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510(k) Data Aggregation
(132 days)
The Jumao JM-P50A Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to adult patients (ages 22 and older) requiring respiratory therapy on a prescriptive basis. It may be used in the home or in professional healthcare facility.
Portable Oxygen Concentrator, model: JM-P50A is a portable oxygen generator that is intended to release oxygen for respiratory therapy by physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula (supplied separately) to channel oxygen from the concentrator to the patient. The JM-P50A is small, portable and may be used in the home or in a professional healthcare facility.
Portable Oxygen Concentrator, model: JM-P50A, uses molecular sieve/pressure swing adsorption technology. Ambient air is drawn through particle filters by a compressor and forced through molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed, and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an air tank. Waste nitrogen is exhausted back into the room. A series of sieve beds, manifolds and precision valves, sensors and embedded software are used to control the cycle to make the system function.
Portable Oxygen Concentrator, model: JM-P50A, can be used in the home or in a professional healthcare facility. Power options include 100 – 240 V (50- 60Hz) AC power supply, rechargeable battery packs.
Oxygen is delivered to the patient on a pulse dose basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. Portable Oxygen Concentrator, model: JM-P50A, senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, through a final filter, into the connected nasal cannula and on to the patient.
The portable oxygen concentrator consists of main unit, battery, power adapter and carry case. The main gas pathway of oxygen concentrator is composed of particle filter, particle filters, air compressor, molecular sieve beds, manifold valve, sensors, air tank.
This is a 510(k) clearance letter for a Portable Oxygen Concentrator (JM-P50A). The document primarily focuses on demonstrating substantial equivalence to a predicate device (Inogen Rove 6 Portable Oxygen Concentrator) through bench testing and compliance with recognized consensus standards. It explicitly states that "There was no clinical testing performed."
Therefore, the provided document does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or human-in-the-loop assessment. The information you're asking for, particularly points 1-7 from your prompt, typically applies to studies proving clinical effectiveness or diagnostic accuracy of AI/software as a medical device (SaMD), which is not the case here.
However, I can extract information related to the device's technical specifications and how its performance was evaluated against standards, which serve as a form of acceptance criteria for this type of device.
Here's an interpretation based on the provided document, addressing what can be extracted and noting what cannot be:
Acceptance Criteria and Device Performance for Portable Oxygen Concentrator (JM-P50A)
Based on the provided 510(k) clearance letter, the acceptance criteria and the "study" (bench testing and standards compliance) focus on demonstrating substantial equivalence to a predicate device and adherence to recognized performance and safety standards. There was no clinical testing performed for this device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the performance specifications of the predicate device and the requirements of various international standards. The "reported device performance" refers to the JM-P50A's demonstrated capability to meet these criteria through bench testing.
| Acceptance Criterion (Based on Predicate Device & Standards) | Reported JM-P50A Device Performance | Discussion of Meeting Criteria |
|---|---|---|
| Oxygen Delivery Mode: Pulse Dose | Pulse Dose | Meets criterion |
| Flow Control Settings: 1,2,3,4,5,6 (Pulse Dose) | Pulse dose setting 1,2,3,4,5,6 | Meets criterion |
| Output Flow (Total volume Per minute, ml/min) per ISO 80601-2-67 +/- 15%: | ||
| - Setting 1: 210 ml/min | 210 ml/min | Meets criterion (within limits) |
| - Setting 2: 420 ml/min | 420 ml/min | Meets criterion (within limits) |
| - Setting 3: 630 ml/min | 630 ml/min | Meets criterion (within limits) |
| - Setting 4: 840 ml/min (Table typo: listed as 84) | 840 ml/min | Meets criterion (within limits) |
| - Setting 5: 1050 ml/min | 1050 ml/min | Meets criterion (within limits) |
| - Setting 6: 1260 ml/min | 1260 ml/min | Meets criterion (within limits) |
