The intended use of the M300 & M400 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Device Description

M300 & M400 Powered Wheelchair is battery powered, center wheel motor driven and is controlled by the PG power wheelchair VR-2 90 amp or R-net 120 amp controller. The user interface is a joystick. M300 & M400 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 25km (15,5 miles), depending on use and the terrain the chair is driven on. The chair frame is a rived nut and welded steel construction and includes two center drive wheels with drive units (motor, gear, brake), batteries and front and rear pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.

AI/ML Overview

The provided document is a 510(k) Summary for a Permobil M300 & M400 Powered Wheelchair. It is a regulatory filing for a medical device that establishes substantial equivalence to a legally marketed predicate device, rather than a study demonstrating clinical performance or acceptance criteria in the context of diagnostic accuracy or similar AI/algorithm-driven devices.

Therefore, many of the requested elements (like acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of regulatory submission for a powered wheelchair.

However, I can extract the relevant information from the document as requested, interpreting "acceptance criteria" and "device performance" in the context of device function and regulatory equivalence.

Acceptance Criteria and Device Performance (Permobil M300 & M400 Powered Wheelchair)

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied by Substantial Equivalence and Intended Use)	Reported Device Performance
Intended Use: Provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.	The M300 & M400 functioned as intended, providing mobility. It is battery-powered, motor-driven, and controlled by a joystick. Features include automatic braking upon joystick release.
Safety and Effectiveness: Demonstrate safety and effectiveness comparable to the predicate device (C350, K071650).	"Performance data demonstrate that the M300 & M400 is as safe and effective as the C350." The submission asserts that minor technological differences from the predicate device "raise no new issues of safety or effectiveness."
Technological Characteristics: Similar technological characteristics and principles of operation to the predicate device.	The M300 & M400 shares the same intended uses and similar indications, technological characteristics, and principles of operation as the C350. Both are powered wheelchairs with joystick control, automatic braking, and likely similar frame constructions and power systems (though specific comparisons beyond "similar" are not detailed in the summary). The M300 & M400 uses PG power wheelchair VR-2 90 amp or R-net 120 amp controllers and two 12VDC 60Ah batteries, offering a driving range of up to 25km (15.5 miles). The chair frame is a riveted nut and welded steel construction.

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

Sample Size: Not applicable. This is a regulatory submission for a physical device, not an AI/algorithm. Performance data is mentioned generally ("In all instances, the M300 & M400 functioned as intended"), but no specific test set sample size (e.g., number of units tested, number of user trials) or data provenance for such a test set is provided in this summary.
Data Provenance: Not applicable in the context of "country of origin of the data, retrospective or prospective." The manufacturer, Permobil AB, is located in Timrå, Sweden.

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

Not applicable. This is a physical product (powered wheelchair). Ground truth in the sense of expert annotation or clinical diagnosis is not relevant here.

4. Adjudication method for the test set

Not applicable. No adjudication method for a test set (e.g., consensus among experts) is mentioned or relevant for this type of device submission.

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 not an AI/diagnostic imaging device.

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

Not applicable. This is a powered wheelchair; it does not have a "standalone algorithm performance" in this context.

7. The type of ground truth used

The "ground truth" for a device like this would be its functional performance against engineering specifications, safety standards, and its intended use. The document states "In all instances, the M300 & M400 functioned as intended," which implies it met its design and functional requirements. Substantial equivalence relies on comparing these functional and safety aspects to a predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary

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ORIGINAL, TRADITIONAL 510(K) NOTIFICATION
PERMOBIL POWERED WHEELCHAIR: M300/M400

Image /page/0/Picture/1 description: The image shows the Permobil logo. The logo is an oval shape with a black background and a white border. The word "permobil" is written in white letters in the center of the oval. The font is sans-serif and the letters are slightly rounded.

MAR - 3 2011 Attachment 11

510(k) Summary

Permobil AB Submitter Box 120 S-861 23 Timrå Sweden

+46 60 595900 Phone: +46 60 575250 Facsimile:

Jan Áström Contact Person: jan.astrom@permobil.se e-mail address:

October, 2010 Date Prepared:

Device name: M300 & M400

Classification Name:

Predicate Devices:

Powered wheelchair

Intended use:

The intended use of the M300 & M400 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

C350 ( K071650) manufactured by Permobil AB.

Description of device:

M300 & M400 Powered Wheelchair is battery powered, center wheel motor driven and is controlled by the PG power wheelchair VR-2 90 amp or R-net 120 amp controller.

The user interface is a joystick.

M300 & M400 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 25km (15,5 miles), depending on use and the terrain the chair is driven on.

The chair frame is a rived nut and welded steel construction and includes two center drive wheels with drive units (motor, gear, brake), batteries and front and rear pivoting casters.

Depending on users needs, the joystick motor control is mounted to the left or right armrest.

When the user activates the joystick, the controller receives a signal to release the brakes.

With the brakes released, the chair is allowed to move in the direction the joystick is actuated.

When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.

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ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: M300/M400

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Performance Data

In all instances, the M300 & M400 functioned as intended.

Substantial Equivalence

The M300 & M400 is substantially equivalent to the C350 (#K071650). The M300 & M400 has the same intended uses and similar indications, technological characteristics and principles of operation. The minor technological differences between the C350 and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the M300 & M400 is as safe and effective as the C350. Thus, the M300 & M400 is substantially equivalent.

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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 stylized graphic of an eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the graphic.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Permobil AB % Jan Astrom Box 120 S-861 23 Timra, Sweden

Re: K103477

Trade/Device Name: M300 and M400 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: January 10, 2011 Received: January 19, 2011

Dear Jan Astrom:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

MAR - 3 2011

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Page 2 - Jan Astrom

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Aj. VS. Mh
for

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 12

INDICATION FOR USE >

510(k) number Not assigned at the writing of this submission.

M300 & M400 Device name:

Indication for Use

The intended use of the CM300/400 series of the powered wheelchair is to provide indoor and outdoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.

Prescription use

Over the counter use __

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Haywood C. Gray

(División Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103477

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).