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Aerolet ToiletLift "K031045" was developed to assist in patient ability to access bathroom facilities due to medical conditions such as the following: Multiple Sclerosis Muscular Dystrophy Arthritis Inclusion Body Myositis Fredricks Ataxia Parkinsons Syndrome Post-Polio Syndrome Fragile elderly Rehabilitation Leg fractures Hip Replacement Knee Replacement Post-Operative Mobility

The Aerolet Toilettift is an ergonomically correct aid to daily living tool that replicates the natural sitting and standing process needed for an individual to void. When standing. the end-user leans slightly back onto the raised Aerolet toilet seat, pushes the down button with either hand and waits for the unit to safely bring them over the bowl at a controlled speed. It is adjustable to accommodate any height toilet and can be custom fitted to an individual or multiple user's height. The Aerolet is also designed to allow the end user to stop on their way up or down allowing perineal cleaning. Afterwards, the end-user pushes the up button to rise to return to a full standing position enabling the user to walk away without assistance. Those desiring less assistance can either manually decrease the ifft at any point by letting off pressure to the up button. A switch can also be adjusted to decrease maximum lift height. The lift will stop at the preset limit and can not rise higher unless reset. An optional wired remote hand control is also available. One side note, the remote hand control overides the manual control built info the arm assembly. Other options include a variety of ergonomically correct seats from Pressalit. Soft seats are available in highly durable Gortex materials for durability. The electronic components are manufactured specifically for the Aerolet by LINAK, Durable Rislan powder coating profects the steels from deterioration from the harsh bathroom environment and corrosive bodily fluids. The mobile Aerolet is designed for the end user to take it with them when they travel or for use in institutional settings. The Bariatric version lifts consumers up to 880 pounds to enjoy the same benefits as that of the standard unit. This variation is accomplished by adding struts to the standard toiletlift. A larger seat adapts for larger users, The AEROLET Toiletifft is the standard product comprised of components. It can also be reconfigured with other components to be used as a Shower lift by removing certain electronics out of the product and attachina the unit to the shower wall for stability. All configurations of the AEROLET ToiletLift comply or exceed Manufacturer Guidelines for the United States of America and the European Union.

This document is a 510(k) summary for the Aerolet ToiletLift, a medical device designed to assist individuals with mobility limitations use the toilet. It does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically seen in submissions for AI/ML-driven devices or those requiring clinical performance evaluation.

The provided text describes the device's functionality, its different versions (standard, mobile, bariatric, shower lift), and its compliance with manufacturing guidelines. It also includes the FDA's substantial equivalence letter, indicating that the device was considered substantially equivalent to a legally marketed predicate device. This type of submission relies on demonstrating similarity to existing devices, rather than presenting novel performance studies against specific acceptance criteria.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) because this document predates the common regulatory requirements for AI/ML device evaluations and focuses on substantial equivalence for a mechanical assistive device.

In summary, the provided text does not contain the information needed to answer your request regarding acceptance criteria and a study proving their fulfillment.

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