| Oxygen Purity: 90% - 3%/+6% at all settings | 90% - 3%/+6% at all settings | Meets criterion |
| Maximum Outlet Pressure: <199 kPa | <199 kPa | Meets criterion |
| Inspiratory Trigger Sensitivity: < 0.12 cm H2O | < 0.12 cm H2O | Meets criterion |
| Warm-up Time: 2 minutes | 2 minutes | Meets criterion |
| Acoustic Noise (Setting 2): 39 dBA (Predicate) | 43 dBA typical at setting 2 | Meets criterion (similar, accepted difference) |
| Acoustic Noise (Maximum system sound pressure): 54 dBA (Predicate) | 61 dBA (JM-P50A) | Meets criterion (similar, accepted difference) |
| Acoustic Noise (Maximum system sound power): 62 dBA (Predicate) | 66 dBA (JM-P50A) | Meets criterion (similar, accepted difference) |
| Safety Standard Compliance: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-1-6, IEC 62133-2, IEC 62366-1 | Compliant with latest versions of these standards | Meets criterion |
| Performance Standard Compliance: ISO 80601-2-69, ISO 80601-2-67 | Compliant with these standards | Meets criterion |
| Biocompatibility: ISO 18562-1, ISO 18562-2, ISO 18562-3, ISO 10993-17 | Compliant with these standards | Meets criterion |
| Software Verification: IEC 62304 and FDA Guidance | Software V&V performed | Meets criterion |
| Operating Environment (Temp): 41 to 104°F (5 to 40°C) | 41 to 104°F (5 to 40°C) | Meets criterion |
| Operating Environment (Humidity): 15% to 90%, non-condensing | 15% to 90%, non-condensing | Meets criterion |
| Operating Environment (Altitude): 0 to 10,000 ft (0-3048m) | 70kPa to 106 kPa (0-10,000 ft) | Meets criterion |
| Shipping & Storage Temp: Within -25 to 70°C (-13 to 158°F) (Predicate range) | -20°C to 60°C (-4°F to 140°F) | Meets criterion (within accepted range) |
| Shipping & Storage Humidity: Up to 90% non-condensing (Predicate) | 10% to 90% non-condensing | Meets criterion (similar, accepted difference) |
| Battery Re-charge Time (Device off): up to 3 hours (Predicate standard battery) | Not more than 3 hours when device is off | Meets criterion |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify a "sample size" in terms of patient data or a test set as would be used in an AI/clinical study. The evaluation was based on bench testing of the device prototype/production unit(s) against engineering specifications and international standards.
- Data Provenance: The data provenance for performance testing originates from bench testing conducted by the manufacturer and/or accredited testing laboratories to demonstrate compliance with standards. The country of origin of the device manufacturer is China (Jiangsu Jumao X-Care Medical Equipment Co., Ltd.). The data is prospective in the sense that it's generated from testing the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was not a study involving human interpretation or clinical data where expert ground truth would be established. The "ground truth" here is the established scientific and engineering principles underpinning device performance, as codified in international standards and the performance of the predicate device.
4. Adjudication method for the test set
Not applicable. No human adjudication was involved as this was not a clinical or AI performance study requiring human interpretation consensus.
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
Not applicable. This device is a medical hardware device (portable oxygen concentrator), not an AI/software-driven diagnostic tool that assists human readers. The document explicitly states: "There was no clinical testing performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-based device in the context of diagnostic performance. The device has "embedded software" that controls its functional cycle, and this software was verified and validated against IEC 62304 and FDA guidance, but this is distinct from an AI generating diagnostic outputs.
7. The type of ground truth used
The "ground truth" in this context is established by:
- International Consensus Standards: e.g., ISO 80601-2-67, ISO 80601-2-69, ANSI AAMI ES60601-1, IEC series, ISO 18562 series. These standards define accepted performance limits and test methodologies for portable oxygen concentrators.
- Predicate Device Specifications: The performance characteristics of the legally marketed predicate device (Inogen Rove 6 Portable Oxygen Concentrator) serve as a benchmark for demonstrating substantial equivalence.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI that requires a "training set" of data in the typical sense.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for AI/ML in this context.
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