FREERIDER MODEL LUGGIE MODEL 168-4IT by FREERIDER LUGGIE SCOOTERS INC

The Freerider Model Luggie is a motorized scooter which provides transportation for an elderly or disabled person. It can be in a variety of indoor and outdoor settings.

Device Description

The Freerider Model Luggie is a motorized three wheeled scooter which is battery operated. It consists of a platform which connects the three wheels, an adjustable tiller, and seat for the rider. It is driven by the rider using hand controls located at the top of the tiller. It can be simply folds under five steps into one unit for transport in a car trunk. It is provided with a battery & a battery charger.

AI/ML Overview

The provided 510(k) summary for the FreeRider Luggie motorized scooter focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for the device itself.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, type of ground truth used, training set details) are not applicable or cannot be extracted from the provided text.

Here's what can be extracted based on the information given:

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

The document does not explicitly list numerical acceptance criteria or specific performance metrics for the FreeRider Luggie.
Instead, it states that "Tests listed in the Guidance Document for the preparation of market Notification [510(k)] Applications for Mechanical and powered wheelchairs, and Motorized Three Wheeled Vehicles, July1995, were conducted and the results included in the subject 510(k) submission."
The performance comparison is qualitative, stating "The device features and use parameters of the Freerider and Tzora scooters are very similar. Both are battery operated, have 0.1 horsepower motors, and have regenerative brake systems. Batteries capacity and battery chargers are similar and are provided with the scooters. Use parameters are very similar, varying only in minor parameters such as the grade climbable by the respective scooters."

Conclusion for Section 1: A table of acceptance criteria and reported device performance cannot be generated from the provided text as the application relies on demonstrating substantial equivalence rather than meeting specific quantifiable performance benchmarks for the new device.

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

The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."
This indicates that there was no test set in the sense of a clinical or performance study with a specific sample size. The evaluation was primarily based on technical specifications and similarities to the predicate device.

Conclusion for Section 2: Not applicable; no test set (clinical or comparative performance study) was conducted or reported in this 510(k) submission.

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

As no test set (clinical study or comparative performance study) was reported, the concept of "ground truth established by experts" is not applicable in this context.

Conclusion for Section 3: Not applicable.

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

As no test set (clinical study or comparative performance study) was reported, adjudication methods are not applicable.

Conclusion for Section 4: Not applicable.

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

The device is an "Electric scooter" or "Motorized three-wheeled vehicle," which is a physical mobility aid, not an AI or diagnostic software.
Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this type of device.

Conclusion for Section 5: Not applicable, as this is a physical medical device, not an AI/diagnostic software.

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

The device is a physical motorized scooter. The concept of "standalone algorithm performance" does not apply to this product.

Conclusion for Section 6: Not applicable.

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

As no clinical or comparative performance study was reported, the concept of a "ground truth" to evaluate device performance against is not relevant to this 510(k) submission. The evaluation was based on technical specifications and comparison to predicate device characteristics.

Conclusion for Section 7: Not applicable.

8. The sample size for the training set

This device is a physical product (motorized scooter), not a machine learning or AI algorithm that requires a "training set."

Conclusion for Section 8: Not applicable.

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

As this is a physical medical device and not an AI/ML algorithm, the concept of a training set and its ground truth is not applicable.

Conclusion for Section 9: Not applicable.

Summary

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

510(k) SUMMARY

K110145

Submitter's Name: JEFFREY L DAVIS

SEP 3 0 2011

FreeRider Corporation No.22, Bengong 510 Road, Kang-Shan Town Kaohsiung County 820, Taiwan

NOVEMEBR 15st, 2010 Date summary prepared Device name:

Proprietary name: Common or usual name: Classification name:

Electric scooter Motorized three-wheeled vehicle, Class II, 21 CFR 890.3800.

Legally marketed device for substantial equivalence comparison:

Tzora Active Systems Ltd –Easy Travel Elite submitted by Tzore Active Systems , Inc, Kibbutz , Tzora

Freerider Luggie

Description of the device:

Intended use of device:

The device provides transportation for an elderly or disabled person. It can be used in variety of indoor and outdoor settings.

Technological characteristics:

The device features and use parameters of the Freerider and Tzora scooters are very similar. Both are battery operated, have 0.1 horsepower motors, and have regenerative brake systems. Batteries capacity and battery chargers are similar and are provided with the scooters. Use parameters are very similar, varying only in minor parameters such as the grade climbable by the respective scooters.

Testing conducted:

Tests listed in the Guidance Document for the preparation of market Notification [510(k)] Applications for Mechanical and powered wheelchairs, and Motorized Three Wheeled Vehicles, July1995, 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).

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

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

SEP 30 2011

FreeRider Luggie Scooters. Inc. % Diagnostic Medical Consultant Mr. Jeffrey L. Davis 4500 Country Glen Court Riverside, CA 92505

Re: K110165

Trade/Device Name: FreeRider Luggie Regulation Number: 21 CFR 890,3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: August 24, 2011 Received: August 24, 2011

Dear Mr. Davis:

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 contractly ability warranties. We remind you, however, that device labeling must be truthful and not micheading.

!f 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 not the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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

Page 2 - Mr. Jeffrey L. Davis

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 Pari 803), please go to

http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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

Freerider TM Model Luggie ' ' 510(k) Notification Page 4

Indications for Statement

KI10165 510(k) Number ( if known): ___________________________________________________________________________________________________________________________________________________

Device name: Freerider Luggie

Indications for Use:

The Freerider Model Luggie is a motorized scooter which provides transportation for an elderly or disabled person. It can be in a variety of indoor and outdoor settings. -

(Please do not write below this line)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Divis Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110165

Prescription Use_ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Over-The-Counter Use_ OR

( Per 21 CFR 801.109)

Regulation Number and Section

§ 890.3800 Motorized three-wheeled vehicle.

(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).