(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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 25 2004
Ms. Margaret Stephens Regulatory Specialist Medline Industries, Inc. One Medline Place Mundelein, Illinois 60060-4486
Rc: K041053
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 Dated: April 22, 2004 Received: April 23, 2004
Dear Ms. Stephens:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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 device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 Cl·R Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter wail and on The FDA finding of substantial equivalence of your device to a legally promated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sincerely yours,
Mark A. Milherson
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Medline Strider MICRO 3
Indications For Use:
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.
Prescription Use x AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A Millunn
Division of General, Restorative. and Neurological Devices
510(k) Number K041053
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§ 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).