Search Results

A&J 5L POCA series Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy at home, in nursing homes, at patient care facilities. A&J 5L POCA series is available by prescription only under the supervision of a physician.

A&J 5L POCA series Oxygen concentrator is AC power electrically operated. The unit separates oxygen from room air (ambient air) which allows high-purity supplemental oxygen to be delivered through the oxygen outlet, although the concentrator filters the oxygen in a room, it will not affect the normal amount of oxygen in your room. Air is drawn into the device with a compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized value and protected from over pressurization by the compressor's pressure relief value.

Oxygen provided by the A&J 5L POCA series Oxygen concentrator is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula or mask. A standard bubble humidifier may be used, if physician has prescribed an oxygen humidifier as part of therapy.

The front panel of the A&J 5L POCA series Oxygen concentrator contains the controls and indicators. These include the status lights (included power light, normal oxygen light, fow oxygen light and service required light), standard power switch, flow meter knob, a circuit breaker which could reset the device after electrical overload shutdown, an oxygen outlet which oxygen is dispersed through, a monitor display which indicates the condition of system status (included pressure status, oxygen purity status and electric hour meter, etc.). The user could operate the device conveniently according to the instructions.

Here's an analysis of the provided text regarding the A&J 5L POCA series Oxygen Concentrator, focusing on acceptance criteria and supporting studies:

Summary of Acceptance Criteria and Device Performance

The device is claiming substantial equivalence to a predicate device (A&J 5L Oxygen Concentrator, Model: POCA01) and therefore the acceptance criteria are implicitly met by demonstrating that its performance is comparable or better than the predicate, and it complies with relevant standards. The table below summarizes the key performance elements compared.

Study Details:

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

   • The document does not explicitly state a "test set" in the context of clinical data for performance evaluation of a diagnostic or algorithmic device. Instead, the testing is bench performance testing and compliance with standards. Therefore, the concept of a "sample size" for a test set and "data provenance" (country of origin, retrospective/prospective) as typically applied to AI/imaging studies does not directly apply here.
   • The studies conducted are laboratory tests to validate and verify design specifications and substantial equivalence to the predicate device.

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

   • Not applicable. This is a medical device (oxygen concentrator) and its performance is evaluated against engineering specifications and physical measurements, and compliance with recognized standards (ASTM, ISO, IEC), not clinical ground truth established by medical experts for diagnostic accuracy.

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

   • Not applicable for the same reasons as above.

4. 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 a standalone medical device (oxygen concentrator) and does not involve AI assistance for human readers or interpretation of medical images/data.

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

   • Yes, in a sense. The performance evaluation is entirely standalone, focused on the device's physical and electrical properties, and its ability to produce oxygen of a specified purity at a specified flow rate, without human intervention in its core function.

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

   • The "ground truth" for this device's performance evaluation comes from:
     • Engineering specifications and measurements: e.g., oxygen percentage (93% ± 2%), delivery rate (0-5 LPM), outlet pressure (8.5 psi), sound level (<45 dbA).
     • Compliance with recognized international standards: ASTM F1464, ISO 8359, IEC 60601-1, IEC 60601-1-2.
     • Demonstration of substantial equivalence to a legally marketed predicate device.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI algorithms that require a "training set" of data. Its design and function are based on engineering principles.

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

   • Not applicable, as no training set was used.

Ask a specific question about this device