(218 days)
The JUMAO Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
JMC5A Ni oxygen concentrator is made up of mainframe and flowmeter. It is an electronically operated device that separates oxygen from ambient air. It provides high concentration of oxygen directly to patient/user through a nasal cannula or other methods.
The Jumao Oxygen Concentrator is a Pressure Swing Adsorption (PSA) type oxygen concentrator which takes 120V ~ power source as power source. The output of oxygen is 0.5 to 5 liter per minute. Room air enters the piston type compressor via a series of filters for removing dust particles. The output compressed air is directed by a pneumatic valve into one of the two sieve beds which is full of adsorption material - molecular sieve. Nitrogen is adsorbed by the molecular sieve as the pressure increases; oxygen flows through the molecular sieve and concentrates at the sieve bed bottom. The enriched oxygen is divided into two streams; one stream enters a storage tank. The pressurized oxygen is regulated down to the suitable pressure, an adjustable flow meter and out to the patient. At the same time the second bed is in exhausted status, the molecular sieve desorbs nitrogen as the pressure decreases; another oxygen stream from first bed enters the bottom of the second bed, promotes purging the nitrogen and is exhausted into the atmosphere. Two sieve beds exchange the role of oxygen concentration and continue to produce 93% oxygen to the patient.
This document is a 510(k) premarket notification for an Oxygen Concentrator (Model: JMC5A Ni) and primarily focuses on demonstrating substantial equivalence to a predicate device. It is not a study report designed to prove a device meets specific acceptance criteria through clinical or large-scale non-clinical performance studies with detailed statistical analysis.
Therefore, many of the requested details about acceptance criteria, study methodologies, sample sizes for test/training sets, expert involvement, and ground truth establishment are not present in this regulatory submission document as they would be in a dedicated performance study report.
The document states, "No clinical testing has been performed." and primarily relies on non-clinical (bench) testing and a usability study to support substantial equivalence. The "acceptance criteria" discussed are more akin to meeting specific established standards and performance specifications for an oxygen concentrator rather than criteria for an AI/algorithm-driven device's performance metrics (like sensitivity, specificity).
Below, I will extract the available information, noting where the requested details are not provided due to the nature of the document.
Device Under Review: JUMAO Oxygen Concentrator (Model: JMC5A Ni)
Device Classification: Class II, Product Code CAW (Portable Oxygen Generator)
Indication for Use: "The JUMAO Oxygen Concentrator is intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life."
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed in a "table" format with reported performance against them as one might find for an AI algorithm's metrics (e.g., sensitivity, specificity). Instead, the document discusses compliance with recognized standards and certain performance specifications.
| Parameter/Characteristic | Acceptance Criteria (from predicate/standards) | Reported Device Performance (JMC5A Ni) | Notes/Comparison to Predicate |
|---|---|---|---|
| Oxygen Concentration | 95.6% to 87% at all flow rates (Predicate) | $93% \pm 3%$ at 0.5 to 5L/min (after turning on 5 minutes) | Similar/Superior: Proposed device has a narrower and higher specified range, suggesting superior performance in this aspect ("superior to the predicate device"). Compliant with ISO80601-2-69. |
| Oxygen Flow | 0.5 – 5 LPM (Predicate) | 0.5~5L/min | Same |
| Outlet Pressure | 38kPa±5kPa (Predicate) | 38kPa±5kPa | Same |
| Noise | 52 dB(A) (Predicate) | Sound level: ≤ 50.5dB(A); Acoustic power level: 58.5dB (A) | Different/Improved: Proposed device has a lower sound level. Compliant with ANSI AAMI ES60601-1. |
| Electr. Classification | Class II, Type B (Predicate) | Class II, Type BF | Similar: Both Class II. Type BF is different from Type B, but proposed device compliant with ANSI AAMI ES60601-1. This difference does not affect safety/effectiveness. |
