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The Pure Tilt™ wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.

The Proactive Comfort Pure Tilt™ wheelchair is an indoor / outdoor manual wheelchair composed of two (2) main components (assemblies): a lower frame assembly and a tilting seat assembly. The lower frame contains two rear wheels, two front casters, two anti-tippers, one pair of brakes and two armrest assemblies. The Seat assembly contains four sub-assemblies; a tilting seat, a leg rest, a backrest and a headrest. The Proactive Comfort Pure Tilt™ possesses the following features:

• A tilting seat with adjusting capability up to 45°;
• User-operated seat tilt adjusting mechanism, which is assisted by a mechanical spring piston;
• Hinged, non-detachable armrests that swing upward and toward the back to facilitate transfer of a subject into or out of the wheelchair;
• Built-in housing for compatible transfer board;
• Mechanical armrest locks that secure the armrests to be used safely as handles for lifting the wheelchair with the user in it;
• Two 21" diameter rear wheels with aluminum hand-rims for self-propelling;
• Two 6" diameter front casters that swivel for easy maneuvering;
• Adjustable seat-to-floor height (2 Settings: 19" and 17");
• Angle-adjustable leg-rest assembly with the following features:
• Foot platform that swings upward to facilitate stowage .
• Telescoping adjustable height .
• User-operated mechanism to adjust leg-position angle, which is assisted by mechanical spring piston;
• Backrest that has adjustable vertical position and that folds 90° forward to facilitate storage and transport; and
• Headrest with adjustable vertical position.

The provided document is a 510(k) Pre-market Notification for a mechanical wheelchair, not an AI/ML medical device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and studies for such devices.

The document describes the Pure Tilt™ wheelchair and seeks to prove its substantial equivalence to a predicate device (BRODA – 587 Manual Wheelchair, K032133). The studies conducted are non-clinical performance tests for mechanical devices, not AI/ML algorithm performance.

Here's why the requested information cannot be extracted from this document:

• AI/ML Specifics: The prompt asks for details like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set sample size, and ground truth establishment for AI/ML models. None of these are relevant or present in a 510(k) for a mechanical wheelchair.
• Acceptance Criteria & Device Performance (Mechanical Context): The acceptance criteria for a mechanical wheelchair revolve around safety, stability, durability, and ergonomic measurements as defined by standards like ISO and RESNA. The "reported device performance" are the "Passed" results for these tests.

Therefore, I cannot fulfill the request as the input document does not pertain to an AI/ML device.

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