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The intended use of the Electric Wheelchair (Robooter E60), Models name: BBR-E60-01,BBR-E60-02, BBR-E60-03, BBR-E60-04,BBR-E60-05,BBR-E60-06,BBR-E60-07,BBR-E60-08, is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

The Electric Wheelchair (Robooter E60), Models name: BBR-E60-01, BBR-E60-02, BBR-E60-03, BBR-E60-04, BBR-E60-05, BBR-E60-06, BBR-E60-07, BBR-E60-08, is an indoor/outdoor, batteryoperated, 2-wheel drive (rear-wheel drive) powered wheelchair.

It consists of four modules: seat system, control system, and drive system. The user sits in the wheelchair seat and uses the control system.

The control pad positioned on the right armrest, user can turn the wheelchair on, control the speed, and direct the movement.

The braking system employs an electromagnetic brake, when release the controller rocker, the electromagnetic brakes will be actuated, and the electric wheelchair will stop in several seconds.

Electromagnetic brake will not take effect immediately, it will take effect after the wheel rotates for 1/2 cycle.

The wheelchair is powered by a 24V DC,20Ah or 25Ah rechargeable lithium-ion battery charged by an offboard lithium-ion battery charger. The wheelchair is driven by two DC motors.

The Electric Wheelchair (Robooter E60), Models name: BBR-E60-01, BBR-E60-02, BBR-E60-03, BBR-E60-04, BBR-E60-05, BBR-E60-06, BBR-E60-07, BBR-E60-08, contains Bluetooth 4.1 BLE technology. The device can be controlled by the controller rocker or remote control by a smartphone app via Bluetooth 4.1 Low Energy (BLE) wireless communication interface. The smartphone app is used to drive the chair remotely. For safety, controller rocker control is priority over the remote control by design. The smartphone app can also view the battery's status, adjust the speed gear level and lock/unlock the unattended device.

The wheelchair can be controlled an optional Bluetooth remote controller (BBR-BLERC series)

The wheelchair can be folded/expanded manually. The Left and right handrails (joystick) can be interchange.

The provided documentation is a 510(k) summary for an Electric Wheelchair (Robooter E60). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive details on a comprehensive clinical study to define and meet specific acceptance criteria in the same way one might for a novel diagnostic or therapeutic device.

Based on the provided text, the "acceptance criteria" are primarily defined by compliance with a comprehensive set of ISO 7176 series standards for wheelchairs, along with other relevant ISO and ANSI standards. The "study" proving the device meets these criteria refers to the non-clinical testing performed against these standards.

Here's the breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially the requirements set forth by the listed ISO and ANSI standards. The reported device performance is that it met these standards. Since the document doesn't provide specific numerical performance values for each standard (e.g., exact braking distance for a specific test case, or specific stability angles beyond the general 9° dynamic stability), but rather states "test results meet its design specification" or "all test results meet the requirements," a direct comparative table with quantitative acceptance vs. performance for each test is not fully derivable. However, we can represent the overall compliance.

2. Sample Sizes used for the Test Set and Data Provenance

The document does not specify sample sizes (e.g., number of devices tested) for the non-clinical tests. It refers to these as "non-clinical tests" and details the standards followed. The data provenance is implied to be from the manufacturer's testing facilities (Shanghai Bangbang Robotics Co., Ltd.) as part of their submission for market clearance. These are prospective tests conducted to demonstrate compliance. There is no mention of country of origin of the data in terms of patient data, as this is a non-clinical submission.

3. Number of Experts used to establish the Ground Truth for the Test Set and the Qualifications of those Experts

This information is not applicable and not provided. The "ground truth" for non-clinical performance standards is defined by the standards themselves (e.g., a specific static stability angle, braking distance, etc.). Compliance is assessed by accredited testing bodies or manufacturer's internal quality systems against these defined requirements. There are no "experts" in the context of clinical interpretation to establish ground truth in this non-clinical submission.

4. Adjudication Method for the Test Set

This is not applicable to non-clinical technical performance testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation by multiple human readers (e.g., radiologists) to establish a consensus ground truth when individual reader opinions might differ.

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 such study was done or reported. This submission is for an electric wheelchair, a physical medical device, not an AI-powered diagnostic or interpretive tool that would involve human readers. The document 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

This is not applicable. The device is an electric wheelchair, not an algorithm, and the testing focuses on its physical and electrical safety and performance characteristics.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is the performance metrics and criteria defined within the referenced international standards (ISO 10993, ISO 7176 series, ANSI C63.27) and the device's design specifications. For example, for static stability, the ground truth is the minimum stability angle specified by ISO 7176-1. For braking, it's the effectiveness criteria of ISO 7176-3.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reason as point 8.

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