(36 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The P & F POWERED WHEELCHAIR, HC-510 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter 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 P & F POWERED WHEELCHAIR, HC-510. The 510(k) pathway demonstrates substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics like sensitivity, specificity, or reader improvement.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative "acceptance criteria" in the typical sense of a medical device performance study (e.g., target true positive rate for an AI diagnostic). Instead, the acceptance criteria for a 510(k) submission are demonstration of substantial equivalence to a predicate, which includes similar:
- Intended use
- Device technology and principles of operation
- Performance (if applicable, through non-clinical testing)
- Safety and effectiveness
The "reported device performance" is primarily qualitative and comparative in nature, focusing on how the new device matches the predicate.
| Acceptance Criterion (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use | "The intended use between the two devices is the same." (Provides mobility to persons restricted to a seated position) |
| Device Characteristics (Mainframe) | Mainframes are fixed. Materials meet strength and fatigue tests; similar material aspects. Mainframes are similar. |
| Device Characteristics (Dimensions/Weight) | Overall dimensions are similar. The new device is heavier than the predicate device. |
| Device Characteristics (Functional) | Weight capabilities, maximum speed, suspension of cross brace, footplates, armrest, and incline degree are all the same. Back upholstery material is also the same fabric. |
| Device Characteristics (Electronic Systems) | Electronic systems between two devices are from the same suppliers (UL certified): electronic controller, batteries, motor, competent switches, and switching power supplies. Different rechargers, but both UL certified. |
| Safety | "Thus the same safety level for the two devices is assured." Overall appearance differences are "not safety aspect." |
| Performance Testing | EMC Report (ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a 510(k) submission for a physical device (powered wheelchair), not an AI/software as a medical device (SaMD) that typically involves a "test set" of data. The "testing" referred to is performance testing for a physical product (e.g., EMC, strength, fatigue). Therefore, the concepts of "sample size for the test set," "data provenance," "retrospective or prospective," are not applicable in the context of this document. The testing would have involved prototypes of the device.
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. This is not an AI/diagnostic device where "experts" would establish "ground truth" for a test set of data. The "ground truth" for a physical product like a wheelchair is compliance with engineering standards and functional specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a study involving expert adjudication of data.
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 a physical medical device, not an AI/SaMD.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be:
- Compliance with recognized engineering standards: 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).
- Functional specifications: Meeting parameters like maximum speed, weight capabilities, and structural integrity (strength and fatigue tests).
- Safety certifications: UL certification for electronic components.
8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve AI model training data.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device and does not involve AI model training data.
§ 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).