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The Monarch Endoscopy Platform (Monarch Platform) and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

The Monarch™ Endoscopy Platform (Monarch Platform) is intended to be used by qualified physicians to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Monarch Platform consists of three major components, (1) Monarch™ Endoscopy Cart, (2) Monarch™ Endoscopy Tower, and (3) Monarch™ Bronchoscope System, and working channel instruments.

The Monarch Cart provides support for the effector arms. It includes two robotic arms and the electronic systems required to power and operate the robotic system.

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. In addition, the tower includes an endoscopic controller that allows the user to control the system during a procedure.

The user controls the system with an endoscopic controller which transmits user inputs through the electromechanical system to the end effectors. The Monarch Bronchoscope System comprising of a bronchoscope and sheath is attached at the end effector of a robotic arm with multiple degrees of freedom. The flexible bronchoscope has a working channel and a camera at the tip. The bronchoscope has an articulated tip that can bend in all directions. The working channel of the bronchoscope is used for irrigation, aspiration and to deliver the working channel instruments.

The single-use manually controlled working channel instruments compatible with the Monarch Platform include the Aspirating Biopsy Needle, Biopsy Forceps, and Cytology Brush. All three have the same technological characteristics as the respective predicates and reference devices, that is, they are intended to operate in the same manner for collection of tissue or cells in the patient's lungs through a flexible endoscope or other working channel.

The Aspirating Biopsy Needle is comprised of a polymeric shaft with a needle joined to the distal end. A Luer fitting at the proximal end of the shaft allows the user to provide suction to the needle via the supplied syringe. A handle mechanism interfaces with the shaft to provide extension and retraction of the needle, and an outer jacket provides protection when the needle is not in use.

The Cytology Brush is comprised of an outer sheath and an inner catheter assembly. The inner catheter assembly consists of a thumb ring at the proximal end and a shaft to connect to the distal end which terminates in a brush. When the catheter is inserted into a working channel, the distal brush would be in a retracted position inside the outer sheath. When the catheter is in position, the brush can be extended into the tissue to obtain samples by advancing the proximal thumb ring.

The Biopsy Forceps instrument is comprised of a coil pipe with a mechanical jaw assembly joined to the distal end. The jaws are opened by sliding the outer handle component distally relative to the inner, longer handle component. The jaws are closed by squeezing the two components together.

The Monarch Endoscopy Platform (Monarch Platform) and its accessories were evaluated for safety and effectiveness through various performance tests, including biocompatibility, electrical safety, electromagnetic compatibility, software verification and validation, specific component performance testing, a navigational accuracy comparative study, animal and cadaver testing, and usability/human factors testing.

Here's a breakdown of the acceptance criteria and the studies performed, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a table format with specific quantitative targets for the Monarch Endoscopy Platform as a whole, or for each individual performance test. Instead, it states that the device "successfully tested for function, performance, and safety per FDA-recognized standards" and "complies with" or "conforms to" specific standards and design specifications. For the Navigational Accuracy Comparative Study, it mentions "substantially equivalent segmental, sub-segmental accuracy and on target accuracy, and thus equivalent Navigation Yield" compared to the predicate.

Therefore, a direct table of "acceptance criteria" and "reported performance" like for a diagnostic accuracy study is not directly extractable for every aspect. However, we can synthesize the information for the Navigational Accuracy Comparative Study:

For all other performance testing categories (Biocompatibility, Electrical Safety, EMC, Software V&V, specific component testing, animal/cadaver, usability/human factors), the acceptance criterion was "compliance with recognized standards" and "meeting intended user requirements/design specifications," and the reported performance was that the device met these.

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

The document does not specify a distinct "test set" and corresponding sample sizes for most of the performance evaluations in terms of human subjects or distinct data points in a clinical context. The studies involved:

• Navigational Accuracy Comparative Study: The document doesn't explicitly state the sample size (number of cases or measurements) used in this comparative study.
  • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
• Animal and Cadaver Testing: Performed to evaluate the Monarch Platform under simulated use conditions.
  • Sample Size: Not specified (number of animals/cadavers).
  • Data Provenance: Prospective, simulated use.
• Usability/Human Factors Testing:
  • Sample Size: Not specified (number of representative users).
  • Data Provenance: Prospective, simulated use.
• Biocompatibility, Electrical Safety, EMC, Software V&V, and individual component performance testing: These are typically bench tests or engineering evaluations, not usually associated with a "test set" sample size in the clinical data sense.

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

This information is not provided in the document for any of the studies described. The studies appear to be primarily engineering, non-clinical (animal/cadaver), and simulated use evaluations rather than studies requiring expert adjudication of ground truth for diagnostic accuracy in patient data.

4. Adjudication Method for the Test Set

Since the document does not describe studies involving human medical experts establishing ground truth for a diagnostic test set, there is no mention of an adjudication method (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned in the provided text. The "Navigational Accuracy Comparative Study" compares the Monarch Platform's navigation metrics to the superDimension™ System, but it's not described as an MRMC study and therefore no effect size of human readers improving with AI vs. without AI assistance is provided. The Monarch Platform is described as a robotic endoscopy system that assists physicians, but the focus of the performance data section is on the device's inherent capabilities and comparison to existing technologies, not on augmented human performance in an MRMC setting.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The performance testing section primarily describes standalone performance aspects of the Monarch Platform and its accessories (e.g., biocompatibility, electrical safety, software V&V, mechanical performance of instruments, navigational accuracy of the system). The navigational accuracy study comparing Monarch and superDimension™ evaluates the system's navigation performance itself. The animal, cadaver, and usability studies involve human users but evaluate the system's safety and effectiveness with human interaction, not a standalone algorithm's diagnostic performance in the absence of human input.

Therefore, while the individual component and software testing represent "standalone" evaluations of those specific parts, a standalone diagnostic algorithm performance study (without human-in-the-loop) for a clinical outcome is not explicitly detailed as described for typical AI/ML devices. The Monarch Platform is a surgical robotic system with navigation features, so its "standalone" performance relates to its ability to perform its function (e.g., navigate, manipulate instruments) rather than to interpret images or diagnose conditions like a standalone AI diagnostic software.

7. The Type of Ground Truth Used

For the specific tests mentioned:

• Navigational Accuracy Comparative Study: The "ground truth" for navigation metrics (segmental, sub-segmental accuracy, on-target accuracy, distance to target) would likely be established through precise measurements against a known anatomical model or imaging data, but the document does not specify the exact method for this ground truth establishment.
• Animal and Cadaver Testing: Ground truth established through observation of the system's performance and impact on the tissues/anatomy, likely assessed by skilled medical professionals involved in the study.
• Usability/Human Factors Testing: Ground truth related to user needs, safety, and effectiveness is established through defined task completion rates, error rates, and user feedback against pre-defined success criteria.
• Other performance tests (biocompatibility, electrical safety, etc.): Ground truth is established by adherence to recognized international standards and engineering specifications.

8. The Sample Size for the Training Set

The document does not mention a training set size. This is expected as the Monarch Platform is described as a robotic surgical system with navigation, not a machine learning or AI diagnostic device that typically requires a large training set of annotated data for model development. The software verification and validation are mentioned, but this refers to traditional software development and testing, not AI/ML model training.

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

As no training set is mentioned in the context of an AI/ML model, there is no information on how its ground truth was established.

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