(21 days)
The intended use of the Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter, is to provide mobility to persons having limited walking capabilities. The compact design and ease of assembly and disassembly, also rrovides a mobility product that transports easily for travel usage.
The intended use of the Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter, is to provide mobility to disabled persons.
The Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter is a compact battery-operated scooter having a digital programmable Controller. Features include a removable molded plastic seat, a foldable tiller, and an off board charger. Additional safety features include electronic regenerative and electromechanical disc brakes, and rear anti-tip wheels. The Go Go Elite Traveller V, Three Wheel Scooter is designed for but not limited to Pride Mobility Products Corp. providers / retailers and their consumers, The Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter is designed with ultimate safety, stability, performance, and portability in mind. The main feature of the Scooter is that it can be disassembled into 4 parts: the rear section, the front section, the battery pack, and the seat. This allows for ease of use when traveling or stority the unit.
This document describes the 510(k) summary for the Pride Mobility Products Corporation Go Go Elite Traveller V / Model SC40EV, Three Wheel Scooter. It focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study to prove performance against those criteria.
Therefore, much of the requested information regarding a specific study, acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not available in the provided text. The submission is a non-clinical testing submission for substantial equivalence.
Here's an attempt to extract and infer information based on the provided text, and point out what is explicitly not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from standards) | Reported Device Performance (Implied from "Compliance" and "passed all necessary testing") |
|---|---|---|
| Performance | Maneuverability, Stability | Substantially equivalent to predicate device |
| Structure | Construction (frame), Weight capacity | Differences noted but do not raise new questions of safety/effectiveness |
| Safety | Electronic regenerative & electromechanical disc brakes, Rear anti-tip wheels | Passed all necessary testing; Substantially equivalent; No new safety questions raised |
| Electrical Systems | As per RESNA WC Vol. 2 2008 DRAFT | Passed all necessary testing |
| Electromagnetic Compatibility (EMC) | As per ANSI/RESNA WC Vol. 2-1998 Section 21 | Passed all necessary testing |
| General Safety (Electrical) | As per IEC 601-1-1 | Passed all necessary testing |
| Flammability | As per CAL 117 | Passed all necessary testing |
| Intended Use Function | Maintain optimum stability, not hinder performance | Similar to predicate device, enables intended use function |
| Portability | Disassembly into 4 parts | Design feature; no formal performance metric stated but implied to meet portability goal |
2. Sample Sizes used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The testing seems to be based on evaluating the design and performance characteristics of the single device model, the Go Go Elite Traveller V / Model SC40EV, against the standards and the predicate device. It's likely one or a few units were tested to demonstrate compliance.
- Data Provenance: Not explicitly stated, but given it's a 510(k) submission from Pride Mobility Products Corporation, it can be inferred that the data comes from internal testing and validation activities of the manufacturer. It is retrospective in the sense that the data was collected prior to the submission for regulatory approval. There is no indication of country of origin of the data beyond the manufacturer's location (Exeter, PA, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not stated. This was a non-clinical device testing submission focusing on compliance with performance standards and comparison to a predicate device, not a diagnostic or AI device requiring expert ground truth for a test set. The "experts" involved would be the engineers and quality assurance personnel performing the tests according to the standards.
- Qualifications: Not applicable/not stated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not stated. This type of adjudication is typically used in clinical studies for diagnostic accuracy, which is not the nature of this submission. The "adjudication" for this type of submission would be the review by regulatory bodies (FDA) of the presented test results against the specified standards.
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
- MRMC Study: No. This is not an AI device or a diagnostic medical device that would involve human "readers." The submission explicitly states "Discussion of Clinical Testing Performed: N/A."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical mobility device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: For this device, "ground truth" would be the objective measurements and adherence to engineering specifications and performance standards (e.g., stability measurements, brake effectiveness, flammability rating, electromagnetic compatibility readings) as defined by the RESNA and IEC standards. The predicate device's established safety and effectiveness also serves as a "ground truth" for comparison.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not a machine learning or AI device. "Training set" is not relevant here.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. As this is not an AI device, there is no "training set" or ground truth to establish for such a purpose.
§ 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).