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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 reprocessed Monarch Bronchoscope, used in conjunction with the Monarch Platform, is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

The 4x reprocessed Monarch Bronchoscope. MBR-000211-B. (hereafter referred to as "Proposed Device") is similar to the 2x reprocessed Monarch Bronchoscope, MBR-000211-B, (hereafter referred to as "Predicate Device").

The Original Monarch Bronchoscope. MBR-000211-A. (hereafter referred to as "Co-Predicate Device") cleared under K193534 is identical to the 2x reprocessed Monarch Bronchoscope ("Predicate Device"), cleared under K203614.

Both device designs are controlled by Auris Health, Inc., throughout their total product lifecycle.

The Monarch Bronchoscope is a component of, and must be used with, the Monarch Platform, cleared under K193534. The Monarch Bronchoscope is connected to the robotic arms of the Monarch Platform to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Proposed Device is a reprocessed single-use device that is either discarded or returned to Auris for reprocessing after clinical use. The original singleuse Monarch Bronchoscope was cleared for one clinical use under K193534. The reprocessed single-use (rSUD) Monarch Bronchoscope was cleared for two (2) clinical uses under K203614. This premarket notification intends to gain market clearance for a reprocessed single-use (rSUD) Monarch Bronchoscope that can be reprocessed up to three (3) times, for a total of four (4) clinical uses.

Identical to the Predicate Device, the Reprocessed Monarch Bronchoscope, consisting of the Inner Scope ("scope") and the Outer Sheath ("sheath"), has 4-way articulation controlled by continuous, direct, visual control of the physician using the Monarch Platform. The Proposed Device contains a working channel through which biopsy devices, or other working channel instruments, may be introduced. The distal tip of the Proposed Device has a camera control unit (CCU) that collects live images that are then transmitted to the physician's display interface of the Monarch Platform. The camera transmits vision data to the Monarch Tower through the camera cable. The single-use, manually controlled, working channel instruments compatible with the Proposed Device are identical to the working channel instruments compatible with the Predicate Device.

The provided text describes the regulatory clearance of a reprocessed medical device, the Monarch Bronchoscope, and its performance testing to demonstrate substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria for a diagnostic algorithm, nor does it detail a study that proves a device meets such criteria in terms of diagnostic performance (e.g., sensitivity, specificity).

The document is a 510(k) premarket notification letter from the FDA, confirming clearance for the "4x reprocessed Monarch Bronchoscope" (meaning it can be reprocessed up to three times for a total of four clinical uses). The performance testing described focuses on the physical and functional integrity of the reprocessed device, not on diagnostic accuracy of an algorithm or an AI component.

Therefore, many of the requested items (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, type of ground truth) are not applicable or cannot be extracted from this document.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent or not relevant to diagnostic algorithm validation:

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

The document provides a list of performance tests conducted for the reprocessed bronchoscope, with "Pass" as the result, indicating that the device met internal design specifications and applicable standards for safe and effective reprocessing. These are functional and safety-related criteria for the physical device, not diagnostic performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The performance tests refer to "worst case device conditioning" but do not specify the number of devices or clinical cases used in these tests. The data provenance is not mentioned.

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)

This information is not applicable to the type of device and testing described. The document pertains to the reprocessing of a physical bronchoscope, not a diagnostic algorithm requiring expert ground truth for image interpretation or diagnosis.

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

This information is not applicable to the type of device and testing described. Adjudication methods are typically relevant for human-in-the-loop or diagnostic studies, which are not detailed here.

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

This information is not applicable to the type of device and testing described. The document does not mention an AI component or any MRMC studies.

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

This information is not applicable to the type of device and testing described. The Monarch Bronchoscope is a physical device; there is no mention of a standalone algorithm.

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

This information is not applicable in the context of diagnostic performance. For the safety and functional tests performed, the "ground truth" would be the established engineering and biological standards and specifications the device aims to meet (e.g., sterility, electrical safety, cleaning effectiveness).

