the intended use of the Invacare M71 Power Wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.

Device Description

The Invacare Model M71 power wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or "non- folding" type power wheelchair, with mid wheel drive capability.

The wheelchair frame is of rigid or non-folding type design. The wheelchair frame is of rigid or non-folding type design. The frame consists predominately of round 1 1/4 " diameter x .07 wall, steel tubing. The frame is of welded construction. The chair can be disassembled into 6 pieces without the use of tools for transport in vehicles that are not equipped with wheel chair lifts and ramps. To easy re-assembly, the mating parts are color-coded or labeled at the joints. Painted shrouds are used to conceal the wheelchair frame, motors and controller.

The wheelchair is designed with front wheel, walking beam type suspension. That is, the front swivel casters are mounted to two separate front extension frame members, and are thus, independent of each other. Each extension frame member pivots independently in a vertical plane about a horizontal axis. This allows the chair to better negotiate small obstacles such as curbs, or ramps, from a complete stop. The rear casters pivot as well, and also serve as wheelchair anti-tippers.

The Invacare M71 wheelchair incorporates a direct, drive, which includes two separate right angle gear motors. Because it is a direct drive system, there are no belts, pulleys, chains, sprockets or the like, to periodically adjust or maintain. Both gearboxes are sealed and maintenance free.

The Invacare M71 wheelchair is powered by two 12 volt, U-1 deep cycle gel cell batteries. The operating range; between battery re-charging is approximately 12 miles. Range will vary with battery condition, surface terrain and operator weight. The On Board Charger is standard.

AI/ML Overview

The provided text is a 510(k) summary for the Invacare Model M71 Power Wheelchair. It focuses on demonstrating substantial equivalence to predicate devices and performing performance testing. It does not describe an AI/ML device or a study involving human readers or ground truth establishment in the typical sense of AI/ML evaluation.

Therefore, many of the requested categories are not applicable to this document. I will fill in the relevant information and indicate when a category is not applicable for this specific type of device submission.

Here's the breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Electromagnetic Compatibility (EMC)
As per ISO EMC Draft Standard 7176-14 (Titled "Draft ISO EMC Group Proposal: Electromagnetic Compatibility Addition" And Dated April 3, 1995) for powered wheelchairs and motorized scooters.	"In all instances, the Invacare M71 Power Wheelchair met the required performance criteria and functioned as intended."
Intended Use
Provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.	The device's design and function are described as providing this mobility. The performance testing (EMC) supports functionality.

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

Sample Size: Not explicitly stated for performance testing. It refers to "the Invacare M71 Power Wheelchair" which implies testing was done on the device (or representative units) itself, not a dataset of patient data.
Data Provenance: Not applicable in the context of typical AI/ML data provenance (e.g., country of origin, retrospective/prospective). The testing relates to the physical device's performance against a standard.

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

Not Applicable. Ground truth, in the context of AI/ML, refers to validated labels or outcomes for data. This document describes performance testing of a physical medical device against an engineering standard, not an AI/ML model evaluated against expert-derived ground truth.

4. Adjudication Method for the Test Set

Not Applicable. As there's no expert-derived ground truth for an AI/ML output, there's no adjudication method described. Performance against the EMC standard would be assessed by engineers and test equipment.

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 document pertains to a power wheelchair, not an AI/ML diagnostic or assistive device where human reader studies would be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This describes a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Not Applicable. The "ground truth" for the device's performance is adherence to the specified engineering standard (ISO EMC Draft Standard 7176-14) for electromagnetic compatibility. This is an objective measurement against defined criteria, not expert consensus, pathology, or outcomes data in the AI/ML sense.

8. The Sample Size for the Training Set

Not Applicable. This device is a power wheelchair, not an AI/ML 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 an AI/ML model, this question is not relevant.

Summary

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K012927

SEP 1 9 2001

510(k) SUMMARY

Invacare Corporation's Model M71 Power Wheelchair

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: August 30, 2001

Name of Device and Name/Address of Sponsor

Model M71 Power Wheelchair

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

Common or Usual Name

Power Wheelchair

Classification Name

Wheelchair, Powered

Predicate Devices

Invacare Corporations' Action Arrow Front Wheel Drive Power Wheelchairs (K991168 June 25, 1999), Invacare Corporations' Ranger II M6 Power Wheelchair (K002157, and Permobil's Chairman Front Wheel Drive Power Wheelchair August 25, 2000), (K960951, April 4, 1997).

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Intended Use

The intended use of the Invacare Model M71 Power Wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.

Technological Characteristics and Substantial Equivalence

A. Device Description

B. Substantial Equivalence

The Invacare Model M71 Power Wheelchair is substantially equivalent to Invacare Corporations' Action Arrow K991168, June 25, 1999), Invacare Corporations' Ranger II M6 Power Wheelchair (K002157, August 25, 2000), and Permobil's Chairman Front Wheel Drive Power Wheelchair (K960951, April 4, 1997).

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PERFORMANCE DATA

As required by FDA's July 26, 1995, draft publication entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three- Wheeled Vehicles", the Invacare M71 Power Wheelchair was tested in accordance with ISO EMC Draft Standard 7176-14 (Titled "Draft ISO EMC Group Proposal: Electromagnetic Compatibility Addition" And Dated April 3, 1995) for powered wheelchairs and motorized scooters. In all instances, the Invacare M71 Power Wheelchair met the required performance criteria and functioned as intended.

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Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing right, with flowing lines suggesting movement or connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2001

Ms. Rae Ann Farrow Manager, Regulatory Compliance Invacare Corporation One Invacare Way Elyria, Ohio 44036-2028

Re: K012927

Trade/Device Name: M71 Power Wheelchair Regulation Number: 890.3860 Regulation Name: Wheelchair, Powered Regulatory Class: II Product Code: ITI Dated: August 30, 2001 Received: August 31, 2001

Dear Ms. Farrow:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. Iisting 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.

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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.

Susan Walk, us

Image /page/4/Picture/5 description: The image contains a simple, hand-drawn symbol that resembles a cursive letter 'G' or a stylized crescent shape. The symbol is drawn with a thick line and has a slightly irregular, organic appearance. The drawing is presented against a plain white background, which provides a clear contrast and emphasizes the shape of the symbol.

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

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i10(k) Number (if known): #BD KO12927

Device Name: Invacare M71 Power Wheelchair

Indications For Use:

the intended use of the Invacare M71 Power Wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative and Neurological DeviceR

Over-The-Counter Use _

Prescription Use (Per 21 CFR 801.109)

510(k) Number_KO12927

(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).