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The AVANTICARE Mechanical Wheelchair, MS-8000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The dcvice can bc disassembled for transport and it is foldable easily. The device uses a standard sling type back and scat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.

AI/ML Overview

The provided document is a 510(k) premarket notification for a mechanical wheelchair (LERADO, AVANTICARE Mechanical Wheelchair, MS-8000). The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study information, based solely on the provided text:

Acceptance Criteria and Device Performance (LERADO, AVANTICARE Mechanical Wheelchair, MS-8000)

Acceptance Criteria	Reported Device Performance
Intended Use	To provide mobility to persons restricted to a sitting position.
Applicable Performance Standards	Meets applicable performance requirements as specified in ANSI/RESNA WC vol. I and ISO 7176 Wheelchair Standards.
Flame Retardancy	Upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
Weight Limit	100 kgs (same as predicate device).
Foldability	Can be disassembled for transport and is easily foldable. Mainframe is foldable (same as predicate device).
Overall Dimensions	Similar to predicate device (with some differences noted, not impacting safety).
Upholstery Material	Back upholstery material is the same resistance-ignitability fabric as the predicate device.
Seat Heights	Small difference compared to predicate device, but not leading to any safety hazard.
Hanger and Rear Axle Designs	Same as predicate device.
Caster Sizes	Different from predicate device; predicate device's caster size is smaller and moves more easily.
Overall Appearance	Differences exist between the new device and predicate device, but these are noted as "not safety aspect."
Weight and Size	Larger than predicate device, intended to make the user feel more comfortable during transport.
Optional Accessories	Same as predicate device, offering users the same choice of needed accessories.

Study Information:

Sample size used for the test set and the data provenance:
The document does not specify a separate "test set" in the context of an AI/algorithm-based device. The performance testing refers to meeting established industry standards (ANSI/RESNA WC vol. I and ISO 7176 Wheelchair Standards) rather than a study on a specific dataset of patient outcomes or expert interpretations. The device itself is a physical product (mechanical wheelchair). Therefore, data provenance is not applicable in the typical sense of medical imaging or diagnostic algorithms.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a mechanical device, not a diagnostic or prognostic algorithm that requires expert ground truth establishment for a test set. Acceptance criteria are based on engineering standards and design comparisons.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as there is no test set requiring expert adjudication for ground truth.
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. The device is a mechanical wheelchair and does not involve AI assistance or human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a mechanical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a mechanical wheelchair, the "ground truth" for performance is established by adherence to recognized engineering and safety standards (ANSI/RESNA WC vol. I and ISO 7176 Wheelchair Standards) and by direct comparison of physical and functional attributes to a legally marketed predicate device. The information provided about "Upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant" is also a type of regulatory-defined ground truth for a specific material property.
The sample size for the training set:
Not applicable. This is a mechanical device, not an algorithm that requires a training set.
How the ground truth for the training set was established:
Not applicable, as there is no training set.

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