8. The sample size for the training set

This information is not provided and is not applicable as there is no mention of an algorithm or machine learning model being developed or trained.

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

This information is not applicable as there is no mention of algorithmic training or ground truth for such a purpose.

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The Monarch® Platform, Urology and its accessories are intended to access and visualize anatomical locations within the urinary tract and interior of adolescents and adults, aged 12 and up, for diagnostic and therapeutic procedures with transurethral access or transurethral access in conjunction with percutaneous access.

The Monarch® Platform, Urology, the Ureteroscope, and endourology accessories are indicated to provide endoscopic visualization and access of organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) with transurethral access or transurethral access in conjunction with percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The Monarch® Platform, Urology ("Proposed Device") is a capital equipment platform that enables electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures. The ureteroscope and suction catheter move only under continuous and direct physician control, via the Monarch Controller.

The proposed device consists of Monarch® Tower, Monarch® Cart, Monarch® Fluidics Pump, Monarch® Software, Monarch® Controller, Monarch® Ureteroscope and endourology instruments and accessories needed to perform Monarch Urology diagnostic and therapeutic procedures. The device as well as its instruments and accessories are used together during urological diaenostic and therapeutic procedures and are bundled in this 510(k) submission so they can be addressed during one review. The summary descriptions of each component are outlined below.

Monarch® Tower: The Monarch® Tower (Tower) contains the primary procedural display interface for the physician that is provided by a touchscreen monitor for physician viewing and computers running the Monarch software. The monitor has a touchscreen and allows for user input during setup and intra-operative use. The tower has integrated electromagnetic (EM) tracking and video signal processing components. In addition, the tower provides connectivity for the endoscope camera as well as the fluidics pump.

Monarch® Cart: The Monarch® Cart (Cart) contains a touchscreen, three robotic arms and electronic systems required to power and operate the robotic arms. The Cart touchscreens accepts user input and shows instructions for arm deployment and cart functions. The robotic arms possess multiple degrees of freedom. The cart transmits the physician directed movement to the Ureteroscope and other instruments during a procedure.

Monarch® Fluidics Pump: The Monarch® Fluidics Pump (Fluidics Pump) controls the irrigation and suction during a procedure. The Fluidics Pump is connected to the Monarch Tower via an umbilical cable allowing electrical and data communication. The Fluidics Pump provides the physician with the ability to control irrigation and suction levels during a procedure. The Urology Irrigation Cartridge and Suction Set are irrigation and suction tubing provided as sterile accessories to connect the Fluidics Pump to the Ureteroscope and Instruments during ureteroscopy or PCNL procedures.

Monarch® Software: The Monarch® Software provides the user with the ability to safely drive the Monarch® Ureteroscope and Monarch® Mini-PCNL suction catheter around the kidney and within the calyces of interest as well as provides optional navigation guidance to the user to insert the needle to the target during Monarch® PCNL procedure. It receives user input from the Monarch® Controller, computes the appropriate robotic motion to coordinate the movement of the robotic arms and endoscopic devices loaded onto the Cart. It provides a graphical user interface where the endoscopic camera view is shown in real time and displays important system status information.

Monarch® Controller: The Monarch® Controller) is a handheld device that serves as the user interface that allows the physician to control the system during a procedure. An Umbilical cord connects the Controller to the Tower.

Monarch® Ureteroscope: The Monarch® Ureteroscope (Ureteroscope) is comprised of an endoscope that provides vision, illumination, and a working channel to the distal tip of the device. The Ureteroscope can be navigated by the user within the bladder, urinary tract, and kidney. It contains a working channel to accommodate compatible commercially available working channel instruments. The Ureteroscope can be articulated 2-directions (along a single plane) when manually driven or can be articulated 4-directions (along two planes) when mounted to the electromechanical arms under command by the physician using the endoscopic controller. The shaft of the ureteroscope can also be rolled 155° in either direction to reorient the camera and working channel. The Ureteroscope is packaged within the Monarch® Ureteroscopy Kit. The Monarch® Ureteroscopy Kit also includes Ureteroscope Valve, Ureteroscope Driver and Laser Driver (accessories for Ureteroscopy procedure).

