(117 days)
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.
| Acceptance Criteria (Inferred from testing descriptions) | Reported Device Performance |
|---|---|
| Biocompatibility requirements per ISO 10993-1 | Met |
| EMC compliance and electrical safety per AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-18 | Fully evaluated and tested, found compliant |
| Overall functionality (pre-operative planning, workflow, latency, functional safety, irrigation/aspiration, general functionality) | Conforms to design specifications, meets intended user needs, satisfied all sub-system specifications, exhibits electrical, mechanical, and functional integrity |
| User needs and safety/effectiveness under simulated use clinical conditions | Design meets intended user requirements and facilitates safe and effective use |
| Safe and effective use by representative users during a simulated bronchoscopy procedure after training | Assessed as safe and effective |
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.
§ 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.