The Invacare Models Lynx and Panther scooters are motor driven indoor and outdoor transportation vehicles. The Lynx series of scooters are three-wheeled vehicles while the Panther Series of scooters are four-wheeled vehicles.

All of the scooters products are basic conventional rear wheel drive, rigid frame vehicles that are battery powered, and include various options and accessories depending upon user needs and preferences. They all consist primarily of a welded steel frame, transaxle motor drive system, braking system, electronic motor controller and an adjustable seat. Like most scooters, they include a tiller handle for steering, and a throttle control to engage and disengage scooter motion in both the forward and reverse directions. They are all powered by two (2) 12 volt DC batteries, and they all include a variety of options and accessories in order to meet the needs and preferences of various users.

AI/ML Overview

This document describes a 510(k) premarket notification for the Invacare Models Lynx and Panther Motorized Scooters. It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details as it is for a low-risk physical device (motorized scooter) and not a diagnostic AI/ML device.

The study that proves the device meets acceptance criteria is primarily through demonstrating substantial equivalence to predicate devices and adherence to established industry standards for motorized wheelchairs/scooters.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of specific acceptance criteria with corresponding device performance metrics in the format requested for AI/ML devices. Instead, it states that the devices meet existing standards.

Acceptance Criteria/Standards Met:
- Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991)
- ISO Standard ISO 7176: 1993 (E) "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs
Reported Device Performance:
The document asserts that the Invacare Models Lynx and Panther scooters meet the applicable requirements specified in the above standards. It also states their "performance specifications for speed, acceleration, deceleration, turning radius and braking" are similar to predicate devices, but without providing specific numerical values.

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

This information is not applicable/provided as the device is a physical motorized scooter, not an AI/ML diagnostic software. The "test set" in this context refers to physical testing performed against engineering standards, not a dataset for an AI model.

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)

This information is not applicable/provided for a physical device. Ground truth, in the context of AI/ML, refers to annotated data. For a scooter, compliance with standards is assessed through engineering testing, not expert consensus on ground truth data.

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

This information is not applicable/provided for a physical device. Adjudication methods are typically relevant for resolving discrepancies in expert labeling of ground truth data for AI/ML.

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

This information is not applicable/provided. This type of study is specific to AI/ML diagnostic devices where human "readers" (e.g., radiologists) interact with or without AI assistance. The device in question is a motorized scooter for mobility.

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

This information is not applicable/provided. "Standalone performance" in this context refers to an AI algorithm operating independently, which is not relevant for a motorized scooter.

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

The "ground truth" for this device's performance is adherence to established engineering and performance standards (RESNA and ISO). This is validated through physical testing and engineering assessment against those standards, not through expert consensus on qualitative data, pathology, or outcomes data in the sense used for AI/ML devices.

8. The sample size for the training set
Not applicable/provided. This document is for a physical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established
Not applicable/provided. This document is for a physical device, and therefore the concept of a training set and its ground truth establishment is not relevant.

Summary

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AUG 12 -

K992053

510(k) SUMMARY INVACARE CORPORATION'S 510(k) PREMARKET NOTIFICATION MODELS LYNX AND PANTHER MOTORIZED SCOOTERS

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: June 11, 1999

Name of Device and Name/Address of Sponsor: Models Lynx and Panther Motorized Scooters.

Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 366-9724

Common or Usual Name Scooter

Classification Name Motorized Three Wheel Vehicle

Predicate Devices

Products which are substantially equivalent to the Model Lynx and Panther Scooters are; Invacare Action Cat three wheeled scooter (K962583, 12/18/96) the Mega Motions Inc. Mega 4 scooter (K982144, 4/14/99), and the Pride Mobility Inc. Celebrity (K944939, 11/7/94).

Intended Use

The intended use of the Lynx and Panther scooters is to is provide mobility to persons limited to a seated position.

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There are two models of Scooters in the Panther series. These are the Panther LX - 4 and the Panther MX - 4. A brief description of each is as follows.

Panther LX - 4

The Panther LX - 4 scooter is basically the same as the Lynx LX - 3 scooter except that the Panther LX -4 is a four wheeled vehicle whereas the Lynx LX - 3 is a three wheeled vehicle. It includes the same transaxle motor drive system, braking system, adjustable seat, upholstery, covers, tiller handle and throttle control as the Lynx LX - 3. Additionally, it incorporates the same Penny & Giles "Solo 60" motor controller and the Lynx version and it has an on board battery charger.

