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Indications for use for the Model A205 AlphaTrac® Powered Wheelchair base:

AlphaTrac® design definitions and functional parameters are indicated for usage for anyone with limited mobility due to weak, amputated or non-functional extremities or improper, unsafe or non-existent gait patterns. Also, due to the specific driving control supplied by the transaxle, persons with spasticity or ataxic movements in their extremity's that are not candidates for other types of mobility without extensive modification may be appropriate for the AlphaTrace with no modifications.

This usage would be indicated but not limited to the following types of injury's:

Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Brown Sequard's Syndrome Severe Arthritics (RA) (OA) Multiple Sclerosis Huntington's Corea Traumatic Brain Injury (TBI) Amyotrophic Lateral Sclerosis (ALS) Anoxic Encephalopathy Anoxia

Guillain-Barre Syndrome Quadriplegia Paraplegia Triplegia Hemiplegia Tetraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke) Quadriparesis Obesity Parkinson's

This is not meant to be an all-inclusive list, anyone needing power assistance with their mobility may be an appropriate client for a AlphaTrac powered wheelchair. This would usually be decided by clinical evaluation of the client's strength, sitting balance, mobility needs, size constraints and driving capability at their local rehab facility.

Not Found

The provided document is a 510(k) premarket notification letter for the AlphaTrac® Model A 205 Powered Wheelchair. It focuses on establishing substantial equivalence to a predicate device, as required for certain medical devices by the FDA. This type of document does not contain the detailed information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The 510(k) clearance process primarily evaluates whether a new device is as safe and effective as a legally marketed predicate device. While some performance data might be submitted as part of a 510(k), the FDA letter itself is a regulatory approval, not a technical study report.

Therefore, I cannot provide the requested information from the given text.

This document does not contain the information requested. It is an FDA 510(k) clearance letter confirming substantial equivalence of the AlphaTrac® Model A 205 Powered Wheelchair to a predicate device, and it does not detail:

• Acceptance criteria and reported device performance beyond what is implicitly covered by substantial equivalence to a predicate.
• Specific studies proving the device meets acceptance criteria.
• Sample sizes, data provenance, number or qualifications of experts, or adjudication methods for test sets.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Type of ground truth used or details about training sets.

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