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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 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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