(32 days)
The intended use of the Medline Strider MICRO 3 scooter is to provide mobility to persons that have difficulty walking for prolonged periods of time. They are intended to increase the mobility of persons who are both physically and mentally capable of assessing and reacting to any driving situation.
The Medline Strider MICRO 3 scooter is constructed for use both indoors and outdoors. They are for use indoors, on pavement, sidewalks, pedestrian zones and areas free from motor traffic. They must not be driven on public roads with the exception of crossing or when no pavements are available.
Medline Strider MICRO 3 scooter
This looks like a 510(k) clearance letter for a motorized three-wheeled vehicle (scooter), not a medical device that would have acceptance criteria based on performance studies. The letter confirms that the Medline Strider MICRO 3 is substantially equivalent to legally marketed predicate devices.
Therefore, many of the requested criteria for medical device studies (like sample size, ground truth, expert qualifications, effect size for AI, etc.) are not applicable in this context. The clearance is based on substantial equivalence to existing devices, meaning it meets the same safety and effectiveness standards, not on a new performance study to establish specific diagnostic or therapeutic metrics.
However, I can extract the general information related to the device and its intended use from the provided text:
Device Information:
- Trade/Device Name: Medline Strider MICRO 3
- Regulation Number: 21 CFR 890.3800
- Regulation Name: Motorized three-wheeled vehicle
- Regulatory Class: II
- Product Code: INI
- Indications For Use: To provide mobility to persons that have difficulty walking for prolonged periods of time. Intended to increase the mobility of persons who are both physically and mentally capable of assessing and reacting to any driving situation. Constructed for use both indoors and outdoors, on pavement, sidewalks, pedestrian zones, and areas free from motor traffic. Must not be driven on public roads with the exception of crossing or when no pavements are available.
Since the request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria," and this document is a 510(k) clearance letter for a mobility device (not a diagnostic or therapeutic AI/imaging device), the typical medical device study components are not present. The "acceptance criteria" here would generally refer to meeting the substantial equivalence requirements to a predicate device in terms of design, materials, safety features, and performance specifications for a motorized vehicle.
If this were a typical AI/diagnostic medical device submission, the requested information would look like this (but based on the provided document, these details are not available):
(Hypothetical Table - Not directly derivable from the provided document)
| Acceptance Criteria (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|
| Safety: Meets established safety standards for motorized wheelchairs/scooters (e.g., stability, braking, electromagnetic compatibility). | (Details would be in a submission document, not the clearance letter) |
| Performance: Maximum speed, range per charge, weight capacity, turning radius, obstacle clearance. | (Details would be in a submission document, not the clearance letter) |
| Durability: Withstands specified usage over time (e.g., cycle tests, environmental tests). | (Details would be in a submission document, not the clearance letter) |
Regarding the other points, based on the provided text, the answer is "Not Applicable" (N/A) for a 510(k) clearance letter of this type of device.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): N/A (For a motorized vehicle, testing would involve engineering and safety standards, not patient data in the typical sense).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth as defined for diagnostic AI is not applicable here).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
- 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: N/A (This is a motorized scooter, not an AI-assisted diagnostic tool).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (No algorithm or AI involved in the medical sense).
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): N/A.
- The sample size for the training set: N/A.
- How the ground truth for the training set was established: N/A.
This document is a regulatory approval for a physical mobility device under a 510(k) pathway, which leverages substantial equivalence to existing devices rather than new performance or clinical studies demonstrating diagnostic accuracy or AI effectiveness.
§ 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).