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K Number
K030387
Device Name
C.T.M. MOBILITY SCOOTER, MODEL HS-890
Manufacturer
C.T.M. HOMECARE PRODUCT, INC.
Date Cleared
2003-03-11

(34 days)

Product Code
INI
Regulation Number
890.3800
Type
Traditional
Panel
PM
Reference & Predicate Devices
K003059
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The C.T.M. Mobility Scooter HS-890 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

Device Description

The C.T.M. Mobility Scooter HS-890 is an indoor/outdoor electric scooter that is battery operated. It has a base with four wheels with adjustable padded seat, armrests, and headrests. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with a battery charger.

AI/ML Overview

The provided text describes a 510(k) submission for a mobility scooter, the C.T.M. Mobility Scooter HS-890. While it details the device and its intended use, it explicitly states that "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This means that the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria through performance testing.

The submission focuses instead on demonstrating substantial equivalence to a legally marketed predicate device (Laser 4, K003059) based on similar technological characteristics. It mentions that "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted." However, the results of these tests and how they relate to specific acceptance criteria are not provided.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
  2. Sample size used for the test set and the data provenance: Not provided, as comparative performance testing was not submitted.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed performance testing for ground truth establishment was not submitted.
  4. Adjudication method for the test set: 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: Not applicable, as this is not an AI device and no clinical effectiveness study was submitted.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
  7. The type of ground truth used: Not applicable, as detailed performance testing for ground truth establishment was not submitted.
  8. The sample size for the training set: Not applicable, as this is not an AI device.
  9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

In summary, the provided document focuses on regulatory compliance through substantial equivalence, not on detailed performance study results against specific acceptance criteria.

§ 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).