Its intended function and use is to aid in the pressure relief to persons confined to a powered wheelchair, by way of posterior tilt and reclining seat back.

It is intended use is to aid in the pressure relief of persons confined to a power wheelchair, by providing a method of tilting the seat and reclining the seat back.

Device Description

The Invacare Model 2G Power Tilt/Recliner Seating System for Power Wheelchairs is a battery powered, motorized seating system designed for use with power wheelchairs. Its intended function and use is to aid in the pressure relief of persons confined to a wheelchair, by providing a method of tilting the seat and reclining the seat back.

The tilting and reclining systems are separate modules and are independent of each other. As such, they will be offered as either a complete tilt/recline system, or as a separate tilt system or reclining system depending upon the users' needs. The reclining system also includes a movable leg rest feature.

The system includes an upper and lower frame assembly both of which are fabricated from welded steel. The lower assembly mounts directly to the wheelchair base using standard mounting screws. It includes the recline drive actuator as well as other mechanical components used to either tilt or recline the seating system.

The upper frame includes the wheelchair seat and back, as well as the tilt drive The seat and back are constructed of aluminum plates without actuator. upholstery. This allows the wheelchair user to decide the type of seat cushion that best meets their individual needs as determine by the health care provider.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Invacare Model 2G Tilt/Recliner for Powered Wheelchairs. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials with detailed acceptance criteria and performance metrics. Therefore, much of the requested information regarding specific acceptance criteria related to statistical performance, sample sizes for test sets, expert involvement, and ground truth establishment, which are typical for AI/ML device studies, is not applicable to this submission.

However, I can extract the information that is present and indicate where the requested details are not available in this type of regulatory document.

Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Safety & Performance	Applicable requirements of RESNA Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993 (E)	The device "meets the applicable requirements" of both standards.
Intended Use	Aid in pressure relief by providing tilting and reclining functions.	The device achieves its intended function.
Substantial Equivalence	Technological characteristics, performance characteristics, drive mechanisms, intended function, materials, operational principles, power source similar to predicate devices.	The device is described as having similar characteristics to predicate devices (Everest & Jennings Power Recliner Wheelchair, Permobile Chairman, LaBac Adjustable Sliding Back Power Recline System, Tarsys Engineering Tilt/Recline Seating System).

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

Sample Size for Test Set: Not applicable. The submission refers to meeting engineering standards (RESNA and ISO) which typically involve device testing on a limited number of units to ensure compliance with mechanical, electrical, and performance specifications. It does not refer to a "test set" in the context of data for an AI/ML algorithm.
Data Provenance: Not applicable. The study involved engineering tests and verification against established standards for wheelchairs, not data collection from human subjects.

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

Number of Experts: Not applicable. Ground truth as typically defined for AI/ML models (e.g., expert labels on images) is not relevant to this type of device submission.
Qualifications of Experts: Not applicable. The "ground truth" for this device is compliance with engineering standards established by organizations like RESNA and ISO, which are developed by committees of engineers, clinicians, and other relevant stakeholders in the field of rehabilitation technology.

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

Adjudication Method: Not applicable. There was no "test set" requiring adjudication in the context of human expert review for data labeling. The compliance is assessed through objective engineering tests according to the specified 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

MRMC Study: No. This is not an AI/ML device; it is a mechanical/electrical medical device.
Effect size of human readers: Not applicable.

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

Standalone Performance: Not applicable. This is not an algorithm.

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

Type of Ground Truth: The "ground truth" for this device's performance is adherence to the technical specifications and test methods outlined 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." These standards define acceptable ranges for parameters like stability, durability, electrical safety, and functional performance.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device does not use an AI/ML training set.

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

Ground Truth Establishment for Training Set: Not applicable. This device does not use an AI/ML training set.

Summary

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KG91119

AUG 19 1999

510(k) SUMMARY INVACARE CORPORATION'S 510(k) PREMARKET NOTIFICATION MODEL 2G TILT/RECLINER FOR POWER WHEELCHAIRS

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared. Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558 Contact Person: Edward A. Kroll, Director, TQM and Regulatory Affairs Date Prepared: March 31, 1999

Name of Device and Name/Address of Sponsor Model 2G Tilt/Recliner for Powered Wheelchairs

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

Common or Usual Name Power Wheelchair

Classification Name Wheelchair, Powered

Predicate Devices

Products which are substantially equivalent to the Model 2G Controls are; Everest & Jennings Power Recliner Wheelchair (K914091, November 19, 1991), the Permobile Chairman (K960951, April 30, 1997), and the LaBac Adjustable Sliding Back Power Recline System (K923363, March 24, 1993).

Intended Use

Its intended function and use is to aid in the pressure relief to persons confined to a powered wheelchair, by way of posterior tilt and reclining seat back.

Technological Characteristics and Substantial Equivalence

A. Device Description
The Invacare Model 2G Power Tilt/Recliner Seating System for Power Wheelchairs is a battery powered, motorized seating system designed for use with power wheelchairs. Its intended function and use is to aid in the pressure relief of persons confined to a wheelchair, by providing a method of tilting the seat and reclining the seat back.

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B. Substantial Equivalence

Products which are substantially equivalent to the Invacare Model 2G Tilt/Recline are; Tarsys Engineering Tilt/Recline Seating System (K 911151, March 29, 1991), the Everest & Jennings Power Recliner Wheelchair (K914091, November 19, 1991), the Permobile Chairman (K960951, April 30, 1997), and the LaBac Adjustable Sliding Back Power Recline System (K923363, March 24, 1993).

Each of these products are battery power, motorized, seating systems designed for use with powered wheelchairs. Performance characteristics and drive mechanisms are similar and all have the same intended function and use which is to aid in the pressure relief of persons confined to a powered wheelchair, by providing a method of tilting the seat and reclining the seat back. Additional, they are all constructed from the same basic materials. have the same basic operational principles and all use DC batteries as their source of power.

PERFORMANCE DATA

The Invacare Model 2G Tilt/Recline Seating System for Power Wheelchairs 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.

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Image /page/2/Picture/1 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 three human profiles facing right, with three wave-like lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 1999

Mr. Edward A. Kroll Director, TQM and Regulatory Affairs Invacare® Corporation One Invacare Way P.O. Box 4028 Elyria, Ohio 44036-2125

K991119 Re:

Trade Name: Tilt/Recliner for Power Wheelchairs, Model 2G Regulatory Class: II Product Code: ITI Dated: July 26, 1999 Received: July 27, 1999

Dear Mr. Kroll:

We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Edward A. Kroll

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Mark N. Melleman

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): TBD

Device Name: Model 2G Power Tilt/Recliner Seating System for Power Wheelchairs

Indications For Use:

It is intended use is to aid in the pressure relief of persons confined to a power wheelchair, by providing a method of tilting the seat and reclining the seat back.

Mark N Millhussen

(Γon Sign-Off)
D on of General Restorative Devices
510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

x 991119

(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).