(157 days)
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The HEARTWAY Electrically Powered Wheelchair, Model P19 is battery powered and configured with four solid wheels, a seat, a controller to control the driving function, a main frame, a foot-rest, a pair of arm-rest, a back-rest, and a set of anti-tippers. Main frame carries a width foldable seat system and a set of rear anti-tipper to prevent a patient from tipping their wheelchairs backward. P19 maximum weight capacity is 250 lbs (113kg). Maximum speed is 3.75 mph (6 km per hour). The device can be folded for transport and is provided with an external battery charger.
This document is a 510(k) premarket notification for the HEARTWAY Electrically Powered Wheelchair, Model P19. It focuses on demonstrating substantial equivalence to a predicate device, not on proving general acceptance criteria for a novel device through a standalone study. Therefore, several aspects of your request (e.g., sample sizes for test/training sets, number of experts for ground truth, MRMC study, how ground truth was established) are not directly applicable or available in this type of submission.
However, I can extract the acceptance criteria (standards applied) and the reported device performance in relation to those standards from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Applied) | Reported Device Performance |
|---|---|
| EMC Testing: | Completed. |
| - ANSI / RESNA WC/Vol.2: 2009 | |
| - CISPR 11: 2004+A2:2006 | |
| - EN61000-4-2: 2008 | |
| - IEC61000-4-3: 2006 | |
| - IEC61000-4-8: 2001 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods) | |
| - ISO 7176-21: Requirements and test method electromagnetic compatibility of powered wheelchairs and motorized scooters, 2009 | |
| Mechanical & Performance Testing (ISO 7176 Series): | Completed. |
| - ISO 7176-1: Determination of static stability, 1999 | Passed. (Implied by conclusion of substantial equivalence) |
| - ISO 7176-2: Determination of dynamic stability of electric wheelchairs, | |
| 2001 (Dynamic incline angle) | Passed. "Two devices all pass the ISO 7176-2 standard, the dynamic stabilities of two devices are all assured." |
| - ISO 7176-3: Determination of effectiveness of brakes, 2012 | Passed. (Implied by conclusion of substantial equivalence) |
| - ISO 7176-4: Energy consumption of electric wheelchairs for determination of | |
| theoretical distance range, 2008 | Passed. (Implied by conclusion of substantial equivalence) |
| - ISO 7176-5: Determination of overall dimensions, mass and manoeuvring space, 2008 | Passed. (Implied by conclusion of substantial equivalence) |
| - ISO 7176-6: Determination of maximum speed, acceleration and deceleration of | |
| electric wheelchairs, 2001 | Passed. (Implied by conclusion of substantial equivalence) |
| - ISO 7176-7: Determination of seating dimensions Definitions and measuring method, 1998 | Passed. (Implied by conclusion of substantial equivalence) |
| - ISO 7176-8: Static, impact and fatigue strength for manual wheelchairs, 1998 | Passed. (Implied by conclusion of substantial equivalence) |
| - ISO 7176-9: Climatic tests for electric wheelchairs, 2009 | Passed. (Implied by conclusion of substantial equivalence) |
| - ISO 7176-10: Determination of obstacle-climbing ability of electrically powered wheelchairs, 2008 | Passed. (Implied by conclusion of substantial equivalence) |
| - ISO 7176-11: Test dummies, 2012 | Passed. (Implied by conclusion of substantial equivalence) |
| - ISO 7176-13: Determination of coefficient of friction of test surfaces, 1989 | Passed. (Implied by conclusion of substantial equivalence) |
| - ISO 7176-14: Power and control system for electric wheelchairs, 2008 | Passed. (Implied by conclusion of substantial equivalence) |
| - ISO 7176-15: Requirements for information disclosure, documentation and | |
| labelling, 1996 | Passed. (Implied by conclusion of substantial equivalence) |
| Ignition Resistance: | Completed. |
| - ISO 7176-16: Requirements and test methods for resistance to ignition of | |
| upholstered parts, 2012 | "Back upholstery material...passed the resistance ignition test." |
| Material Biocompatibility: | Completed. |
| - ISO 10993-1:2009 | "Same" as predicate (which references these standards). |
| - ISO 10993-5:2009 | |
| - ISO 10993-10:2010(E) | |
| Charger Safety Certification: | Completed. |
| - UL-certified (UL E201162) | "Two chargers are UL-certified and there are no safety and effectiveness hazards." |
| - UL 1310 (Predicate device charger) | (Predicate's standard, not explicitly stated for subject, but subject's charger is UL-certified) |
2. Sample size used for the test set and the data provenance
- Sample Size: This document does not specify a "test set" in the context of a statistical study with a specific number of units. The testing refers to conformity with established international and national standards (ISO, ANSI/RESNA, CISPR, IEC) for medical devices like powered wheelchairs. Typically, such testing involves a limited number of physical units (prototypes or production samples) of the device being evaluated, not a large "test set" of data samples. The exact number of units tested is not provided.
- Data Provenance: The tests were performed according to international standards for wheelchair performance and safety. The location where these tests were conducted is not explicitly stated, but the manufacturer is based in Taiwan, R.O.C., so it is likely undertaken by a certified lab either in Taiwan or abroad. The nature of these tests is prospective (evaluation of the device itself) rather than retrospective data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable to this type of submission. "Ground truth" in this context is established by the well-defined and quantitative metrics and methodologies specified within the cited international engineering and safety standards (e.g., ISO 7176 series). Expertise is embedded in the standards themselves and the accreditation of the testing facility, rather than a panel of clinical experts establishing ground truth for individual cases.
4. Adjudication method for the test set
- Not applicable. Performance against engineering and safety standards is typically determined by objective measurements and pass/fail criteria defined within the standards, not through adjudication by multiple experts.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging AI devices, where human readers (e.g., radiologists) interpret images with and without AI assistance. The HEARTWAY Electrically Powered Wheelchair is a physical medical device for mobility, not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical powered wheelchair, not an algorithm. Its performance is evaluated through physical and electrical testing against established standards, not as a standalone algorithm.
7. The type of ground truth used
- The "ground truth" for the device's performance is defined by adherence to the objective, measurable parameters and criteria set forth in the international engineering, safety, and electromagnetic compatibility standards (e.g., ISO 7176 series, ANSI/RESNA WC/Vol.2, CISPR, IEC for EMC, ISO 10993 for biocompatibility, UL for chargers). These standards represent an industry consensus on acceptable performance and safety for such devices.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device. There is no 'training set' in the context of algorithm development.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set mentioned in this context.
§ 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).