(9 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The PRO WALKER ML-300 Foldable Wheelchair is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
This 510(k) premarket notification for the PRO WALKER ML-300 Foldable Wheelchair does not describe a clinical study of the device's performance against acceptance criteria in the way a diagnostic or AI-driven medical device submission would. Instead, it demonstrates substantial equivalence to a predicate device through adherence to recognized performance standards for mechanical wheelchairs.
Here's an analysis based on the provided text, focusing on how a device like this meets its "acceptance criteria":
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Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Performance Requirements) Reported Device Performance (Compliance) ANSI/RESNA WC Vol. 1 Wheelchair Standards Meets applicable performance requirements ISO 7176 Wheelchair Standards Meets applicable performance requirements CA Technical Bulletin CAL 117 (Flame Retardant) Upholstery fabric meets standard Intended Use: Provide mobility to persons restricted to a seated position Device intended for this purpose Weight Limit: 100 kgs Same as predicate device (100 kgs) Foldability Foldable easily, essential feature same as predicate -
Sample Size used for the test set and the data provenance:
The document does not specify a "test set" in terms of patient data or
clinical images. The "testing" refers to mechanical and material
performance evaluations of the wheelchair itself. Therefore, sample sizes
would refer to the number of wheelchairs or components tested to verify
compliance with the standards. This information is not explicitly provided,
but typically involves a limited number of units or material samples from
manufacturing for destructive and non-destructive testing per the
standards.- Data Provenance: Not applicable in the context of clinical data. The
testing would have been conducted by the manufacturer or a certified
testing lab. The submitter's address is in Taiwan.
- Data Provenance: Not applicable in the context of clinical data. The
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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 this context refers to the defined
parameters and limits within the ANSI/RESNA and ISO standards for
wheelchair performance, as well as the California Technical Bulletin for
flame retardancy. These standards themselves are established by expert
committees in their respective fields (e.g., biomechanical engineers,
rehabilitation specialists for wheelchair standards; fire safety experts for
flammability standards). The submission implies that the device met these
pre-established criteria, not that new ground truth was created by experts
for this specific device's test set. -
Adjudication method:
Not applicable. There's no clinical data or expert review process
described that would require an adjudication method. Compliance with
standards is typically determined by testing results falling within
defined ranges or passing specific procedures. -
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 mechanical wheelchair and does not involve AI or human "readers" interpreting data. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a mechanical wheelchair and does not
involve an algorithm. -
The type of ground truth used:
The "ground truth" for this device's performance is compliance with established international and national performance standards for wheelchairs (ANSI/RESNA WC Vol. 1 and ISO 7176) and material safety standards (California Technical Bulletin CAL 117 for flame retardance). These standards define objective, measurable criteria for safety and performance (e.g., stability, fatigue, static strength, braking effectiveness, flammability). -
The sample size for the training set:
Not applicable. This device is a mechanical wheelchair; there is no "training set" in the context of machine learning or AI. -
How the ground truth for the training set was established:
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The PRO WALKER ML-300 Foldable Wheelchair demonstrated that it meets its acceptance criteria through performance testing against recognized national and international standards for mechanical wheelchairs and fire retardancy. The submission states, "ML-300 Foldable Wheelchair meet the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards... and the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant."
This type of submission for a Class I device typically relies on engineering and laboratory testing to assure compliance with these established standards, rather than clinical trials with human subjects. The substantial equivalence argument further reinforces that the device's design, materials, and performance characteristics are comparable to a device already deemed safe and effective (the BIOTECH B900 SUPER LIGHT Wheelchair, K020472), with any differences (like overall dimension and weight) not impacting safety aspects.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).