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Indications for use for the Alpha Trac powered wheelchair base:

Alpha Trac design definitions and functional parameters are indicated for anyone with limited mobility due to weak, amputated or non-functional extremities or improper, unsafe or non-existent gail 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 AlphaTrac 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) Parkinson's Amputees Brown Sequard's Syndrome and resultant paralysis Severe Arthritics (RA) (OA) Multiple Sclerosis (MS) Amyotrophic Lateral Sclerosis (ALS) Huntington's Corea Traumatic Brain Injury (TBI) Anoxic Encephalopathy Anoxia Guillain-Barre Syndrome Quadriplegia Paraplegia Triplegia Hemiplegia Tetraplegia Proximal weakness Quadriparesis Paranaresis Cercural vascular Accident (C

AlphaTrac™ Powered Wheelchair

This document is a 510(k) clearance letter from the FDA for a powered wheelchair, not a study describing acceptance criteria and device performance based on a clinical study. Therefore, I cannot provide the requested information.

The document states that the FDA has reviewed the 510(k) notification for the AlphaTrac™ Powered Wheelchair and determined it to be "substantially equivalent" to devices marketed prior to May 28, 1976. This substantial equivalence determination means that the device is considered as safe and effective as a legally marketed predicate device, and thus does not require a new premarket approval (PMA) based on a full clinical trial demonstrating safety and effectiveness.

For devices cleared through the 510(k) pathway, the "acceptance criteria" are generally established by demonstrating substantial equivalence to a predicate device, often through bench testing, non-clinical performance testing, and sometimes limited clinical data showing that the new device performs as intended and introduces no new safety or effectiveness concerns compared to the predicate. The FDA letter is not a report detailing such testing or setting specific performance metrics and outcomes.

To answer your questions, I would need a clinical study report or a 510(k) submission that includes performance testing and clinical data. This document does not contain that information.

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