(1278 days)
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.
| TEST | DESCRIPTION | ACCEPTANCE CRITERIA | REPORTED DEVICE PERFORMANCE (Results) |
|---|---|---|---|
| ISO 7176-1 | Static Stability | Informative | Comparison Data |
| ISO 7176-3 | Effectiveness of Brakes | Informative | Comparison Data |
| ISO 7176-5 | Dimensions, Mass, Space | Informative | Comparison Data |
| ISO 7176-7 | Measurements | Informative | Comparison Data |
| ISO 7176-8 | Static, Impact, Fatigue Strength | Pass/Fail Limits | PASS |
| ISO 7176-30 | OABSS - Tilt Wheelchair Testing | Informative & Pass/Fail Limits | Comparison Data |
| WC-4: 19 | Transit test | Pass/Fail Limits | PASS |
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.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).