(99 days)
The power wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The D25 power wheelchair is a four wheeled personal mobile device with a complementary chair support system that is powered by two motors. The traveling speed is controlled by the motor, and the traveling direction is controlled by the passenger. This product is a device suitable for disabled people with mobility difficulties and elderly people and it is intended to provide mobility to a disabled or elderly person limited to a seated position. The power wheelchair can be travelled on flat and obstacle ground surface, and direction and speed of the wheelchair can be controlled by the passenger's hand with the help of the joystick. The device can be used to provide indoor and outdoor mobility at a certain distance but not allowed to be travelled on the road or highway. The wheelchair (Model D25) has a base with aluminum alloy frame, two front wheels, two rear wheels, a seat, an adjustable steering column, a tiller console, two electric motors, an electromagnetic brake, 1 rechargeable Lithium-lon Battery with an off-board charger. The movement of the wheelchair is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the wheelchair is not in use and the brake cannot be used manually.
The provided document is a 510(k) premarket notification for a Power Wheelchair (Model D25). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets a specific set of acceptance criteria through a clinical study or performance goals with associated metrics and thresholds.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study design for proving device performance against these criteria, sample sizes, expert involvement, ground truth establishment, or comparative effectiveness studies (MRMC).
The document primarily focuses on:
- Comparison to a predicate device (K113463): It lists similarities and differences in technical characteristics.
- Compliance with consensus standards: It states that the device complies with numerous ISO and IEC standards related to wheelchairs, general medical device safety, and biocompatibility. These standards contain test methods and passing criteria, which implicitly serve as "acceptance criteria" for demonstrating safety and performance in the context of a 510(k) submission for this type of device.
However, the document does not explicitly present:
- A table of "acceptance criteria" with specific quantitative thresholds (like accuracy, sensitivity, specificity, or AUC) that the device itself must meet, alongside its "reported device performance" against those thresholds.
- Details of a standalone algorithm performance study or a multi-reader, multi-case (MRMC) comparative effectiveness study, as these are typically relevant for AI/ML-enabled software devices that perform diagnostic or interpretative functions. This power wheelchair is a physical medical device for mobility.
To answer your request based on the provided text, I must state that the information is not present in the format you've asked for because the submission type (510(k) for a power wheelchair) does not typically require that level of performance study detail as would an AI/ML diagnostic device.
The "study" that proves the device meets the "acceptance criteria" (which are implicitly the requirements of the cited standards) is the non-clinical performance testing summarized in Section VIII.
Here's a breakdown of what is available vs. what is not:
1. A table of acceptance criteria and the reported device performance:
- Not explicitly provided in the requested format with quantitative metrics like accuracy, sensitivity, etc.
- Implicit Acceptance Criteria: Compliance with the listed ISO and IEC standards (e.g., ISO 7176 series for wheelchairs, ISO 10993 series for biocompatibility, IEC 60601-1-2 for EMC). The "reported device performance" is that the device "complied with the requirements of" these standards. For example, for "Minimum braking distance from maximum speed" the subjective device reports "Forward: 0.9 m" while the predicate reports "Forward: 1.5 m". The discussion notes that the subject device has a shorter braking distance, which is considered a positive difference, ensuring safety.
- The "Discussion/Conclusion" column in the comparison table indirectly serves as reported performance against implicitly accepted characteristics.
2. Sample sized used for the test set and the data provenance:
- For physical device testing against standards, the "sample size" is typically a limited number of test units of the device itself (e.g., one or more new units manufactured according to specifications). This is not a "data set" in the way AI/ML models use it.
- Data provenance: Testing was performed by Anhui JBH Medical Apparatus Co., Ltd. in China, as per the manufacturer's location. The document does not specify if the testing was retrospective or prospective, but performance testing of a physical product is inherently prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This type of information (expert review for ground truth) is for diagnostic or interpretative devices, not a power wheelchair. The "ground truth" for a power wheelchair's performance is determined by physical measurements, engineering tests, and adherence to established safety and performance standards by qualified testing personnel and engineers, not by medical experts establishing diagnostic ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. This is relevant for image interpretation or diagnostic studies where human agreement on a diagnosis or finding is needed. For a power wheelchair, adherence to a standard is binary (pass/fail) for each test.
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, not done. This is explicitly for AI/ML-driven diagnostic aids. This document is for a physical mobility device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This refers to AI algorithm performance. While the device has an "Electronic controller" (software), its performance is integrated into the physical device's function and verified through the ISO 7176-14 standard and general software validation, not a standalone algorithmic performance study as understood in AI/ML.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering specifications and compliance with international consensus standards. For example, braking distance is measured against a standard, not determined by expert consensus on a diagnosis. Stability is tested against physical requirements. Biocompatibility is tested against established ISO standards for material safety.
8. The sample size for the training set:
- Not applicable. This term is exclusively for machine learning models. The power wheelchair is a physical product, not a software algorithm that undergoes machine learning training.
9. How the ground truth for the training set was established:
- Not applicable. (See answer to #8).
In summary, the document describes a traditional 510(k) submission for a physical medical device. The "proof" of meeting "acceptance criteria" comes from demonstrating compliance with established international performance and safety standards through bench testing, rather than an AI/ML-style clinical study with human readers and ground truth data sets.
§ 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).