The indication for use of the Ability Power Gurney is to provide mobility to persons limited to a prone position, that have the capability of operating a powered wheelchair.

Device Description

The Ability Power Gurney is a battery powered, motor driven device consisting of a platform mounted on a wheeled frame that is designed to provide mobility and transportation to physically challenged persons that may be restricted to a horizontal position. The device may have patient securement straps and supports for fluid infusion equipment.

A Penny and Giles VSI controller joystick and a 70amp controller is used to operate the Ability Power Gurney, the same as the predicate device, the Invacare Storm Power Wheelchair. The Ability Power Gurney is powered by two 12VDC, Group U-1 Gel Batteries and has a range of up to 15 miles on a full charge. The base of the stretcher is made of welded steel construction.

The Ability Power Gurney and the predicate both have a caster mounted design with a variable height top surface. The top may be controlled by the client for pressure relief and access to different heights. Optional material meets California 117 standards for fire retardancy.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Ability Power Gurney," a powered wheeled stretcher. It focuses on establishing substantial equivalence to predicate devices, rather than an AI/ML medical device. As such, the specific metrics and study types requested in your prompt (e.g., acceptance criteria for algorithm performance, sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance) are not applicable to this submission.

The document demonstrates compliance with recognized safety and performance standards for medical electrical equipment and wheelchairs, which serves as the "acceptance criteria" for this type of device.

Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations regarding typical AI/ML device evaluations:

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

Acceptance Criteria (Voluntary Standards/Regulations)	Reported Device Performance
Safety & Performance for Power and Control Systems:
ANSI/RESNA WC/14 (1991)	The motors and control mechanisms (same as Invacare Storm power wheelchair) meet the applicable requirements specified in this standard.
ISO 7176:1993 (E)	The motors and control mechanisms (same as Invacare Storm power wheelchair) meet the applicable requirements specified in this standard.
General Safety for Medical Electrical Equipment:
IEC 601-1-1	The Ability Power Gurney will comply with this standard.
IEC 601-1-2	The Ability Power Gurney will comply with this standard.
UL 2601-1	The Ability Power Gurney will comply with this standard.
CAN/CSA-C22.2 No. SD1.1-M90	The Ability Power Gurney will comply with this standard.
Material Flammability (Optional):
California 117 standards for fire retardancy	Optional material meets California 117 standards for fire retardancy.

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 applicable and not provided in the document. The evaluation of this device is based on compliance with established engineering and safety standards for medical devices and wheelchairs, rather than a clinical trial with human subjects or a dataset for AI model evaluation.

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 applicable and not provided. "Ground truth" in the context of AI/ML evaluation does not apply to this type of device submission. The "truth" is whether the device meets the physical and electrical safety standards.

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

This information is not applicable and not provided. Adjudication methods are relevant for resolving disagreements among multiple experts generating ground truth for AI model testing.

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

An MRMC study is not applicable and was not done. This type of study is used to evaluate the impact of AI assistance on human performance in diagnostic tasks. The Ability Power Gurney is a mobility device, not an AI diagnostic tool.

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

A standalone performance assessment (in the context of an AI algorithm) is not applicable and was not done. The device itself is a standalone product, but not an AI algorithm.

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

The "ground truth" for this device's acceptance is its compliance with internationally recognized consensus standards for safety, performance, and electrical characteristics of powered wheelchairs and medical electrical equipment. This is a technical and engineering "ground truth," not a clinical one.

8. The sample size for the training set

This information is not applicable and not provided. There is no AI model being trained for this device.

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

This information is not applicable and not provided. There is no AI model or training set involved. The "ground truth" for compliance with the standards is established by testing the physical device against the defined parameters and requirements within those standards.

Summary

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510(k) SUMMARY

K042699

MAR 1 6 2005 Gator Custom Mobility, Inc. 510 (k) Premarket Notification Power Gurney

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

Gator Custoni Mobility, Inc. 501 NE 23td Ave. Gainesville, I'L 32609 Phone: (352) 373-9673 Fax: (352) 271-9070

Contact Person: Gregory S. Sims Vice President

Date Propared: September 8, 2004

Name of Device and Name/Address of Sponsor:

Ability Power Gurney

Gator Custom Mobility, Inc. 501 NE 23td Ave. Gainesville, FL 32609 Phone: (352) 373-9673 Fax: (352) 271-9070

Common or Usual Name: Powered Wheeled Stretcher

Classification Name: Powered Wheeled Stretcher

Regulatory Class: Class II

Predicate Devices:

Products that are substantially equivalent to the Ability Power Gurney are the Stryker Powered Wheeled Stretcher (K022309, August 13, 2002) and the Invacare Storm Series power wheelchair (K993413, October 12, 1999)

Intended Use:

The intended use of the Ability Power Gurney is to provide mobility to persons limited to a prone position, that have the capability of operating a powered wheelchair

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Technological Characteristics and Substantial Equivalence

A. Device Description

B. Substantial Equivalence

Products which are substantially equivalent to the Ability Power Gurney are the Stryker Powered Wheeled Stretcher (K022309, August 13, 2002) and the Invacare Storm Series power wheelchair (K993413, October 12, 1999)

Performance Data

The motors and control mechanisms for the Ability Power Gurney, the same that are on the Invacare Storm power wheelchair, meet the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176:1993 (E) "ISO Standard, Wheelchairs-Requirments and Test Methods for the Power and Control Systems of Electric Wheelchairs.

The Ability Power Gurney will comply with the following voluntary standards:

IEC 601-1-1	Medical Electrical Equipment- Part 1: General Requirements forSafety 1: Safety Requirements for Medical Electrical Systems
IEC 601-1-2	Medical Electrical Equipment- Part 1: General Requirements forSafety 2: Electromagnetic Capability- Requirements and Tests
UL 2601-1	Standard for Medical Electrical Equipment-Part 1: GeneralRequirements for Safety
CAN/CSA-C22.2	No. SD1.1-M90, Medical Electrical Equipment Part 1: GeneralRequirements for Safety

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a snake winding around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus. The seal is in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 16 2005

Mr. Gregory S. Sims Vice President Gator Custom Mobility, Inc. 501 NE 22RD Avenue Gainesville, Florida 32609

Re: K042699

Trade/Device Name: Ability Power Gurney Regulation Numbers: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Codes: ITI Dated: March 9, 2005 Received: March 11, 2005

Dear Mr. Sims:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above und nave acteming ally marketed predicate devices marketed in interstate 10 use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner to May 20, 1978) in accordance with the provisions of the Federal Food, Drug, devices that have occh receasined in assess as a proval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merore, mains of the Act include requirements for annual registration, listing of general controlo provider ing 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 If your device is exassined controls. Existing major regulations affecting your device can may be subject to back at 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 r lease be advisod that i bring that your device complies with other requirements of the Act that I Dr. Has intess and regulations administered by other Federal agencies. You must or any I edetal the Act's requirements, including, but not limited to: registration and listing (2 l CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of N Fart 007), its ensterns (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 -- Mr. Gregory S. Sims

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and will and organ mains of substantial equivalence of your device to a legally premailted 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 If you desire specific acrio ior you (240) 276-0120. Also, please note the regulation entitled, Colliabl the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/cdrl/industry/support/index.html.

Sincerely yours,

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K042699 Device Name: Abili rower Gurney Indications For Use:

The indication for use of the Ability Power Gurney is to provide mobility to persons limited to a prone position, that have the capability of operating a powered wheelchair.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpert C)

(PLEASE DO NOT WRITE BELOW THIS I.INE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K042699

Page of

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).