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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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The Model 300D Home Oxygen Liquefier is intended for use in liquefying oxygen supplied by a concentrator equipped with an oxygen sensing device. The concentrator used with the home oxygen liquefier should generate >90% oxygen purity nominally, and alert the user if this purity drops to unacceptable levels. This liquid oxygen is intended for use with the liquid portable products rated for 93% oxygen such as the Caire Spirit 300 HAS product. This system and the associated portable are intended for use with 93% (+3%) oxygen.

It may be used in the home or institution. It is intended to be used with both pediatric and adult patients. It is not intended to be a life sustaining or life supporting device. The device has no contraindications.

The COPD Partners' model 300D is a home oxygen liquefaction device. The product is intended to connect to an oxygen concentrator that is equipped with an oxygen sensing device to assure adequate levels of oxygen purity. The model 300D then splits the gas source from the concentrator, giving the patient their desired level of gas flow and uses the remaining flow for the liquefaction portion of the unit. The liquefaction portion of the device consists of desiccants, a boost pump compressor, a high pressure compressor, a series of heat exchangers, a dual stage cascade refrigeration pre-cooler, a microcontroller based controller system, and a Dewar with a Joule Thompson (JT) valve. This device pressurizes the gas, cools it, and then expands the gas through the JT valve, where a portion of the gas will convert to liquid oxygen will be used to fill a liquid oxygen portable such as the COPD Partners' Model 300P. The device indicates the level of liquid in the Dewar and has a control system to display this information to the user. In addition, it automatically turns on to maintain a desired level of liquid in the Dewar.

The provided 510(k) summary for the COPD Partners Model 300D Home Oxygen Liquefier details its performance and testing. However, it does not include all the specific information requested in your prompt regarding clinical studies, expert involvement, and detailed ground truth methodologies, as these are more typical for diagnostic AI/ML device submissions. This device is a home oxygen liquefier, which is a hardware device, not an AI/ML diagnostic tool. Therefore, the questions related to AI/ML specific aspects (like MRMC studies, training/test sets, expert ground truth establishment for algorithm performance) are not applicable to this submission.

Here's a breakdown of the available information based on your request, with an explanation for the missing AI/ML related details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document mentions "Bench testing" and "Independent testing and evaluation" for verification and validation. However, it does not specify a sample size in terms of number of devices or number of test cases.
• Data Provenance: The testing was "Bench testing" and "Independent testing and evaluation" implying laboratory-based assessments. No information on country of origin of data (though the submitter is based in PA, USA) or whether it was retrospective or prospective in a clinical setting is provided. Given the nature of the device (hardware), this likely refers to engineering and performance testing rather than clinical study data.

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

• This question is not applicable as the device is a hardware for liquefying oxygen, not a diagnostic device where expert ground truth for interpretation would be relevant. The "ground truth" here is objective physical measurements and adherence to safety standards.

4. Adjudication method for the test set

• This question is not applicable for the same reasons as above. Adjudication methods are relevant for subjective interpretations, typically in diagnostic imaging or clinical assessments. Device performance was verified against pre-defined engineering and safety specifications.

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

• This question is not applicable as the device is a home oxygen liquefier and does not involve AI or human readers for interpretation.

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

• This question is not applicable as the device is a hardware product, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance is based on objective engineering specifications and recognized safety standards. This includes:
  • Measured liquefaction rates.
  • Measured oxygen purity levels.
  • Compliance with UL 60601-1-1:2006 (Medical electrical equipment safety).
  • Compliance with IEC 60601-1-2:2007 (Electromagnetic compatibility).
  • Verification of safety mitigations identified in the risk assessment.

8. The sample size for the training set

• This question is not applicable as the device is a hardware product and does not involve an AI/ML model requiring a training set.

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

• This question is not applicable as the device is a hardware product and does not involve an AI/ML model requiring a training set.

Summary of Study that Proves Device Meets Acceptance Criteria:

The 510(k) summary states that "Verification and Validation testing has been completed on the COPD Partners Model 300D Liquefier to assure that the device meets the safety and performance requirements described in the specifications." The testing included:

1. Bench testing: This verified that the liquefaction rates and oxygen purity levels met product specifications and that safety mitigations from the risk assessment were completed.
2. Independent testing and evaluation: This verified that the device met the requirements of UL 60601-1-1:2006 (Medical electrical equipment safety) and IEC 60601-1-2:2007 (Electromagnetic compatibility).

The document explicitly states: "All results of tests met the acceptance criteria."

It's important to reiterate that this is a submission for a physical medical device (oxygen liquefier), not a software or AI/ML-based diagnostic tool. Therefore, many of the questions asked, which are highly relevant for AI/ML device evaluations, do not apply to this specific 510(k) filing.

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