(449 days)
The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.
The Electrically Powered Wheelchair - Model HP358E is powered by Li-ion battery, driven by DC motor. Users control direction and adjust speed by controller. The main frame of the wheelchair is made of aluminum alloy. It has a seat base with four-wheeled and two with a back cover on the frame. Wheels are connected to the stainless steel axle receivers via stainless steel axles. On the front end of the frame are assembled two caster housings. Caster forks are mounted to these housings via steel axles. There are two rear caster wheels in back and anti-tip wheels in front to prevent the power chair from tipping. On the front end of the frame, upon the caster, a foot platform is assembled for foot holding. Two non-adjustable armrests are mounted on the frame for user's arm holding. Two grips mounted on the top end of the frame with a brake, and another brake is designed under the seat base. The backrest can be adjusted by squeezing yellow catches on the back together. A storage compartment located between the seat and foot platform. The joystick can be mounted on the left or right side using the quick release mechanism. The subject device has two 2 inch Anti-tippers, two 8 inch front wheels and two 12 inch rear wheels. The motor is DC24V 250W; the battery is 25.2 V 10.4Ah Li-ion battery; the charger is DC 24V, 2A. Max. loading can not be over than 125Kg, the maximum distance of travel on the fully charged battery is 10km and its maximum speed is 6km/h. The braking time is about 2~3s, and the braking distance is ≤1.0m.
The provided text is a 510(k) Summary for an Electrically Powered Wheelchair (Model HP358E). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of a device's performance against specific acceptance criteria in the context of AI or advanced diagnostic algorithms. Therefore, much of the requested information regarding AI device evaluation (e.g., sample size for test set, provenance, expert adjudication, MRMC studies, standalone performance, training set details) is not applicable or present in this document.
However, I can extract the relevant "acceptance criteria" (which in this context are performance and safety standards) and the "device performance" as reported for the proposed device, along with other applicable details.
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for this wheeled device are derived from various ISO and IEC standards that it claims to comply with, and the "reported device performance" are the measured specifications of the HP358E. These are primarily found in the "Non-Clinical Test Summary" and the "Performance Comparison" table.
Acceptance Criteria & Reported Device Performance for Electrically Powered Wheelchair - Model HP358E
| Acceptance Criteria (from Standards/Predicate Device) | Reported Device Performance (Model HP358E) |
|---|---|
| Material/Construction Standards (Implied Compliance) | |
| Main frame material: Aluminum alloy (per ASTM B221 for predicate) | Main frame: Aluminium alloy |
| Performance Standards (ISO & EN) | |
| Static Stability: Conforms to ISO 7176-1:2014 | Static stability forward: 22.4° |
| Static stability rearward: 18.2° | |
| Static stability sideways: 23° | |
| Dynamic Stability: Conforms to ISO 7176-2:2017 | (Not explicitly stated as a single value, but compliance implies meeting the standard's criteria) |
| Effectiveness of Brakes: Conforms to ISO 7176-3:2012 | Minimum braking distance: 1 m (Same as predicate) |
| Energy Consumption & Distance Range: Conforms to ISO 7176-4:2008 | Cruising Range: 10 km (Predicate: 18 km - shorter cruising range noted, but implies compliance with standard) |
| Dimensions, Mass & Maneuvering Space: Conforms to ISO 7176-5:2008 | Dimensions: 960mm635mm880mm (37.8"x25.0"x34.6") |
| Weight, w/ Battery: 59.15 lbs / 27.2 kg | |
| Min. Turning Radius: 57.5" (1460mm) (Larger than predicate 32.5", but compliance implies meeting the standard) | |
| Max Speed, Acceleration & Deceleration: Conforms to ISO 7176-6:2018 | Max Speed: 6 km/h (Same as predicate) |
| Max Speed Forwards: 3.75 mph (6 km/h) (Same as predicate) | |
| Max Speed Backward: 1.80 mph (2.9 km/h) (Predicate: 1.86 mph - noted as different but implies compliance with standard) | |
| Seating & Wheel Dimensions: Conforms to ISO 7176-7:1998 | Front wheel: 8" (PU solid tire) |
| Rear tire: 12" (Pneumatic tire) | |
| Static, Impact & Fatigue Strengths: Conforms to ISO 7176-8:2014 | Max. loading: 275 lbs (125 kg) (Larger than predicate 264 lbs) |
| Climatic Tests: Conforms to ISO 7176-9:2009 | (Implied compliance) |
| Obstacle-climbing ability: Conforms to ISO 7176-10:2008 | Obstacle climbing: 2.36" (60mm) (Larger than predicate 1.36") |
| Maximum obstacle climbing: 2.36" (60mm) (Larger than predicate 1.36") | |
| Test Dummies: Conforms to ISO 7176-11:2012 | (Implied compliance) |
