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The Salter Labs Trach-Vac endotracheal tubes are indicated for nasal or oral intubation of the trachea for anesthesia and airway management, including mechanical ventilation and suctioning of accumulated subglottic secretions in the trachea of adult patients.

The Salter Labs Trach-Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff TM (polyurethane) and The Salter Labs Trach-Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip™ and Salter ThinCuff TM (polyvinylchloride) are cuffed, sterile, single-use devices supplied with a standard 15mm conical connector. They are made primarily of polyvinylchloride with either a polyurethane (PU) or PVC cuff. In addition to the main lumen, the tube has a separate cuff inflation line and Evac lumen which has a dorsal opening above the cuff. A capped luer-style connection tube allows access to the separate lumen, enabling the health care professional to apply the suction to remove patient secretions. The tube incorporates a Magill curve, a hooded tip with two Murphy Eyes and a radiopaque line over the full length of the tube to assist in radiographic visualization.

The provided text describes a 510(k) premarket notification for a medical device, the Salter Labs Trach-Vac Endotracheal Tube. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study proving performance against acceptance criteria in the context of an AI/ML device.

Therefore, many of the requested categories for AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this document.

However, I can extract information related to the device's technical specifications and how its performance was evaluated to demonstrate substantial equivalence for a non-AI/ML medical device.

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the way an AI/ML study would define performance metrics and thresholds. Instead, it demonstrates performance by showing compliance with recognized standards and similarity to a predicate device. The "reported device performance" is essentially the device meeting these standards and exhibiting similar characteristics to the predicate.

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