(59 days)
The Power wheelchair 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.
It is a motor driven, indoor and outdoor 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 Li-ion Battery pack (25.2V 10.4Ah*2) with 20 Km 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) summary for an Electrically Powered Wheelchair (Models: YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel AI/ML algorithm or its associated performance study.
Therefore, the document does not contain the information requested in questions 2 through 9 regarding sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is typically found in submissions for AI/ML-powered devices, which require specific clinical performance studies to validate their effectiveness.
However, I can extract information related to acceptance criteria (safety and performance standards) and the "study" that proves the device meets them, which in this case, refers to non-clinical testing against recognized performance standards.
Here's the relevant information from the document:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this device are primarily adherence to a comprehensive set of ISO 7176 series standards for wheelchairs, along with biocompatibility standards (ISO 10993) and electromagnetic compatibility (EMC) standards. The "reported device performance" is essentially a statement of compliance with these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Biocompatibility | |
| ISO 10993-5: 2009 (In Vitro Cytotoxicity) | All user directly contacting materials are compliant with ISO 10993-5. |
| ISO 10993-10: 2010 (Irritation And A Skin Sensitization) | All user directly contacting materials are compliant with ISO 10993-10. |
| Functional & Performance Standards (ISO 7176 Series) | |
| ISO 7176-1: 2014 (Static stability) | Test results meet design specification. |
| ISO 7176-2: 2017 (Dynamic stability of Powered Wheelchairs) | Test results meet design specification. |
| ISO 7176-3: 2012 (Effectiveness of brakes) | Test results meet design specification. |
| ISO 7176-4: 2008 (Energy consumption & theoretical distance range) | Test results meet design specification. |
| ISO 7176-5: 2008 (Overall dimensions, mass and manoeuvring space) | Dimensions and mass determined. |
| ISO 7176-6: 2018 (Maximum speed, acceleration and deceleration) | Maximum speed, acceleration, and deceleration determined. |
| ISO 7176-7 (Measurement of seating and wheel dimensions) | Seating and wheel dimensions determined. |
| ISO 7176-8: 2014 (Static, impact and fatigue strengths) | All test results meet requirements in Clause 4 of ISO 7176-8. |
| ISO 7176-9: 2009 (Climatic tests for Powered Wheelchairs) | Device continues to function according to manufacturer's specification. |
| ISO 7176-10: 2008 (Obstacle-climbing ability) | Obstacle-climbing ability determined. |
| ISO 7176-11: 2012 (Test dummies) | Test dummies used meet requirements of ISO 7176-11. |
| ISO 7176-13: 1989 (Coefficient of friction of test surfaces) | Coefficient of friction determined for use in other 7176 series tests. |
| ISO 7176-14: 2008 (Power and control systems) | All test results meet requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14. |
| ISO 7176-15: 1996 (Information disclosure, documentation and labeling) | Information disclosure, documentation, and labeling meet requirements. |
| ISO 7176-16: 2012 (Resistance to ignition of postural support devices) | Performance of resistance to ignition meet requirements. |
| ISO 7176-21: 2009 (EMC of electrically powered wheelchairs) | EMC performance results meet requirements. |
| ISO 7176-25: 2013 (Batteries and chargers for powered wheelchairs) | Performance of batteries and charger meet requirements in Clause 5 and 6. |
| Other | |
| Label and labeling (FDA Regulatory) | Conforms to FDA Regulatory. |
The Study that Proves the Device Meets Acceptance Criteria:
The "study" to demonstrate that the Electrically Powered Wheelchairs meet the acceptance criteria is described as non-clinical tests conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device.
Specifically, the document states: "Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards."
The specific standards listed above (ISO 10993 series, ISO 7176 series, and ISO 7176-21) constitute the framework for these non-clinical tests. These tests assess various aspects of the wheelchair's safety and performance, such as stability, braking, speed, obstacle climbing, material biocompatibility, and electromagnetic compatibility.
The following questions (2-9) are not applicable to this 510(k) submission as it focuses on substantial equivalence of a physical medical device (powered wheelchair) through non-clinical testing against recognized standards, rather than the performance of an AI/ML algorithm or a clinical study.
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Sample size used for the test set and the data provenance: Not applicable. This submission relies on non-clinical engineering tests performed on the physical device, not on a dataset or test set in the context of AI/ML.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI/ML, is not relevant to the non-clinical testing of a physical medical device against performance standards. The "ground truth" for these tests is defined by the objective pass/fail criteria of the specified ISO standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept applies to expert review and consensus for ground truth establishment in AI/ML performance studies, which is not present here.
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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 a traditional medical device (powered wheelchair), not an AI-assisted diagnostic or therapeutic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm being evaluated in this submission.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a powered wheelchair's performance is objective compliance with engineering and safety standards, as measured by standard test procedures, not clinical outcomes or expert labels.
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The sample size for the training set: Not applicable. There is no AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established: Not applicable. There is no AI/ML algorithm that requires a training set.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).