SOLO+, SOLO and SERVO turn a manually propelled wheelchair into a powered wheelchair. They are intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.

Device Description

The subject devices SOLO, SOLO+ and SERVO are power-wheelchair-conversion-kits that add powered propulsion to a manual wheelchair, thereby, turning a manual wheelchair into a powered wheelchair. They consist of two powered wheels (each incorporating an electrical motor) a control unit with its bracket and a battery pack. A battery charger and a bag for the battery pack are included in the delivery as well. The powered wheels substitute the conventional manual wheels from selected wheelchairs. The battery-pack and the controller-unit can easily be attached to the wheelchair. Speed, acceleration and deceleration are microprocessor-controlled. A preselection of the maximum speed can be done with buttons on the control unit. The wheelchair will accelerate or drive with steady speed when the joystick (SOLO and SOLO+) or the hand-rims (SERVO) are pushed into the travel-direction. The motors will steadily reduce the driving force until the wheelchair stops if no driving-signal (deflection of the joystick or the rim) is provided. The safety-brakes lock automatically when the wheelchair stopped (SOLO, SOLO+). The manual parking brakes can also be used to prevent unintended movement. After ten minutes of non-use the device turns off automatically. The powered wheels can be disengaged if the user wants to drive with manual propulsion, only.

AI/ML Overview

The provided document describes the Food and Drug Administration's (FDA) substantial equivalence determination for the AAT Alber Antriebstechnik GmbH's SOLO+, SOLO, and SERVO powered wheelchair conversion kits (K142770). It specifies the devices, their intended use, and a comparison to a predicate device. The document details the non-clinical tests performed to demonstrate substantial equivalence to legally marketed predicate devices, focusing on various ISO standards.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific pass/fail values. Instead, it refers to performing non-clinical tests according to recognized standards. The "reported device performance" is generally stated as meeting these standards or being similar to the predicate device, implying compliance with the standards' requirements.

However, a comparison table and a discussion of differences between the subject device (SOLO / SOLO+ / SERVO) and the predicate device (e-motion, K003449) are provided, which indirectly indicate performance attributes.

