(190 days)
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.
| Test Name | Acceptance Criteria (Implicit: Met relevant standards/specifications) | Reported Device Performance |
|---|---|---|
| Cleaning Validation | Device can be returned to a like-new condition | Pass |
| Functional Performance and System Compatibility | Performance not negatively impacted by reprocessing | Pass |
| Electromagnetic Compatibility and Electrical Safety | Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-18 | Pass |
| Biocompatibility | Evaluates end-of-life biocompatibility per ISO 10993-1:2018 | Pass |
| Sterilization | Assessed per ISO 11135:2018; residuals per ISO 10993-7:2008 | Pass |
| Sterility Assurance Level (from Sterilization test) | Minimum of 10^-6 | Achieved (Implied by Pass) |
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.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.