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The intended use of the STREET powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Street Powered Wheelchair is battery powered, rear wheel motor driven and is controlled by the PG power wheelchair PM100Amp controller. The user interface is a joystick. The Street is powered by two 12VDC 73Ah, Group 24 batteries, approximate driving range on fully charged batteries is up to 35 km (22 miles), depending on use and the terrain the chair is driven on. The chair frame is of welded steel construction and includes two rear drive wheels with drive units (motor, gear, brake), batteries and front pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.

The provided text describes a 510(k) submission for a powered wheelchair named "STREET" (K032765). This is a traditional medical device submission, focusing on establishing substantial equivalence to a predicate device, rather than proving the performance of a novel AI/ML-driven device through a study with acceptance criteria.

Therefore, many of the requested categories (such as acceptance criteria, sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of submission.

The document primarily focuses on demonstrating that the STREET wheelchair is safe and effective by showing its substantial equivalence to a previously cleared predicate device, the Quantum Blast (K011993).

Here's a breakdown of the information that is available in the provided text, and an explanation of why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable. The 510(k) submission for this powered wheelchair does not detail specific acceptance criteria or performance metrics in a way that would be typical for an AI/ML device. Instead, it relies on demonstrating that its technological characteristics and intended use are substantially equivalent to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Not Applicable. This is a hardware device (powered wheelchair). There is no "test set" in the context of an AI/ML algorithm. The performance is assessed through non-clinical testing and comparison to the predicate device. The information provided does not specify any particular sample size or data provenance related to a test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. There is no "ground truth" establishment in the context of an AI/ML algorithm for this powered wheelchair submission. Safety and effectiveness are demonstrated via engineering design, compliance with relevant standards (not explicitly detailed in this summary but implied by the 510(k) process), and substantial equivalence to a predicate.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

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 is not an AI/ML device, and therefore, an MRMC study comparing human performance with and without AI assistance is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not Applicable. This is a powered wheelchair; it does not have a standalone algorithm in the sense of an AI/ML device.

7. The Type of Ground Truth Used

• Not Applicable. There is no "ground truth" as it would be understood for an AI/ML algorithm. The safety and effectiveness are established through engineering principles, adherence to manufacturing practices, and comparison to a legally marketed predicate device.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware device; there is no "training set" in the context of an AI/ML algorithm.

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

• Not Applicable. See point 8.

Summary of Relevant Information from the Provided Text:

• Device Name: STREET Powered Wheelchair
• Predicate Device: Quantum Blast (K011993) manufactured by Pride Mobility.
• Intended Use: To provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
• Safety and Effectiveness Justification: "The STREET has in substantially the same intended use and similar technological characteristics as the Quantum Blast. Moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in technological characteristics do not raise any new questions of safety or effectiveness. Thus, the STREET device is substantially equivalent to the predicate device."

Conclusion:

The provided document describes a traditional 510(k) submission for a physical medical device (a powered wheelchair). The framework for acceptance criteria and study design requested in the prompt is specific to AI/ML-driven devices, which this product is not. The "study" described is the process of comparing the STREET wheelchair to its predicate device, the Quantum Blast, through non-clinical testing and characterization of its technological features to demonstrate substantial equivalence.

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