Feature	Predicate device (e-motion K003449)	Subject devices (SOLO / SOLO+ / SERVO)	Discussion and Indication of Performance
Technical Data
Wheels	22" / 24"	24"	"The subject and the predicate devices are available with 24-inch wheels. The predicate device is also available with smaller 22-inch wheels... However, the wheel-size has no influence on the safety of the powered propulsion." (Indicates safety equivalence despite size difference).
Weight	22 kg	22.9kg / 22.9kg / 24.8kg	"The weight differences occur from design details. The subject devices are able to carry a higher max. load while the basic material is the same. Therefore, the design is reinforced, more rigged and consequently a bit heavier. The weight differences have no negative influence on the safety of the subject devices." (Implies safety performance is maintained despite weight difference).
Max. user weight	130 kg	160kg / 200kg / 150kg	"The subject devices are designed to carry a higher user-weight. This is actually an advantage. It lowers the risk of unintended overloading the wheelchair. All mechanical and driving characteristics are well approved to ensure a safe use under the max. load. The differences have no negative influence on the safety." (Improved performance in terms of max load, safety maintained).
Total weight approved	180 kg	210kg / 250kg / 200kg	"The total weight of the subject devices is consequently higher because of the higher product-weight and max. user-weight. The differences have no negative influence on the safety." (Safety maintained despite higher total weight).
Braking technologies	Electro-magnetic spring loaded drum brakes.	Electro-magnetic spring loaded drum brakes.	"same" (Equivalent performance). Non-clinical tests were performed according to ISO 7176-3: Determination of effectiveness of brakes. (Indicates meeting this standard).
Speed, acceleration, deceleration	Preselected max-speed, microprocessor-controlled speed, acceleration and deceleration.	Preselected max-speed, microprocessor-controlled speed, acceleration and deceleration. The user controls these parameter with the joystick or rim-propulsion.	"same" (Equivalent performance). Non-clinical tests were performed according to ISO 7176-6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs. (Indicates meeting this standard).
User Interface	same as SERVO	Joystick (SOLO, SOLO+) / rim with hall-sensor (SERVO)	"The SOLO and SOLO+ have a Joystick to steer the wheelchair... This opportunity has no negative influence on the safety of the device. It expands the range of users." (Indicates safety maintained, expanded usability).
Driving force	Approx. 10N to push or pull the joystick or rim.	Approx. 10N to push or pull the joystick or rim. Rim-sensor-sensitivity is adjustable.	"same as SERVO" (Equivalent performance).
Forward/backward movement	same as SERVO	Joystick (SOLO, SOLO+)/ rim with hall-sensor (SERVO)	"same as SERVO" (Equivalent performance).
Locks to prevent unintended movement	manual parking brake (SERVO)	manual parking brake (SERVO); SOLO, SOLO+ have an electro-magnetic spring loaded drum brakes in addition	"same as SERVO" plus additional brakes on SOLO/SOLO+ (Potentially improved safety/redundancy, but not explicitly stated as an "acceptance criteria" improvement over predicate in this section). Performance implicitly meets ISO 7176-3.
Foldable wheelchair still foldable?	Foldable, after detaching the battery	Foldable, after detaching the battery	"same" (Equivalent performance).
Performance
Range (ISO 7176-14)	up to 15.5 mil	up to 22mil / 9.3mil / 34mil	"The theoretical driving distance from our subject devices differ from the predicate device because of different weight capacities and the possibility to choose different batteries. This difference has no influence on the safety of the devices. It only has an influence on the comfort of the devices." (Performance difference, but safety maintained). Non-clinical tests according to ISO 7176-4: Energy consumption of electric wheelchairs... for determination of theoretical distance.
Speed: forward/backward	3.8 mil/h / 1.9 mil/h	3.8 mil/h / 1.9 mil/h	"same" (Equivalent performance). Non-clinical tests were performed according to ISO 7176-6.
Electrical data
battery	25.2V, 6.0 Ah (Li-Ion)	28.8V, 16Ah (Pb) / 24V, 8.5 Ah (Li-Ion)	"The user of the SOLO, SOLO+ and SERVO can choose between Pb-batteries and Li-lon batteries... The differences have no influence on the safety of the devices." and "Both battery types are approved and have their advantages." (Different options, safety maintained). Non-clinical tests according to ISO 7176-14.
motor	25.2V; DC; 60W	24-28.8V; DC, 150W/70W (microprocessor controlled adaption to the power source (PB or LI-Ion))	"While the material and design is similar, the electrical data differ. The motor-characteristics may have little influence on driving characteristics but they don't result it any safety differences." (Different characteristics, but no safety impact). Non-clinical tests according to ISO 7176-14.

Acceptance Criteria (Implied by Standards Met):

The device is deemed to meet acceptance criteria by conforming to the following recognized standards:

Static stability: ISO 7176-1: Determination of static stability.
Dynamic stability: ISO 7176-2: Determination of dynamic stability.
Brake effectiveness: ISO 7176-3: Determination of effectiveness of brakes.
Power system effectiveness (range): ISO 7176-4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance.
Speed, acceleration, deceleration: ISO 7176-6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs.
Measurement comparability: ISO 7176-7 and ANSI / RESNA WC-1:2009 section 7: method of measurement of seating and wheel dimensions.
Mechanical strength and durability: ISO 7176-8 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths.
Climatic tests: ISO 7176-9 Wheelchairs - Part 9: Climatic tests for electric wheelchairs.
Load tests comparability: ISO 7176-11 Wheelchairs - Part 11: Test Dummies.
Driving and braking tests comparability: ISO 7176-13 Wheelchairs – Part 13 Determination Of Coefficient Of Friction Of Test Surfaces.
Electrical safety, software-validation and performance: ISO 7176-14 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters -Requirements and test methods.
Electromagnetic compatibility: ANSI/RESNA wc/ vol.2 and ISO 7176-21 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers.
Biocompatibility: ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity.

