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The Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.

The Heelbo Life Jacket with Crotch Support is a poncho-style safety vest with padded crotch support. The vest has three sets of two straps that are secured to various components of a wheelchair or geriatric chair to support the upper torso. When all the straps are connected per the instructions the Heelbo Life Jacket with Crotch Support is intended to help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair.

The Life Jacket with Crotch Support is available in a polyester and cotton blend (9400) or a polyester mesh material (9400B).

The provided text is a 510(k) summary for the Heelbo Life Jacket with Crotch Support. It is a regulatory document intended to demonstrate substantial equivalence to a predicate device, not a study describing the de novo establishment of acceptance criteria and device performance. As such, the document does not contain the information requested regarding acceptance criteria from a study for a new device.

Specifically, the document focuses on demonstrating that the "new" Heelbo Life Jacket with Crotch Support is identical to its predicate device, with the only change being a revision to product labeling to comply with regulatory guidance. It 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."
• "The subject devices are identical in components materials to the predicate devices."

Therefore, it does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set or data provenance.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication methods.
5. Multi-reader multi-case comparative effectiveness studies.
6. Standalone algorithm performance (as this is a physical device, not an algorithm).
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document serves as evidence of substantial equivalence based on a change in labeling for an existing device, rather than a clinical study evaluating the performance of a newly designed device against specific acceptance criteria.

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