The scooter is designed to enhance user mobility. This device is ideal for users that are unable to walk yet able to transfer from one platform to another, users that have some difficulty walking, and users who simply prefer to ride but can, if need be, walk.

Device Description

This is a modular electrically-powered scooter including as modular components a seat, seat post, main front frame and, motor assembly, removeable rear plastic body and 2-12VDC batteries connected in series to provide a 24VDC power source The scooter is built in a manner allowing quick and easy assembly/disassembly.

The mainframe includes a rotably-affixed front wheel and tiller for steering, a seat post pedestal I he maintrains modules a panel with direction/speed control, a headlight, a rear half weldment (anti-ip wheelie bars and leaf springs) hinged to main floor pan and a latch/receiver mechanism to capture motor assembly locking bar.

The motor assembly includes a pair of rear wheels coupled to a transaxle which is driven by an electric motor. The motor assembly also includes an electric brake, motor control board, battery charger, 2-12VDC batteries, a battery tray and a connector panel for battery and control signal cable hook-ups.

The motor assembly is secured to main front frame by threading motor carriage pins just under rear weldment leaf springs, rotating motor assembly to a vertical (upright) position, placing motor assembly locking bar into main frame latch receiver and moving latch to a vertical (upright) position, placing motor assembly locking bar into main frame latch receiver and moving latch to a vertical (upright) position, insert seat post into seat pedestal (receiver), hold latch in a "locked" upright position.

AI/ML Overview

The provided text describes the Golden Eagle GT2000 motorized 3-wheeled vehicle (K971043) and its substantial equivalence to a predicate device, the Pride Health Care Legend Scooter (K926295). It lists safety and effectiveness information based on adherence to various ISO and IEC standards through testing.

However, the document does not contain the specific information required to complete the detailed table and answer all questions regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The provided text is related to a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial data or performance metrics for complex AI/ML devices. Therefore, much of the requested information is not applicable or not present in this document.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of acceptance criteria and the reported device performance

The document lists standards the device was tested against, and in some cases, indicates "PASS" or "PASS WITH FIX". It does not provide specific numerical acceptance criteria or detailed performance metrics beyond this.

Acceptance Criteria (Standard)	Reported Device Performance
UL Listed 9F15 Battery charger	Implicitly passed (used commercially available charger)
ISO 01 (Static Stability) - ISO/CD 7176-1:1995-05-03 (E)	See Section 6A for results (not provided here)
ISO 02 (Dynamic Stability) ISO 7176-2:Draft 1996-02-09	See Section 6A for results (not provided here)
EMC Evaluation in accordance with Draft ISO EMC Addition to IS 7176-14
ENSSOII Radiated emissions	PASS
ENSSOII Conducted emissions	PASS WITH FIX
IEC 801-2 Electrostatic Discharge Immunity	PASS
IEC 1000-4-3 Radiated Electric Field Immunity (Draft)	PASS

2. Sample size used for the test set and the data provenance

Sample size: Not specified. The document states "The scooter has been tested to the following standards," implying physical testing of one or more units, but does not quantify the number of units or test iterations.
Data provenance: Not explicitly stated. The testing seems to be internal and/or by a third-party lab against international standards (ISO, IEC, UL). Location of testing, and whether it's retrospective or prospective, is not mentioned.

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

This information is not applicable to the type of device and testing described (physical product safety and performance against engineering standards). Ground truth, in the context of expert review, is typically relevant for interpretative tasks, e.g., image analysis or diagnostic support, which is not the function of this device.

4. Adjudication method for the test set

Not applicable as this is not a study requiring adjudication of expert interpretations.

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. This is not an AI/ML device, and no MRMC comparative effectiveness study is mentioned.

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

Not applicable as this is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for the tests performed would be defined by the specifications and pass/fail criteria within the referenced UL, ISO, and IEC standards for physical product safety, stability, and electromagnetic compatibility. For example, for static stability, the ground truth would be whether the scooter maintains stability under defined conditions according to the standard.

8. The sample size for the training set

Not applicable as this is not an AI/ML device.

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

Not applicable as this is not an AI/ML device.