The document states that the devices are "as safe, as effective and perform as well as the predicate device" based on these non-clinical tests, implying that the performance meets the necessary standards for substantial equivalence.

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

The document explicitly states that non-clinical tests were performed. These types of tests typically involve testing the physical devices themselves (e.g., a sample of the SOLO, SOLO+, and SERVO models) under controlled laboratory conditions, rather than a "test set" of patient data as might be relevant for AI or diagnostic devices.

The document does not specify the sample size for the devices tested (e.g., number of units of each model).

The data provenance is not explicitly stated as country of origin or retrospective/prospective. However, given that it's a submission to the U.S. FDA by AAT Alber Antriebstechnik GmbH (Germany-based company), the tests were likely performed either in Germany or by a certified testing facility relevant to international standards (ISO). The testing is prospective in the sense that the tests were conducted for the purpose of this submission to demonstrate compliance and substantial equivalence before commercial distribution. It is not retrospective data from real-world usage.

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

This information is not applicable to this type of device and submission. The tests performed are non-clinical, mechanical, electrical, and materials-based assessments against recognized engineering and medical device standards (ISO). There is no "ground truth" derived from expert interpretation of clinical data in the way one would for an AI diagnostic device. The "ground truth" here is the physical performance of the device measured against the established parameters and limits of the ISO standards.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3. "Adjudication" typically refers to resolving discrepancies in expert interpretations or clinical outcomes. In non-clinical engineering tests, the results are quantitative measurements against predefined criteria in the standards.

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

This information is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation (e.g., radiologists reading images) where AI assistance might improve their performance. The SOLO+, SOLO, and SERVO are powered mobility devices, not diagnostic or AI-powered devices, and therefore an MRMC study would be irrelevant.

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

This information is not applicable. These devices are not AI algorithms. They are electromechanical devices with microprocessors controlling speed, acceleration, and deceleration, but this is embedded control logic, not a "standalone algorithm" in the context of an AI device. The phrase "algorithm only without human-in-the-loop performance" specifically refers to AI models making decisions independently, which is not what these devices do. They assist a human user in propelling a wheelchair.

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

As discussed in point 3, for these non-clinical tests, the "ground truth" is established by the definitions and quantitative limits within the referenced ISO and ANSI/RESNA standards. For example:

For static stability (ISO 7176-1), the ground truth is whether the device remains stable at specified angles.
For brake effectiveness (ISO 7176-3), the ground truth is whether the brakes can stop the device within specified distances or hold it on a specified incline.
For biocompatibility (ISO 10993-5), the ground truth is the chemical and biological response of materials.

There is no expert consensus on clinical findings, pathology, or outcomes data involved in these specific tests for this device.

8. The sample size for the training set

This information is not applicable. These are not machine learning or AI devices that require a "training set" of data.

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

This information is not applicable as there is no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

June 9, 2015

AAT Alber Antreibstechnik GmbH c/o Ms. Stefanie D. Bankston Official Correspondent BEO MedConsulting Berlin GmbH 3001 Ferndale Drive League City, TX 77573

Re: K142770

Trade/Device Name: SOLO+, SOLO and SERVO Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: April 20, 2015 Received: April 23, 2015

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. Isting 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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aquel -S

Carlos L. Peña, PhD, MS

for Director

Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142770

Device Name SOLO+, SOLO and SERVO

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows a blue square with rounded corners. Inside the square, there are three white letters, "AAT", stacked vertically. The letters are bold and sans-serif. The overall design is simple and clean.

510(k) SUMMARY

May 09, 2015

Office of Device Evaluation U.S. Food & Drug Administration

Dear Madame/Sir;

In accordance with Section 510(k) of the Federal Food & Drug and Cosmetic Act, and in conformance with 21 CFR Part 807, pre-market notification is hereby made of the intention of AAT Alber Antriebstechnik GmbH to interstate commerce for commercial distribution the motorized add-on drive for wheelchairs.

