The products c-max and s-max offer motorized stair-climbing support for disabled seated persons e.g. with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.to move from one level to another with or without manual wheelchair adaption.

Device Description

The products c-max and s-max offer motorized stair-climbing support for disabled seated persons to move from one level to another with or without manual wheelchair adaption.

AI/ML Overview

The provided text describes two medical devices, c-max and s-max, which are motorized stair-climbing support systems for disabled individuals. The information focuses on a 510(k) premarket notification for substantial equivalence, rather than a clinical study evaluating the device against specific acceptance criteria for performance.

Therefore, much of the requested information regarding acceptance criteria, study data, sample sizes, and expert adjudication methods is not present in the provided document, as it outlines a regulatory submission for device clearance, not a performance study report.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" but lists safety and performance standards that the devices are stated to meet and provides technical data. The "acceptance criteria" can be inferred from the "Performance Standards" section.

Acceptance Criteria (Inferred from Performance Standards)	Reported Device Performance (c-max and s-max families)
EN 12182: 1999 Technical aids for disabled persons-general requirements and test methods	Devices meet this standard
ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters -Requirements and test methods	Devices meet this standard
ISO 7176-16:1997 Wheelchairs - Part 16: Resistance to ignition of upholstered parts --Requirements and test methods	Devices meet this standard
ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers	Devices meet this standard
ISO 7176-23: 2002 Wheelchairs - Part 23: Requirements and test methods for attendant-operated stair-climbing devices	Devices meet this standard
Specific Technical Data (Examples from Tables):
Max. Lifting Capacity (s-max)	120 kg, 135/160 kg, 160 kg (model dependent)
Max. Lifting Capacity (c-max)	140kg / 160kg (model dependent)
Climbing Speed (s-max)	app. 300 steps, continually adjustable
Climbing Speed (c-max)	8 - 23 steps / minute, continually adjustable
Capacity with one battery charge (s-max)	15 - 30 floors, depending on the load
Capacity with one battery charge (c-max)	app. 300 steps, depending on the load
Maximum height of step (s-max)	22 cm, 25.5 cm (model dependent)
Maximum height of step (c-max)	21 cm
Noise level	Typically below 70 dB(A)
Vibrations	Weighted RMS value of acceleration the upper body is exposed to lies typically below 2.5 m/s²
Biocompatibility Information	Approval for seat material according to DIN EN ISO 10993-5

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 provided in the document. The document refers to meeting performance standards, but does not detail the testing methodology, sample sizes, or data provenance (e.g., specific test reports, countries of origin, or if the testing was retrospective or prospective).

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 information is not provided in the document. The document refers to meeting established performance standards (e.g., ISO, EN) but does not involve expert consensus on a test set for clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. As this is a regulatory submission based on technical standards, not a clinical study with subjective interpretations, an adjudication method for a "test set" as typically understood in AI/clinical studies would not apply.

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 provided in the document. The devices (c-max and s-max) are motorized assistance devices, not AI-driven diagnostic or interpretative tools that would involve human "readers" or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The devices are physical medical devices, and the submission is focused on their engineering and safety standards, not on the performance of a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated as "ground truth" in the context of a clinical study. However, the "ground truth" for demonstrating compliance with performance standards would be the results of standardized tests and measurements carried out according to the specified EN and ISO standards (e.g., measurements of lifting capacity, noise levels, vibration, battery life, step climbing height, and resistance to ignition).

8. The sample size for the training set
This information is not provided in the document. This is not a machine learning or AI-driven device, so there is no concept of a "training set" in the context presented.

9. How the ground truth for the training set was established
This information is not provided in the document. See point 8.

Summary

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1. 510(k) SUMMARY

DEC 3 0 2010

September 1386, 2010

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

Dear Sir/Madam:

K103122

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 introduce into interstate commercial distribution the motorized lift devices c-max and s-max.

The following information is being submitted in conformance with CDRH-Guidance document "Bundling Multiple Devices in a Single Application", 21 CFR Part 807.87,the "DCRND Guidance for Format and Content for Premarket Notification (510(k)) Submissions", the DCRND November 1996 Draft "Reviewer Guidance for Premarket Notifications: Anesthesiology and Respiratory Devices Branch" Guideline as follows.

