(213 days)
The A&J-POCA01 Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc. The A&J-POCA01 is available by prescription only under the supervision of a physician, and is not intended to support or sustain life.
The A&J-POCA01 Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc. The A&J-POCA01 is available by prescription only under the supervision of a physician, and is not intended to support or sustain life.
The A&J-POCA01 is an 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-POCA01 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-POCA01 contains the controls and indicators. These include the status lights (included power light, normal oxygen light, low oxygen light and service required light), standard power switch, flow meter and the flow meter knob, a circuit breaker which could reset the device after electrical overload shutdown, a 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 operated the device conveniently according the instructions.
The provided 510(k) summary for the A&J-POCA01 Oxygen Concentrator describes a medical device seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring a detailed clinical study with acceptance criteria and ground truth validation as would be typical for novel or higher-risk devices.
Therefore, the document does not contain information on:
- Acceptance criteria in the manner of performance metrics (e.g., sensitivity, specificity) for diagnosing or detecting a condition.
- A "study that proves the device meets the acceptance criteria" in a clinical sense with a test set, ground truth, and expert evaluation.
- Sample sizes for test sets or training sets for an AI/algorithm.
- Number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance studies.
- Type of ground truth used (e.g., pathology, outcomes data).
Instead, the submission focuses on bench performance testing to demonstrate functional equivalence and safety.
Here's a summary of the information available, framed in response to your request, but highlighting the type of study conducted:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence submission for an oxygen concentrator, the "acceptance criteria" are not based on diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they are related to engineering specifications and functional safety. The document does not provide a table with specific numerical targets and measured performance for each criterion. However, it states:
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Design Specifications | Met all design specifications. |
| Substantial Equivalence | Demonstrated substantial equivalence to the predicate device (Mark 5 Nuvo Oxygen Concentrator). |
| Environmental Testing | Compliant with FDA's DCRND November 1993 "Reviewer Guidance Document for Premarket notification Submissions" Draft Guidance Document. |
| Industry Standards Compliance | Compliant with ASTM F1464, ISO 8359, IEC60601-1, IEC60601-1-2, IEC60601-1-4, and ISO14971. |
| Safety & Effectiveness | Technologies "bring forth no new questions of safety and effectiveness." Differences from predicate (dimensions, weight, storage, power consumption, oxygen percentage) do not affect safety and efficiencies, with some characteristics being "better than the predicate." |
| Hazard Analysis | Performed, and testing conducted to validate system's overall operation. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of a clinical test set for diagnostic performance. The testing involved laboratory and bench testing of the device itself.
- Data Provenance: Not applicable for clinical data. The testing was conducted in a laboratory setting by the manufacturer, Zhongshan A & J Medical Equipment CO., LTD in China, to evaluate the device against specified engineering and regulatory standards. The testing was described as "Laboratory testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This is not applicable as the study did not involve a clinical test set requiring expert-established ground truth for diagnostic purposes. The "ground truth" for this device would be its adherence to engineering specifications and performance standards as measured by laboratory equipment.
4. Adjudication Method for the Test Set
- Not applicable as there was no clinical test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The device is an oxygen concentrator, not an imaging or diagnostic AI tool that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Not applicable. The device is a physical medical device (an oxygen concentrator), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this medical device submission is its functional performance measured against established engineering specifications, safety standards, and regulatory requirements. This includes:
- Compliance with various international and national standards (e.g., ASTM F1464, ISO 8359, IEC60601-1).
- Verification against the predicate device's performance characteristics where relevant.
- Results from hazard analysis.
- Meeting internal design specifications.
8. The Sample Size for the Training Set
- Not applicable. This device does not use machine learning or AI that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).