Applicant:	AAT Alber Antriebstechnik GmbHEhestetter Weg 11D-72458 Albstadt-EbingenPhone: Tel. +49.7431.1295-0Fax +49.7431.1295-35Email: info@aat-online.de
Organization Number:	239600
Contact Person:	Ms Stefanie D. Bankston / Mr Michael Vent3001 Ferndale DrLeague City TX 77573Phone: (713) 483 4617Email: s.bankston@beoberlin.com
Device:	a. Proprietary: SOLO, SOLO+ and SERVOb. Common Name: Powered wheelchair

Classification Name: Powered wheelchair C.
d. Device Class: II, 21 CFR 890.3860
Classification Panel: Physical Medicine e.
f. Product Code: ITI

Predicate Device Information:

We claim substantial equivalence for the subject devices SOLO, SOLO+ and SERVO in intended use, design and function to the predicate device e-motion (K003449) by Ulrich Alber GmbH.

Intended Use:

SOLO, SOLO+ and SERVO turn a manually propelled wheelchair into a powered wheelchair. They are intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.

Device Description:

The subject devices SOLO, SOLO+ and SERVO are power-wheelchair-conversion-kits that add powered propulsion to a manual wheelchair, thereby, turning a manual wheelchair into a powered wheelchair.

AAT Alber Antriebstechnik GmbH · Ehestetter Weg 11 · D-72458 Albstadt-Ebingen Tel. +49.7431.1295-0 · Fax +49.7431.1295-35 · info@aat-online.de · www.aat-online.de Postfach 100 560 · D-72426 Albstadt-Ebingen

Unsere Bankverbindungen Sparkasse Zollernalb · Konto 31712831 · BLZ 65351260 Swift Code: SOLADES1BAL IBAN: DE06 6535 1260 0031 7128 31

Volksbank Ebingen eG · Konto 83153004 · 65390120 LBBW · Konto 4765671 · 60050101

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Image /page/4/Picture/0 description: The image shows a logo with the letters "AAT" in white on a blue background. The logo is a rounded square shape. The letters are in a bold, sans-serif font. The blue background is a solid color. The logo is simple and clean.

They consist of two powered wheels (each incorporating an electrical motor) a control unit with its bracket and a battery pack. A battery charger and a bag for the battery pack are included in the delivery as well.

The powered wheels substitute the conventional manual wheels from selected wheelchairs. The battery-pack and the controller-unit can easily be attached to the wheelchair.

Speed, acceleration and deceleration are microprocessor-controlled. A preselection of the maximum speed can be done with buttons on the control unit. The wheelchair will accelerate or drive with steady speed when the joystick (SOLO and SOLO+) or the hand-rims (SERVO) are pushed into the travel-direction.

The motors will steadily reduce the driving force until the wheelchair stops if no driving-signal (deflection of the joystick or the rim) is provided. The safety-brakes lock automatically when the wheelchair stopped (SOLO, SOLO+). The manual parking brakes can also be used to prevent unintended movement.

After ten minutes of non-use the device turns off automatically. The powered wheels can be disengaged if the user wants to drive with manual propulsion, only.

Image /page/4/Figure/6 description: The image shows a SERVO Set, which includes five different components. Component 1 is a power adapter with a cord and plug. Component 2 is a pair of wheels with the word "SERVO" on the hub. The remaining components are a controller (3), a control box (4), and a metal box with a screen (5).

SOLO+/SOLO Set

Image /page/4/Figure/8 description: The image shows five different parts of a wheelchair. The parts are labeled with numbers 1 through 5. Part 1 is the charger, part 2 is the powered wheels, part 3 is the control unit with its bracket, part 4 is the battery pack, and part 5 is the bag for the battery pack.

