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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The SOLEUS POWERED WHEELCHAIR, FAD-2 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

The provided text is a 510(k) summary for the SOLEUS POWERED WHEELCHAIR, FAD-2. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not include a study that details acceptance criteria and proves the device meets them in the way typically associated with AI/ML-based medical devices or effectiveness studies.

The "Performance Testing" section primarily lists standards to which the device was tested, which are safety and electrical compatibility standards for powered wheelchairs, not performance metrics related to a specific clinical outcome or algorithm.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth (beyond meeting engineering standards).
8. Training set sample size.
9. How training set ground truth was established.

This document is a regulatory submission for a physical medical device (a powered wheelchair) and focuses on demonstrating its safety and equivalence to an existing device, rather than evaluating the performance of a diagnostic or predictive algorithm.

Here's what the document does provide regarding "performance" and "acceptance criteria" from a regulatory perspective for this type of device:

"Acceptance Criteria" (Implied by Regulatory Standards) and "Reported Device Performance":

Explanation of Missing Information:

The type of "study" described in the prompt is generally conducted for devices that perform an analytical function (like AI/ML algorithms). This 510(k) pertains to a powered wheelchair, which is a mechanical/electrical device. The "performance testing" referenced is about its safety, electrical compatibility, and mechanical integrity according to established engineering and safety standards (e.g., ANSI/RESNA, CISPR, IEC, EN, UL).

Therefore, there is no mention of:

• Sample sized used for the test set and the data provenance: Not applicable for a physical device being tested against engineering standards.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is defined by the technical specifications of the standards themselves (e.g., passing specific electrical discharge thresholds, structural integrity under load).
• Adjudication method: Not applicable.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable, as this is for evaluating human performance with/without AI assistance.
• Standalone (i.e. algorithm only without human-in-the loop performance): Not applicable for a powered wheelchair.
• The type of ground truth used: Ground truth here refers to meeting the specified technical requirements of the listed international and national standards for safety and performance of powered wheelchairs.
• The sample size for the training set: Not applicable; there is no "training set" in the context of this device's regulatory submission.
• How the ground truth for the training set was established: Not applicable.

The "study" in this context is the performance testing against the listed standards, which ensures the device is safe and functions as intended, demonstrating substantial equivalence to the predicate device in these aspects.

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