Procedural specific instruments and accessories for the proposed device are outlined below, these devices are single-use devices and sterilized via EO.

• Monarch® Mini-PCNL Suction Catheter: The Monarch® Mini-PCNL Suction Catheter ● (Suction Catheter) is part of the Monarch® Mini-PCNL Kit. The Suction Catheter is a flexible device that is inserted into the kidney via antegrade tract under direct visualization from the ureteroscope. It has a center lumen which allows for the suction of stone debris and can articulate in 4 directions. The suction catheter is manipulated by one robotic arm under the control of a physician who is concurrently controlling the Ureteroscope.
• Dilation Set: The Dilation Set is part of the Monarch® Mini-PCNL Kit. The Dilation Set ● includes:
  • 8Fr dilator
  • 10Fr catheter
  • Percutaneous Sheath Dilator ●
• Percutaneous Sheath: The Percutaneous Sheath is part of the Monarch® Mini-PCNL Kit. The Percutaneous Sheath consists of an inner metal sheath with a threaded connection and a metal outer sheath. It is designed to establish percutaneous access and designed to allow simultaneous irrigation and suction of fluid to support removal of kidney stones. The outer sheath has a molded hub with an angled luer connection for irrigation and an insertion depth marking on the distal end.

The provided text describes performance data but does not specify quantifiable acceptance criteria for the Monarch® Platform, Urology device. Instead, it states that the device was tested against internal design specifications and applicable performance standards to demonstrate safety and effectiveness, and that "all intended user needs evaluated met their acceptance criteria." However, what those specific quantitative acceptance criteria were for different aspects (e.g., accuracy, reliability, image quality) and the reported performance against them are not detailed in the provided document.

Therefore, the following information is based on what can be extracted or inferred from the provided sections, recognizing the absence of explicit quantitative acceptance criteria and specific performance metrics for the device itself.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned above, the document does not provide a table of explicit acceptance criteria with specific quantitative targets and corresponding reported device performance values. The general statements are that all tests "Passed" or "met acceptance criteria."

Therefore, I cannot construct the requested table with specific numerical values for acceptance criteria and reported device performance.

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

The document mentions "live porcine model" for Design Validation and "Acute Animal Safety" studies.

• Sample Size for Test Set: Not explicitly stated as a numerical count for either the Design Validation or Acute Animal Safety studies. The phrasing "live porcine model" and "live animal model" are general.
• Data Provenance: The studies were conducted using "live porcine model" and "live animal model," indicating animal testing (pre-clinical). The location or country of origin is not specified, but it suggests a controlled laboratory setting. The studies are prospective in nature, as they involve active testing and data collection.

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

The document mentions "intended users" and "representative users" in the context of Human Factors and Usability evaluation and Design Validation. However, it does not specify the number of experts used to establish ground truth for any test set or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing ground truth for any test set. The term "ground truth" itself is not explicitly used in the context of expert review in the provided text.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

The document does not mention or describe a Multi Reader Multi Case (MRMC) comparative effectiveness study. The Monarch® Platform is described as a capital equipment platform with electromechanical articulation and control, and software for navigation, but there is no indication of an AI component designed to assist human readers in interpretation or diagnosis, nor any study comparing human performance with and without AI assistance.

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

The document describes the Monarch® Platform as a system that requires "continuous and direct physician control" and where "Device movement is only at the command of the physician." The software provides "optional navigation guidance." This indicates that the device is designed for human-in-the-loop operation, and the description does not support the idea of a standalone (algorithm-only) performance study.

7. The Type of Ground Truth Used

Based on the descriptions:

• Design Validation and Acute Animal Safety: The "ground truth" for these studies would implicitly be established through direct observation, physiological measurements, and potentially post-mortem examination in the animal models, assessing safety and functionality in a simulated use environment. This is a form of direct-measurement or observation-based ground truth specific to animal model performance.
• Other tests (Reprocessing, Sterility, Biocompatibility, Electrical Safety, Software, Verification Testing, Human Factors): These rely on adherence to established standards and internal specifications, where "ground truth" is defined by the objective pass/fail criteria of technical tests rather than expert consensus on diagnostic images or pathology.