1.1	Applicant:	AAT Alber Antriebstechnik GmbH
		Ehestetter Weg 11
		D-72458 Albstadt-Ebingen
		Phone: Tel. +49.7431.1295-0
		Fax +49.7431.1295-35
		Email: info@aat-online.de

Organization Number: 239600

1.2 Contact Person: Mrs. Stefanie D. Bankston BEO MedConsulting Berlin GmbH 2611 Shark Circle Texas City TX 77591 Phone: (409) 229 0022 email: s.bankston@beoberlin.de

1.3 Devices Name:

Proprietary: c-max, c-max U1, c-max U1 160kg, c-max U2, c-max U2 160kg a.
- s-max, s-max aviation, s-max sella, s-max sella 160kg, s-max sella aviation
Common Name: Wheelchair elevator b.
Classification Name: Wheelchair elevator C.
Device Class: II, 21 CFR 890.3930 ದ.
Classification Panel: Physical Medicine e.
ت Product Code: ING

1.4 Performance Standards:

The devices meet the performance standards:

EN 12182: 1999 Technical aids for disabled persons-general requirements and test methods ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters -Requirements and test methods

ISO 7176-16:1997 Wheelchairs - Part 16: Resistance to ignition of upholstered parts --Requirements and test methods

Unsere Hausanschrift

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

{1}------------------------------------------------

ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers ISO 7176-23: 2002 Wheelchairs - Part 23: Requirements and test methods for attendantoperated stair-climbing devices

1.5 Intended Use:

Device Description:

1.6

The products c-max and s-max offer motorized stair-climbing support for disabled seated persons to move from one level to another with or without manual wheelchair adaption.

Image /page/1/Figure/3 description: The image shows the features of the s-max family of devices. The image includes a labeled diagram of the s-max, with numbers pointing to different parts of the device. The handle unit includes the control unit (1), handle (2), tightening knob for horizontal adjustment (3), tightening knob for height adjustment (4), column (5), and tightening knob for the column (6). The climbing unit includes the upper rod (7), battery pack (8), main wheel (9), climber (10), safety brakes (11), lower rod (12), and membrane keypad (13). There are also images of the s-max, s-max sella, s-max aviation, and s-max sella aviation.

Unsere Hausanschrift

AAT Alber Antriebstechnik GmbH · Ehestetter Weg 11 · D-72458 Albstadt-Ebingen Tei. +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

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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Technical data s-max	s-max	sella	aviation	sella
				aviation
Height (mm)	1200-1650	1100-1470	1096-1500	1190-1570
width handle / unit (mm)	517/321	517/321	474/379	517/375
depth handle / unit (mm)	230/320	210/320	860/985	210/340
total weight (kg)	20,5	33,5	36	35,5
maximum lifting capacity (kg)	120	135/160	160	160
batteries	2 x 12 V / 3,3 Ah sealed lead acid
direct current motor	24 V / 178 W (275W)		24 V / 275 W
climbing speed	app. 300 steps, continually adjustable
capacity with one battery charge	15 - 30 floors, depending on the load
maximum height of step	22 cm	22 cm	25,5 cm
noise level	the device's A weighted noise level lies typically below 70 dB
	(A)
storing/operating temperature,device	0° C up to + 60° C / - 30° C up to + 50° C
storing/operating temperature,batteries	0° C up to + 60° C / - 30° C up to + 50° C
vibrations	the weighted RMS value of acceleration the upper body is exposed to lies typically below 2.5 m/s2

Unsere Hausanschrift

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 1BAN: 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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c-max family
2.2Features of the c-max
1 = control unit
2 = handles, adjustable
3 = back rest
4 = arm rest, swivels out
5 = C-part plus seat
6 = climbing frame
7 = foot rest, folds in
8 = main wheel
9 = lever with chain drive
10 = climber and climbing foot
11 = safety brake
12 = climbing unit
13 = battery pack
14 = tightening knobs for the back rest
15 = single step switch
16 = tightening knob for the handle
c-max u1		c-max u2

Technical data c-max	U1	U2
height	1090 mm	1130 mm
width without arm rests	440 mm	430 mm
width with arm rests attached	485 mm	680 mm
depth with the foot rest folded in	730 mm	670 mm
depth with the foot rest folded out	915 mm	785 mm
total weight	31,7 kg	35,7 kg
maximum lifting capacity		140kg / 160kg
batteries		2 x 12 V / 5 Ah sealed lead acid
direct current motor		24 V / 275 W
climbing speed		8 - 23 steps / minute, continually adjustable
capacity with one battery charge	app. 300 steps, depending on the load
maximum height of step	21 cm
noise level	the device's A weighted noise level lies typically below 70 dB

