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The Ki Mobility Power Tilt System kit design is intended for use on a manual wheelchair to provide patients with posterior tilt for positioning and seating pressure relief.

The Ki Power Tilt System is an assembly that can be used to provide powered tilt on a manual wheelchair. It is an option for the Focus CR manual wheelchair to allow user control of the seating tilt angle. The system uses a battery operated motor gear drive connected between the base frame and the rotational seat tilt frame. A curved gear rack is coupled to the rocker frame and driven by the motor gearbox to control tilt motion. The user controls tilt using a toggle switch or hand pendant control connected to the motor control box. Adaptive switches, such as head arrays, may be connected to an interface control box that connects to the control box. An external battery charger is provided to charge the system. The motor control system uses a soft start/soft stop for ramping down the motor speed with a current limit to momentarily shut down power supply to the motor. End of travel in the tilt range will engage the current limit and the Focus CR Tilt Stops can be used to limit the tilt range from the unrestricted range of 0° to 50°.

The provided text describes the regulatory clearance of a medical device, the Ki Mobility Power Tilt System, and its substantial equivalence to a predicate device. It outlines the device's design, intended use, and technological characteristics. However, the document does not contain the specific details required to answer your questions about acceptance criteria and a study proving device performance in the context of AI or algorithmic evaluation.

The "Performance Data" section discusses:

• Physical performance characteristics (tilt range, weight capacity) of the Ki Power Tilt System compared to the predicate.
• Biocompatibility testing (ISO 10993).
• Mechanical and safety testing against various ISO 7176 standards (wheelchair standards).

The document does not describe an AI/ML-driven device or study related to AI performance, algorithmic acceptance criteria, human reader improvement with AI, standalone algorithm performance, or how ground truth for an AI model would be established.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and a study proving device performance in the context you've provided, as this information is not present in the given text.

If your request pertains to a different type of medical device (e.g., an AI-powered diagnostic tool), please provide the relevant text.

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The Ki Mobility Focus CR manual wheelchair is a manually operated device with wheels that is intended to provide mobility to adults restricted to a sitting position.

The Ki Mobility Focus CR manual wheelchair is intended to provide mobility to adults limited to a sitting position. The primary use is by adult users in need of manual wheeled mobility offering an operator adjustable body support system. The Focus CR offers both seat tilt and an optional reclining backrest, with both adjustable by the attendant.

The Focus CR manual wheelchair can be propelled by the occupant with access to hand-rims on the rear wheels or moved by an attendant with access to push handles are used by the attendant to control the seat tilt function and recline of the backrest. Hand control levers on the push handles or a foot-operated pedal on the frame are used to release a slide-locking mechanism for changing the seat tilt angle. The backrest recline is controlled through hand control levers on the push handles which release sliding mechanical wrapped spring rod locks to change the backrest angle.

The Focus CR wheelbase is of a welded high-strength aluminum frame, upon which an inner high-strength forged aluminum frame can rotate on four rollers (two on each side) fixed to the base frame. The use of two control paths rolling on the fixed rollers is designed to create a complex rotation (CR) with a neutral resting angle of 20° tilt and minimizes the translation of the user-loaded system weight for safely controlling the change in seat tilt angle. The high-strength tubular aluminum seat frame assembles to the inner rotating frame and can be adjusted for seat depth and to adjust the user loaded center of gravity (CG) relative to the frame. Seat adjustment is optimal when the user-loaded and unlocked seating system will rest without force applied at 20°. CG adjustment is made with two easily accessed bolts are align to a series of holes through the seat frame and connected to the inner rotating frame.

The Focus CR manual wheelchair has a folding backrest frame for ease of storage for transport. A non-folding backrest and a reclining backrest are options. The adjustable tubular aluminum seat and backrest frame assembly is made to adapt to planar seating systems which have hardware adapted to mount to tubes. A solid mounted and depth adjustable aluminum seat pan is available for use with wheelchair seat cushions and the backrest frame accepts contoured wheelchair backrests. The seating system is a separate medical device adapted for use to the Focus CR and is the primary contact surface to the occupant. Focus CR components such as armrests and footrests will also have contact to the occupant.

