The LSA Helium offers 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 LSA Helium is a manually propelled standup wheelchair. It is propelled and steered by varying the speed of the two back wheels. Front castors support the front of the chair and allow indirect steering through the turning back wheels. A gas-spring-system supports the customer in putting the seat manually into a seating or standing position.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, the LSA Helium manually propelled standup wheelchair. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving new clinical efficacy or performance beyond established safety standards. Therefore, many of the typical "acceptance criteria" and "study" components you'd expect for a novel AI/software medical device are not applicable here.

Here's a breakdown based on the information provided, highlighting the differences:

The "acceptance criteria" in this context refer to compliance with internationally recognized safety and performance standards for wheelchairs, rather than specific performance metrics for an AI algorithm. The "study" is the battery of non-clinical tests performed to meet these standards.

1. Table of Acceptance Criteria (Standards) and Reported Device Performance (Compliance):

Acceptance Criteria (Standard)	Description	Reported Device Performance (Compliance)
EN 12182: 1999	Technical aids for disabled persons. General requirements and test methods	Performed at test-laboratories of European notified bodies.
EN 12183: 1999	Manually propelled wheelchairs. Requirements and test methods	Performed at test-laboratories of European notified bodies.
ISO 7176-1: 1999	Wheelchairs. Determination of static stability	Performed at test-laboratories of European notified bodies.
ISO 7176-3: 1988	Wheelchairs. Determination of effectiveness of brakes	Performed at test-laboratories of European notified bodies.
ISO 7176-5: 1986	Wheelchair tests. Methods for determination of overall dimensions, mass and turning space	Performed at test-laboratories of European notified bodies.
ISO 7176-7: 1998	Measurement of seating and wheel dimension	Performed at test-laboratories of European notified bodies.
ISO 7176-8: 1998	Wheelchairs. Requirements and test methods for static, impact and fatigue strengths	Performed at test-laboratories of European notified bodies.
ISO 7176-15: 1996	Wheelchairs. Requirements for information disclosure, documentation and labeling	Performed at test-laboratories of European notified bodies.
ISO 10993-5: 1999	Biological evaluation of medical devices. Tests for in vitro cytotoxicity	Performed at test-laboratories of European notified bodies.
NFP 92503:	Flammability (Specific test method not detailed)	Performed at test-laboratories of European notified bodies.
NFP 92505:	Flammability (Specific test method not detailed)	Performed at test-laboratories of European notified bodies.
ISO 6941: 2003	Textile fabrics. Burning behavior. Measurement of flame spread properties of vertically oriented specimens	Performed at test-laboratories of European notified bodies.

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

Sample Size: Not explicitly stated in terms of number of devices tested for each standard. The phrasing "tests according to current applicable standards where performed at test-laboratories" implies that the device (or representative samples) underwent testing as prescribed by these standards, which typically involve specific sample sizes or test configurations defined within the standard itself.
Data Provenance: The tests were performed at "test-laboratories of European notified bodies." This indicates an external, accredited testing facility within Europe. The tests are non-clinical (i.e., not involving human subjects).

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

Not applicable. This pertains to an AI/software device where ground truth is typically established by human experts reviewing medical images or patient data. For a physical medical device like a wheelchair, "ground truth" refers to the objective physical measurements and mechanical properties as defined by the engineering standards. The "experts" are the technicians and engineers at the notified body laboratories who conduct the tests according to the standard protocols. Their qualifications are inherent in the accreditation of the notified body.

4. Adjudication Method for the Test Set:

Not applicable. This term is usually relevant for clinical studies or AI performance evaluations where there can be disagreement among reviewers or a need for a consensus mechanism. For compliance with engineering standards, the results are typically objective measurements against defined pass/fail criteria.

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. This type of study is specifically for evaluating the impact of AI on human reader performance, usually in diagnostics. The LSA Helium is a physical mobility device and does not involve "human readers" or "AI assistance" in this context.

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

Not applicable. As an entirely mechanical device, there is no "algorithm" to be evaluated in a standalone manner.

