(254 days)
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.
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.
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.
§ 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).