Search Results

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.

Ask a specific question about this device

The KISS Dynamic Solid Drop Seat and Back Support devices are wheelchair components intended for medical purposes that are generally sold as an integral part of a wheelchair but may also be sold separately as a replacement part.

The KISS Dynamic Solid Drop Seat and Back Support are intended to assist posture and positioning for a person seated in a wheelchair by way of providing a solid seating platform or back support with dynamic motion.

The KISS devices are wheelchair components intended for medical purposes generally sold as an integral part of a wheelchair but may also be sold separately as a replacement seat and back support. The KISS devices are intended to assist posture and positioning for a person seated in a wheelchair by way of providing a solid seat and back support with dynamic motion.

The KISS Seat consists of (1) a solid seating platform, (2) an adjustable seat frame, (3) pivot blocks, and (4) springs. The KISS seat replaces the standard cloth seat on a wheelchair frame. It attaches to the wheelchair with (5) four drop hooks and is locked in place with (6) securing hardware.

The KISS Back Support consists of (1) a lumbar support with (2) mounting brackets and (3) an upper back support with a solid ventilated (4) backrest. The lumbar support and the upper back support are hinged together with (5) springs therebetween. (6) Mounting hardware connects the KISS back support to the wheelchair frame in place of the standard cloth backrest. (7) A removable upholstered cover encases the back support assembly.

The provided document describes a 510(k) Premarket Notification for a medical device, the KISS Dynamic Solid Drop Seat and Back Support. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials for a novel technology.

Therefore, the document does not present a typical study proving a device meets specific acceptance criteria in the manner of a clinical trial for a new drug or a novel, high-risk device. Instead, it focuses on demonstrating that the performance characteristics of the KISS devices are similar to or better than predicate devices, and that they comply with relevant international standards for wheelchair components.

Here's an analysis of the available information in the context of your questions, noting where the information is absent due to the nature of a 510(k) submission for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table of "acceptance criteria" for clinical performance in the way you might see for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, it focuses on engineering specifications, safety standards, and comparative performance to predicates.

Here's a summary of the performance claims based on the described tests, which serve as the implicit "acceptance criteria" for substantial equivalence:

Important Note: The "acceptance criteria" here are largely implicit from the standards the device was tested against and its mechanical properties relative to predicates, rather than strict clinical outcome thresholds (like symptom reduction or disease progression). The failure on one part of the ISO 16840-10 test is noted, but the overall conclusion still asserts substantial equivalence.

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

For mechanical and engineering tests (ISO, RESNA, bench tests), "sample size" typically refers to the number of devices or components tested. The document doesn't provide specific numbers (e.g., "3 units were tested for ISO 16840-3"). It simply states "The KISS devices passed..." For the "Influences of the KISS dynamic seat on a Wheelchair Cushion's Force-Deflection relationship" and "Wheelchair Compatibility," it implies single or small numbers of tests rather than a large "dataset."

For the clinical testing for interface pressure, the document mentions "Clinical testing indicates..." but provides no details on:

• Sample Size: Not stated.
• Data Provenance: Not stated (e.g., country of origin, retrospective/prospective). Given the nature of a 510(k) for this type of device, it's highly likely it was a small, focused study, possibly done domestically. It is not presented as a large, multi-center trial.

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

This concept (experts establishing ground truth for a test set) is typically relevant for AI/ML devices that interpret images or signals, where human experts label the data. For a mechanical device like a wheelchair component, "ground truth" is established by:

• Objective physical measurements: Performed by engineers and technicians according to standard protocols (e.g., measuring dimensions, force, deflection).
• Standardized test methods: As defined by ISO or RESNA.
• Predicate device specifications: Used for comparison.

Therefore, this section is not applicable in the traditional sense for this device.

4. Adjudication Method for the Test Set

Again, this is largely applicable to AI/ML or clinical imaging studies involving human readers. For mechanical testing, test results are typically objective, and adjudication (e.g., 2+1 reader consensus) is not performed.

Therefore, this section is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.

No. An MRMC study is relevant for evaluating the impact of AI assistance on human readers' diagnostic performance (e.g., radiologists interpreting images with or without AI). This type of study was not conducted for the KISS devices as they are mechanical components, not diagnostic aids.

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

This question is primarily for AI/ML algorithms. The KISS devices are mechanical. While they were tested as "standalone" components in some bench tests (e.g., ISO and RESNA tests are performed on the device itself or installed on a wheelchair frame, without a human user actively operating them as part of the test setup), it's not "algorithm only performance."

Therefore, this concept is not applicable in the context of AI.

7. The Type of Ground Truth Used

For this device, the "ground truth" is primarily based on:

• Engineering specifications and measurements: Directly measured physical properties of the devices.
• Adherence to International Standards (ISO, RESNA): The device's performance is compared against predefined, objective pass/fail criteria from these standards.
• Comparison to Predicate Devices: Demonstrating similar physical and performance characteristics to existing, legally marketed devices.
• Limited Clinical Observation (Interface Pressure): The "clinical testing" mentioned likely involved measuring interface pressure under controlled conditions, with the "truth" being the pressure readings themselves, compared against previous data or industry understanding of acceptable pressure levels to prevent issues like pressure injuries. This would not typically involve "pathology" or "outcomes data" in the sense of long-term patient health outcomes for a 510(k) of a wheelchair component.

8. The Sample Size for the Training Set

This question applies to AI/ML models. The KISS devices are mechanical components and do not involve a "training set" in the machine learning sense.

Therefore, this section is not applicable.

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

As there is no "training set" for an AI/ML model for this mechanical device, this question is not applicable.

In summary of the provided text:

The document serves as a 510(k) submission for a Class I wheelchair component. It demonstrates substantial equivalence primarily through:

• Compliance with relevant mechanical and material standards (ISO, RESNA).
• Bench testing to show physical characteristics and performance (e.g., deflection, compatibility).
• Limited clinical observation (interface pressure) to ensure the device does not negatively impact user safety/comfort in this specific aspect.
• Direct comparison of technical specifications and intended use with predicate and reference devices.

The "study" here is a combination of engineering and bench tests, with a small clinical observation for specific parameters, rather than a large-scale clinical trial to prove efficacy or diagnostic accuracy.

Ask a specific question about this device