(146 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 powered wheelchair DYW30A(D09) is driven by two DC motors, and is suitable for indoor uses. It is an individual transportation vehicle for disabled and elderly people that experience difficulties in walking. The powered wheelchair DYW30A(D09) comes as preassembled, designed to be lightweight, easily maneuvered, highly portable, and most importantly, safe and comfortable.
It consists of two foldable armrests, a seat belt, a backrest, a seat cushion, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller.
The device is powered by two 12 volt / 6 Ah Lithium-ion batteries with 11.2 miles travel range that can be recharged by an off-board battery charger that can be plugged into an AC outlet (110-220 V, 50-60 Hz), when the device is not in use.
The user can activate the joystick to move in the direction of the joystick is actuated. When the user releases the joystick, the device slows to stop and the brakes are automatically re-engaged. The maximum weight capacity of DYW30A(D09) is 264 lbs and its maximum speed is 3.75 mph.
The provided document is a 510(k) summary for a Powered Wheelchair (DYW30A(D09)). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study of an AI/algorithm-based device and its acceptance criteria as requested in the prompt.
Therefore, many of the specific questions regarding acceptance criteria and study methodologies for an AI/algorithm-based device (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) cannot be answered from the provided text.
The document primarily addresses the safety and effectiveness of a physical medical device (a powered wheelchair) through performance testing against established ISO and IEC standards, and a comparison to a predicate device.
However, I can extract the information relevant to the performance testing and comparison aspects that serve as the "acceptance criteria" for this specific medical device.
Here's what can be extracted based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria for this medical device are based on compliance with a comprehensive set of international standards (ISO and IEC) for wheelchairs. The document reports that the device "passed" these tests, implying compliance with the requirements within those standards. The specific performance values are not always listed as "reported device performance" in a separate row but are implicitly confirmed by passing the tests and in the comparison table.
| Acceptance Criteria (Standard / Test) | Reported Device Performance (Implied by "Passed" / Stated in Comparison) |
|---|---|
| ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability | Passed |
| ISO 7176-2:2001 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs | Passed |
| ISO 7176-3:2013 Wheelchairs - Part 3: Determination of effectiveness of brakes | Passed (Minimum braking distance: 1m, which is smaller/better than predicate's 1.5m) |
| ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range | Passed (Cruising Range: 11.2 miles (18 km), which is larger than predicate's 9.3 miles) |
| ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space | Passed (Dimensions: 37.4" x 22.6" x 36.2"; Weight: 51.8 lbs / 23.5 kg) |
| ISO 7176-6:2001 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs | Passed (Max Speed Forwards: 3.75 mph (6 km/h); Max Speed Backward: 1.86 mph (3.0 km/h)) |
| ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions | Passed (Front wheel: 7"x1.77"; Rear wheel: 12.5"x2.25") |
| ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strength | Passed |
| ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs | Passed |
| ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs | Passed (Maximum obstacle climbing: 1.36" (34.5 mm)) |
| ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies | Passed |
| ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces | Passed |
| ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods | Passed (Controller: Changzhou Billon Electronic Appliance Co., Ltd., WS-1) |
| ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling | Passed |
| ISO 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices | Passed |
| ISO 7176-21:2009 Wheelchairs - Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters | Passed |
| ISO 7176-25:2013 Wheelchairs - Batteries and chargers for powered wheelchairs | Passed (Battery: Lithium-ion, 6 Ah x 24 VDC x 2 pcs; Charger: High Power Technology Inc., HP0060W(L2)) |
| IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | Passed |
| IEC 662133:2012 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications | Passed |
| Biocompatibility Testing (ISO 10993-5 and ISO 10993-10) for patient-contacting parts (Seat, Backrest, Safety belt, Joystick, Armrest) | Conducted (implies passed for PVC Vinyl and PU Foam, with rationale based on common use and no adverse claims for thousands of units sold in market). |
| Maximum Safe Operational Incline | 8 degrees (restricted from predicate's 12 degrees, deemed sufficient for indoor use) |
| Max Loading | 264 lbs (compared to predicate's 250 lbs) |
| Turning Radius | 32.5" (833 mm) (compared to predicate's 31.5", difference deemed minor inconvenience, not safety concern) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the performance tests. Typically, device testing standards involve a certain number of units or test cycles, but this is not detailed in the summary.
- Data Provenance: The testing was conducted by or on behalf of Nanjing Jin Bai He Medical Apparatus Co., Ltd. in Nanjing, Jiangsu, China. The document is a summary of findings, not raw data. The testing is assumed to be prospective as it's to demonstrate compliance for a new 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 device is a physical product being tested against engineering standards, not an AI/algorithm-based diagnostic tool requiring expert consensus for ground truth. The "ground truth" is established by the specifications and measurement methodologies defined in the listed ISO and IEC standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for physical device performance testing against engineering 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 device is a powered wheelchair, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for this device comes from the established and recognized international standards (ISO and IEC) for wheelchair performance and safety. These standards define the test methods, acceptance limits, and measurement criteria.
8. The sample size for the training set:
Not applicable. This is not an AI/algorithm-based device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 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).