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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria (Standard)	Reported Device Performance
ANSI/RESNA WC/14 (1991)	Met
ISO 7176: 1993(E)	Met
Load Capacity	500 pounds (stated as a characteristic)
Maximum Stroke	8 inches (stated as a characteristic)
Speed Reduction (Elevated > 0.75 inches)	Reduced to 20% of max speed (not exceeding user-programmed speed) (stated as a characteristic)
Tilt Sensor (MIV TAC only)	Elevating seat will not elevate if tilted > 20 degrees; will not tilt if elevated > 0.75 inches (stated as a characteristic)

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.

Summary

{0}------------------------------------------------

510(k) SUMMARY

DEC 1 3 2001

Invacare Corporation's Invacare Elevating Seat Option

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

Invacare Corporation One Invacare Way PO Box 4028 Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558

Contact Person:

Rae Ann Farrow Manager, Regulatory Compliance

Date Prepared: October 19, 2001

Name of Device and Name/Address of Sponsor

Invacare Elevating Seat Option

Invacare Corporation One Invacare Way Elyria, Ohio 44036-2028 Phone: (440) 329-6000 Facsimile: (440) 365-4558

Common or Usual Name

Elevating Seat

Classification Name

Wheelchair, Powered

Predicate Devices

Accelerated Rehab Designs, Inc. "E-2000 Power Elevating Seat System" (K992828, 2/3/2000)

Intended Use

{1}------------------------------------------------

Technological Characteristics and Substantial Equivalence

A. Device Description

MKIV TAC

{2}------------------------------------------------

The MIV Elevating Seat Toggle and the MIV TAC are to be used in conjunction with the Invacare Model MCC-MKIV Motor Controller , Joystick and options. FDA granted this controller marketing clearance on June 2, 1994, under 510(k) Accession Number K940972.

B. Substantial Equivalence

The Invacare Elevating Seat is substantially equivalent to the Accelerated Rehab Designs, Inc. "E-2000 Power Elevating Seat System" (K992828, 2/3/2000).

PERFORMANCE DATA

The Invacare Elevating Seat meets the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993(E), "ISO Standard, Wheelchairs -Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs."

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2001

Rae Ann Farrow Manager, Regulatory Compliance Invacare Corporation One Invacare Way Elvria, Ohio 44036-2125

Re: K013516

Trade Name: Invacare Elevating Seat Option ESS6 Regulation Number: 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: II Product Code: ITI Dated: October 19, 2001 Received: October 23, 2001

Dear Ms. Farrow:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

Page 2 - Ms. Rae Ann Farrow

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Mclherson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Number (if known): TBD

Device Name: Invacare Elevating Seat Option

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR
(Per 21 CFR 801.109)

Over-The-Counter Use _

estorative

510(k) Number

(Optional Format 1-2-96)

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).