The Skippi is propelled by two DC Motors, Micro Motor AG PMGST 76/40 L/R 6 Km/H at 24 Volts. The controller is the enAble 40 manufactured by Curtis Instruments, AG. The closed "H" frame is rigid (not foldable), all four wheels are suspended independently. The Skippi has 12.5 inch knobby rear tires. Options available to the end user are the following: Seat Tilt Mechanism, Electric or with Gas Compression Spring. Electric Backrest Angle Adjustment. Seating Shell Adapter. Tray. Control for Attendant. Bumper Bar. Single Panel Footrest. Colors (Yellow, Blue, or Red).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Skippi Powered Wheelchair for Children" by Otto Bock Healthcare LP. While it establishes the device's substantial equivalence and general information, it does not contain the detailed information requested regarding specific acceptance criteria, device performance metrics, or the methodologies of a specific study to prove those criteria.

Instead, the document states: "The Skippi was tested by TÜV Product Service to the following standards: EN 12184, ISO 7176 -- Series, ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC with the conclusion that 'the test sample fulfills the requirements.'" This indicates compliance with established industry standards but does not provide the specific performance data or study details typically associated with the requested items.

Therefore, I cannot fully complete the requested table and answer all questions based on the provided text.

Here's an analysis of what can be extracted and a clear indication of what is missing:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Standard Compliance)	Reported Device Performance
Compliance with EN 12184	"the test sample fulfills the requirements."
Compliance with ISO 7176 -- Series	"the test sample fulfills the requirements."
Compliance with ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC	"the test sample fulfills the requirements."

Missing Information for Table: Specific quantitative or qualitative performance metrics (e.g., speed, battery life, weight capacity, stability angles, turning radius) that would usually define acceptance criteria for a medical device are not provided beyond the general statement of fulfilling requirements of broad standards.

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

Sample Size: Not specified. The document refers to "the test sample" (singular), implying at least one wheelchair was tested, but a specific number is not given.
Data Provenance: Not specified. The testing organization, TÜV Product Service, is a German company, suggesting the testing likely occurred in Europe or by a branch of TÜV, but the country of origin of the data itself is not explicitly stated. It is a prospective test, as it was conducted for the purpose of this 510(k) submission.

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 type of information is not applicable to the testing described. The "ground truth" here is compliance with engineering and safety standards, determined through formal testing procedures by a recognized testing body (TÜV Product Service), not through expert clinical consensus or interpretation of medical images.

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

Not applicable. This adjudication method is typically used in clinical studies involving multiple expert readers assessing data (e.g., radiological images) to establish a consensus ground truth. The testing for a powered wheelchair's compliance to engineering standards does not involve this methodology.

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. An MRMC comparative effectiveness study is not applicable to this device or the type of testing described. This is a powered wheelchair; its evaluation focuses on safety, performance against engineering standards, and substantial equivalence, not the impact of AI on human reader performance.

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

Not applicable. This question pertains to AI/algorithm performance. The device is a physical powered wheelchair, not an algorithm.

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

The "ground truth" is adherence to established international and national standards for wheelchairs (EN 12184, ISO 7176 -- Series, ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC). These standards define acceptable performance and safety parameters, which are evaluated through specific test procedures.

8. The sample size for the training set:

Not applicable. This refers to a "training set" used in machine learning or AI development. The Skippi Powered Wheelchair is a physical device, and its evaluation relies on testing against established standards, not on statistical models trained on data.

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

Not applicable. (See point 8).

Summary

{0}------------------------------------------------

Otto Bock®

K070318

MAY 1 1 2007

510(k) SUMMARY of SAFETY and EFFECTIVENESS

A. General Information

1.	Submitter's Name:	OTTO BOCK HealthCare LP
2.	Address:	Two Carlson Parkway N., Suite 100Minneapolis, MN 55447-4467
3.	Telephone:	763-253-5607
4.	Contact Person:	Shannon Tufvander
5.	Date Prepared:	January 18, 2007
6.	Registration Number:	2182293
Device
1.	Name:	Skippi Powered Wheelchair for Children
2.	Trade Name:	Skippi Powered Wheelchair for Children
3.	Common Name:	Powered wheelchair

Classification Name: Powered wheelchair

ITI 5. Product Code:

1. Class: II
1. Regulation Number: 890.3860

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

Otto Bock®

C. Identification of Legally Marketed Devices

1. Name:	A-200
2. K Number:	K052706
3. Date Cleared:	December 27, 2005

D. Description of the Device

The Skippi is propelled by two DC Motors, Micro Motor AG PMGST 76/40 L/R 6 Km/H at 24 Volts. The controller is the enAble 40 manufactured by Curtis Instruments, AG.

The closed "H" frame is rigid (not foldable), all four wheels are suspended independently. The Skippi has 12.5 inch knobby rear tires.

Options available to the end user are the following:

Seat Tilt Mechanism, Electric or with Gas Compression Spring .
Electric Backrest Angle Adjustment .
Seating Shell Adapter .
. Tray
. Control for Attendant
. Bumper Bar
Single Panel Footrest .
Colors (Yellow, Blue, or Red) .

E. Intended Use Statement

The Skippi is a rear wheel drive powered wheelchair with caster front wheels for indoor use (primarily) but can be used outdoors as well. These wheelchairs provide mobility to physically challenged persons. The wheelchair can be moved by the user operating the Curtis Instruments enAble 40 that is connected to the Micro Motor. The wheelchair is steered by different rotation of the rear wheels.

F. Technological Characteristics Summary

{2}------------------------------------------------

Otto Bock®

QUALITY FOR LIF

The Skippi Wheelchair is substantially equivalent to the OTTO BOCK A-200 Wheelchair, cleared on December 27, 2005 as K052706.

Each wheelchair is a powered wheelchair for the active user, with a rigid frame and similar characteristics. The Skippi is for children or small people up to 110 pounds, whereas the A-200 is for anyone up to 200 pounds.

The Skippi was tested by TÜV Product Service to the following standards:

. EN 12184
ISO 7176 -- Series .
ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC .

with the conclusion that "the test sample fulfills the requirements."

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three distinct, curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1 2007

OTTO BOCK HealthCare, LP % Mr. William Jackson Regulatory Consultant 2247 Jennifer Lane St. Paul, Minnesota 55109-2851

Re: K070318

Trade/Device Name: Skippi Powered Wheelchair for Children Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: April 18, 2007 Received: April 27, 2007

Dear Mr. Jackson:

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.

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

Page 2 - Mr. William Jackson

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 vor

for
Mark N. Melkerson
Romm 5/16/07

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

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): To be determined

Device Name: Skippi Powered Wheelchair for Children

Indications for Use:

Provide mobility to persons physically challenged and limited to sitting positions. �
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH Office of Deyice uation (ODE)

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

510(k) Number K070318

Page 1 of 1

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).