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The MONARCHTM Bronchoscope and the MONARCHTM Platform and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

The MONARCH Platform is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The MONARCH Platform enables robotic electro-mechanical articulation and precise control of a flexible bronchoscope under continuous and direct control by a physician operator.

The MONARCH Platform allows for precise access of the lung anatomy and continuous visualization using the bronchoscope distal tip camera. The MONARCH Platform consists of four major components, (1) MONARCHTM Cart, (2) MONARCHTM Tower, (3) MONARCHTM Bronchoscope, (4) MONARCHTM Controller and working channel instruments and accessories. The MONARCH Cart provides support for the effector arms. It includes up to three robotic arms and the electronic systems required to power and operate the robotic system. The robotic arms possess multiple degrees of freedom. The MONARCH Tower is the primary user (i.e. physician) procedural display interface. It contains a monitor for user viewing and computers running the system software. The tower provides connectivity for the bronchoscope camera and lighting, as well as the fluidics system. The user controls the system with an endoscopic controller which transmits user inputs through the electromechanical system to the bronchoscope. The flexible MONARCH Bronchoscope has a working channel and a camera at the distal end. The working channel of the Bronchoscope is used for irrigation, aspiration and to deliver the working channel instruments.

Additionally, the Monarch Platform includes electromagnetic (EM) navigation and integrates a pre-operative computed tomography (CT) scan into an intra-operative interface, displaying the modeled bronchoscope tip location relative to the pre-operative scan anatomy.

The MONARCH Platform is being updated to receive 3D imaging data via an ethernet connection directly from a Cone Beam CT (CBCT) System with 3D imaging technology. This will enable real time navigation updates during a procedure with the device. This integration feature is optional for the user, but if selected, use of the MONARCHTM Window Field Generator is required.

The modified device includes software updates for navigation and presentation of the anatomy for display and planning purposes, firmware updates for a revised controller, and hardware and software revisions for the purposes of cybersecurity.

The document provided does not contain a table of acceptance criteria and reported device performance. It outlines various non-clinical performance tests conducted to verify the modified MONARCH™ Platform's safety and effectiveness.

Here's the information that could be extracted from the document:

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

The document does not provide a specific table with acceptance criteria and corresponding reported device performance values. However, it lists several non-clinical tests performed and states that the device "passed all tests in accordance with appropriate test criteria and standards."

Non-Clinical Performance Tests Performed:

• Proof of Design electrical tests: Verified all hardware modules perform within specifications.
• Location accuracy tests: For navigation purposes.
• Software functional tests: Covered complete system functionality, including error handling, usability, time, and ability to receive, process, and display imaging data from cone beam CT Systems.
• Safety, EMC, and mechanical tests: Performed by an independent nationally recognized testing laboratory to verify compliance with safety and EMC standards for medical devices to address hardware changes.
• Simulated use accuracy test: A complete CT image registration and instrument navigation workflow was performed to verify the overall accuracy of the system.
• Usability (Human Factors) Pre-clinical (cadaver) tests: Designed to mimic surgical procedures using the MONARCH™ Platform in a simulated clinical environment to assess the execution of a complete robotically assisted bronchoscopy procedure workflow and to qualitatively estimate the system clinical accuracy.

Reported Performance (General Statement):

"The proposed MONARCH Platform passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness."

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 mentions "Simulated use accuracy test" and "Usability (Human Factors) Pre-clinical (cadaver) tests."

• For the simulated use accuracy test, no specific sample size (number of cases or measurements) is provided.
• For the usability (human factors) pre-clinical tests, it states "cadaver tests," indicating ex-vivo human anatomical models were used.
• The document does not specify the country of origin or whether the data was retrospective or prospective.

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)

The document does not provide information on the number or qualifications of experts used to establish ground truth for any of the tests. For the human factors/cadaver testing, it states the tests were "designed to mimic surgical procedures...to qualitatively estimate the system clinical accuracy," implying expert involvement, but no details are given.

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

The document does not mention any adjudication method used for either the test set (if referring to the simulated or cadaver testing) or for establishing ground truth.

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

The document does not describe an MRMC comparative effectiveness study or any study evaluating the improvement of human readers with vs. without AI assistance. The focus of this submission is on updates to the MONARCH™ Platform for direct Cone Beam CT integration and cybersecurity, rather than a new AI-driven diagnostic or assistive feature assessed with human readers.

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

The document specifically describes the MONARCH™ Platform as enabling "robotic electro-mechanical articulation and precise control of a flexible bronchoscope under continuous and direct control by a physician operator." The tests performed are in the context of this human-in-the-loop operation, for example, "Simulated use accuracy test, in which a complete CT image registration and instrument navigation workflow was performed." Therefore, a standalone algorithm-only performance study without human-in-the-loop was not performed or described as relevant to this device update. The closest to an 'algorithm only' test would be software functional tests and location accuracy tests, but these are components of the overall human-controlled system.

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

The document refers to "location accuracy tests," and "simulated use accuracy test" which implies a quantitative ground truth for positional accuracy. For the "Usability (Human Factors) Pre-clinical (cadaver) tests," the goal was to "qualitatively estimate the system clinical accuracy," suggesting subjective expert assessment in a simulated environment, without specifying a formal ground truth like pathology or outcomes data.

8. The sample size for the training set

The document does not mention a training set or its sample size. This submission focuses on modifications to an existing device (software updates for navigation and display, firmware for a revised controller, and cybersecurity revisions) and integrates new input from CBCT, rather than describing a new AI model that would typically require a training set.

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

As no training set is mentioned, information on how its ground truth was established is not provided.

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