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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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The Monarch 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 three major components, (1) Monarch Cart, (2) Monarch Tower, and (3) Monarch Bronchoscope, and working channel instruments and accessories. The Monarch Cart provides support for the robotic arms. It includes up to three robotic arms and the electronic systems required to power and operate the robotic system. The flexible Monarch Bronchoscope has a working channel and a camera at the tip. 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 that integrates a pre-operative computed tomography (CT) scan into an intra-operative interface. displaying the modeled bronchoscope tip location relative to the preoperative scan anatomy. Two options of field generators are available to enable electromagnetic navigation. The current Monarch Navigation Field Generator and a new Window Field Generator (WFG). The new WFG is being added to increase compatibility of the Monarch system with advanced imaging systems (Cone Beam and Mobile CT).

Here's an analysis of the provided text regarding the Monarch Platform's acceptance criteria and study information:

Device Acceptance Criteria and Performance Study Analysis

The document describes the Monarch Platform, a robotic bronchoscopy system. The premarket notification (K211493) focuses on modifications to an existing cleared device (K193534), specifically the introduction of a "Window Field Generator (WFG)" as an optional accessory and minor software changes. Therefore, the performance data presented is primarily to demonstrate that these changes do not raise new questions of safety or effectiveness compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of quantitative acceptance criteria with specific thresholds (e.g., accuracy > 95%). Instead, it generally states that the device was tested to ensure it performs "as intended" and that changes "do not raise different questions of safety or effectiveness."

Here's a summary of the reported device performance based on the general statements:

2. Sample Size and Data Provenance

The document does not specify the sample size used for the test set. It mentions "evaluations of the pertinent parts of workflow impacted by this change with accredited bronchoscopists," but provides no numbers for patients, cases, or procedures.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin. Given the context of a 510(k) submission for a medical device cleared in the U.S., it's highly likely the data would come from U.S. clinical settings, but this is an inference.

3. Number and Qualifications of Experts

The document states that "accredited bronchoscopists" were involved in the "Validation Testing including evaluations of the pertinent parts of workflow." It does not specify the number of experts or their years of experience/specific qualifications beyond being "accredited bronchoscopists."

4. Adjudication Method

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set or for establishing ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No mention is made of a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The study described focuses on verifying the safety and effectiveness of device modifications rather than assessing the AI's impact on human reader performance.

6. Standalone Performance (Algorithm Only)

The document does not explicitly state that a standalone (algorithm only without human-in-the-loop performance) study was done for the navigation updates. The "navigation was updated for smoother virtual views when transitioning between predicted airways" and "An additional condition for which a "Segmentation Failure" notification would be triggered" suggest algorithm internal testing, but no formal standalone performance study results are provided in the summary. The Monarch Platform is an integrated robotic system where the navigation is an aid to the physician, not a standalone diagnostic tool.

7. Type of Ground Truth Used

The type of ground truth for the device's performance, particularly for the navigation and segmentation aspects, is not explicitly defined. However, given the context of bronchoscopic visualization and access, the "ground truth" for the device's ability to maintain its intended function would likely involve:

• Imaging data: Pre-operative CT scans are used for EM navigation, and live endoscopy views provide real-time visualization.
• Expert assessment: "Accredited bronchoscopists" evaluated workflow, implying their professional judgment against clinical standards would serve as a form of ground truth for usability and functional performance.
• Engineering specifications: Performance verification against design specifications would constitute a ground truth for many technical aspects.

Pathology or extensive outcomes data are not mentioned as being used for the performance testing described.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. This is because the submission is for modifications to an already cleared device, and the focus is on verification and validation of the changes, not a de novo AI algorithm development where training data would typically be detailed.

9. How Ground Truth for the Training Set Was Established

Since no training set information is provided, there is no information on how its ground truth would have been established.

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The Monarch 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 three major components, (1) Monarch Cart, (2) Monarch Tower, and (3) Monarch Bronchoscope, and working channel instruments and accessories. The Monarch Cart provides support for the effector arms. It includes 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 tip. The working channel of the Bronchoscope is used for irrigation, aspiration and to deliver the working channel instruments. The singleuse manually controlled Auris instruments compatible with the Monarch Platform include the Aspirating Biopsy Needle, Biopsy Forceps, and Cytology Brush.

Additionally, the Monarch Platform includes electromagnetic (EM) navigation that 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.

This document is a 510(k) summary for the Auris Health, Inc. Monarch Platform, a bronchoscope. It describes the device, its intended use, and a comparison to a predicate device, focusing on functional aspects and basic performance testing rather than specific AI/ML performance metrics typically found in diagnostic device submissions.

Based on the provided text, there is no mention of acceptance criteria or a study that evaluates the device's performance in terms of AI/ML or diagnostic accuracy, which would typically involve metrics like sensitivity, specificity, or accuracy compared to a ground truth. The performance data section focuses on general device functionality, safety, and usability.

Therefore, many of the requested elements for AI/ML performance studies cannot be extracted from this document, as it describes a robotic-assisted bronchoscope rather than an AI-powered diagnostic tool.

However, I can extract information related to the general performance testing and ground truth establishment for the device's functionality:

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

The document does not provide a formal table of acceptance criteria with specific quantitative performance metrics typically associated with AI/ML diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, it describes general verification and validation testing outcomes.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated for specific quantitative metrics or AI model evaluation. The document mentions "animal and cadaver testing" and "simulated use testing."
• Data Provenance: Not specified. Animal and cadaver testing
  and simulated use testing are mentioned, implying experimental data rather than patient data from a specific country. This is prospective testing in a controlled environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable to this type of device submission's performance data. The device's "performance" here refers to its mechanical and functional integrity and usability, not diagnostic accuracy requiring expert ground truth in the traditional sense. The "user needs" and "safe and effective use" would implicitly involve clinical experts as testers/evaluators.

4. Adjudication method for the test set

Not applicable. The performance testing described is mechanical, electrical, and usability verification, not a clinical trial requiring adjudication of diagnostic outcomes.

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

Not applicable. This device is a robotic-assisted bronchoscope, not an AI diagnostic tool. No AI component is described as assisting human readers in interpreting medical images or data. The "AI" in this context refers to robotic control and electromagnetic navigation, not diagnostic decision support.

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

Not applicable. This device is a human-controlled robotic system. Its function inherently involves a human operator ("physician operator").

7. The type of ground truth used

The "ground truth" for the verification and validation tests are:

• Biocompatibility: Established by adherence to ISO 10993-1 standards and the results of specific biological evaluations.
• Electrical Safety and EMC: Established by compliance with international standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18).
• System Level Tests: Established by meeting predefined "design input requirements" and "sub-system specifications."
• Validation Testing (Animal/Cadaver): Established by the device meeting "intended user requirements" and facilitating "safe and effective use" in simulated clinical scenarios. This is essentially functional ground truth based on simulated procedural outcomes.
• Human Factors and Usability Testing: Established by the device being assessed for "safety and effective use" by representative users in simulated procedures, likely against predefined usability objectives.

8. The sample size for the training set

Not applicable. This device is described as a robotic platform for physical procedures, not an AI/ML model that requires a training set of data.

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

Not applicable. As no AI/ML training set is described.

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