Unsere Hausanschrift

Unsere Bankverbindungen Sparkasse Zollernalb · Konto 31712831 · BLZ 65351260 Swift Code: SOLADES1BAL IBAN: DE06 6535 1260 0031 7128 31

Amtsgericht Stuttgart HRB 1006 · Sitz: Albstadt · Ust ID Nr. DE 173669635 Geschäftsführer: Thomas Alber, Markus Alber

Volksbank Ebingen eG · Konto 83153004 · 65390120 LBBW · Konto 4765671 · 60050101

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Image /page/5/Picture/0 description: The image is a logo for AAT, which is displayed in a blue square with rounded corners. The letters "AAT" are written in a sans-serif font and are colored in light gray. The logo is simple and clean, with a focus on the acronym "AAT".

Comparison to legally marketed device (Substantial Equivalence):

The SOLO, SOLO+ and SERVO are essentially equivalent in intended use, design and function with the e-motion by Ulrich Alber GmbH (K003449). However, there are some minor differences discussed below.

	Subject devicesSOLO / SOLO+ / SERVO	Predicate devicee-motion(K003449)
Technical data
Wheels	24"	22" / 24"
Weight	22.9kg/22,9kg/24,8kg	22 kg
Max. user weight	160kg/200kg/150kg	130 kg
Total weight approved	210kg/250kg/200kg	180 kg
Braking technologies	Electro-magnetic spring loaded drum brakes.	same
Speed, acceleration,deceleration	Preselected max-speed, microprocessor-controlledspeed, acceleration and deceleration. The user controlsthese parameter with the joystick or rim-propulsion.	same
User Interface	Joystick (SOLO, SOLO+) / rim with hall-sensor (SERVO)	same as SERVO
Driving force	Approx. 10N to push or pull the joystick or rim. Rim-sensor-sensitivity is adjustable.	same as SERVO
Forward/backwardmovement	Joystick (SOLO, SOLO+)/ rim with hall-sensor (SERVO)	same as SERVO
Locks to preventunintended /unanticipatedmovement	manual parking brake (SERVO)SOLO, SOLO+ have an electro-magnetic spring loadeddrum brakes in addition	same as SERVO
Foldable wheelchair stillfoldable?	Foldable, after detaching the battery	same
Performance
Range(ISO 7176-14)	up to 22mil / 9.3mil / 34mil	up to 15.5 mil
Speed:forward/backward	3.8 mil/h / 1.9 mil/h	same
Electrical data
battery	28,8V, 16Ah(Pb)24V, 8,5 Ah(Li-Ion)	25,2V, 6,0 Ah (Li-Ion)
motor	24-28,8V; DC, 150W/70W (microprocessor controlledadaption to the power source (PB or LI-Ion))	25,2V; DC; 60W

The Chart summarizes technical similarities and differences:

Differences:

Differences	Discussion
Wheel size	The subject and the predicate devices are available with 24-inch wheels. Thepredicate device is also available with smaller 22-inch wheels. Some user maychoose smaller wheels to reach the floor with their feet for foot-propulsion orsimply because they feel a 24-inch wheelchair is too large. However, thewheel-size has no influence on the safety of the powered propulsion.
Weight differences	The weight differences occur from design details. The subject devices are ableto carry a higher max. load while the basic material is the same. Therefore, thedesign is reinforced, more rigged and consequently a bit heavier. The weightdifferences have no negative influence on the safety of the subject devices.
Max. user weight	The subject devices are designed to carry a higher user-weight. This is actuallyan advantage. It lowers the risk of unintended overloading the wheelchair. Allmechanical and driving characteristics are well approved to ensure a safe useunder the max. load. The differences have no negative influence on the safety.

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Image /page/6/Picture/0 description: The image is a square logo with a blue background and white text. The text "AAT" is prominently displayed in the lower portion of the logo. The upper-right corner of the logo has a rounded edge, giving it a modern and clean appearance.

