The LEVO combi stand-up electrical power wheelchair is a product which changes peoples position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.

Device Description

The LEVO combi powered wheelchair is centre wheel driven, battery powered, motor driven and is controlled by the Penny & Giles compact power wheelchair controller Pilot+. The joystick is integrated in the controller. The wheelchair is powered by two 12V55Ah batteries with a theoretical driving range of 35km on the fully charged batteries. The wheelchair consists of the following basic sub-sections:

Base with two direct-drive units with integrated parking brakes, two 12V55Ah batteries, two 14"x2¾" centre wheels, two 8"x2" front wheels, and one 5½"x1½" rear wheel with suspension.
Penny & Giles power electronics Pilot+.
Seating system including mechanisms for all possible positions, stand-up actuator and optional lift and/or backrest actuator.
The base is of welded steel construction and includes the base frame, front castor wheels, centre driving wheels with drive unit (motor/gear/brakes), batteries and pivoting rear castor. The motor controller is mounted to the left or right armrest, depending on the user's needs.

AI/ML Overview

The provided 510(k) summary for the LEVO combi device does not contain acceptance criteria or detailed study results to prove the device meets specific performance metrics.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (LEVO mobil LCM) based on intended use, materials, and a comparison of technological characteristics. The manufacturer asserts that the LEVO combi's design is "basically developed on experience of the LEVO mobil LCM" and that "the minor changes declared in the submission do not raise new questions of safety and effectiveness."

Therefore, I cannot provide a table of acceptance criteria or details of a study proving the device meets those criteria, as this information is not present in the provided text. The document does not describe a clinical study, an MRMC study, or a standalone algorithm performance study.

Here's what can be extracted from the document based on your request, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified	Not specified
(No quantitative or qualitative performance metrics are provided as acceptance criteria for the LEVO combi.)	(The document states the device has "the same safety and effectiveness as the predicate device(s)" but does not present specific performance data.)

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

Test set sample size: Not applicable/Not provided. No dedicated test set for performance evaluation is described.
Data provenance: Not applicable. The document refers to "experience of the LEVO mobil LCM" but does not detail any data, its origin (country), or whether it was retrospective or prospective.

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

Not applicable/Not provided. No test set requiring expert ground truth establishment is described.

4. Adjudication method for the test set

Not applicable/Not provided. No test set requiring an adjudication method is described.

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

No MRMC comparative effectiveness study was done. This device is a physical medical device (stand-up electrical power wheelchair), not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant in this context.

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

No standalone algorithm performance study was done. This device is a physical medical device and does not involve a standalone algorithm in the sense of AI or software performance evaluation.

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

Not applicable/Not provided. No ground truth is described as part of a performance evaluation. The substantial equivalence argument relies on comparing the new device's features and safety profile to an existing, legally marketed device.

8. The sample size for the training set

Not applicable/Not provided. There is no mention of a "training set" in the context of device development or testing as would be seen for an AI/ML device. The device's development leveraged "experience of the LEVO mobil LCM."

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

Not applicable/Not provided. As no training set or ground truth in that context is mentioned, this information is not available.

Summary of what the document does state (related to safety and effectiveness):

The LEVO combi's safety and effectiveness claim is based on its substantial equivalence to the predicate device, LEVO mobil LCM (K963817). The core argument is:

Intended Use: The LEVO combi has the same intended use as the predicate (position changes from sitting to standing and vice-versa, reclining, seat/back lift, indoor and outdoor mobility).
Materials: Substantially equivalent materials.
Technological Characteristics: The LEVO combi was "basically developed on experience of the LEVO mobil LCM" and has "in substantial the same technological characteristics" as the predicate.
Changes: Minor changes (rear suspension, outdoor mobility, different controller - Pilot+ vs. PG8, and additional position capabilities like reclining to lying/relax) are highlighted.
Conclusion: The manufacturer asserts that these minor changes "do not raise new questions of safety and effectiveness" and that the device therefore has "the same safety and effectiveness as the predicate device(s)."

This type of 510(k) submission relies on a comparative analysis rather than new, extensive performance studies for the device itself, assuming the predicate device has already established its safety and effectiveness.

Summary

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510(k) Summary of Safety and Effectiveness

K030893

LEVO combi

APR - 2 2003

Submitter:	LEVO AGP.O. Box 1272Anglikerstrasse 20CH-5610 Wohlen, Switzerland
Phone:Fax:	+41 56-618 44 11+41 56-618 44 10
Contact Person:	Mr. Thomas Raeber, Managing Director orDr. Kurt H. Fischer, CEO
E-Mail-Address:	raeber@levo.ch fischer@levo.ch
Device Name:	LEVO combi
Classification Name:	Electrical Power Wheelchair, Stand-up
Identification ofPredicate Devices:	LEVO mobil LCM (K 963817)
Indtended Use:	The LEVO combi stand-up electrical power wheelchairis a product which changes peoples position not onlyfrom sitting to standing and standing to sitting but alsoreclines and lifts the seat and back position. The productprovides indoor and outdoor mobility.
Description ofthe Device:	The LEVO combi powered wheelchair is centre wheeldriven, battery powered, motor driven and is controlledby the Penny & Giles compact power wheelchaircontroller Pilot+. The joystick is integrated in thecontroller.The wheelchair is powered by two 12V55Ah batterieswith a theoretical driving range of 35km on the fullycharged batteries.The wheelchair consists of the following basic sub-sections:

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Base with two direct-drive units with integrated . parking brakes, two 12V55Ah batteries, two 14"x2¾" centre wheels, two 8"x2" front wheels, and one 5½"x1½" rear wheel with suspension.
Penny & Giles power electronics Pilot+ .
Seating system including mechanisms for all possible . positions, stand-up actuator and optional lift and/or backrest actuator.

The base is of welded steel construction and includes the base frame, front castor wheels, centre driving wheels with drive unit (motor/gear/brakes), batteries and pivoting rear castor. The motor controller is mounted to the left or right armrest, depending on the user's needs,

Substantial Equivalence:

The LEVO combi is substantial equivalent with respect to intended use, and materials to the predicate device. The key changes are rear suspension, outdoor mobility. the use of the Pilot+ controller from Penny & Giles instead of the PG8 controller from Penny & Giles, as well as additional possibilities to change positions (reclining up to lying, relax position).

Safety and Effectiveness:

LEVO combi was basically developed The on experience of the LEVO mobil LCM. However being able to provide additional outdoor mobility as well as further improvements in the geometric for an excellent biomechanical response to the user's body, there are a few additional functions and adjustments integrated. The rest of it is simply colour and design changes. So the LEVO combi has in substantial the same technological characteristics and the same safety and effectiveness as the predicate device(s) and the minor changes declared in the submission do not raise new questions of safety and effectiveness.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 2 2003

LEVO AG c/o Mr. Stefan Preiss TUV America, Inc. 1775 Old Highway 8 New Brighton, MN 55112

Re: K030893

Trade/Device Name: LEVO combi Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: II Product Code: IPL Dated: March 21, 2003 Received: March 21, 2003

Dear Mr. Preiss:

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.

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 - Mr. Stefan Preiss

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premar:et notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

sincerely yours,

Mark N. Mulkerson

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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Statement of Indication for Use

Device Name: LEVO combi

Intended Use:

Target Population:

For all individuals who need a power wheelchair with the possibility to change positions and who can not stand on their feet themselves such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..

Mark N. Milken

Division Sign-Of Division of Genera storative and Neurological L . ces K 030893

510(k) Number_

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Regulation Number and Section

§ 890.3900 Standup wheelchair.

(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).