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The Power Wheelchair (Model: JMPW-01W) 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 Lead-acid Battery pack (24V 20Ah) with 8 miles 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, 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.

The provided document is a 510(k) premarket notification for a power wheelchair (Model: JMPW-01W). It assesses the substantial equivalence of the new device to a legally marketed predicate device (K163204). The document does not describe an AI/ML-driven device or diagnostic study. Instead, it focuses on the engineering and physical performance of a medical device (a power wheelchair) and its compliance with established international standards for such devices.

Therefore, many of the requested elements for an AI/ML device study (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, effect size) are not applicable to this document as it pertains to a physical medical device.

However, I can extract the closest analogous information regarding acceptance criteria and performance based on the provided text, particularly from the "Non-Clinical Test Conclusion" and "Comparison with predicate Device" sections.

Acceptance Criteria and Device Performance for Power Wheelchair (Model: JMPW-01W)

Since this is a physical medical device (power wheelchair) and not an AI/ML diagnostic device, the "acceptance criteria" are primarily based on compliance with international standards (ISO 7176 series for wheelchairs) and demonstrating substantial equivalence to a predicate device. The "performance" is reported as meeting the requirements of these standards.

1. Table of Acceptance Criteria & Reported Device Performance

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not applicable in the context of an AI/ML study. For a physical device like a power wheelchair, testing is typically done on a representative sample or a single unit to demonstrate compliance with standards. The document does not specify a "sample size" in the way it would for a clinical trial or AI/ML validation.
• Data Provenance: The tests were non-clinical, conducted to verify the device meets design specifications and complies with ISO standards. The country of origin for the testing itself is not explicitly stated, but the applicant (manufacturer) is based in Jiangsu, China. The data is from non-clinical testing, not retrospective or prospective patient data.

3. Number of Experts and Qualifications for Ground Truth:

• Not Applicable. Ground truth, in the context of an AI/ML study, refers to the definitive label for data, typically established by human experts. For a physical device, compliance is determined by adherence to engineering standards and test protocols, not expert interpretation of outputs.

4. Adjudication Method:

• Not Applicable. Adjudication is a process to resolve disagreements among human experts in establishing ground truth for AI/ML validation data. This concept does not apply to the conformity testing of a physical medical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not Applicable. MRMC studies are specific to evaluating how AI assistance impacts human reader performance in diagnostic tasks. This is a physical device, not an AI diagnostic tool. No human readers or diagnostic tasks are involved in proving the performance of a power wheelchair.

6. Standalone Performance (Algorithm Only without Human-in-the-loop):

• Not Applicable. This concept applies to AI algorithms. The device is a power wheelchair, which operates based on mechanical and electrical engineering principles, not an AI algorithm. Its "standalone performance" refers to its intrinsic functional capabilities as demonstrated through the ISO standard tests, not an AI algorithm's output.

7. Type of Ground Truth Used:

• Engineering Standards and Test Protocols. For this device, the "ground truth" is established by compliance with the specified international engineering standards (ISO 7176 series, ISO 10993 series) and specific performance metrics (e.g., braking distance, max speed, load capacity). The objective is to demonstrate that the device's measured performance meets the requirements set forth in these standards.

8. Sample Size for Training Set:

• Not Applicable. This is a physical device, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. (See point 8).

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