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K Number
K991954
Device Name
THE BRUNO POWERBASE, MODEL PSB-2200
Manufacturer
BRUNO INDEPENDENT LIVING AIDS, INC.
Date Cleared
1999-11-02

(145 days)

Product Code
ITI
Regulation Number
890.3860
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Bruno Powerbase Model 2200 is designed to assist those Homecare Patients whose afflictions or disabilities require them to use motorized assistance for daily mobility. Typically these users would not be able to maintain independence with a manual wheelchair. The Bruno Powerbase is intended to be used in a primarily indoor environments with limited use on hard relatively level outdoor surfaces such as sidewalks, ramps and hard packed garden plots.

Device Description

Power Wheelchair Model 2200

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a power wheelchair, Model PSB-2200 (also referred to as Model 2200). It focuses on the substantial equivalence of the device to a predicate device and its indications for use. The document does not contain any information regarding acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy), sample sizes for testing or training, ground truth establishment, or details of specific studies proving the device meets acceptance criteria.

Therefore, I cannot answer the questions directly from the provided text. The output of the desired information would be:

  1. A table of acceptance criteria and the reported device performance: Not provided in the document.
  2. Sample sized used for the test set and the data provenance: Not provided in the document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided as there's no mention of a ground truth for a test set.
  4. Adjudication method for the test set: Not provided in the document.
  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 a physical medical device (power wheelchair), not an AI/imaging diagnostic device.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
  7. The type of ground truth used: Not applicable/provided.
  8. The sample size for the training set: Not provided in the document.
  9. How the ground truth for the training set was established: Not applicable/provided.

The document is a regulatory clearance letter, not a clinical study report or technical specification detailing performance metrics.

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).