7. The type of ground truth used:

Engineering Standards and Objective Measurements: The "ground truth" for this device's compliance is defined by the specific parameters, test methods, and acceptance limits outlined in the referenced EN and ISO standards (e.g., static stability, brake effectiveness, dimensions, strength, flammability). The tests yield objective, measurable data that is compared against these predetermined criteria.

8. The sample size for the training set:

Not applicable. This is a non-AI/ML device. There is no "training set" in the context of an algorithm learning from data. The device itself is designed and manufactured, and then tested for compliance.

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

Not applicable. As above, there is no training set.

Summary of the Study:

The "study" described is a series of non-clinical performance tests conducted to demonstrate that the LSA Helium manually propelled standup wheelchair meets internationally recognized safety and performance standards for such devices. These tests were performed by accredited European notified bodies. The purpose was to show substantial equivalence to a legally marketed predicate device (LEVO Active Easy, K971873) by demonstrating compliance with established (non-AI/ML specific) medical device standards. Clinical tests were explicitly stated as NOT performed.

Summary

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LifeStand "Vivre-Debout" Rond-point de Rosarge 40, rue Palverne F 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

EXHIBIT #1

K042596

JAN 2 6 2005

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: September 06", 2004

1. Name of the Device: LSA Helium
1. Common or Usual Name: manually propelled standup wheelchair

Device Description: 4.

Maximum end-user weight :	100 kg
Wheelchair width	36/38/40/42/44/46cm
Wheelchair seat depth	40 to 50 every 2 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 125mm x 29mm, solid
Rear wheels	Ø 600mm x 25mm, 1000kPa
Brakes	Hand, by pushing
Propulsion	Manual
Elevation	Manual assisted by gas-powered springs, adjustable according to the user's weight.
Rear stabilization	Anti-tip wheels (optional).
Idle weight	17,9kg

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Image /page/1/Picture/0 description: The image shows a logo with the word "LIFESTAND" at the bottom. Above the text, there are three vertical lines of varying thicknesses. The lines are arranged in a way that they appear to be connected, forming an abstract shape.

Intended Use:

The I.S.A Helium offers manually 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.

Comparison to Predicate Devices: 6.

The LSA Helium is substantially equivalent to the standup wheelchair LAE (LEVO Active Easy) by LEVO, K971873

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

To approve the performance of the LSA Helium, tests according to current applicable standards where performed at test-laboratories of European notified bodies:

EN 12182: 1999	Technical aids for disabled persons. Generalrequirements and test methods
EN 12183: 1999	Manually propelled wheelchairs. Requirements and testmethods
ISO 7176-1: 1999	Wheelchairs. Determination of static stability
ISO 7176-3: 1988	Wheelchairs. Determination of effectiveness of brakes
ISO 7176-5: 1986	Wheelchair tests. Methods for determination of overalldimensions, mass and turning space
ISO 7176-7: 1998	Measurement of seating and wheel dimension
ISO 7176-8: 1998	Wheelchairs. Requirements and test methods for static.impact and fatigue strengths
ISO 7176-15: 1996	Wheelchairs. Requirements for information disclosure.documentation and labeling
ISO 10993-5: 1999	Biological evaluation of medical devices. Tests for invitro cytotoxicity
NFP 92503:	flammability
NFP 92505:	flammability
ISO 6941: 2003	Textile fabrics. Burning behavior. Measurement offlame spread properties of vertically oriented specimens

8. Discussion of Clinical Tests Performed:

Clinical tests were not performed

9. Conclusions:

Lifestand believes that the LSA Helium is substantially equivalent to the predicate and is safe and effective for it's intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 € 2005

Ms. Stephanie D. Bankston Official Correspondent for Lifestand Lifestand 10925 Beamer #290 Houston, Texas 77089

Re: K042596

Trade/Device Name: LSA Helium Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: II Product Code: IPL Dated: January 11, 2005 Received: January 14, 2005

Dear: Ms. Stephanie D. 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. Stephanie D. Bankston

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter witification. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Milken

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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Exhibit #3

Page 1 of 1

510(k) Number (if known): KO4 2596

Device Name: LSA Helium

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)

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

510(k) Number.

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).