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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.

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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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Indications for use for the Model Z105 ΩmegaTrac® Powered Wheelchair base:

IntegaTract 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 SmegaTrac® 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 an QmegaTrac® 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.

Model Z105 Ωmega Trac® Powered Wheelchair

The provided document is a 510(k) premarket notification letter from the FDA for a powered wheelchair, the Model Z105 Ωmega Trac®. It includes a determination of substantial equivalence to a legally marketed predicate device and the indications for use.

This document DOES NOT contain the information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment.

The request asks for details typically found in a clinical study report or a 510(k) submission summary that describes the testing and validation of an AI/ML powered medical device. The provided text is a regulatory clearance letter, not a technical report detailing the device's development and validation.

Therefore, I cannot fulfill the request based on the provided input.

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Indications for use for the ΩmegaTrac® Powered Wheelchair base:

ΩmegaTrac® 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 ΩmegaTrac® 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 Scierosis Huntington's Corea Traumatic Brain Injury (TBI) Amyotrophic Lateral Scierosis (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 an ΩmegaTrac® 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.

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I am sorry, but based on the text provided, I cannot answer the question regarding the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a powered wheelchair, the OmegaTrac®. It confirms the device is substantially equivalent to a predicate device but does not contain information about specific acceptance criteria or details of a study proving those criteria were met, such as sample sizes, ground truth establishment, or expert qualifications. The document is a regulatory approval letter, not a clinical study report.

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The TEFTEC Corporation FirstClass™ Power Tilt & Recline Seating System has been designed for use by anyone needing pressure relief while in a seated position.

The FirstClass™ Power Tilt & Recline Seating System could provide pressure relief by postural change for persons having the following condition or injury:

Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Hyper Reflexia Chronic Pain Burn Trauma Patient Severe Scar Tissue build up Brown Sequard's Syndrome Multiple Sclerosis Heterotrophic Ossification Traumatic Brain Injury (TBI) Amyotrophic Lateral Sclerosis (ALS) Quadriplegia Cerebral Palsy Paraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke)

This is not meant to be an all-inclusive list, anyone needing pressure relief or positional change that is unable to facilitate those movements independently would be able to accomplish them with this unit. This would usually be decided by clinical evaluation of the client's strength, sensation level, upper extremity strength, mobility needs and seating needs.

Not Found

The provided document is a 510(k) summary for the FirstClass™ Power Tilt & Recline Seat System Model S400. It is a clearance letter from the FDA stating that the device is substantially equivalent to a predicate device.

This document does NOT contain information about acceptance criteria, device performance, a study conducted to prove the device meets acceptance criteria, or any of the detailed study parameters requested.

The letter only confirms that the device can be marketed based on its substantial equivalence to pre-existing devices. It does not provide any clinical trial data, performance metrics, or study designs typically associated with proving a device meets specific acceptance criteria.

Therefore, I cannot populate the requested information from the provided text.

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The TEFTEC Corporation FirstClass™ Power Recline Seating System has been designed for use by anyone needing pressure relief while in a seated position.

The FirstClass™ Power Recline Seating System could provide pressure relief by postural change for persons having the following condition or injury:

Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Hyper Reflexia Chronic Pain Burn Trauma Patient Severe Scar Tissue build up Brown Sequard's Syndrome Multiple Sclerosis Heterotrophic Ossification Traumatic Brain Injury (TBI) Amyotrophic Lateral Sclerosis (ALS) Quadriplegia Cerebral Palsy Paraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke)

This is not meant to be an all-inclusive list, anyone needing pressure relief or positional change that is unable to facilitate those movements independently would be able to accomplish them with this unit. This would usually be decided by clinical evaluation of the client's strength, sensation level, upper extremity strength, mobility needs and seating needs.

FirstClass™ Power Recline Seat System Model S500

This document is a 510(k) premarket notification decision letter for the FirstClass™ Power Recline Seat System Model S500. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. Therefore, I cannot extract the requested information from the provided text.

The letter explicitly states:
"We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

This indicates that the FDA's decision is based on a finding of "substantial equivalence" to a legally marketed predicate device, rather than on a study demonstrating the device meets specific performance acceptance criteria. The document does not describe any specific performance tests, data analysis, or clinical study results.

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The TEFTEC Corporation FirstClass™ Power Tilt Seating System has been designed for use by anyone needing pressure relief while in a seated position. The First Class™ Power Tit Seating System could provide pressure relief by postural change for persons having the following condition or injury: Spinal Cord Injury (SCI) Head Injury (CHI) Muscular Dystrophy (MD) Cerebral Palsy (CP) Hyper Reflexia Chronic Pain Burn Trauma Patient Severe Scar Tissue build up Brown Sequard's Syndrome Multiple Scierosis Heterotrophic Ossification Traumatic Brain Injury (TBI) Amyotrophic Lateral Sclerosis (ALS) Quadriplegia Cerebral Palsy Paraplegia Proximal Extremity Weakness Cerebral Vascular Accident (CVA or Stroke) This is not meant to be an all-inclusive list. Anyone needing pressure relief or positional change that is unable to facilitate those movements independently, would be able to accomplish them with this unit. This would usually be decided by clinical evaluation of the client's strength, sensation level, upper extremity strength, mobility needs and seating needs.

FirstClass™ Powered Tilt Seat System, Model S300

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is an FDA 510(k) clearance letter for the FirstClass™ Powered Tilt Seat System, Model S300. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information and instructions for the manufacturer.

The letter includes:

• Device Name: FirstClass™ Power Tilt Seat System Model S300
• Indications for Use: Designed for use by anyone needing pressure relief while in a seated position, specifically listing various conditions and injuries that might necessitate such a device. These indications are based on clinical evaluation of a client's strength, sensation level, upper extremity strength, mobility needs, and seating needs.

However, there is no mention of:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes or data provenance for any test sets.
3. Number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance studies.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is solely an FDA clearance letter based on substantial equivalence, not a detailed technical report or study showing performance metrics against specific acceptance criteria.

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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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