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510(k) Data Aggregation
(62 days)
PRO WALKER PL-200 POWER WHEELCHAIR
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.
| Feature/Criterion (Comparison to Predicate) | Reported Device Performance (PRO WALKER PL-200 vs. SINON W401) |
|---|---|
| Intended Use | Same: provide mobility to persons restricted to a seated position. |
| Batteries | Same brand, similar U1 type. |
| Control Systems | Same brand (Dynamic), different types (SHARK for new, DL for predicate). Deemed substantially equivalent as "different types" don't lead to safety concerns. |
| Chargers | Same supplier, UL certified. |
| Foldable Frame | Same. |
| Removable Armrest Type | Same. |
| Weight Limit | Same. |
| Back Upholstery Material | Same, passed resistance ignition test by SGS. |
| Cruising Range | 20-25 miles (new) vs. 20 miles (predicate). New device has longer range due to presumably larger batteries (predicate's batteries are smaller). Deemed substantially equivalent as "real range depends on practice environments" and the difference is not a safety concern. |
| Maximum Speed | 4.7 mph (new) vs. 4 mph (predicate). Deemed substantially equivalent as "do not lead any safety considerations" and "higher speed means the predicate device shall meet relevant requirements for the braking time, distance, and dynamic stability for safety considerations." |
| Appearance Dimensions (Overall dimensions, wheel size, seat dimensions) | Different. Deemed substantially equivalent as "For the regular operator, these differences for the two devices do not lead to any performance differences." |
| Safety Standards Adherence | EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and the chargers - requirements and test methods). |
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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