Unsere Hausanschrift

Unsere Bankverbindungen Sparkasse Zollernalb · Konto 31712831 · BLZ 65351260 Swift Code: SOLADES18AL 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

{4}------------------------------------------------

	(A)
storing/operating temperature,device	0° C up to + 60° C / - 30° C up to + 50° C
storing/operating temperature,batteries	0° C up to + 60° C / - 30° C up to + 50° C
vibrations	the weighted RMS value of acceleration the upper body isexposed to lies typically below 2.5 m/s²

1.7 Comparison to legally marketed device (Substantial Equivalence):

The c-max and s-max product families are essentially equivalent in intended use, design and function to the SCALAMOBIL by Ulrich Alber GmbH (K920105).

The Chart below summarizes the similarities and differences:

	c-max	s-max	Scalamobil(K920105)
Stairclimber
Height	1090 / 1130 mm	1096 - 1650 mm	1150 - 1550 mm
Width	440 - 680 mm	321 - 517 mm	480 mm
Max. Load	140 / 160 kg	120 / 135 / 160 kg	160 kg
Total weight	31,7 / 35, 7 kg	36 kg	24,5 kg
Performance
steps	app. 300	app. 300	Up to 300
speed	8 - 23 steps / minutecontinually adjustable	8 - 23 steps / minutecontinually adjustable	6-16 steps / minutecontinually adjustable
battery	2x12V, 275 W	2x12V, 178/275W	2x12V. 176 W

Further information on Scalamobil refer to Exhibit #7.

1.8 Biocompatibility Information:

Approval for seat material according to DIN EN ISO 10993-5.

1.9 Labeling:

Exhibit 5 shows the labels that are applied to the device.

1.10 Quality Assurance and Manufacturing Controls:

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

We would appreciate your reviewing this information at your earliest convenience so that a prompt reply to our request for 510(k) clearance can be processed.

If you have any questions, or require additional information, please call me at (409) 995 0741 or email me at s.bankston@beoberlin.de.

Sincerely,

AAT Alber Antriebstechnik GmbH

i. A. C.

Stefanie D. Bankston Official Correspondent for Lifestand

Unsere Hausanschrift

Unsere Bankverbindungen Sparkasse Zollernalb · Konto 31712831 · BLZ 65351260 Swift Code: SOLADES1BAL 18AN: DE06 6535 1260 0031 7128 31

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

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Image /page/5/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 a stylized image of an eagle or bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

AAT Alber Antriebstechnik GmbH % BEO MedConsulting Berlin GmbH Mrs. Stefanie D. Bankston 2611 Shark Circle Texas City, Texas 77591

DEC 30 2010

Re: K103122

Trade/Device Name: c-max, c-max U1, c-max U1 160kg, cmax U2, c-max U2 160kg, s-max, s-max 160kg, s-max aviation, s-max sella, s-max sella 160kg, s-max sella aviation

Regulation Number: 21 CFR 890.5150 Regulation Name: Powered patient transport Regulatory Class: II Product Code: ILK Dated: September 13, 2010 Received: October 21, 2010

Dear Mrs. 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. 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

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Page 2 - Mrs. Stefanie D. Bankston

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.h1m.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEC 3 0 2010

ー Page of

510(k) Number (if known): 1103122

Device Names:

c-max, c-max U1, c-max U1 160kg, c-max U2, c-max U2 160kg .
s-max 160kg; s-max aviation, s-max sella, s-max sella 160kg, s-. max sella aviation

Indications For Use:

Prescription Use (Per 21 CFR 801 Subpart D) Over-The Counter Use_ X (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)

Vance D. Brand

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103122

Regulation Number and Section

§ 890.5150 Powered patient transport.

(a)
Powered patient stairway chair lifts —(1)Identification. A powered patient stairway chair lift is a motorized lift equipped with a seat and permanently mounted in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by moving a person up and down a stairway.(2)
Classification. Class II. The stairway chair lift is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption:(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of American Society of Mechanical Engineers (ASME) A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the chair in the event of a device failure;
(ii) Appropriate analysis and nonclinical testing must demonstrate the ability of the device, including armrests, to withstand the rated load with an appropriate factor of safety;
(iii) Appropriate restraints must be provided to prevent the user from falling from the device (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”);
(iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety; and
(v) Appropriate analysis and nonclinical testing must demonstrate the resistance of the device upholstery to ignition.
(b)
All other powered patient transport —(1)Identification. A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.(2)
Classification. Class II.