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The Heelbo Waist and Chest Vest is intended to 1) help support and help prevent a patient from slumping or sliding forward while seated in a wheelchair or geriatric chair and 2) help prevent a patient from falling out of bed or climbing over slide rails.

The Heelbo Waist and Chest Vest is a poncho style safety vest that has two sets of two straps that are secured to a wheelchair to support the upper torso. When all the straps are connected per the instructions the Heelbo Waist and Chest Vest is intended to help prevent the patient from slumping or sliding forward while seated in a wheelchair and helps to prevent a patient from falling out of bed. The Waist and Chest Vest is available in a polyester/cotton blend (9340) or a polyester mesh material (9340B).

The provided text is a 510(k) summary for the Heelbo Waist and Chest Vest. It describes the device, its intended use, and compares it to predicate devices. However, the document does not contain information about a study that proves the device meets specific acceptance criteria in the manner requested.

Instead, the submission focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) based on intended use and technological characteristics, which is the primary requirement for a 510(k) premarket notification. This type of submission typically does not include extensive clinical trial data with specific performance metrics and acceptance criteria in the way a new, non-substantially equivalent device might.

Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met cannot be extracted from the provided text.

Here's what can be gathered:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics. The underlying "acceptance criteria" for a 510(k) submission are generally that the device is safe and effective for its intended use and is substantially equivalent to predicate devices.
• Reported Device Performance: The document claims the device is "safe and effective for its intended use and is substantially equivalent to the predicate device." However, no specific performance data (e.g., how effectively it prevents falls, or slumping) is provided.

Table (based on substantial equivalence comparison, not performance metrics):

2. help prevent a patient from falling out of bed or climbing over slide rails. |
   | Materials | Generally safe materials for patient contact (as evidenced by predicate) | Polyester Cotton Blend, Polyester Mesh (materials identical to previously cleared Heelbo devices K963099 and K963041) |
   | Number of straps | Same as predicate (2 straps) | 2 |
   | Where used | Same as predicate (wheelchair, geriatric chair, bed) | wheelchair, geriatric chair, bed |

2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of a performance study is described. The submission relies on a comparison to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is discussed.

4. Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document describes a medical device for physical support, not an AI-assisted diagnostic or imaging device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or software device.

7. The type of ground truth used: Not applicable in the context of a performance study. The "ground truth" for this 510(k) submission is the regulatory acceptance of the predicate devices as safe and effective.

8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an algorithm development.

9. How the ground truth for the training set was established: Not applicable. No training set is mentioned.

Summary of available information regarding the "study":

The "study" in this context is the 510(k) submission itself, which primarily demonstrates substantial equivalence to predicate devices. The arguments presented are:

• Comparison Chart: A direct comparison of the proposed device's characteristics (intended use, materials, number of straps, where used) to a predicate device (Posey® Waist and Chest Vest) and other cleared Heelbo devices.
• Biocompatibility: The materials used are identical to those cleared in previous Heelbo devices (K963099, K963041). The suppliers have a history of safe use in clothing/garment, and Heelbo Inc. reports no adverse biological incidents over 15 years with these materials.

In essence, the document implies that because the device is technologically similar and has the same intended use as already legally marketed devices, it can be considered safe and effective without requiring new clinical performance studies.

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