Search Results

The LEVO stand-up electrical power wheelchair is a product which changes peoples position from seating to standing and standing to seating.

An electrical stand-up mechanism is integrated in an electrical power wheelchair which allows the user to stand up easily when and where ever he wants to.

This 510(k) summary does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device effectiveness. The provided text is a premarket notification for a medical device (a power wheelchair) and focuses on substantial equivalence rather than a detailed performance study with statistical results.

Here's an analysis based on the provided information, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Quantitative Acceptance Criteria: The document describes the device's function and features but does not provide specific, measurable acceptance criteria (e.g., "must allow user to stand in X seconds," "must support Y weight," "must operate for Z cycles without failure"). The "Performance" section is descriptive rather than quantitative.
• Formal Study Results: The document states "Performance" in a descriptive manner but does not reference a formal study with reported performance metrics against predefined acceptance criteria. This is common for 510(k) submissions focusing on substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Information Not Found in the Document.

This document is a 510(k) premarket notification, which typically focuses on demonstrating "substantial equivalence" to an already legally marketed predicate device rather than presenting extensive de novo clinical trial data. Therefore, details about a "test set" in the context of AI/software performance are not applicable or provided here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Information Not Found in the Document.

Given that this is a mechanical power wheelchair (not an AI/diagnostic device), the concept of "ground truth" established by experts for a test set is not relevant to this submission.

4. Adjudication Method for the Test Set

Information Not Found in the Document.

This information is not applicable to the type of device and submission provided.

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

Information Not Found in the Document.

This is a physical medical device (power wheelchair), not an AI-assisted diagnostic or imaging system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or included.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Information Not Found in the Document.

This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Information Not Found in the Document.

The concept of "ground truth" (expert consensus, pathology, outcomes data) is not applicable to this type of device and submission. The "ground truth" for a power wheelchair's function would be its ability to physically perform the described actions (e.g., lift a user from sitting to standing) and meet safety standards, typically demonstrated through engineering testing and compliance with recognized standards, not by expert interpretation of data.

8. The Sample Size for the Training Set

Information Not Found in the Document.

As this is not an AI/machine learning device, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Information Not Found in the Document.

As this is not an AI/machine learning device, there is no "training set" or corresponding ground truth establishment process.

Ask a specific question about this device

The LEVO stand-up wheelchair is a product which changes position from seating to standing and standing to seating.
Target population: For whole those who need a wheelchair and can not stand on their on feet such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..

An electrical power suported stand-up mechanism is integrated in a manual driven wheelchair which allows the user to stand up easily when and where ever he wants to.
Material: Main frame: Colour painted aluminium. Major stressed parts: Reinforced brass casting. Uphoistery: Flame impeded. Battery: 2 Gel, sealed lead acid battery (12V/2.9Ah in series=24V/2.9Ah). Stand-up motor: Linak Power Drive LA 28.405-150-24-001 24 VDC, 2500N.

This is a 510(k) clearance letter for the LEVO Compact-Easy LCE stand-up wheelchair, dated December 23, 1997. As such, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, as these were not standard requirements for 510(k) submissions at that time.

The document merely states that the device is "substantially equivalent" to legally marketed predicate devices. It lists the indications for use, target population, design, material, and some performance characteristics, but these are descriptive and do not constitute acceptance criteria or results from a formal study.

Therefore, I cannot provide the requested information based on the provided text.
I can, however, extract the descriptive information about the device:

Device Name: LEVO compact-easy LCE

Indications For Use:

• The LEVO stand-up wheelchair is a product which changes position from seating to standing and standing to seating.

Target population:

• For those who need a wheelchair and cannot stand on their own feet, such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.

Design:

• An electrical power supported stand-up mechanism is integrated into a manual driven wheelchair which allows the user to stand up easily when and wherever he wants to.

Material:

• Main frame: Colour painted aluminium.
• Major stressed parts: Reinforced brass casting.
• Upholstery: Flame impeded.
• Battery: 2 Gel, sealed lead acid battery (12V/2.9Ah in series = 24V/2.9Ah)
• Stand-up motor: Linak Power Drive LA 28.405-150-24-001 24 VDC, 2500N

Performance (descriptive, not quantified):

• The LEVO compact easy LCE allows the user to stand up easily when and wherever he wants to. Whether to reach things without help of others, whether take part in discussions standing up and show influence, whether just to do daily therapy individually.

Ask a specific question about this device

The LEVO stand-up wheelchair is a product which changes position from seating to standing and standing to seating.
Target population: For whole those who need a wheelchair and can not stand on their on feet such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..

Design: A manual stand-up mechanism is integrated in a manual driven wheelchair which allows the user to stand up easily when and where ever he wants to.
Material: Main frame: Colour painted aluminium. Major stressed parts: Reinforced brass casting. Upholstery: Flame impeded.

I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter from the FDA for a medical device called "LEVO active-easy LAE", which is a stand-up wheelchair.

The document primarily states that the device has been found substantially equivalent to a legally marketed predicate device and outlines regulatory information and responsibilities. It includes the indications for use and a brief description and performance claim for the device, but this is not a detailed study report or a list of acceptance criteria.

Therefore, I cannot provide the requested information based on the input text.

Ask a specific question about this device

Ask a specific question about this device