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To provide an optional means of mobility for physically challenged people.

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This document is a 510(k) clearance letter for the "Zippy" powered wheelchair. It is a regulatory document and does not contain information about acceptance criteria or a study proving device performance as it would be presented for an AI/ML-based medical device.

Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from this document. The document primarily focuses on:

• Regulatory Clearance: Affirming that the device meets the substantial equivalence requirements for market entry.
• Device Classification: Assigning a regulatory class (Class II) and product code (ITI).
• General Controls: Reminding the manufacturer of ongoing regulatory responsibilities.
• Indications for Use: Stating the intended purpose of the device (to provide an optional means of mobility for physically challenged people).

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To provide an optional means of mobility for physically challenged people.

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This document is a 510(k) premarket notification letter from the FDA to Pillar Technology, Inc. for their "Zippy Powered Wheel Base, Model TE 888W". It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. It is a regulatory approval letter, not a study report or clinical trial summary.

Therefore, I cannot provide the requested information based on this document.

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To provide an optional means of mobility for physically challenged people.

Not Found

This document is a 510(k) clearance letter from the FDA for a device called "ZIPPY". It does not contain information about acceptance criteria, study details, or performance metrics. Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device