Search Results

The Robin Hood Vest ™ is intended for use in healthy infants aged 0-15 months to aid in the prevention of skull deformities that can arise from consistent back-sleeping postures, the condition known as deformational (or positional) plagiocephaly.

The Robin Hood Vest ™ is a sleeveless vest, with a pocket on the back for an insertable foam wedge, that an infant wears while sleeping. The device positions a foam wedge under the infant during sleep to direct the head so that it does not always rest on the same spot.

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for the Robin Hood Vest™, which is a pediatric position holder. It declares the device's substantial equivalence to a predicate device based on its intended use and description, but it does not detail any performance studies, acceptance criteria, or specific data about the device's effectiveness or accuracy in preventing skull deformities.

Therefore, I cannot provide the requested table and information about a study based on the given text.

Summary of what cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory submission and substantial equivalence, not performance metrics.
2. Sample size used for the test set and the data provenance: Not present. No test set or data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment is described.
4. Adjudication method for the test set: Not present. No test set or adjudication is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not relevant or present. This device is a physical pediatric position holder, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not relevant or present.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

Ask a specific question about this device