(41 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The P & F POWERED WHEELCHAIR, HC-500SB is an indoor / outdoor 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.
Here is the information about the acceptance criteria and study for the P & F POWERED WHEELCHAIR, HC-500SB:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from Predicate Device) | Reported Device Performance (P & F POWERED WHEELCHAIR, HC-500SB) |
|---|---|
| Mainframe strength and fatigue test compliance | Mainframes meet strength and fatigue tests, material aspects are similar. |
| Maximum speed | Same as predicate device. |
| Suspension of cross brace | Same as predicate device. |
| Footplates | Same as predicate device. |
| Armrest | Same as predicate device. |
| Wheel lock | Same as predicate device. |
| Seat and back upholstery material resistance ignition test compliance | Same fabric as predicate device, passed resistance ignition test by SGS. |
| Electronic systems (controller, batteries, motor, switches, power supplies) UL certification | Same suppliers, all passed UL certification. |
| Recharger UL certification | Different recharger than predicate, but also passed UL certification. |
| Safety level | Assured to be the same safety level as the predicate device. |
| Overall dimensions (comparable for intended use) | Different (lighter and more ingenious), but "overall appearance differences are not safety aspect" and considered substantially equivalent. |
| Weight capabilities (comparable for intended use) | Different, but considered substantially equivalent. |
| Incline degree (comparable for intended use) | Different, but considered substantially equivalent. |
| Cruising range (comparable for intended use) | Different, but considered substantially equivalent. |
| EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods) | Device was tested against these standards. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a distinct "test set" in terms of patient data or a specific number of devices tested for each individual criterion. The testing appears to have been conducted on a single prototype or representative unit of the P & F POWERED WHEELCHAIR, HC-500SB.
- Data Provenance: Not applicable in the context of patient data for a diagnostic/AI device. The testing was conducted by the manufacturer (P & F BROTHER IND., CORP.) and potentially third-party labs (e.g., SGS for upholstery, UL for electronics) on the device itself, not on patient data. This is product performance testing, not clinical data testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI or diagnostic device that relies on expert interpretation of data to establish a ground truth for a test set. The "ground truth" here is compliance with established engineering and safety standards.
4. Adjudication method for the test set:
- Not applicable. There was no "test set" of patient data requiring adjudication. Compliance with engineering standards and comparison to a predicate device were the primary methods.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a powered wheelchair, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not an algorithm-based device. Performance testing focused on the physical and electrical safety and functionality of the wheelchair itself.
7. The type of ground truth used:
- The "ground truth" for this submission is based on:
- Compliance with established international and national standards: Specifically, EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995, and UL certification for electrical components.
- Substantial Equivalence to a legally marketed predicate device: The P & F POWER WHEELCHAIR, HC-510 (K070350). The performance characteristics of the predicate device serve as the benchmark for many of the "acceptance criteria."
8. The sample size for the training set:
- Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. There was no 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).