned for a mechanical device; ground truth would typically be established by comparing device performance to engineering specifications using calibrated measurement equipment.

4. Adjudication method for the test set

• Not applicable/mentioned for this type of mechanical device testing.

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

• No, an MRMC study was not done. This type of study is relevant for interpretive medical devices (e.g., AI in radiology), not for a mechanical oxygen conserving regulator.

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

• Yes, the "performance, mechanical, and environmental testing" would be considered standalone testing of the device itself, without human intervention in its core "performance" assessment (though human operators would conduct the test).

7. The type of ground truth used

• The ground truth for this device's performance would be established through a comparison of the device's output (e.g., oxygen flow, conservation rate) against its design specifications and the performance characteristics of its predicate device, using calibrated measurement equipment. The document states it was proven through "lab testing."

8. The sample size for the training set

• This is not applicable as the Oxy-Serve II is a mechanical device, not an AI/machine learning algorithm that requires a training set.

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

• Not applicable for this type of device.

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