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The intended use of this device (power/manual wheelchair) is the same as the predicate device, the Commuter (K934232). The intended use for the power/manual wheelchair is to provide mobility to physically impaired individuals. These chairs will allow the user to have a battery powered wheelchair or they can disengage the drive mechanism and have a manual wheelchair.

The specific medical conditions for which the device is indicated are listed as, but not limited to:

Spinal chord injury Stoke/CVA Post Polio Syndrome Spina Bifada Amputee Multiple Sclerosis Arthrogriposis Muscular Dystrophy Lower and upper extremity paralysis

The TiPower RimPower and PowerDrive X and SX are folding power/manual titanium wheelchairs.

The provided text describes the 510(k) summary for the TiPower RimPower and PowerDrive X & SX folding power/manual wheelchairs. This document focuses on demonstrating substantial equivalence to a predicate device (Commuter, K934232) and ensuring compliance with relevant standards, rather than detailing a clinical study with a device performance vs. acceptance criteria table, sample sizes, expert ground truth, or MRMC studies for AI devices.

Therefore, many of the requested elements for an AI device study are not applicable or cannot be extracted from this document, as it pertains to a physical medical device (wheelchair) and its compliance with established performance standards.

Here's a breakdown of what can be extracted based on the provided text:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing involved compliance with engineering standards, not clinical data sets with "test sets" in the context of AI or imaging devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device and testing. Ground truth in this context refers to compliance with established engineering and safety standards, not expert medical diagnoses.

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

This information is not applicable to this type of device and testing. Adjudication methods are typically used in clinical trials or AI model evaluation.

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

This information is not applicable as this is not an AI device or a diagnostic device involving human readers.

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

This information is not applicable as this is not an algorithm or AI device.

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

The "ground truth" for this device's performance is adherence to recognized international and national standards for wheelchairs (ISO 7176, ANSI/RESNA WC, EN 12184). These standards define objective performance and safety requirements.

8. The sample size for the training set

This information is not applicable as this is not an AI device with a "training set."

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

This information is not applicable as this is not an AI device with a "training set."

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