The LSC offers electrically powered seated and standing mobility to users with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.

Device Description

The LSC is a powered standup wheelchair. It is propelled and steered by varying the speed of the two back wheels. Front castors support the front of the caain and allow indirect steering through the turning back wheels. An electric lineanan anot system puts the seat into a seating or standing position.

AI/ML Overview

The provided document describes the LSC device, a powered standup wheelchair, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML medical device submission.

This document is a 510(k) summary for a physical medical device (a wheelchair). The Acceptance Criteria and Study sections below are tailored to what is presented in the document regarding the device's conformity to standards and safety/effectiveness, rather than AI-specific performance metrics.

Here's the information extracted and interpreted based on the provided text:

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

For the LSC powered standup wheelchair, the "acceptance criteria" are the specific requirements and test methods outlined in various EN and ISO standards for wheelchairs. The "reported device performance" is the successful completion of tests according to these standards, as stated: "To approve the performance of the LSC, tests according to current applicable standards where performed at test-laboratories of European notified bodies."

Acceptance Criteria (Standard & Requirement)	Reported Device Performance
EN 12182: 1999 - Technical aids for disabled persons. General requirements and test methods	Tests performed according to standard
EN 12184: 1999 - Electrically powered wheelchairs, scooters and their chargers - requirements and test methods	Tests performed according to standard
ISO 7176-1: 1999 - Wheelchairs. Determination of static stability	Tests performed according to standard
ISO 7176-2: 2001 - Wheelchairs. Determination of dynamic stability of electric wheelchairs	Tests performed according to standard
ISO 7176-3: 1988 - Wheelchairs. Determination of effectiveness of brakes	Tests performed according to standard
ISO 7176-4: 1997 - Wheelchairs. Energy consumption of electric wheelchairs and scooters for theoretical distance	Tests performed according to standard
ISO 7176-5: 1986 - Wheelchair tests. Methods for determination of overall dimensions, mass and turning space	Tests performed according to standard
ISO 7176-6: 2001 - Wheelchairs. Determination of maximum speed, acceleration and deceleration	Tests performed according to standard
ISO 7176-7: 1998 - Wheelchairs. Measurement of seating and wheel dimension	Tests performed according to standard
ISO 7176-8: 1998 - Wheelchairs. Requirements and test methods for static, impact and fatigue strength	Tests performed according to standard
ISO 7176-9: 2001 - Wheelchairs. Climatic test for electric wheelchairs	Tests performed according to standard
ISO 7176-10: 1988 - Wheelchairs. Determination of obstacle-climbing ability of electric wheelchairs	Tests performed according to standard
ISO 7176-14: 1997 - Power and Control systems for electric wheelchairs – Requirements and test methods	Tests performed according to standard
ISO 7176-15: 1996 - Wheelchairs. Requirements for information disclosure, documentation and labeling	Tests performed according to standard
ISO 7176-16: 1997 - Wheelchairs - Part 16: Resistance to ignition of upholstered parts	Tests performed according to standard
ISO 7176-20: 2001 - Wheelchairs. Determination of the performance of stand-up type wheelchairs	Tests performed according to standard
ISO 7176-21: 2003 - Wheelchairs. Requirements and test methods for electromagnetic compatibility	Tests performed according to standard
EN ISO 10993-1: 2003 - Biological evaluation of medical devices. Evaluation and testing	Tests performed according to standard
EN ISO 10993-5: 1999 - Biological evaluation of medical devices. Tests for in vitro cytotoxicity	Tests performed according to standard

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

This information is not explicitly detailed in the provided 510(k) summary for each specific test mentioned. For physical devices, compliance with standards often involves testing a specific number of units from a production batch, rather than data sets in the AI/ML context. The tests were performed "at test-laboratories of European notified bodies," implying European provenance. The nature of these tests (e.g., fatigue, stability, brake effectiveness) suggests a controlled laboratory environment.

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 is not applicable to the type of device and testing described. The "ground truth" here is objective physical measurements and adherence to engineering and safety standards, performed by qualified personnel at accredited test laboratories, not by medical experts establishing diagnostic ground truth.

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

Not applicable. The tests are based on objective performance metrics against established standards, not on expert consensus or adjudication of subjective data.

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 a physical medical device (wheelchair), not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was performed.

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

Not applicable. This is a physical device, not an algorithm.

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

The "ground truth" for this device's performance is adherence to established international and European standards (EN and ISO) for wheelchairs, which involve objective physical measurements, mechanical stress tests, electrical component tests, and biological safety evaluations.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As above, this is a physical medical device and does not involve a training set or corresponding ground truth establishment in the AI/ML sense.

Summary

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K061726
Page 1 of 3
EXHIBIT #1

Image /page/0/Picture/1 description: The image shows a logo with the word "LIFESTAND" at the bottom. Above the text, there is an abstract graphic that appears to be composed of vertical lines of varying heights. The lines are arranged in a way that suggests a stylized representation of a cityscape or a series of standing figures. The overall design is simple and modern.