Because the Panther LX - 4 is a four wheel vehicle, the welded steel frame is slightly different than the Lynx version. While the rear section of the frame is basically the same, the front portion differs such that it can accept two front wheels as opposed to one wheel on the Lynx. With these exceptions, the Panther LX - 4 is basically the same as the Lynx LX - 3.

Panther MX - 4

The Panther MX - 4 is the largest scooter in the Invacare Lynx/Panther. Like the Panther LX -4 , the Panther MX - 4 is a four wheeled vehicle. It has the same intended function and use as the others, and consists of the same technology and construction. Like the others, it basically consists of a welded steel frame, transaxle drive mechanism. braking system and seat assembly. Also, it includes a tiller handle for steering, and a throttle control to engage and disengage scooter motion in both the forward and reverse directions.

The Panther MX - 4 differs from the others in the Lynx/Panther series in that it is designed as a heavy duty, more durable scooter with a recommended weight limitation of 400 lbs. maximum. It is larger and heavier than the others, and includes more options and features. As such the frame, transaxle drive and braking system are different from the others and , the Panther MX - 4 scooter is powered using a Penny & Giles model "Solo 110" motor controller.

Substantial Equivalence

Products which are substantially equivalent to the Invacare Action Cat three wheeled scooter (K962583, 12/18/96) the Mega Motions Inc. Mega 4 scooter (K982144, 4/14/99), and the Pride Mobility Inc. Celebrity (K944939, 11/7/94). Each of these products are motorized, three and four wheeled scooters with the same intended function and use of providing mobility to persons limited to a seated position. All are all constructed from the same basic materials and components, all have the same basic operational principles and all use DC batteries as their source of power. Drive mechanisms and braking systems are also similar as are performance specifications for speed, acceleration, deceleration, turning radius and braking.

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Technological Characteristics and Substantial Equivalence

Device Description

LYNX SERIES SCOOTERS

Lynx SX-3 and SX-3P

As stated above the Lynx series of scooters are three-wheeled vehicles as opposed to the Panther series which are four wheeled. The Lynx series includes three different models These are the Lynx SX-3, Lynx SX-3P and the Lynx LX-3. The models are basically same with a few subtle differences.

The SX 3 and SX 3P differ only in that the SX - 3 includes an "on board" battery charger, which is fixed to the scooter, while the SX - 3P requires a remote and separate battery charger. There are also certain cosmetic differences such as shroud color availability, bumper trim, wood grain decorative decals and the like, which are included on the SX-3 version, but, not on the SX 3P version.

Lynx LX-3

The Lynx LX-3 scooter is similar to the Lynx SX-3 and SX-3P, but, is stightly larger. Like the SX-3 and SX3P, it is a three-wheel vehicle. However, it is designed to be a more heavy duty version scooter, with higher maximum weight capacity than the others in the Lynx series. Where the SX versions are rated for a maximum user weight of 200 lbs., the LX-3 version is rated for a maximum user weight of 250lbs.

PANTHER SERIES

The Invacare Models Panther scooters are motor driven indoor and outdoor four wheeled transportation vehicles. Like the Lynx series of scooters these products are basic conventional rear wheel drive, rigid frame vehicles that are battery powered, and include various options and accessories depending upon user needs and preferences. They also consist primarily of a welded steel frame, transaxle motor drive system, braking system, electronic motor controller and an adjustable seat. They include a tiller handle for steering, and a throttle control to engage and disengage scooter motion in both the forward and reverse directions, and are powered by two (2) 12 volt DC batteries.

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PERFORMANCE DATA

The Invacare Models Lynx and Panther scooters meet 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/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three parallel lines curving upwards and to the right, resembling a bird in flight. The caduceus is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1:2 1999

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

Re: K992052

Trade Name: Models "Lynx" and "Panther" metorized scooters Regulatory Class: II Product Code: INI Dated: June 17, 1999 Received: June 18, 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, subiect 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 yours,

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: Invacare Models Lynx and Panther Motorized Scooters

Indications For Use: To provide mobility to persons limited to a seated position..

(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

(Optional Format 1-2-96)

K992052

(Division Sign-Off) (Division of General Restorative Devices 510(k) Number .

Regulation Number and Section

§ 890.3800 Motorized three-wheeled vehicle.

(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).