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Yagabond for Neonatal Transport: This soft restraint system is indicated for transport of neonates from one hospital to another when isolets are necessary for perservation of life. The Vagabond Neonate Transport System safely insures the well being in the event of sudden jarring or accident. The neonate is proteced withi this special device from lateral or vertical movement due to collision or rough ride.

Vagabond for EMS Transport: This application is used for adults and pediatric patients when they are picked up in the field by Emergency Medical Service personnel and an EMS board is used for transport. Instead of using single straps the Vagabond provides eight points of secure side release locks along iwth a combination of webbing and netting to safely secure the patient to the baord for transport.

Vagabond for Panoose Application: The papose application is necessary for the pediatric patients who require emergency room procedures sucha as suturing or other Minor procedures where they need to remain tionary. The Vagabond board and restrain system comfortabily holds the child in place and can serve as an and for transport whent he child might need to be transferred to another dept. of a hospital. This is accomplished by merely lifting the patient and the board onto a cot or rolling bed.

Yagabond for bed restraint: This restraint is used when patients are sedated or disoriented and there is concern over thier falling out of bed. The Vagabond restraint helps to insure the and there is concent by providing a comfortable restraint that serves to keep them in bed.

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The provided document is a 510(k) clearance letter from the FDA for a device called the "Vagabond Soft Restraint System." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment typically found in a clinical trial or performance evaluation.

However, based on the nature of the document, we can infer some aspects and highlight what information is missing.

What the document tells us (and what it doesn't):

The document grants substantial equivalence to a predicate device, which means the FDA has determined the new device is as safe and effective as a legally marketed device. This process typically relies on comparing the new device's design, materials, and intended use to an existing, approved device, rather than requiring extensive new performance studies against specific acceptance criteria.

Response to your questions based on the provided document:

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

   • Acceptance Criteria: The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, or mechanical stress limits). The acceptance criterion implicitly met is "substantial equivalence" to a predicate device, meaning it performs as safely and effectively as a legally marketed device.
   • Reported Device Performance: The document does not report specific device performance metrics resulting from a study. It only describes the "Indications For Use" for which the device is considered substantially equivalent. These indications describe how it's meant to be used, implying it performs adequately for these uses, but without quantitative data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document does not mention any specific test set sample size or data provenance for a study demonstrating performance. The 510(k) process primarily involves comparing the new device to a predicate, and often relies on bench testing, previous clinical data for the predicate, or design specifications rather than a new large-scale clinical trial for every submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This information is not provided. As no specific test set or clinical study is detailed, the establishment of ground truth by experts is not discussed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This information is not provided. There is no mention of a test set or an adjudication method.

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:

   • This is not applicable. The "Vagabond Soft Restraint System" is a physical restraint device, not an AI-assisted diagnostic tool or an imaging device that would typically involve human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • This is not applicable as the device is a physical restraint system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Since there's no mention of a specific performance study in this document, there's no information on the type of ground truth used. The "ground truth" for a physical restraint device would typically relate to its mechanical integrity, durability, and effectiveness in securing patients according to established safety standards, which are usually assessed through engineering tests and comparison to predicate devices, not clinical outcomes data in the same way as a diagnostic device.

8. The sample size for the training set:

   • This is not applicable. The device is a physical restraint system, not an AI model requiring a training set.

9. How the ground truth for the training set was established:

   • This is not applicable. The device is a physical restraint system.

In summary: The provided document is a regulatory clearance letter, not a scientific study report. It confirms the "Vagabond Soft Restraint System" is substantially equivalent to a legally marketed predicate device for various indications, but it does not detail the specific performance studies, acceptance criteria, or methodological aspects that would be present in a research paper. These types of details are usually contained in the 510(k) submission itself, which is a much larger and more technical document.

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