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The devices included in this 510(k) submission provide anterior postural support. The products are closed around the wheelchair by hook and loop straps. An optional strap can be secured behind the patient to prevent the tray from being pushed forward. If the patient cannot easily self release the product, it may be considered a restraint. These products are intended to provide postural support and a surface for activities.

The devices included in this 510(k) submission provide anterior postural support. The products are closed around the wheelchair by hook and loop straps. An optional strap can be secured behind the patient to prevent the tray from being pushed forward. If the patient cannot easily self release the product, it may be considered a restraint.

This document is a 510(k) premarket notification for "Posey® Laptop Trays." It does not contain information about an AI/ML powered medical device, an associated study, or acceptance criteria related to a device's performance characteristics.

The document discusses:

• The device: Posey® Laptop Trays, designed for anterior postural support and a surface for activities for wheelchair users.
• Regulatory context: The submission is in response to a new FDA rule requiring 510(k) notification for protective restraints, specifically revoking exemptions for devices like these.
• Predicate device: The "devices used for comparative purposes are identical to the laptop trays as described in this submission and produced or sold by the J.T. Posey Co." This indicates that the comparison is against their own legally marketed products that were previously exempt, not against a different type of device or technology.

Therefore, I cannot provide the requested information regarding acceptance criteria or a study proving a device meets them, as this submission is for a traditional medical device and not an AI/ML powered one.

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