| Coefficient of Friction of Test Surfaces: Conforms to ISO 7176-13:1989 | (Implied compliance) |
| Power & Control Systems: Conforms to ISO 7176-14:2008 | Controller: Shanghai Micon Mechanical&Electrical Co.,Ltd., M7084 (Evaluated per standard and software validation) |
| Information Disclosure, Documentation & Labeling: Conforms to ISO 7176-15:1996 | (Implied compliance, and stated "Comply with FDA Regulatory Requirements" in 'Safety Comparison' table) |
| Resistance to Ignition of Postural Support Device: Conforms to ISO 7176-16:2012 | (Implied compliance, and "flame retardant test of the seat cushion/back cushion and armrest" mentioned in summary discussion) |
| Electromagnetic Compatibility: Conforms to ISO 7176-21:2009 | (Implied compliance) |
| Setup Procedures: Conforms to ISO 7176-22:2014 | (Implied compliance) |
| Electrically powered wheelchairs, scooters and their chargers: EN 12184:2014 | (Implied compliance) |
| Basic Safety and Essential Performance: IEC 60601-1: 2012 | (Implied compliance) |
| Electromagnetic Disturbances: IEC 60601-1-2 Edition 4.0 2014-02 | (Implied compliance) |
| Safety of secondary cells and batteries: IEC 62133:2012 | Battery: Lithium-ion, FH2410 10.4Ah x25.2VDC x1 pc (Implied compliance) |
| Biocompatibility Standards | |
| Biocompatibility: Comply with ISO 10993-1, FDA Guidance | Cytotoxicity (ISO 10993-5:2009) |
| Irritation and Skin Sensitization (ISO 10993-10:2010) (for other patient-contacting materials; Joystick materials refer to predicate K070501) | |
| Software Standards | |
| Software Validation: In accordance with FDA Nov 2005 guidance | Software validation conducted; Moderate level of concern designation |
| General Operational Limits | |
| Maximum safe operational incline: (Predicate 8 degrees) | Maximum safe operational incline: 10 degrees (Larger than predicate) |
2. Sample sized used for the test set and the data provenance:
This document describes the testing of a physical medical device (an electrically powered wheelchair) against engineering and safety standards. The "test set" here refers to the actual device prototypes or samples subjected to the described non-clinical tests. The number of individual devices tested is not specified, but it's standard practice in such non-clinical testing to test a representative sample size to ensure reliability and repeatability according to the testing standards (e.g., ISO and IEC).
- Sample Size: Not explicitly stated for each test, but implied to be a sufficient number of device units to perform the required non-clinical tests according to the cited ISO/IEC standards.
- Data Provenance: The tests are non-clinical engineering and safety performance tests, not clinical data from patients. The document does not specify the location where these tests were performed, but the manufacturer is based in China. The data would be derived from the physical testing of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the "ground truth" for non-clinical performance and safety of a wheelchair is established by the objective measurements against established international engineering and safety standards (ISO, IEC, EN). There are no "experts" establishing a "ground truth" in the way radiologists establish ground truth for an AI diagnostic algorithm; rather, the device's performance is measured and compared against the limits and criteria defined by the standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable for non-clinical engineering and safety tests. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical imaging studies, particularly for AI device evaluations where human expert consensus is required for labeling 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:
This is not applicable. The device is an electrically powered wheelchair, not an AI-powered diagnostic tool, and therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical medical device, not an algorithm, so the concept of standalone algorithm performance is irrelevant.
7. The type of ground truth used:
The "ground truth" for the device's performance and safety is derived from established international engineering and safety standards (ISO, IEC, EN). The device's physical and functional attributes were measured and assessed to ensure they comply with the stipulated requirements of these standards. For biocompatibility, the ground truth is established by adherence to ISO 10993 series standards and related FDA guidance, with specific tests like cytotoxicity, irritation, and skin sensitization. For software, the ground truth for its safety and functionality is established through validation against FDA guidance for "Moderate Level of Concern" software.
8. The sample size for the training set:
This is not applicable. The document does not describe an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable, as there is no training set for this device.
§ 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).