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The indended use of the Frontier Power wheelchair is to provide mobility to persons limited to a sitting position, who have the capability of operating a power wheelchair

The Frontier Power Wheelchair is a battery powered, electric motor driven device with the intended function of providing mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair. It is a mid wheel drive format wheelchair as it's basic configuration with direct drive motors and four swivel castors. The wheelchair frame is of a non-folding type with a mid mounted drive wheels on individual, front pivoting extension arms ending in front mounted swivel castors. The rear of the main frame ends with a lateral pivoting beam arm with swivel castors mounted on each side. This frame design allows for all 6 wheels to contact the ground over uneven terrain.

The frame consists of a combination of 2" diameter round steel tube. 1 ¼" diameter round steel tube and 1 ¼" square tube. The wheelchair consists of the following basic components: frame with articulated drive wheels and casters, seat, armrests, and footrests.

The provided document, K030783, describes a 510(k) premarket notification for the "Frontier Power Wheelchair." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for an AI/ML powered medical device. Therefore, much of the requested information (like sample sizes for test/training sets, expert qualifications, and MRMC studies) is not applicable to this type of submission.

However, I can extract information related to the performance testing conducted and how it relates to general acceptance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable as the document describes physical performance testing of a wheelchair, not an AI/ML algorithm requiring a test set of data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the document describes physical performance testing of a wheelchair, not an AI/ML algorithm requiring expert-established ground truth. The "ground truth" here would be the physical measurements and observations during the standardized tests.

4. Adjudication Method for the Test Set

This information is not applicable. The performance testing was conducted according to established international and national standards (ISO/CD 7176-21 and ANSI/RESNA Vol.2 Section 21 Amendments). These standards define specific test procedures and criteria, eliminating the need for an adjudication method in the context of expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating human reader performance with and without AI assistance, which is not applicable to a power wheelchair.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is a power wheelchair, a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing was established by objective measurements and observations according to the detailed methodologies outlined in the referenced international and national standards: ISO/CD 7176-21 and ANSI/RESNA Vol.2 Section 21 Amendments for powered wheelchairs and motorized scooters.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of a physical power wheelchair being tested for performance against established standards.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the reasons stated in point 8.

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