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

Device Description

Electro Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the PG power wheelchair VSI 70 amp controller. The user interface is a joystick. The Electro is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 25 km (16 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 front drive wheels with drive units (motor, gear, brake), batteries and back 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 powered wheelchair, the Permobil Electro. It does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria, as typically found in submissions for AI/ML-enabled medical devices.

Here's why and what information is missing:

This 510(k) submission is for a traditional medical device (a powered wheelchair) and precedes the widespread adoption and specific regulatory requirements for AI/ML-enabled devices. Therefore, the performance data section is very brief and focuses on the device functioning as intended and its substantial equivalence to a predicate device, rather than quantitative performance metrics against specific acceptance criteria.

Missing Information:

A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, precision, etc.) or report detailed performance metrics for the Electro powered wheelchair in this format. The "Performance Data" section simply states, "In all instances, the Electro functioned as intended."
Sample size used for the test set and the data provenance: Not applicable. Performance for a powered wheelchair typically involves engineering testing for safety and functionality, not a "test set" of data in the AI/ML sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of an AI/ML device, refers to a verified label or diagnosis. For a powered wheelchair, this is not relevant.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable. MRMC studies are specific to image interpretation or diagnostic aid effectiveness, not powered wheelchairs.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The Electro is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable. The Electro is not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

What the document does state about performance and equivalence:

Performance Data: "In all instances, the Electro functioned as intended." This is a qualitative statement indicating that engineering and functional tests showed no failures.
Substantial Equivalence: The primary method for demonstrating safety and effectiveness in this 510(k) is through substantial equivalence to a predicate device: the Chairman 2k (K991658).
- The Electro has the "same intended uses and similar indications, technological characteristics and principles of operation" as the predicate device.
- "The minor technological differences between the Electro and its predicate device raise no new issues of safety or effectiveness."
- "Performance data demonstrate that the Electro is as safe and effective as the Chairman 2K." This performance data would typically be in the form of engineering tests, bench testing, and potentially some limited user testing to confirm basic functionality, stability, braking, speed, etc., rather than clinical study data with specific quantitative metrics.

Summary

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ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHÁIR: ELECTRO

Image /page/0/Picture/1 description: The image shows the text "KO4-12-19" at the top. Below the text is a dark oval shape. Inside the oval shape is some text that is difficult to read due to the image quality. The text inside the oval appears to be a brand name or product name.

AUG - 4 2004

Attachment 11

510(k) Summary

Submitter	Permobil ABBox 120S-861 23 TimråSweden
Phone:	+46 60 595900
Facsimile:	+46 60 575250
Contact Person:	Jan Åström
e-mail address:	jan.astrom@permobil.se
Date Prepared:	April 29, 2004
Device name:	ELECTRO
Classification Name:	Powered wheelchair
Predicate Devices:	Chairman 2k (1280) (K991658) manufactured by Permobil AB.
Intended use:	The intended use of the ELECTRO powered wheelchair is to provideoutdoor and indoor mobility to persons limited to a seated position that arecapable of operating a powered wheelchair.
Description of device:	Electro Powered Wheelchair is battery powered, front wheel motor drivenand is controlled by the PG power wheelchair VSI 70 amp controller.The user interface is a joystick.The Electro is powered by two 12VDC 60Ah, Group M34 batteries,approximate driving range on fully charged batteries is up to 25 km (16miles), depending on use and the terrain the chair is driven on.The chair frame is a rived nut and welded steel construction and includestwo front drive wheels with drive units (motor, gear, brake), batteries andback pivoting casters.Depending on users needs, the joystick motor control is mounted to the leftor right armrest.When the user activates the joystick, the controller receives a signal torelease the brakes.With the brakes released, the chair is allowed to move in the direction thejoystick is actuated.When the user releases the joystick, the chair slows to a stop and the brakesare automatically re-engaged. The solenoid electromechanical brakes allowthe user stop by letting go of the joystick.

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ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: ELECTRO

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Performance Data

In all instances, the Electro functioned as intended.

Substantial Equivalence

The Electro is substantially equivalent to the Chairman 2K (#K991658). The File Electro has the same intended uses and similar indications, technological characteristics and principles of operation. The minor technological differences between the Electro and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Electro is as safe and effective as the Chairman 2K. Thus, the Electro 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 and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged 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

AUG - 4 2004

Mr. Jan Astrom Quality Engineer Permobil AB Box 120 S-861 23 Timra Sweden

Re: K041219 Trade/Device Name: Electro Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: May 24, 2004 Received: May 28, 2004

Dear Mr. Astrom:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 31 (x), pecies is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars the Medical Device Amendments, or to commerce prox to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices mat have occh receitsomed in assee approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that do not require to the general controls provisions of the Act. The You may, therefore, thanket the devices, books requirements for annual registration, listing of gencial controls provisions of ractice, 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 If your device is classified (600 world) als. Existing major regulations affecting your device can thay be subject to suell additional controller Listing of the 21, Parts 800 to 898. In addition, FDA may be found in the Our neements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advised that I Dr I S issuants over device complies with other requirements of the Act that I DA has made a doter regulations administered by other Federal agencies. You must of any i cacal statutes and regarants, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Jan Astrom

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ough manieing of substantial equivalence of your device to a legally prematics notification: The PDF intelligestion 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), please If you desire specific acries is. J 301) 594-4659. Also, please note the regulation entitled, Contact the Oriece of Compunited in (21CFR Part 807.97). You may obtain Misolanung of reference to premainters in the Act from the Division of Small other general informational 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.

Mih. A. Millers

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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ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: ELECTRO

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Attachment 12

INDICATION FOR USE

510(k) number K041219

Device name: Electro

Indication for Use

The intended use of the Electro 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 (Part 21 CFR 801 Subpart D)

Over the counter use (Part 21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mud. N. Millkin

Division of General, Restorative, and Neurological Devices

510(k) Number K041219

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).