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The Heelbo Wrap Around Vest is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Wrap Around Vest is also intended to limit the patient's movement while lying in bed or on a gurney to prevent the patient from falling out of bed or climbing over the side rails.

The Heelbo Wrap Around Vest is a crisscross-style safety vest. The Heelbo Wrap Around Vest is intended to help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair. The Heelbo Wrap Around Vest is also intended to limit the patient's movement while lying on a bed or gurney to prevent the patient from falling out of bed or climbing over the side rails.

The vest is secured to the bed or wheelchair frame with two straps. There are also loops sewn to the shoulder area of the vest in the event extra support is needed.

The Wrap Around Vest is available with a knotless system (quick disconnect option). This option allows the caregiver to quickly and easily disconnect the restraint from the chair or bed frame by eliminating time consuming untying of knots.

The Wrap Around Vest is available in a poly/cotton blend or a polyester mesh material. Five sizes accommodate a wide range of patients. The Wrap Around Vest is made of durable machine washable materials and is color coded for easy size identification.

The provided document is a 510(k) Premarket Notification for a medical device called the "Heelbo Wrap Around Vest." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel safety and effectiveness through clinical studies with acceptance criteria in the typical sense of AI/algorithm performance.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets acceptance criteria in the context of an AI algorithm, specifically:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or training set details.
• The type of ground truth used for any such studies.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device by comparing:

• Intended use
• Technological characteristics (design, materials, manufacturing, physical/mechanical specifications)
• Safety and effectiveness

Here's a summary of what the document does state regarding safety and effectiveness:

• Intended Use: The device is intended to help support and prevent patients from slumping/sliding forward in a wheelchair or geriatric chair, and to limit patient movement in bed/gurney to prevent falls or climbing over side rails.
• Technological Characteristics Comparison: The document explicitly states: "The subject devices are identical in intended use, design, materials, manufacturing process, physical and mechanical specifications and issues of safety and effectiveness to the devices prior to the submission of this notification."
• Biocompatibility: The materials are identical to predicate devices, and suppliers have a history of safe use in the clothing and garment industry. Heelbo, Inc. is unaware of reports or complaints of skin irritation.
• Conclusion: Based on the information, the proposed Heelbo Wrap Around Vest is concluded to be "safe and effective for its intended use and is substantially equivalent to the predicate device."

In essence, the "study" demonstrating safety and effectiveness in this context is a detailed comparison to an already cleared predicate device, rather than a clinical trial with statistical performance metrics.

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