Search Results

The intended function and use of the Invacare Elevating Seat is to provide powered elevation of the wheelchair seat and user in order to assist the user with daily activities, transfers and general accessibility.

The Invacare Elevating Seat consists of a pedestal actuator, mounting weldments with mounting hardware, and a toggle control. The intended function and use of the elevating seat is to provide powered elevation of the wheelchair seat and user in order to assist the user with daily activities, transfers and general accessibility.

The bottom of the actuator assembly is mounted to the base of the wheelchair via the seat support weldment, which is specific to the particular wheelchair model. The top of the actuator assembly mounts to the wheelchair seat assembly via the seat mount bracket, which is specific to the seat assembly of the wheelchair. The ball drive pedestal actuator has a load capacity of 500 pounds and a maximum stroke of 8 inches. The elevating seat is available for select models of power wheelchair as a factory installed option.

The MIV Elevating Seat Toggle is standard with the elevating seat option. It is a DC brush type motor controller that is used to control the elevating actuator on power wheelchair systems with the elevating seat option installed. A double throw momentary position switch is used to drive the actuator. Current through the motor is limited and drive speed reduction occurs when the chair is in an elevated position.

The MIV Elevating Seat Toggle connects to the Power Take Off (PTO) connector of the wheelchair battery harness. Therefore, the power supply for the elevating seat toggle is taken directly from the wheelchair battery harness through a 15 amp fused power block, and the elevate function can be activated even when the wheelchair drive controls are turned off.

The MIV Elevating Seat Toggle also connects to a proximity switch, which senses when the seat is elevated. When the switch senses that the seat is elevated more than .75 inches, the speed of the wheelchair is reduced to 20% of the maximum possible speed of the chair. However, the reduced speed will not exceed the user-programmed speed.

For certain wheelchair models, the MIV TAC, a two-actuator control, is available as an option to the MIV Elevating Seat Toggle. The MIV TAC allows the elevating seat to be combined with the tilt feature of the wheelchair seating system and it allows the elevating seat to be controlled through the joystick of the wheelchair.

In addition to the features described under the MIV Elevating Seat Toggle, the MIV TAC has an additional tilt sensor that detects the overall back angle of the seating system. If the seat is tilted more than 20 degrees the elevating seat will not elevate. Also, if the seat is elevated more than .75 inches, the seat will not tilt.

The provided text describes the Invacare Elevating Seat Option, a powered wheelchair seat elevation system, seeking 510(k) clearance. However, the document is a 510(k) summary, not a detailed study report. Therefore, it primarily focuses on establishing substantial equivalence to a predicate device and states that the device meets certain standards, rather than providing a detailed study proving it meets acceptance criteria with specific data.

Based on the provided text, here's what can be extracted and what information is not available:

1. Table of Acceptance Criteria and the Reported Device Performance

Missing Information:
The document states that the device "meets the applicable requirements" of the specified standards but does not provide specific numerical performance data against quantifiable acceptance criteria within those standards. For example, it doesn't say "the device was tested for stability according to RESNA WC/14 section X and passed with a value of Y," or "the device's power consumption was Z, meeting the requirement of <A."

The following sections are not applicable or cannot be answered based on the provided text, as the document describes a physical medical device (wheelchair accessory) and its mechanical/electrical performance standards, not an AI/algorithmic device requiring clinical study data, ground truth, or expert review for its performance evaluation. The "study" referenced is compliance with engineering standards, not a clinical trial.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable: This pertains to clinical studies for AI/diagnostic devices. The document references compliance with engineering performance standards (RESNA, ISO), which would involve testing the physical device, not analyzing a dataset. The sample size would typically refer to the number of units tested, but this detail is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable: Ground truth and expert review are relevant for diagnostic algorithms or clinical effectiveness studies. For an elevating seat, "ground truth" is established by engineering specifications and physical test methods defined in the standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable: Adjudication methods are for resolving discrepancies in expert interpretations during clinical data labeling. This is not relevant for testing a physical mechanical device against engineering 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 is for evaluating AI-assisted diagnostic tools. The Invacare Elevating Seat is a mechanical/electrical assistive device, not involved in interpretation or cognitive tasks.

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

• Not Applicable: This is for AI algorithms. The device is a physical product designed for human interaction (user in the wheelchair).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable/Redefined: For this device, "ground truth" is defined by the technical specifications and performance requirements outlined in the ANSI/RESNA and ISO standards (e.g., ability to lift 500 lbs, stroke length, speed reduction percentages). It's based on engineering principles and test protocols.

8. The sample size for the training set

• Not Applicable: Training sets are for machine learning algorithms.

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

• Not Applicable: Training sets are for machine learning algorithms.

Ask a specific question about this device