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The Aegis Transit System is intended to aid the surgeon in direct visualization of the mediastinum and facilitate the introduction and removal of surgical instruments during surgical procedures (e.g., lung, tracheal and esophageal procedures, access to aorta for transcatheter valve procedures and/or thoracic endovascular aortic repair).

The Aegis Transit System is specifically indicated for use in the anterior, superior and middle mediastinum.

The proposed Aegis Transit System introduces modifications to the Instructions for Use to propose the use of the two previously cleared Aegis Illuminated Mediastinal Access Ports as a two-step system to improve access and visualization during surgical procedures. The predicate Illuminated Mediastinal Access Ports were cleared under K141622 and K160171. The modifications discussed in this 510(k) submission are listed below:

• . The Directions for Use in the IFU have been clarified to address the use of the two previously cleared Illuminated Mediastinal Access Ports as a two-step system within a single procedure. Please note, the procedural steps that are included in the revised IFU are consistent with the procedural steps that were submitted in K141622 and K160171;
• The indications for use statement has been enhanced to provide examples of the types of procedures in which the transit system may be used;
• . The small (dissecting) trocar handle has been revised to incorporate the ergonomic handle cleared with the large (delivery) trocar under K160171;
• . The polycarbonate material used in the trocar and cannula of both devices has been changed from industrial grade polycarbonate to medical grade polycarbonate; and
• . The packaging has been changed from a nylon/Tyvek heat sealed pouch to a PETG tray with a Tyvek lid.

Both devices are being used in accordance with their cleared indications for use.

This document is a 510(k) premarket notification for the Aegis Transit System, which is a medical device intended to aid surgeons in visualizing the mediastinum and facilitating surgical instrument introduction and removal. The document does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria in terms of clinical accuracy or effectiveness.

Instead, this submission focuses on demonstrating substantial equivalence to already cleared predicate devices (Aegis Surgical, Ltd., Illuminated Mediastinal Access Port, K141622 and K160171) based on technological characteristics and design modifications.

Here's why the requested information cannot be provided from this document:

• Type of Device: The Aegis Transit System is a surgical access system (a mediastinoscope and accessories), not a diagnostic AI/ML device that would typically have performance metrics like sensitivity, specificity, or AUC based on clinical data. Its "performance" is primarily related to its mechanical and material properties, and its ability to provide access and visualization.
• Nature of Submission: A 510(k) submission generally aims to prove that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, or different technological characteristics that do not raise new questions of safety and effectiveness. It does not typically involve showing improved clinical outcomes or diagnostic accuracy via large-scale clinical trials in the way an AI/ML diagnostic would.

Therefore, the following points are not applicable or cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: This document does not establish performance acceptance criteria for clinical accuracy or present data against such criteria. The "performance data" section states "No new bench testing was required" and refers to prior testing for the predicate devices, focusing on the mechanical and material changes.
2. Sample size used for the test set and the data provenance: Not applicable, as there's no clinical "test set" for performance metrics like sensitivity/specificity.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned as this is not an AI/ML diagnostic or image interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as there is no AI/ML component.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide concerning "performance" and "acceptance":

The document effectively describes the changes from the predicate devices and argues that these changes do not raise new questions of safety or effectiveness. The "acceptance criteria" here are implied to be the demonstration of substantial equivalence by showing that:

• The intended use is the same (with enhanced examples of procedures).
• The principle of operation is the same.
• Material changes (from industrial grade to medical grade polycarbonate) are considered improvements or equivalent, leveraging prior testing of the handle design.
• The shelf life has been extended from 3 months to 3 years, implying successful shelf-life testing, though details are not provided in this summary.
• Packaging changes are noted.

The crucial statement regarding performance is in section 1.7: "No new bench testing was required for an assessment of substantial equivalence; the bench testing submitted and reviewed under K141622 and K160171 is applicable to the proposed Aegis Transit System." This indicates that the previous predicate devices' performance data (presumably related to mechanical integrity, biocompatibility, sterilization, etc.) formed the basis for accepting the current device's performance, as the changes were deemed not to impact safety or effectiveness. The modification to the small trocar handle incorporated a design cleared under K160171, and thus, previous testing of that handle was deemed sufficient.

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