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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.

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The Power Wheelchair (Model: JMPW-01W) is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

This Power wheelchair is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people. The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, pedal, battery box and charger. The device is powered by Lead-acid Battery pack (24V 20Ah) with 8 miles range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use. The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

The provided document is a 510(k) premarket notification for a power wheelchair (Model: JMPW-01W). It assesses the substantial equivalence of the new device to a legally marketed predicate device (K163204). The document does not describe an AI/ML-driven device or diagnostic study. Instead, it focuses on the engineering and physical performance of a medical device (a power wheelchair) and its compliance with established international standards for such devices.

Therefore, many of the requested elements for an AI/ML device study (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, effect size) are not applicable to this document as it pertains to a physical medical device.

However, I can extract the closest analogous information regarding acceptance criteria and performance based on the provided text, particularly from the "Non-Clinical Test Conclusion" and "Comparison with predicate Device" sections.

Acceptance Criteria and Device Performance for Power Wheelchair (Model: JMPW-01W)

Since this is a physical medical device (power wheelchair) and not an AI/ML diagnostic device, the "acceptance criteria" are primarily based on compliance with international standards (ISO 7176 series for wheelchairs) and demonstrating substantial equivalence to a predicate device. The "performance" is reported as meeting the requirements of these standards.

1. Table of Acceptance Criteria & Reported Device Performance

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not applicable in the context of an AI/ML study. For a physical device like a power wheelchair, testing is typically done on a representative sample or a single unit to demonstrate compliance with standards. The document does not specify a "sample size" in the way it would for a clinical trial or AI/ML validation.
• Data Provenance: The tests were non-clinical, conducted to verify the device meets design specifications and complies with ISO standards. The country of origin for the testing itself is not explicitly stated, but the applicant (manufacturer) is based in Jiangsu, China. The data is from non-clinical testing, not retrospective or prospective patient data.

3. Number of Experts and Qualifications for Ground Truth:

• Not Applicable. Ground truth, in the context of an AI/ML study, refers to the definitive label for data, typically established by human experts. For a physical device, compliance is determined by adherence to engineering standards and test protocols, not expert interpretation of outputs.

4. Adjudication Method:

• Not Applicable. Adjudication is a process to resolve disagreements among human experts in establishing ground truth for AI/ML validation data. This concept does not apply to the conformity testing of a physical medical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not Applicable. MRMC studies are specific to evaluating how AI assistance impacts human reader performance in diagnostic tasks. This is a physical device, not an AI diagnostic tool. No human readers or diagnostic tasks are involved in proving the performance of a power wheelchair.

6. Standalone Performance (Algorithm Only without Human-in-the-loop):

• Not Applicable. This concept applies to AI algorithms. The device is a power wheelchair, which operates based on mechanical and electrical engineering principles, not an AI algorithm. Its "standalone performance" refers to its intrinsic functional capabilities as demonstrated through the ISO standard tests, not an AI algorithm's output.

7. Type of Ground Truth Used:

• Engineering Standards and Test Protocols. For this device, the "ground truth" is established by compliance with the specified international engineering standards (ISO 7176 series, ISO 10993 series) and specific performance metrics (e.g., braking distance, max speed, load capacity). The objective is to demonstrate that the device's measured performance meets the requirements set forth in these standards.

8. Sample Size for Training Set:

• Not Applicable. This is a physical device, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. (See point 8).

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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.

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.

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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.

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