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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The PRO WALKER Power Wheelchair, PL-200 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

The provided text describes a 510(k) premarket notification for a powered wheelchair, the PRO WALKER Power Wheelchair, PL-200. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with acceptance criteria based on performance metrics. Therefore, many of the requested elements are not applicable in this context.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission seeking substantial equivalence, "acceptance criteria" and "device performance" are typically framed in terms of comparison to a legally marketed predicate device, rather than specific quantitative performance goals met by the new device in a standalone study. The criteria for acceptance in this context are demonstrating that the new device is as safe and effective as the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: Not applicable. This submission doesn't involve a clinical "test set" in the traditional sense of patient data. The performance testing is based on engineering standards and direct comparison of specifications between the new device and the predicate.
• Data provenance: Not applicable for clinical data. The performance testing refers to industry standards (e.g., ANSI / RESNA WC/Vol.2-1998) and electromagnetic compatibility standards (e.g., CISPR 11: 1990). The device manufacturer is PRO WALKER INC. located in Taiwan.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No "ground truth" was established by experts for a clinical test set. The evaluation is based on engineering specifications and adherence to recognized standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or adjudication of expert interpretations was performed.

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/software device and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/software device. The performance testing mentioned (EMC Report, ANSI/RESNA standards) are for the physical device's safety and functionality, not an algorithm's standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this type of device and submission, "ground truth" is established by adherence to recognized performance standards (e.g., ANSI/RESNA for wheelchairs, CISPR/EN/IEC for EMC) and by demonstrating that design differences do not raise new questions of safety or effectiveness compared to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is not a machine learning device, so there is no training set.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth for one.

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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":

1. 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

2. 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.

3. 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.

4. 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.

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 mechanical wheelchair and does not involve AI or human "readers" interpreting data.

6. 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.

7. 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).

8. 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.

9. 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.

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