The Tuffcare Cruiser P5500 Challenger powered wheelchair is an indoor / outdoor powered wheelchair that is battery operated. The product has a metal frame with four wheels and front anti tipping devices, adjustable seat with armrests, and a controller attached to one armrest. The controller allows the rider to control the movement of the chair. The chair can be disassembled for thansport and is provided with a battery charger.

AI/ML Overview

This 510(k) notification describes a powered wheelchair, not an AI/ML powered device. As such, most of the requested information regarding acceptance criteria for AI/ML performance, study design with human readers, ground truth establishment, and training set information is not applicable.

However, I can extract information related to the physical device's testing and regulatory approval process.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific acceptance criteria or quantitative performance metrics for the Cruiser PP5500 Challenger Powered Wheelchair. Instead, it states that:

"Test listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the subject 510(k) submission."

This indicates that the device was tested against (and presumably met) the standards set forth in a specific FDA guidance document for wheelchairs. The exact pass/fail criteria or performance results are not detailed in this summary.

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 in the provided text. The testing likely involved physical prototypes of the wheelchair.
Data Provenance: Not specified, but implied to be from the tests conducted on the physical device. The country of origin of the data is not mentioned, but the submitter is E1 Enterprises Inc / Tuffcare, based in Pompano Beach, FL, USA.
Retrospective or Prospective: Not applicable to this type of device testing. This would be a prospective test of a physical product.

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 is not applicable as this is a physical medical device (powered wheelchair), not an AI/ML algorithm requiring expert opinion for ground truth. Testing would involve engineering and safety standards, not expert clinical interpretation.

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

This is not applicable to a physical device. Adjudication methods are typically used in clinical studies or for establishing ground truth for AI/ML models.

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 is not applicable. This is a physical powered wheelchair, not an AI-assisted diagnostic or therapeutic device. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."

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

This is not applicable as this is a physical powered wheelchair, not an AI/ML algorithm.

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

For a physical device like a powered wheelchair, "ground truth" would be established by objective engineering standards and safety tests outlined in the relevant FDA guidance document. Examples would include successful completion of tests for stability, braking, durability, battery life, maximum speed, and weight capacity according to pre-defined specifications. The document states that tests were conducted according to the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995."

8. The sample size for the training set

This is not applicable as this is a physical powered wheelchair, not an AI/ML algorithm.

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

This is not applicable as this is a physical powered wheelchair, not an AI/ML algorithm.

Summary

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K080385

Cruiser PP5500 Challenger Powered Wheelchair 510(K) Notification

510(K) SUMMARY

MAY 13 2008

Submitter's Name:	E1 Enterprises Inc / Tuffcare1290 S. W. 30th Ave.Pompano Beach, FL 33069(800)548-6596
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Date Summary Prepared: 1/29/2008

Device Name:

Proprietary name: Cruiser PP5500 Challenger Power Wheelchair. Common or usual name: Power Chair. Classification name: Powered Wheelchair, Class II, 21 CFR890.3860

Legal Marketed Device for Substantial Equivalence Comparison:

Pronto M51 powered wheelchair submitted by Invacare Corp. and cleared for marketing under 510(k) #K021680.
Description of the Device:

Intended Use of Device:

The Tuffcare Cruiser PP5500 Challenger powered wheelchair provides enhanced mobility to physically challenged persons limited to a sitting position.

Technological Characteristics:

The device features and use parameters of the Cruiser PP5500 Challenger powered wheelchair and the Pronto M51 powered wheelchair are very similar. Both have tubular metal frames, are batteries operated, have two motors, and have automatic braking systems. Both use similar controller. Battery chargers and instructions for their use are supplied with both chairs. Use parameters are very similar as well, with minor variations in such areas as travel range and maximum speed.

Testing Conducted:

Test listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the subject 510(k) submission.

Performance Testing:

Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars above it, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2008

E1 Enterprises Incorporated % Mr. Jack Cheng Operation Manager 1290 Southwest 30th Avenue Pompano Beach, Florida 33069

Re: K080385

Trade/Device Name: Cruiser PP5500 Challenger Powered Wheelchair. Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: 89ITI Dated: April 14, 2008 Received: May 05, 2008

Dear Mr. Cheng:

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 - Mr. Jack Cheng

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Mcllveen

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

Enclosure

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Cruiser PP5500 Challenger Powered Wheelchair 510(K) Notification

INDICATIONS FOR USE

510(k) Number (if known) K080385

Cruiser PP5500 Challenger Powered Wheelchair. Device Name:

Indications for Use:

To provide cnhanced mobility to physically challenged persons limited to a sitting position.

Prescription Use .

AND / OR

Over - The - Counter Use X

003

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(Please do not write below this line) Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P.O. for man
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K080385

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).