The Focus CR wheelchair is custom configured to the user requirements by order form selection of components and accessories. The standard weight capacity for all models is 300 pounds, with an option for configuration as a heavy-duty weight capacity of 400 lbs. The seat tilt range is -5° to 50° with an accessory tilt stop available to limit the range. The backrest recline option range is available from 0 to 65°, 10° to 75° or 20° to 85°. The Focus CR, CRe & TTL are the same product with order form variations to meet different market configuration requirements only for pricing.

This document is a 510(k) Summary for a medical device called the "Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL," which is a mechanical wheelchair. The purpose of this summary is to demonstrate substantial equivalence to previously marketed predicate devices (Ki Mobility Focus CR to Invacare (K181090) and Sunrise Medical, Quickie IRIS (K123975)).

The acceptance criteria and study that proves the device meets these criteria are primarily based on non-clinical performance testing against recognized international standards for wheelchairs. There are no clinical studies mentioned or required for this submission. Therefore, for a device like a mechanical wheelchair, the "performance" is demonstrated through adherence to engineering and safety standards, rather than clinical efficacy or diagnostic accuracy.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are generally "Pass/Fail Limits" as defined by the recognized standards, or "Informative" for comparison data. The reported device performance is "PASS" for tests with pass/fail limits and "Comparison Data" for informative tests.

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify a numerical sample size for the mechanical wheelchairs tested. It implies that "the Focus CR" (singular, referring to the model) was tested according to the standards. For non-clinical, bench testing of physical devices, "sample size" typically refers to the number of units tested. However, the standards themselves often dictate the number of test pieces required (e.g., prototypes, production units). It's reasonable to assume standard engineering practices were followed, which usually involve testing a small number of representative units to destruction or for endurance.
• Data Provenance: The tests were conducted by a "Third party lab testing." The country of origin is not explicitly stated, but the standards cited (ANSI/RESNA, ISO) are international. The nature of the testing is retrospective in the context of the 510(k) submission, as these tests were completed before the submission to demonstrate compliance. They are not prospective clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable in the context of this device. The "ground truth" for a mechanical wheelchair's performance is established by objective engineering measurements and adherence to predefined specifications within recognized international standards. There are no human experts "establishing ground truth" in the way radiologists interpret images for an AI study. The "experts" here would be the engineers and technicians at the third-party lab who conduct the tests and ensure they conform to the standard's methodology. Their qualifications would be expertise in mechanical testing and adherence to quality systems.

4. Adjudication method for the test set

Not applicable. There is no subjective interpretation that requires adjudication. The tests involve quantifiable measurements (e.g., angles, forces, dimensions) and observations (e.g., breakage, slippage) against pass/fail criteria defined by the standards.

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

Not applicable. This device is a mechanical wheelchair, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical wheelchair. There is no "algorithm only" performance separate from the physical device itself.

7. The type of ground truth used

The "ground truth" for the performance evaluation of this mechanical wheelchair is:

• Established engineering standards and specifications: Compliance with objective, quantifiable metrics defined by ANSI/RESNA WC-1:2009, WC-4:2012, and the ISO 7176 series (e.g., static stability angles, brake effectiveness, fatigue strength limits).
• Physical performance measurements and observations: Direct measurements and observations during bench testing conducted by a third-party laboratory.

8. The sample size for the training set

Not applicable. This is a physical mechanical device, not a machine learning model. Therefore, there is no "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for a mechanical wheelchair. For this specific device, the closest analog to "ground truth establishment" would be the initial design specifications, engineering calculations, and component testing, long before full product integration and final performance testing against standards.

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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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The Ki Mobility Little Wave Arc and Little Wave Flip manual wheelchairs are intended to provide mobility to pediatrics limited to a seating position.

