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The Ki Mobility Little Wave Clik, Rogue XP, and Spark manual wheelchairs are intended to provide mobility to pediatrics limited to a seating position.

The Ki Mobility Little Wave Clik manual wheelchair is intended to provide mobility to pediatrics restricted to a sitting position. The Little Wave Clik manual wheelchair can be self-propelled by the occupant with access to hand-rims on the rear wheels or moved by an attendant with access to push handles. It is a rigid frame wheelchair wight capacity for all models of 165 pounds/75 kg. The Little Wave Clik wheelchair has a welded tubular high strength 1.125″ aluminum frame with bend/trim configurations that vary the seat angle, knee angle, front and rear seat heights, seat depth, and caster wing offsets provide more room for the user's legs without increasing the frame length or reducing seat support.

The seat frame is dimpled to create a consistent array for frame mounted components in 0.25" increments. An adjustable clamp is used to set the rear wheel center of gravity position relative to the backrest. A set of clamps and an aluminum cross tube comprise an adjustable cross strut to seat width. The strut position may be adjusted for optimal positioning for rigidity for rigidity for rigidity for rigidity for rigi any given seat depth. The front caster mount also contains a button to mate with dimples along the front tubes for vertical caster adjustment.

The Little Wave Clik has several components intended to grow with the pediatric user either with built in adjustment, or growth kits of separate parts. The Clik cross tubes come in growth kits with multiple accommodated chair widths. Growth of the chair is also accommodated from footplates that can handle multiple widths and are adjustable to fit footrest length.

The Little Wave Clik manual wheelchair has a folding backrest frame for ease of storage and transport. It utilizes discrete holes to adjust the backrest angle relative to the seat tube. It also utilizes an adjustable position backrest to adjust the seat depth.

The tubular aluminum frame accommodates both seat slings and removable depth adjustable aluminum seat pans that have overlapping portions that can grow in depth. The pans and slings are with wheechair seat cushions. The backrest frame accommodates either back upholstery or planar/contoured wheelchair backrests. For adjustable back upholstery has straps that accommodate multiple seat widths. Seat pans and slings have overlapping portions that can grow in depth. The frame is also designed to accommodate aftermarket seating.

The seat cushion is a separate medical device adapted for use to the Little primary contact surface to the occupant along with the backrest upholstery. Little Wave Clik components such as amrests will also have contact to the occupant. The chair may be used as a seat in a motor vehicle and conforms to ISO 7176-19:2022 as well as ANSI/RESNA WC-4 Section 19: 2017 requirements. Two sets of transit tie down loops are bolted to the frame.

The Clik XP and Clik XPe order forms are order form variations of the same device to meet different market's requirements for pricing and reimbursement. All can be configured identically.

The Ki Mobility Rogue XP manual wheelchair is intended to provide mobility to pediatics restricted to a sitting position. The Rogue XP manual wheelchair an be self-propelled by the occupant with access to hand-rims on the rear wheels or moved by an attendant with access to push handles. It is a rigid frame wheelchair with a standard weight capacity for all models of 200 pounds/91 kg. The Rogue XP wheelchair has a welded tubular high strength 1.375" aluminum frame with bend/trim configurations that vary the seat angle, knee angle, front and rear seat heights, seat depth. Taper frames provide additional positioning of user's legs without the use of other components or accessories.

The Roque XP frame has an index of holes for mounting the backrest. Additional hole can be provided behind the backrest to accommodate adjustable clamp is used to set the rear wheel center of gravity position relative to the backrest. The chair utilizes a welded cross strut to maximize the rigidity of the chair. The Rogue XP has a welded caster wing for stiffness with a knuckle housing. An internal pinion allows adjustment of caster and backwards. The caster mount takes multiple fork and caster types, including a +3/4" stem option.

The Rogue XP has several components intended to grow with the pediatric user either with built in adjustment, or growth kits of separate parts. The cross tube weldment is split in the can grow the chair up to 3 inches in width the rigidizer bar on the backrest has a similar split with insert to grow the width of the chair is also accommodated from footplates that can handle multiple widths and are adjustable to fit footrest length.

The Rogue XP manual wheelchair has a folding backrest frame for ease of storage and transport. It utilizes discrete holes the backrest angle relative to the seat tube.

The tubular aluminum frame accommodates both seat slings and removable aluminum seat pans. The pans and slings are available for use with wheelchair seat cushions by adherence view AB tape. The backrest frame accommodates either back upholstery or planar/ contoured wheelchair backrests. For adjustable back upholstery has straps that accommodate multiple seat widths. The frame is also designed to accommodate aftermarket seating.

The seat cushion is a separate medical device adapted for use to the Rogue XP and is the primary contact surface to the occupant along with the backrest upholstery. Rogue XP components such as armrests will also have contact to the occupant.

The chair may be used as a seat in a motor vehicle and conforms to ISO 7176-19:2022 as well as ANSJ/RESNA WC-4 Section 19: 2017 requirements. Two sets of transit tie down loops are bolted to the frame.

The Rogue XP, Rogue XPe and Rogue XP TTL order form variations of the same device to meet different market's requirements for pricing and reimbursement. All can be configured identically.

