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The Sleeper Jacket and the Houdini Safety Sleeper are intended for patients who require restraint while in bed or in the wheelchair and who easily remove standard vest-style and poncho-style restraints.

The Houdini Safety Sleeper is recommended for patients who slide or move toward the foot of the bed or who slide off the wheelchair seat.

Sleeper Jacket: A polyester upper body, jacket-style garment. It has short sleeves, a brass back zipper, 1 1/8-inch-wide- polyester webbing ties sewn across the waist. Each webbing end is terminated with a metal clip that secures to the bed frame. The webbing criss-crosses in front of the patient to allow him/her to roll from side to side while sleeping in bed. The edges of the garment are finished with bias cut binding in a color that corresponds to the garment size as described on package insert. The device has instructions that show how it can be applied in both the bed and the wheelchair.

Houdini Safety Sleeper: Has the same features as the Sleeper Jacket with the addition of a 1 1/2-inch-wide strap sewn to the back of the garment. The strap is brought between the patient's legs and secured in front of the garment. The purpose of this strap is to prevent the patient from sliding down in the bed or wheelchair.

This document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Sleeper Jacket and Houdini Safety Sleeper. It describes the device, its indications for use, and comparative information to a predicate device. It also discusses regulatory context around restraints.

The submission is from 1996 and is for a physical restraint device, not a software or AI/ML device that would typically have acceptance criteria, a test set, ground truth, or an MRMC study as described in your request.

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