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The Inch Quilted Limb Holder with quick release closure is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The device can be used in the supine or sitting positions

The Inch Quilted Limb Holder with quick release snap closure is a quilted limb holder with a Velcro® fastener, quick release snap closure and straps that secure to a bed, gurney, chair, geri-chair or wheelchair. The Inch Quilted Limb Holder with quick release closure is intended to be a protective limb restraint that limits the patient's movement to the extent necessary for treatment, examination, or protection of the patient or others. The Inch allows for wrist adjustment to provide a secure fit without cinching. The knotless quick release snap closure is simple to use and allows the caregiver fast and easy access to the patient. A slide harness allows for supine or sitting positions. The Inch limb holders are machine washable.

This document describes a medical device called "The Inch Quilted Limb Holder" and its safety and effectiveness summary for a 510(k) submission. However, the provided text does not contain any information regarding acceptance criteria, study details, sample sizes for test or training sets, ground truth establishment, expert involvement, or any performance metrics expected for such a study.

The document primarily focuses on:

• Administrative details: Submitter information, device name, predicate device.
• Device description: Physical characteristics, intended use, variations.
• Technological characteristics statement: Explicitly states the subject devices are identical to predicate devices in all aspects (intended use, design, materials, manufacturing, specs, safety, effectiveness). The only difference cited is revised product labeling to comply with Agency requirements.
• Biocompatibility assessment: Also states the devices are identical in component materials to predicate devices, and that suppliers have a history of safe use in the clothing industry, with no reported skin irritation complaints.
• Conclusion: Based on the above, the device is considered safe, effective, and substantially equivalent to the predicate device.

Therefore, it is impossible to answer the user's questions as the requested information (acceptance criteria, study details, performance data) is not present in the provided text.

The document is a premarket notification for a device that is claimed to be substantially equivalent to an existing one, with the primary change being labeling. In such cases, extensive new performance studies proving acceptance criteria are often not required, as the safety and effectiveness are established by the predicate device.

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