(133 days)
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.
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.
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.
§ 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).