Search Results
Found 3 results
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.
Ask a specific question about this device
(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.
Ask a specific question about this device
(474 days)
The W28 Manual Wheelchair is to provide mobility to persons limited to a sitting position.
A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability. The device is intended for adults only.
W28 is a mechanical wheelchair including four wheels, a steel frame cover black paint and a textilene upholstery that is flame resistant. W28 has a physical dimension of 1100mm × 908mm (depth × width × height) with the seat itself has a dimension of 415mm × 500mm × 475mm (depth × height). The device has a weight capacity of 136 kilograms, and weighs about 20.5 kilograms. The color is dark black.
Occupant mass group of the manual wheelchair belongs to III. Armrest is non flip back/non height adjustable. Rear axle is offset axle, quick release axle.
The components include frame, back upholstery, seat upholstery, handgrip, armrest, armrest pad, side panel, rear wheel, handrim, wheel lock, caster, caster fork, footrest, footplate.
Main materials: Steel (frame, armrest, wheel lock, caster fork, footrest, footplate), PVC (handgrip, side panel, handrim, caster, back upholstery, seat upholstery, armrest pad, rear wheel)
The provided text describes the regulatory clearance for the "Manual Wheelchair (Model W28)" and its substantial equivalence to a predicate device. It does not describe an AI/ML powered medical device, an acceptance criteria table related to AI model performance, or a study to prove an AI model meets acceptance criteria.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets those criteria based on the provided document. The document details the physical characteristics, performance standards, and biocompatibility of a manual wheelchair.
However, I can extract the acceptance criteria and study information related to the manual wheelchair's physical and performance aspects if that is what you intended. Please clarify if you are interested in the acceptance criteria and performance study for the manual wheelchair itself, rather than an AI/ML device.
Ask a specific question about this device
Page 1 of 1