8. The Sample Size for the Training Set

The document describes pre-market testing and validation for a medical device (Monarch® Platform, Urology). It does not mention a "training set" in the context of machine learning or AI, as the primary focus seems to be on the electromechanical system and software components rather than a learning algorithm that requires a training set.

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

As no "training set" for an AI/ML algorithm is mentioned, this question is not applicable based on the provided text.

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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 reprocessed Monarch Bronchoscope, used in conjunction with the Monarch Platform, is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

The reprocessed Monarch Bronchoscope, MBR-000211-B, (hereafter referred to as "Proposed Device") is identical to the Original Monarch Bronchoscope, MBR-000211-A, (hereafter referred to as "Predicate Device"), which is a component of, and must be used with, the Monarch Platform, cleared under K193534. The Monarch Bronchoscope is connected to the robotic arms of the Monarch Platform to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Proposed Device is a reprocessed single-use device that can be reprocessed up to one (1) time.

The Monarch Bronchoscope, consisting of the Inner Scope ("scope") and the Outer Sheath ("sheath"), has 4-way articulation controlled by continuous, direct, visual control of the physician using the Monarch Platform. The Proposed Device contains a working channel through which biopsy devices, or other working channel instruments, may be introduced. The distal tip of the Proposed Device has a camera control unit (CCU) that collects live images that are then transmitted to the physician's display interface of the Monarch Platform. The camera transmits vision data to the Monarch Tower through the camera cable. The single-use, manually controlled, working channel instruments compatible with the Proposed Device are identical to the working channel instruments compatible with the predicate Monarch Platform bronchoscope.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document implies the acceptance criteria through the description of the tests and the "Pass" results. Specific numerical or qualitative thresholds for "Pass" are not detailed in the provided text.

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

The document does not explicitly state the numerical sample size used for the test set for each performance test. It mentions "worst case device conditioning" for several tests, implying that specific devices were subjected to these conditions.

Regarding data provenance:

• Country of Origin: Not specified in the provided text.
• Retrospective or Prospective: Not explicitly stated. Given the nature of performance testing for reprocessing validation, it would typically involve prospective testing of reprocessed devices.

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

This information is not provided in the given text. The tests described are primarily engineering and safety validation tests (cleaning, functional, electrical, biocompatibility, sterilization) rather than clinical studies requiring expert interpretation of results to establish ground truth in a diagnostic context.

4. Adjudication Method for the Test Set:

This information is not provided in the given text. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading) where disagreement needs resolution. The described tests are objective performance tests which would not typically involve such adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in the provided document. The submission focuses on demonstrating the safety and effectiveness of a reprocessed bronchoscope compared to its original form, primarily through laboratory and performance testing, not direct comparative clinical effectiveness with human readers.

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

This question is not applicable to the device described. The Monarch Bronchoscope is a physical medical device, specifically a reprocessed bronchoscope, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The performance tests described (cleaning, functional, electrical, biocompatibility, sterilization) are evaluations of the hardware itself.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests is established by:

• Engineering Specifications/Design Requirements: Functional and system compatibility tests verify performance against the original design.
• International Standards: Compliance with standards like AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-18 for electrical safety and EMC, ISO 10993-1:2018 for biocompatibility, and ISO 11135:2018 for sterilization.
• Validated Processes: For cleaning and sterilization, the ground truth is established by the successful validation of the reprocessing protocol itself, ensuring devices meet specified cleanliness and sterility levels (e.g., SAL of 10-6).

8. The Sample Size for the Training Set:

This information is not applicable as the device is a reprocessed physical instrument, not an AI/ML algorithm that requires a "training set."

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

This information is not applicable as the device is a reprocessed physical instrument, not an AI/ML algorithm.

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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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