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Provide tracheal access for airway management and subglottic secretion management in adult patients. It is also intended for use with percutaneous dilatational tracheotomy (PDT) procedures.

The subject device is a single patient use tracheostomy tube that features an outer cannula with a radiopaque line alonq its length and a standard 15mm connector for direct connection to standard ventilation and anesthesia equipment. It has an integrated evac suction line in the outer cannula for suctioning of subqlottic secretions that may pool above the cuff. It is available in three configurations: single cannula (no inner cannula), disposable inner cannula (DIC) and single patient use reusable inner cannula (RIC).

It appears there may be a misunderstanding. The document provided is an FDA 510(k) clearance letter and associated summary for a medical device (tracheostomy tube), not a study proving an AI/software device meets acceptance criteria.

The document details the equivalence of a new tracheostomy tube (Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff) to previously cleared predicate devices, based on similar technological characteristics, intended use, and performance data from bench testing, biocompatibility, sterilization, and human factors. It does not involve AI or software, and therefore, it does not contain the information you requested about acceptance criteria and a study proving an AI device's performance.

To answer your request, I would need a document describing an AI/software medical device's performance study, including its acceptance criteria and the results of that study.

The document you provided is about a conventional medical device.

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Portex® Blue Line® SACETT™ is intended for oral intubation only for airway management of patients anticipated to require prolonged mechanical ventilation in critical care units. The product may be inserted in the emergency room or pre-hospital to avoid the need for re-intubation, SACETT™'s dorsal suction lumen allows drainage by continuous or intermittent suctioning of contaminated mucous and subglottis secretion that accumulate above the cuff.

Single use Tracheal tube with integral suction line for lavage and evacuation above the cuff. The product design is based upon a tracheal tube with the addition of a third (integral) lumen within the tube. The lumen terminates above the cuff via a 'notch' which enables the entrance (via suction) of secretions which have pooled above the cuff into the third (suction) lumen. Approximately half way along the tube length the suction lumen is joined to a suction line which is external to the main tube. The suction line is joined to the suction lumen in a similar manner to that of the joint between the inflation line and the inflation lumen. The distal (clinician) end of the suction line terminates in a connector which can be connected to either suction tubing or a syringe.

This is a 510(k) summary for a medical device called the Portex® Blue Line® SACETT™ Suction Above the Cuff Tracheal Tube. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, there are no explicit acceptance criteria or reported device performance metrics that would typically be found in a study proving the device meets specific performance thresholds (e.g., sensitivity, specificity, accuracy).

The document is a 510(k) premarket notification, which focuses on demonstrating "substantial equivalence" to existing, legally marketed predicate devices, rather than proving a new device's performance against predefined acceptance criteria from a clinical trial.

Instead, the submission states:

• "The Portex® Blue Line® SACETT™ Suction Above the Cuff Tracheal Tube has the same intended use as the Mallinckrodt Medical Hi-Lo™ Evac Endotracheal Tube."
• "The Portex® Blue Line® SACETT™ Suction Above the Cuff Tracheal Tube is composed essentially of the same materials as the Portex Tracheal Tube and the Portex® Blue Line® Ultra Suctionaid (BLUS) Tracheostomy Tube."
• "The Portex® Blue Line® SACETT™ Suction Above the Cuff Tracheal Tube incorporates a number of design and performance characteristics from the Mallinckrodt Hi-Lo™ Evac Endotracheal Tube, the Portex Tracheal Tube and the Portex® Blue Line® Ultra Suctionaid Tracheostomy Tube, including similar sterilisation and packaging processes."
• "The determination of substantial equivalence of the Portex® Blue Line® SACETT™ Suction Above the Cuff Tracheal Tube to the predicate devices was based on a comparison of device technological characteristics and materials of composition."

Therefore, the "acceptance criteria" are implied to be that the device's technological characteristics, materials, intended use, and performance characteristics are substantially equivalent to the cited predicate devices. There are no quantitative performance metrics for the SACETT™ device itself presented in this summary to fill a table.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable. The document does not describe a study with a test set in the conventional sense of a clinical trial or performance evaluation with patient data. The basis for equivalence is a comparison of design, materials, and intended use, not observed performance on a sample of patients or specimens.
• Data Provenance: Not applicable, as there's no study explicitly described providing new data. The information is based on the design and characteristics of the new device in comparison to existing predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. There is no mention of experts establishing a ground truth for a test set. The assessment is a regulatory review by the FDA based on the provided technical documentation and comparison to predicate devices, not an expert panel reviewing performance data.

4. Adjudication Method for the Test Set:

• Not applicable. There is no test set or adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. The document presents a 510(k) summary for a physical medical device (tracheal tube), not an AI-powered diagnostic tool. Therefore, an MRMC study and effects of AI assistance are not relevant or described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• Not applicable in the context of device performance data. The "ground truth" for the 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices, against which the new device is compared for substantial equivalence in terms of design, materials, and intended use.

8. The Sample Size for the Training Set:

• Not applicable. As a physical medical device, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. There is no training set for a physical medical device.

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