The Ki Mobility Little Wave XP manual wheelchair is intended to provide mobility to pediatics restricted to a sitting position. The Little Wave XP manual wheelchair can be self-propelled by the occupant with access to hand-rims on the rear wheels or moved by an attendant with access to push handles. It is a rigid frame wheelchair with a standard weight capacity for all models of 165 pounds/75 kg. The Little Wave XP wheelchair has a welded tubular high strength 1.375″ aluminum frame with bend/trim configurations that vary the seat angle, knee angle, front and rear seat heights, seat depth, and front frame provide additional positioning of user's legs without the use of other components or accessories.

The Little Wave XP frame has an index of holes for mounting the backrest. Additional holes can be provided behind the backrest to accommodate adjustable depth. An adjustable clamp is used to set the rear wheel center of gravity position relative to the backrest. The chair utilizes a welded cross strut to main . The front caster mount is a two-part system with a clamp embedded that allows adjustment of caster angle front to back. The caster mount takes multiple fork and caster types, including a +3/4" stem option.

The Little Wave XP has several components intended to grow with the pediatric user either with built in adjustment, or growth kits of separate parts. The cross-tube weldment is split in the center with an insert that up to 3 inches in width. The rigidizer bar on the backrest has a similar split with insert to grow the chair. Growth of the chair is also accommodated from footplates that can handle multiple widths and are adjustable to fit footrest length.

The Little Wave XP manual wheelchair has a folding backrest frame for ease of storage and transport. It utilizes discrete holes to adjust the backrest angle relative to the seat tube.

The tubular aluminum frame accommodates both seat slings and removable aluminum seat pars. The pans and shor use with wheelchair seat cushions by adherence via AB tape. The backrest frame accommodates either back upholstery or planar/ contoured wheelchair backrests. For adjustment, the tension adjustable back upholstery has straps that accommodate multiple seat widths. The frame is also designed to accommodate aftermarket seating.

The seat cushion is a separate medical device adapted for use to the primary contact surface to the occupant along with the backrest upholstery. Little Wave XP components such as armrests will also have contact to the occupant.

The chair may be used as a seat in a motor vehicle and conforms to ISO 7176-19: 2022 as well as ANSI/RESNA WC-4 Section 19: 2017 requirements. Two sets of transit tie down loops are bolted to the frame. All available options and accessories are listed on the order form in the labeling section of this submission. The Ki Mobility Spark manual wheelchair is intended to provide mobility to pediatics restricted to a sitting position. The Spark manual wheelchair can be self-propelled by the occupant with access to handrims on the rear wheels or moved by an attendant with access to push handles. It is a folding frame wheelchair with a standard weight capacity for all models of 165 pounds/75 kg.

The Spark wheelchair has a welded tubular high strength aluminum frame with configurations that vary the front and rear seat heights, seat depth, rear wheel position and caster housing position. A width adjustable cross brace connects the wheelchair side frames and allows for folding of the frame for storage.

The Spark has several components intended to grow with built in adjustment within a range of its initial configuration. Arm rests offer multiple options, including a pediatric t-arm with integrated side guard, standard thatable locking extendable flip up arm rests and tubular flip up arm rests. Footplates can handle multiple widths and are adjustable to fit footrest length.

The tubular aluminum frame accommodates aluminum seat pans for use with wheelchair seat cushions. The frame is designed to accommodate aftermarket seating systems.

The Spark manual wheelchair has a folding backrest frame for ease of storage and transport. It utilizes discrete holes the backrest angle relative to the seat tube and to adjust the seat depth.

Seat cushions and backrests are separate medical devices and are primary contact surfaces to the occupants such as armrests and footrests will also have contact to the occupant.

The chair may be used as a seat in a motor vehicle and conforms to ISO 7176-19:2022 as well as ANSI/RESNA WC-4 Section 19: 2017 requirements. Two sets of transit tie down loops are bolted to the frame.

The provided document is a 510(k) premarket notification from the FDA for several manual wheelchairs (Little Wave Clik, Rogue XP, Little Wave XP, Spark). It describes the devices, their intended use, and compares them to a predicate device (Zippie GS).

Crucially, this document does not describe the acceptance criteria and study proving a device meets acceptance criteria for an AI/ML medical device. It pertains to a Class I mechanical wheelchair.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, ground truth, MRMC study, etc.) from this document as it is completely irrelevant to AI/ML device performance testing.

The document discusses:

• Regulatory Classification: Class I, Mechanical Wheelchair.
• Indication for Use: To provide mobility to pediatrics limited to a seating position.
• Substantial Equivalence: Comparing the new devices to a legally marketed predicate device (Zippie GS) based on intended use, design, materials, operating principles, and non-clinical testing to consensus standards (e.g., ISO 7176 series for wheelchairs).
• Testing: Non-clinical tests were performed based on recognized consensus standards for wheelchairs (e.g., static stability, brake effectiveness, dimensions, strength, resistance to ignition).

None of the information requested in your prompt (related to AI/ML device performance, ground truth, expert adjudication, etc.) is present in this document.

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