The Ki Mobility Little Wave Arc is used by pediatrics up to 165lb (75kg) in need of manual wheeled mobility offering an operator adjustable body support system. Angular repositioning of the occupant alters the seated pressure distribution to reduce potential of pressure ulcers, improve comfort, facilitate improved transfer and for improved daily activities such as eating, breathing and social interaction. The Little Wave Arc offers a tilting seat frame that tilts up to 45°, reclining backrest that recline up to 60°, and elevating leg rest, all adjustable by an attendant.

The Ki Mobility Little Wave Flip is used by pediatrics up to 165lb (75kg) in need of manual wheeled mobility offering an operator adjustable body support system. Angular repositioning of the occupant alters the distribution to reduce potential of pressure ulcers, improve comfort, facilitate improved transfer and for improved daily activities such as ocial interaction. The Little Wave Flip offers a tilting seat frame that tilts up to 45°, reclining backrest that recline up to 60°, and elevating leg rest, all adjustable by an attendant.

The provided document is a 510(k) Premarket Notification from the FDA for two manual wheelchairs, the "Little Wave Arc" and "Little Wave Flip." It focuses on demonstrating substantial equivalence to a legally marketed predicate device (R82 Kudu).

This document does not describe acceptance criteria for a medical device that relies on algorithms or AI assistance, nor does it detail a study proving such a device meets acceptance criteria. The devices in question are mechanical wheelchairs.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance for an AI/algorithmic device.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size with AI assistance.
6. Standalone (algorithm only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document instead focuses on non-clinical testing for mechanical wheelchairs against recognized consensus standards.

Here's the relevant information that is present in the document about the mechanical wheelchairs:

Acceptance Criteria and Study for Mechanical Wheelchairs:

The acceptance criteria for the "Little Wave Arc" and "Little Wave Flip" manual wheelchairs are implied by their successful testing against a series of recognized consensus standards for mechanical wheelchairs. The study described is a non-clinical testing summary.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria (Implied by Standards)	Reported Device Performance (as stated in document)
   Compliance with ANSI/RESNA WC -4:2017 Section 19 (Wheelchairs in motor vehicles)	"Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs.
   Compliance with ISO-7176-1:2014 (Static stability)	"Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs.
   Compliance with ISO 7176-5:2008 (Dimensions, mass, maneuvering space)	"Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs.
   Compliance with ISO 7176-7:1998 (Seating and wheel dimensions)	"Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs.
   Compliance with ISO 7176-8:2014 (Static, impact, and fatigue strengths)	"Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs. Specifically, the aluminum base frames have been "qualified through fatigue testing."
   Compliance with ISO 7176-11:2012 (Test Dummies)	"Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs.
   Compliance with ISO 7176-13:1989 (Coefficient of friction of test surfaces)	"Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs.
   Compliance with ISO 7176-15:1996 (Information disclosure documentation/labeling)	"Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs.
   Compliance with ISO 7176-16:2012 (Resistance to ignition of postural support devices)	"Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs.
   Compliance with ISO 7176-19:2022 (Wheeled mobility devices for use as seats in motor vehicles)	"Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs.
   Compliance with ISO 7176-22:2014 (Set-up procedures)	"Little Wave Arc and Little Wave Flip met or passed the recognized test standard requirements" for manual wheelchairs.
   Maintain intended function and safety (Overall)	The non-clinical testing "exhibits that the device will perform as intended and risk analysis has documented risk reduction and identified requirements for labeling for safe and effective use of the device."

2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/algorithmic device. For the mechanical wheelchairs, the testing would involve specific samples (e.g., a certain number of manufactured units) tested under laboratory conditions to the specified standards. The document does not specify the exact number of units tested, but rather confirms that "Design testing... met or passed the recognized test standard requirements."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for mechanical performance is defined by the objective pass/fail criteria of the engineering standards.

4. Adjudication method: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. It is non-clinical performance testing of mechanical devices.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. These are mechanical devices, not algorithms.

