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This Electric 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 product is intended only carry one person and used as a means of transportation for the old and infirm who have difficulty in moving.

The maximum occupant mass is 100kg.

The Electric Wheelchair is a battery powered four wheeled vehicle. It consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery power indicator, ON/OFF button, horn button, speed indicator, speed control button, joystick, Battery charger socket), arm supports, two rear wheels, two casters(front wheels), Foot support, anti-tip devices.

The wheelchair can easily fold and unfold for transportation or storage.

The provided text describes the FDA 510(k) clearance for an Electric Wheelchair. However, it does not include information about acceptance criteria for a device performance study in the typical sense of a clinical or analytical performance study with specific metrics like sensitivity, specificity, or accuracy.

Instead, the "acceptance criteria" for this device are demonstrated through adherence to a comprehensive set of international standards for wheelchairs. The study that proves the device meets these criteria is a series of non-clinical tests conducted against these standards.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Electric Wheelchair are largely defined by compliance with a comprehensive set of ISO and IEC standards related to wheelchairs. The reported device performance is demonstrated by its successful adherence to these standards.

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." This typically implies testing of a representative sample of the manufactured device models. Specific numbers for each test (e.g., how many units were tested for static stability) are not provided.
   • Data provenance: The tests were performed by the manufacturer, Ningbo Baichen Medical Devices Co., Ltd., which is located in China. The data would be considered retrospective in the sense that the testing was completed prior to the 510(k) submission, but it's prospective in relation to the design validation process.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable in the context of this device and study type. The "ground truth" for non-clinical performance (e.g., static stability, brake effectiveness) is defined by the technical specifications and limits set forth in the international standards (ISO, IEC). The testing involves objective measurements rather than expert interpretation of data like in an image-based diagnostic study.

3. Adjudication method for the test set:

   • This question is not applicable. Adjudication typically refers to resolving discrepancies in expert interpretations (e.g., 2+1 means 2 out of 3 experts agree, 3+1 means 3 out of 4 agree, with a fourth to resolve ties). Since these are objective physical performance tests against established numerical standards, there is no expert adjudication process. The results are either within the standard's limits or they are not.

4. 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. This is an Electric Wheelchair, a physical medical device, not an AI software intended for interpretation by human readers. Therefore, an MRMC study is not relevant.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • This is not applicable. This is a physical medical device. While it contains an "Electronic controller" (SYC-PM30), the performance described (e.g., speeds, stability, braking) is a property of the integrated physical device, not a standalone algorithm. Software validation was performed for the control system, as mentioned under the difference D#11, but this is part of the overall device's non-clinical testing, not a standalone algorithm performance study in the context of diagnostic AI.

6. The type of ground truth used:

   • The "ground truth" for this device's performance is established by international consensus standards (ISO and IEC). These standards define the acceptable performance parameters and test methods for electric wheelchairs to ensure their safety and effectiveness.

7. The sample size for the training set:

   • This question is not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI algorithms for this type of device. The design and validation are based on engineering principles and compliance with established standards.

8. How the ground truth for the training set was established:

   • This question is not applicable, as there is no training set for this device.

In summary, the provided document details a non-clinical performance study demonstrating substantial equivalence through rigorous adherence to internationally recognized safety and performance standards for electric wheelchairs. The specific metrics are defined by these standards, and the device's performance met these criteria through objective physical testing.

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The Power wheelchair BC-EA8000 is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

This Power wheelchair is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people. The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, pedal, battery box and charger. The device is powered by Li-ion Battery pack (24V 6Ah) with 10 Km range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use. The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for a power wheelchair (Model: BC-EA8000) manufactured by Ningbo Baichen Medical Devices Co., Ltd. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K220747).

It is important to note that this document does not describe an AI/ML medical device. Therefore, information regarding acceptance criteria and studies for AI/ML devices (such as clinical trials, ground truth establishment, expert consensus, MRMC studies, etc.) is not present.

The document primarily relies on non-clinical testing to prove the device meets acceptance criteria, which are defined by adherence to relevant ISO 7176 series standards for wheelchairs.

Here's an analysis based on the provided text, while acknowledging that it's not an AI/ML device submission:

1. A table of acceptance criteria and the reported device performance:

The document implicitly defines acceptance criteria by conformity to specific parts of the ISO 7176 series standards. The "reported device performance" is essentially a statement that the device met these standards, and in some cases, provides specific values for comparison with the predicate.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified for individual tests. For non-clinical performance testing of physical devices, the sample size is often minimal (e.g., typically one or a few units) unless destructive testing or statistical process control is required. The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications".
• Data Provenance: The tests were conducted by the manufacturer, Ningbo Baichen Medical Devices Co., Ltd., in China. The data would be considered prospective, as it was generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is a submission for a power wheelchair, not an AI/ML device relying on expert interpretation for ground truth. The acceptance criteria are based on objective performance specifications defined by international standards (ISO 7176 series).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This concept pertains to consensus-based evaluation for AI/ML outputs, not physical device performance tests against objective 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:

• No MRMC study was done. This study type is relevant for AI/ML devices where human-in-the-loop performance is evaluated. The submission explicitly states: "No clinical study is included in this submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a physical power wheelchair, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Ground Truth: The "ground truth" for this device is its demonstrated compliance with pre-defined, objective performance specifications outlined in the ISO 7176 series of international standards. For example, a brake must stop the wheelchair within a certain distance (ISO 7176-3), or the device must withstand specific static and dynamic stability tests (ISO 7176-1, ISO 7176-2). There is no "truth" that requires expert consensus or pathological assessment.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set for an AI/ML model.

Summary of the study to prove the device meets acceptance criteria:

The study conducted to prove the power wheelchair meets acceptance criteria was a series of non-clinical performance tests based on the comprehensive ISO 7176 family of standards for wheelchairs. These tests objectively evaluate various aspects of the wheelchair's safety and performance, such as:

• Stability: Static and dynamic (ISO 7176-1, ISO 7176-2)
• Braking effectiveness: (ISO 7176-3)
• Energy consumption and range: (ISO 7176-4)
• Dimensions and maneuvering space: (ISO 7176-5)
• Speed, acceleration, and deceleration: (ISO 7176-6)
• Seating and wheel dimensions: (ISO 7176-7)
• Strength and durability: Static, impact, and fatigue (ISO 7176-8)
• Environmental performance: Climatic tests (ISO 7176-9)
• Obstacle climbing: (ISO 7176-10)
• Test dummy specifications: (ISO 7176-11)
• Surface friction: (ISO 7176-13)
• Power and control systems: (ISO 7176-14)
• Labeling and documentation: (ISO 7176-15)
• Ignition resistance: (ISO 7176-16)
• Electromagnetic compatibility (EMC): (ISO 7176-21)
• Battery and charger performance: (ISO 7176-25)

The conclusion of these tests was that the proposed device "met all design specifications" and demonstrated "Substantial Equivalence (SE)" to the predicate device, implying its safety and effectiveness based on these established engineering and performance standards. Differences in specific parameters (e.g., maximum incline, loading weight, dimensions, battery range) were acknowledged but deemed not to "influence the intended use of the device" or have a "deleterious effect on safety and effectiveness," as they were still within acceptable ranges as verified by the ISO standard tests.

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