| Alarms | Oxygen low-flow monitor, Low oxygen purity, Power failure, Compressor 40 psi pressure relief valve, Thermal protection on compressor (Predicate) | Start-up fail alarm, Low oxygen concentration alarm, Power supply failure alarm, Pressure failure alarm (Outlet block, oxygen flowrate below 0.6 Lpm; Compressor stop) | Similar/Same Principle: Different expressions but similar underlying principles. Proposed device's pressure alarm takes into account more specific scenarios and is compliant with IEC 60601-1-8. |
| Normal Operating Ambient | Temp: 10°C - 35°C; RH: 30-75%; Alt: Up to 7,500 feet (Predicate) | Temp: 5°C ~ 40°C; RH: ≤80%; Pressure: 86kPa ~ 106kPa; Alt: 1828 meter (5997 feet) | Different: Wider temperature and humidity range; lower maximum altitude. |
| Biocompatibility | Not explicitly detailed for predicate | Evaluated per ISO 10993-1, ISO 18562-1, ISO 18562-2, ISO 18562-3, ISO 10993-5, ISO 10993-10, ISO 10993-23. | Compliance with these standards is the acceptance criterion. |
| Electrical Safety & EMC | IEC 60601-1:2005, IEC 60601-1-2:2007 (Predicate) | ANSI AAMI ES60601-1, IEC 60601-1-2, IEC TR 60601-4-2, AIM Standard 7351731, IEC 60601-1-11, IEC 60601-1-8, ISO 80601-2-69 | Similar/Updated Standards: Compliance with newer/updated versions of standards and additional relevant standards (e.g., for home use, alarms). This demonstrates meeting current safety requirements. |
| Software Verification & Validation | Not explicitly detailed for predicate | Performed as intended per FDA Guidance for Premarket Submissions for Software Contained in Medical Devices. | Compliance with FDA V&V guidance is the acceptance criterion. |
| Performance Testing (Bench) | General functional and safety requirements for oxygen concentrators | Appearance, Gas tightness, Sound pressure level, Operation, Accuracy of continuous flowrate, Oxygen yield and oxygen concentration, Oxygen output pressure, Alarm, Error of flowmeter, Leakage current, Dielectric strength. | All bench test results provided in a Performance Test Report (not enclosed). This implies meeting the functional specifications for each. |
| Use Life Test | Not explicitly detailed for predicate | Accelerated life test and performance test after accelerated life test. | Pass/fail implicit in conclusion of substantial equivalence. |
| Cleaning & Disinfection Verification | Not explicitly detailed for predicate | Simulated cleaning and disinfection test and performance test after simulated cleaning and disinfection test. | Pass/fail implicit in conclusion of substantial equivalence. |
| Usability Study | Not explicitly detailed for predicate | 15 participants able to understand user manual/labeling and safely/effectively use device. | Demonstrated successful use by an adequate number of participants. |
2. Sample size used for the test set and the data provenance
- Test Set (for performance/engineering tests): The document doesn't specify a "sample size" in terms of number of devices for specific performance tests (e.g., number of concentrators tested for oxygen concentration). It states "All the bench test results are provided in Performance Test Report," implying that the necessary testing in accordance with the standards was performed on a representative sample of devices.
- Data Provenance: Not explicitly stated, but given the manufacturer is based in China, it's highly probable the non-clinical testing was conducted in China or by labs retained by the manufacturer. It's retrospective in the sense that the tests were completed before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as there is no "ground truth" to be established by experts in the context of human-read images or data for an AI/algorithm. The device is an oxygen concentrator, and its performance is measured against engineering specifications and industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for the type of device and testing performed. This typically applies to human reader studies or image interpretation.
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 is not an AI/algorithm-assisted diagnostic device. No clinical studies were 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 device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is defined by the technical specifications and requirements outlined in recognized national and international standards for oxygen concentrators (e.g., ISO 80601-2-69, various IEC and ISO biocompatibility and electrical safety standards). Performance data (e.g., oxygen concentration, flow rate, noise level) is measured directly from the device against these established benchmarks.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
§ 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).