Total weight	The total weight of the subject devices is consequently higher because of thehigher product-weight and max. user-weight. The differences have no negativeinfluence on the safety.
Theoretical drivingrange	The theoretical driving distance from our subject devices differ from thepredicate device because of different weight capacities and the possibility tochoose different batteries. This difference has no influence on the safety of thedevices. It only has an influence on the comfort of the devices. The user is freeto choose the configuration that suits his habits the best. The user is able toeasily reset the wheels to manual propulsion at any time if the batteries run outof energy.
Battery capacity	The user of the SOLO, SOLO+ and SERVO can choose between Pb-batteriesand Li-lon batteries. Both battery types are approved and have theiradvantages. While the Pb-battery is cheaper and has a higher capacity, the Li-lon battery is faster recharged, less heavy and suitable for more recharges.The user should choose the configuration that suits his habits the best. Thedifferences have no influence on the safety of the devices.
Battery technology	The predicate device is available with Li-Ion battery, only. The subject devicesare also available with Pb-batteries. Both battery types are approved and havetheir advantages. While the Pb-battery is cheaper and has a higher capacity,the Li-Ion battery is faster recharged, less heavy and suitable for morerecharges. The user should choose the configuration that suits his habits thebest. The differences have no influence on the safety of the devices.
Motor	While the material and design is similar, the electrical data differ. The motor-characteristics may have little influence on driving characteristics but they don'tresult it any safety differences.
User Interface	The SOLO and SOLO+ have a Joystick to steer the wheelchair. User with alimited capability to use the rim can steer the wheelchair like a classicalpowered wheelchair with a joystick. This opportunity has no negative influenceon the safety of the device. It expands the range of users.

Performance Standards:

To demonstrate substantial equivalence we performed non-clinical tests according recognized standards:

To demonstrate the static stability (tilt-over-value) we performed non-clinical tests according to ISO 7176-1: Determination of static stability.
. To demonstrate the dynamic stability (tilt-over-value while driving) we performed nonclinical tests according to ISO 7176-2: Determination of dynamic stability.
. To demonstrate effectiveness of the device's brakes we performed non-clinical tests according to ISO 7176-3: Determination of effectiveness of brakes.
. To demonstrate effectiveness of the power system we performed non-clinical tests according to ISO 7176-4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance.
. To demonstrate safety related to speed, acceleration and deceleration we performed non-clinical tests according to ISO 7176-6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs.
To ensure comparability with other test results all measurements were made in conformity . with ISO 7176-7 and ANSI / RESNA WC-1:2009 section 7: method of measurement of seating and wheel dimensions
. To demonstrate mechanical strength and durability, non-clinical tests were performed according to ISO 7176-8 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatique strengths.
To demonstrate safe use and performance under different climations, non-clinical tests were performed according to ISO 7176-9 Wheelchairs - Part 9: Climatic tests for electric wheelchairs

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Image /page/7/Picture/0 description: The image is a logo for AAT, which is a blue square with rounded corners. The letters "AAT" are written in white in the bottom left corner of the square. The logo is simple and clean, and the blue and white colors give it a professional look.

. To ensure comparability with other test results all load tests were performed in conformity with ISO 7176-11 Wheelchairs - Part 11: Test Dummies
. To ensure comparability with other test results all driving and braking tests were performed in conformity with ISO 7176-13 Wheelchairs – Part 13 Determination Of Coefficient Of Friction Of Test Surfaces
. To demonstrate electrical safety, software-validation and performance, non-clinical tests were performed according to ISO 7176-14 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters -Requirements and test methods
. To demonstrate electromagnetic compatibility, non-clinical tests were performed according to ANSI/RESNA wc/ vol.2 and ISO 7176-21 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
. To demonstrate the device's biocompatibility, we performed non-clinical tests according to ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity

Quality Assurance and Manufacturing Controls:

AAT Alber Antriebstechnik GmbH operates to an established and certified quality management system according to ISO 9001, and ISO 13485 requirements.

Conclusion:

The subject devices, SOLO, SOLO+ and SERVO, are as safe, as effective and perform as well as the predicate device.

Sincerely,

AAT Alber Antriebstechnik GmbH

Stefanie D. Bankston / p.p. Michael Vent Official Correspondent for AAT Alber Antriebstechnik

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).