LifeStand "Vivre-Debout" Rond-point de Rosarge 40, rue Palverne - 01700 LES ECHETS-FRANCE Tel : +33(0)4 37 26 27 28 Fax :+33(0)4 37 26 27 29 VAT :FR 23 312 906 613 00079

BEC - 4 2006

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________

1. Submitter's Identification:
  Lifestand Rond-point de Rosarge 40, rue Palverne F 01700 LES ECHETS-FRANCE

Date Summary Prepared: June 12, 2006

1. Name of the Device: LSC
1. Common or Usual Name:

powered standup wheelchair

4. Device Description:

Maximum end-user weight	:	120 kg
Wheelchair width	:	67 cm
Wheelchair length	:	87-109 cm
Frame	:	Rigid, in magnesium, epoxy paint
Seat	:	Depth adjustable, with sore proof cushion
Backrest	:	Inclinable. Folds down for transport
Upholstery	:	Polyester fireproof material (M4), washable
Foot-rests	:	Height adjustable
Front wheels	:	Ø 200mm x 50mm, solid
Rear wheels	:	Ø 350mm x 70mm, solid
Brakes	:	automatic electro-magnetic brake and
		manual standard parking brake
Propulsion	:	electric powered
Elevation	:	electric powered
Rear stabilization	:	Anti-tip wheels (optional).
Idle weight	:	94.7kg

5. Intended Use:

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Image /page/1/Picture/1 description: The image shows a logo with the text "LIFESTA" at the bottom. Above the text, there are three vertical lines of varying heights. The lines appear to be connected at the top, forming a stylized graphic element. The image is in black and white.

The LSC offers electrically operated seated and standing mobility to users with ambulatory impairments, including people with spinal cord injury, spina bifibia, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.

6. Comparison to Predicate Devices:

The LSC is substantially equivalent to its forerunner model LSC Compact by Lifestand, K041535 and the standup wheelchair LCM by LEVO, K963817

Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows:
To approve the performance of the LSC, tests according to current applicable standards where performed at test-laboratories of European notified bodies:

EN 12182: 1999	Technical aids for disabled persons. General requirementsand test methods
EN 12184: 1999	Electrically powered wheelchairs, scooters and their chargers-requirements and test methods
ISO 7176-1: 1999	Wheelchairs. Determination of static stability
ISO 7176-2: 2001	Wheelchairs. Determination of dynamic stability of electricwheelchairs
ISO 7176-3: 1988	Wheelchairs. Determination of effectiveness of brakes
ISO 7176-4: 1997	Wheelchairs. Energy consumption of electric wheelchairs andscooters for determination of theoretical distance
ISO 7176-5: 1986	Wheelchair tests. Methods for determination of overalldimensions, mass and turning space
ISO 7176-6: 2001	Wheelchairs. Determination of maximum speed, accelerationand deceleration of electric wheelchairs
ISO 7176-7: 1998	Wheelchairs. Measurement of seating and wheel dimension
ISO 7176-8: 1998	Wheelchairs. Requirements and test methods for static,impact and fatigue strength
ISO 7176-9: 2001	Wheelchairs. Climatic test for electric wheelchairs
ISO 7176-10: 1988	Wheelchairs. Determination of obstacle-climbing ability ofelectric wheelchairs
ISO 7176-14: 1997	Power and Control systems for electric wheelchairs –Requirements and test methods
ISO 7176-15: 1996	Wheelchairs. Requirements for information disclosure,documentation and labeling
ISO 7176-16: 1997	Wheelchairs - Part 16: Resistance to ignition of upholsteredparts - Requirements and test methods
ISO 7176-20: 2001	Wheelchairs. Determination of the performance of stand-uptype wheelchairs
ISO 7176-21: 2003	Wheelchairs. Requirements and test methods forelectromagnetic compatibility of electrically poweredwheelchairs and motorized scooters
EN ISO 10993-1: 2003	Biological evaluation of medical devices. Evaluation andtesting

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Image /page/2/Picture/0 description: The image shows a logo with the word "LIFESTAND" at the bottom. Above the text, there is an abstract graphic that appears to be three vertical lines of varying heights. The lines are not solid but seem to be made up of smaller elements, giving them a textured appearance.

K061726
Page 3 of 3

Biological evaluation of medical devices. Tests for in vitro EN ISO 10993-5: 1999 cytotoxicity

Discussion of Clinical Tests Performed: 8. Clinical tests were not performed
1. Conclusions:

Lifestand believes that the LSC is substantially equivalent to the predicate and is safe and effective for its intended use.

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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 features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 4 2006

LifeStand "Vivre-Debout" % Ms. Stefanie D. Bankston Rond-point de Rosarge 40, rue Palverne F 01700 Les Echets- France

Re: K061726

Trade/Device Name: LSC Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: Class II Product Code: IPL Dated: November 20, 2006 Received: November 28, 2006

Dear Ms. Bankston:

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 – Ms. Stefanie D. Bankston

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 (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Cahmz

Mark N. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit #3

Page ﻠﺴﻴ of 1

K061726 510(k) Number (if known):

Device Name: LSC

Indications For Use:

Prescription Use _ × (Per 21 CFR 801 Subpart D)

Over-The Counter Use (21 CFT 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K061726

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

510(k) Number. K061726

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).