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The COPD Partners Model 300P Liquid Oxygen Portable will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing medical grade liquid oxygen, and then dispensing it to the patient via an integral electronic conserving device. The Model 300P Liquid Oxygen Portable is neither a life-sustaining nor life-supporting device.

The COPD Partners' Model 300P is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum-insulated cryogenic Dewar, an economizer regulator, electronic printed circuit board (PCB), an oxygen conserving system, and a protective case.

The Dewar has a capacity and capability to store 0.33 liters of liquid oxygen. Dependant on the flow selection setting, the control system either delivers the oxygen to the conserving device or delivers a 2 LPM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow method selector. The conserving device has an equivalent setting for 1, 2, 3, 4, and 5 LPM prescriptions. At the various conserving device settings, the outlet oxygen gas is delivered in quick pulses beginning at the start of inhalation.

The device also has a provision to track the patient's breath rate and in the event of an increase in breath rate, will deliver an increased volume of oxygen. There are two levels of increased volume, one at 4 breath per minute (BPM) over normal breath rate and another at 8 BPM over normal breath rate. The device delivers an extra 16 cc at each of these two thresholds. The COPD Partners Model 300P is transfilled from a commercially available medical grade liquid oxygen source.

The provided text describes a 510(k) summary for a medical device, the COPD Partners Model 300P Liquid Oxygen Portable. This document primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing and compliance with electrical safety standards. It does not contain information about studies involving human readers, ground truth established by experts, or the specific details typically found in studies for AI/algorithm-driven diagnostic or prognostic devices.

Therefore, many of the requested categories cannot be filled from the provided text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. The testing described is bench testing of the device's physical and electronic performance, not testing on a patient data set.
• Data Provenance: Not applicable.

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. Ground truth as typically understood for diagnostic/AI devices (e.g., expert consensus on medical images or pathology reports) is not relevant for this type of device and testing.

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

• No MRMC comparative effectiveness study was done. This device is a portable oxygen unit, not an AI-assisted diagnostic or prognostic tool.

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

• Stand-alone performance was assessed for the device's oxygen delivery mechanism and safety features through bench testing. The "algorithm" for adjusting oxygen delivery based on breath rate was tested as part of the device's overall function. No specific "algorithm-only" performance metrics are provided in isolation from the integrated device.

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

• The "ground truth" for this device's performance is based on engineering specifications and regulatory standards. For example, oxygen purity levels are compared against an acceptable standard, and delivery rates are compared against the intended programmed output (e.g., 16cc per breath increase).

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

• Not applicable.

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