7. The type of ground truth used: Not applicable in the AI/algorithmic sense. For mechanical testing, the "ground truth" is defined by the technical specifications and pass/fail criteria set forth in the international and national consensus standards (e.g., ISO, ANSI/RESNA).

8. The sample size for the training set: Not applicable. These are mechanical devices, not AI/ML models.

9. How the ground truth for the training set was established: Not applicable.

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The Catalyst wheelchair is a manually operated device intended to be used as a means of mobility for persons restricted to a sitting position.

The Catalyst is a traditional folding cross-brace wheelchair. It is made of lightweight aluminum tubing similar to what is used on existing products. The frame utilizes two cross tube sets and, when opened, nestles inside of the frame onto 4 hooks to create a box like rigid assembly. Upon the outside of this framework, and to the rear, are assembled 2 machined aluminum axle plates. Stainless steel receivers are mounted within the axle plates. Wheels of varying size and type are connected to the receivers via stainless steel axles. On the front end of the frame are assembled 2 aluminum housings. Caster forks are mounted to these housings via stainless steel axles. A variety of caster wheels and tires are then connected to the forks. Upon the top of the frame is attached a seat sling. Into the rear of the frame assembly 2 backtubes are inserted to the desired height. Backrest upholstery is affixed to the backtubes. Armrests receivers bolt onto the rear of each side frame. Individual Swing Away tubular arms are then inserted into the receivers. If flipback armrests are chosen a receiver is mounted onto the from of each side frame to catch the forward most section of the arm and the rear mounting is pivoting to allow the arm to rotate backward. Height Adjustable arms fit into a receiver that mounts onto the outside of the frame. Wheel locks mount onto the upper side frame and are adjusted so that the brake arm engages with the tire and when in the locked position prevents to the wheel from rotating. Swing Away footrests with footplates and heel loops attach at the front of the chair. There is a plug at the top of the footrest hanger that inserts into an opening at the top front of the wheelchair frame. The footrest hanger is turned 90 degrees away from the frame. Hold the latch, which is midway down the hanger, tightly against the front of the frame and rotate the footrest back towards center. The latch will engage once the footrest hanger is centered.

The provided document is a 510(k) Summary of Safety and Effectiveness for the Catalyst manual wheelchair. It outlines the device description, intended use, comparison to a predicate device, and performance testing results.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It states that the "Catalyst has been tested," implying a physical testing of the device itself rather than a data-driven study on a set of cases.

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

This information is not applicable and not provided in the document. The "ground truth" for a medical device like a wheelchair is established through adherence to engineering and safety standards, not through expert consensus on diagnostic interpretations. The device's performance is measured against these established standards.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided in the document. Adjudication methods are typically associated with studies involving human interpretation or subjective assessments, which is not the case for the physical testing of a wheelchair against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance:

This information is not applicable and not provided in the document. The device is a manual wheelchair, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study or assessment of AI assistance is irrelevant.

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

This information is not applicable and not provided in the document. The device is a physical mechanical wheelchair, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for this device's acceptance is based on adherence to recognized international engineering and safety standards, specifically:

• ANSI/RESNA WC Volume 1 - 1998 Standards - Sections 1, 5, 7, 8, 16 & 93.
  • Section 1: Determination of static stability
  • Section 5: Determination of Overall Dimensions, Mass and Turning Space
  • Section 7: Measurement of seating and wheel dimensions
  • Section 8: Static, impact, and fatigue strengths
  • Section 16: Determination of Flammability
  • Section 93: Maximum Overall Dimension

These standards themselves define the "ground truth" for what constitutes a safe and effective manual wheelchair.

8. The Sample Size for the Training Set:

This information is not applicable and not provided in the document. As a physical product, there is no "training set" in the context of an algorithm or AI model development. The design and manufacturing processes are likely informed by engineering principles, material science, and previous product development, rather than a formal data training set.

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

This information is not applicable and not provided in the document for the reasons explained in point 8. The "ground truth" for manufacturing a wheelchair is established through engineering specifications, material properties, and quality control processes to ensure the final product meets the defined safety and performance standards.

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