Summary

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Image /page/0/Picture/4 description: The image shows the logo for "Golden Technologies, inc.". The word "Golden" is in large, bold, and slightly slanted font. Below "Golden" is the word "Technologies" in a similar font, but smaller. To the right of "Technologies" is ", inc." in a smaller, handwritten-style font.

K971043

aug. 1, 1997

11:41

401 Bridge Street Old Forge, PA 18518 (717) 451-7477 - Fax (717) 451-7494 HTTP://www.GoldToch.com

510(k) SUMMARY

This 510(k) Summary is submitted, in conjunction with a full submission, this 19th 1. day of March, 1997, by:

Chris McConnell Director of Operations/Engineering Scooter Division Golden Technologies 401 Bridge Street Old Forge, PA 18518

Telephone: 717-498-6962 717-451-7477 x 241 (Chris McConnell) 717-451-7477 x 232 (Fred Kiwak) Fax: 717-451-7494

2. The device is as follows:

Trade name: Golden Eagle GT2000 Common Name: Motorized 3-wheeled vehicle Classification Name: Motorized electric 3-wheeled vehicle (per 21 CFR 890.3800) Class II 89INI

Predicate device on which we base equivalence: 3.

Pride Health Care Legend Scooter (K926295) Product Code 89INI

র্ব. Description of Device:

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Intended use of the device 4.

ડ. Similarities and Differences to predicate device Similarities

The "Golden Eagle" and "Legend" scooters both use a 24VDC permanent magnet motor .............................................................................................................................................................................. attached to a transaxle drive unit.
1. Both use a disc-type coil-activated electric brake.
רי The motor control boards are of the same basic design and concept.
ণ Each has an industry-typical wig-way potentiometer, forward/reverse speed control, along with a speed limit potentiometer
Both scooters feature upholstered seats with removable arms and height adjustment capability. vi Seats on each swivel 360°
Each uses 2 12VDC U-1 type batteries as their power source, and each uses a commercially 6. available built-in charger to replenish depleted batteries.
1. All major dimensions are similar
The "control panel" on each has a voltage meter, horn switch and speed limit potentioneter 8.

163

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Differences
	Legend	Golden Eagle
Suspension	No suspension system	Leaf springs near rear ofscooter and coil springs onthe front fork
Tires	Pneumatic tires	Solid tires (no flats)
Wig-wag paddle controls	Lower thumb type only	Upper and lower wig-wagpaddle controls
Seat post	Tube with clevice pinheight adjustment	Gas-filled for auto heightadjustment and cushionedride.
Lights	None	Standard front safety light
Seat pedestal	Mounts on back of scooterBatteries on front half	Mounts on front of scooterBatteries on rear motor assb

6. Safety and Effectiveness Information

The scooter has been tested to the following standards:

UL Listed 9F15 Battery charger ISO 01 (Static Stability) - ISO/CD 7176-1:1995-05-03 (E) (See Section 6A for results) ISO 02 (Dynamic Stability) ISO 7176-2:Draft 1996-02-09 (See Section 6A for results) EMC Evaluation in accordance with the Draft ISO EMC Addition to IS 7176-14 ENSSOII Radiated emissions PASS ENSSO! ! PASS WITH FIX Conducted emissions IEC 801-2 Electrostatic Discharge Immunity PASS IEC 1000-4-3 Radiated Electric Field Immunity (Draft) PASS

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chris McConnell Golden Technologies, Inc. 401 Bridge Street Old Forge, Pennsylvania 18518

Re : K971043 Golden Eaqle GT2000 K971050 Golden Hawk Regulatory Class: II Product Code: INI Dated: May 28, 1997 Received: May 30, 1997 AUG - 1 1997

Dear Mr. McConnell:

We have reviewed your Section 510 (k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. T Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Chris McConnell

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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SECTION 3 DEVICE DESCRIPTIVE INFORMATION

Intended Use SECTION 3A

The Golden Technologies, Inc Golden Hawk is designed to enhance user mobility This device is ideal for users that are unable to walk yet able to transfer from one platform to another, users that " have some difficulty walking, and users who simply prefer to ride but can, if need be, walk

scolpo

(Division Sign-Off)
Division Restorative Devices
510(k) Number KA71050

Over-the-Counter Use

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).