(209 days)
The device is a power wheelchair intended to provide mobility to persons restricted to a sitting position.
The Electric wheelchair (Model S7204, S7205) is a power wheelchair intended to provide mobility to persons restricted to a sitting position. The Electric wheelchair (Model S7204, S7205) is about 136 kg weight capacity. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a welded-aluminum frames, sealed transaxle motors drive system, electromagnetic braking system, electric motor controller and Li-ion batteries with an off-board battery charger. It is powered by rechargeable batteries with 45 km which maximum speed up to 7 km/h. The controller with a joystick attaches to either armrest and allows the rider to control the movement and velocity of the powered wheelchair. When the joystick is released. the electromagnetic brake will be actuated and the power wheelchair is slow to stop. It consists of three parts which are chair part, control part and drive part. Overall it mainly has a basic aluminum alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a footrest, an controller, an electric motor, an electromagnetic brake and a Lithium battery with an off-board charger. The result of "tiltover" tests performed laterally (12° ), posteriorly (16° ), and anteriorly (12° ) with a user of maximum allowable weight in the least stable configuration: No overturn performed laterally, posteriorly, and anteriorly with 136kg in the least stable configuration.
The provided text is a 510(k) summary for an Electric Wheelchair, Models: S7204, S7205. It describes the device, its intended use, and comparative testing against predicate devices to establish substantial equivalence.
However, the document does not describe an AI medical device or a study involving human readers or AI assistance. It focuses on the physical and functional characteristics of an electric wheelchair and its compliance with various ISO and IEC standards relevant to wheelchairs and medical electrical equipment.
Therefore, many of the requested criteria cannot be extracted from this document, as they pertain to AI/ML device performance and clinical studies involving expert readers, which are not present here.
Here's a breakdown based on the information available:
Acceptance Criteria and Device Performance Study (Electric Wheelchair)
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" in a typical table format for an AI device. Instead, it refers to compliance with various international standards for wheelchairs and medical electrical equipment. The "reported device performance" is mainly a comparison of the subject device's specifications against those of two predicate devices, with notations on substantial equivalence.
Key Performance & Safety Standards (implicit acceptance criteria by compliance):
| Standard | Purpose/Criteria | Device Performance / Compliance |
|---|---|---|
| ISO 7176-1: 2014 | Static stability | Performed. No overturn performed laterally (12°), posteriorly (16°), and anteriorly (12°) with 136kg in the least stable configuration. (Also mentioned in Device Description) |
| ISO 7176-2: 2017-10 | Dynamic stability | Compliant (implied by inclusion in "Tests Summary" and overall SE conclusion) |
| ISO 7176-3: 2012 | Effectiveness of brakes | Compliant. Minimum Braking Time: 1.54s, Minimum Braking Distance: 1.5m, Brake distance-Normal operation (Horizontal-Forward-Max speed): 1.5-1.8m. These values, though different from predicate, still comply with ISO 7176-3. |
| ISO 7176-4: 2008-10-01 | Energy consumption & theoretical distance range | Range: 45km. Compliant with standard requirements (implied by inclusion in "Tests Summary" and Note 2 stating compliance with ISO 7176 series standards). |
| ISO 7176-5: 2008-06-01 | Overall dimensions, mass & maneuvering space | Compliant. Various dimensions and masses are provided for models S7204/S7205 (e.g., Size, Overall length, Overall width, Total mass, Mass of heaviest part, Minimum turning diameter). Differences from predicates are noted but deemed not to raise safety/effectiveness issues as they are "mechanical parameters" and "very similar." |
| ISO 7176-6: 2018-06 | Maximum speed, acceleration & deceleration | Compliant. Speed: 7km/h (4.3mph). Differences from predicates are noted but deemed not to raise safety/effectiveness issues as they comply with ISO 7176 series standards. |
| ISO 7176-7: 1998-05-15 | Seating and wheel dimensions | Compliant. Effective seat depth: 480mm, Effective seat width: 520mm, Back support height: 810mm, Front of arm support to back support: 250mm, Tires: 6" front, 14" middle, 6" rear (solid wheels). Differences from predicates are noted but deemed not to raise safety/effectiveness issues as they are "mechanical parameters" and "very similar." |
| ISO 7176-8: 2014 | Static, impact and fatigue strengths | Compliant (implied by inclusion in "Tests Summary") |
| ISO 7176-9: 2009 | Climatic tests | Compliant (implied by inclusion in "Tests Summary") |
| ISO 7176-10: 2008 | Obstacle-climbing ability | Safe Gradient / Maximum Gradient: 10°. Compliant with standard requirements (implied by inclusion in "Tests Summary" and Note 2 stating compliance with ISO 7176 series standards). |
| ISO 7176-11: 2012-12-01 | Test dummies | Used in testing (implied by inclusion in "Tests Summary") |
| ISO 7176-13: 1989-08-01 | Coefficient of friction of test surfaces | Used in testing (implied by inclusion in "Tests Summary") |
| ISO 7176-14: 2008 | Power and control systems | Compliant (implied by inclusion in "Tests Summary") |
| ISO 7176-15: 1996 | Information disclosure, documentation and labeling | Compliant (implied by inclusion in "Tests Summary") |
| ISO 7176-16: 2012-12-01 | Resistance to ignition of postural support devices | Compliant (implied by inclusion in "Tests Summary") |
| ISO 7176-21: 2009-04-01 | Electromagnetic compatibility (EMC) | Compliant ("EMC" row in comparison table explicitly states "ISO 7176 - 21") |
| ISO 10993-5:2009 & ISO 10993-10: 2009 | Biocompatibility (In Vitro cytotoxicity, Irritation & delayed-type hypersensitivity) | All user directly contacting materials are compliant with ISO10993-5 and ISO10993-10 requirements. |
| IEC 62304: 2006 | Medical device software life-cycle processes | Not applicable for a non-software/AI medical device submission where software is not the primary mechanism of action or being evaluated as an AI. It's likely general software development for embedded control. |
| IEC 60601-1-6: 2010 & IEC 62366: 2007 | Usability engineering | Compliant (implied by inclusion in "Tests Summary"). These apply to the device's operational interface and safety for the user. |
| Maximum capacity | Weight capacity | 136 kg. Substantially Equivalent to predicate devices (one had 150 kg, the other 136 kg). |
2. Sample size used for the test set and the data provenance
Not applicable. The "test set" here refers to the device itself and components undergoing engineering and safety tests, not a dataset for an AI model. Testing was performed on the electric wheelchair models S7204 and S7205. The provenance of the data is from specific tests conducted by the manufacturer/laboratories against established international standards.
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/ML device requiring expert ground truth for a diagnostic or prognostic task. The "ground truth" is established by the specifications defined in the international standards (e.g., how to measure static stability, speed, brake performance).
4. Adjudication method for the test set
Not applicable. This concept typically applies to expert review of data for AI model training or evaluation, which is not relevant here. The evaluation is based on compliance of physical and functional tests with established standards.
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 an electric wheelchair, not an AI-assisted diagnostic or prognostic device. No MRMC study or evaluation of human readers with/without AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an electric wheelchair. There is no standalone algorithm being evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" is defined by the objective performance criteria and methodologies outlined in the referenced ISO and IEC standards. For example, static stability is measured according to ISO 7176-1, brake performance according to ISO 7176-3, and biocompatibility according to ISO 10993. These are engineering and safety standards, not clinical ground truth of a diagnostic nature.
8. The sample size for the training set
Not applicable. This is not an AI/ML device relying on a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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).