(246 days)
The Medrobotics Flex® System is a device that is intended for robot-assisted visualization and surgical site access to the oropharynx, hypopharynx, and larynx in adults (≥ 22 years of age). The Flex System also provides accessory channels for compatible flexible instruments used in surgery.
The Flex® Robotic System is an operator-controlled flexible scope that provides the benefits of both a rigid endoscope and a computer assisted controller. The Flex® Robotic System allows for the scope to be introduced via an operator-controlled user interface easily providing visualization and access of structures within the oropharynx and hypopharynx and larynx. Visualization is provided by a HD 2D/3D digital camera attached at the distal end of the scope. The Flex Robotic System's scope also provides two accessory channels for use of varied flexible instruments.
The provided document does not describe a study proving the device meets specific acceptance criteria in terms of diagnostic performance or clinical outcomes. Instead, it details the verification and validation (V&V) testing performed to demonstrate that the Medrobotics Flex® Robotic System (K170453), a modified version of a previously cleared predicate device, maintains its functional, performance, and safety specifications. The device is a surgical robotic system for visualization and access, not a diagnostic AI.
Therefore, many of the requested categories, such as "reported device performance," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set sample size," and "how ground truth for training set was established," are not applicable to the regulatory submission described. The acceptance criteria relate to engineering and safety standards, rather than diagnostic accuracy or clinical effectiveness in the way an AI model for diagnosis would be evaluated.
Here's an overview of the information that is present in relation to acceptance criteria and "studies" (which are primarily engineering and usability tests):
1. Table of Acceptance Criteria and Reported Device Performance
As noted, this device is a surgical robotic system, and its "performance" is assessed against engineering, safety, and functionality standards. There are no performance metrics directly comparable to those for a diagnostic AI (e.g., sensitivity, specificity). The "acceptance criteria" are compliance with established standards, and the "reported device performance" is that it successfully met these standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Reliability | Testing performed and successfully met specifications. Specific metrics not detailed but implied to meet internal design requirements. (p. 4) |
| Vision and Video Subsystem and System | Testing performed and successfully met specifications. Camera performance and reliability testing demonstrated minor differences from predicate do not raise new questions of safety or effectiveness. (p. 4, 8) |
| Software Verification and Validation | Classified as "moderate level of concern" and verified/validated per FDA guidance. (p. 4) |
| Reusable Camera Testing | Testing performed successfully. (p. 4) |
| Ship Testing | Met applicable ISTA standards, demonstrating ability to withstand anticipated shipping conditions. (p. 4, 5) |
| Mechanical Requirements Testing | Testing performed successfully. (p. 4) |
| Safety Subsystem Testing | Testing performed successfully. (p. 4) |
| System Electrical and Board Requirements | Testing performed successfully. (p. 4) |
| Usability/Human Factors | Met intended user requirements and facilitated safe and effective user interactions per FDA guidance and other reference. (p. 5) |
| Electrical Safety | Compliant with IEC 60601-1 Ed: 3.1, ANSI/AAMI ES60601-1, IEC 60601-1-6, IEC 62366, IEC 60601-1-4. (p. 5, 17) |
| Electromagnetic Compatibility (EMC) | Compliant with EN 60601-1-2:2007/AC:2010 and IEC 60601-1-2 Ed 3.0. (p. 5, 6, 17) |
| Biocompatibility | Patient-contacting materials (Flex Drive and Camera) classified as "external communicating device," "tissue/bone/dentin" contact, "limited exposure" (≤24 hrs). Testing performed per ANSI/AAMI/ISO/EN 10993-1, or rationale provided for not testing. (p. 6, 9) |
| Sterilization (Flex® Drive) | EtO cycle validated to a Sterility Assurance Level (SAL) of 10-6 per ANSI/AAMI/ISO 11135-1, AAMI TIR 11135-2, AAMI TIR 28, ANSI/AAMI/ISO/EN 10993-7. (p. 6) |
| Sterilization (Reusable Components - Flex® Camera, Flex® Instrument Support) | Recommended cleaning and sterilization instructions validated per AAMI TIR12, AAMI TIR30, EN ISO 17664, ANSI/AAMI ST81, ISO TS 15883-5, ANSI/AAMI ST77, ANSI/AAMI ST79, ANSI/AAMI/ISO 14937, ANSI/AAMI/ISO 17665-1, ISO 17665-2, FDA guidance. (p. 6, 7, 17) |
| Shelf Life (Flex® Drive) | Functional testing demonstrated stability over labeled shelf life. (p. 6) |
| Comparison to Predicate Device | Concluded to be substantially equivalent to the predicate device (K150776) in terms of safety and effectiveness, despite minor differences in camera, illumination, and housing. (p. 7-9, 17) |
2. Sample Size for Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The "tests" described are engineering, safety, and functionality validations, not evaluations of diagnostic accuracy on a case dataset.
- Data Provenance: Not applicable. The tests are bench tests, usability studies (likely in a simulated environment with human participants, but not using clinical patient data in the typical sense of AI model evaluation), and compliance testing against international standards for medical devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: The usability/human factors testing involved "representative end users (i.e., surgeons and nurses/technicians)" (p. 5). The exact number is not specified in this summary.
- Qualifications of Experts: "Surgeons and nurses/technicians" are mentioned as representative end-users for usability testing. Further specific qualifications (e.g., years of experience, subspecialty) are not provided in this document.
- Ground Truth: For usability, the "ground truth" would be safe and effective interaction and meeting user needs, based on observation and feedback from these representative users.
4. Adjudication Method for the Test Set
- Not applicable in the context of diagnostic performance. For usability testing, adjudication methods would typically involve observers and analysis of user performance against predefined tasks and error rates, but specific details are not provided beyond the general statement that testing "demonstrated that the Flex® Robotic System design meets the intended user requirements and facilitates safe and effective user interactions."
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
- No, an MRMC comparative effectiveness study was not done. This device is a surgical robotic system for visualization and access, not an AI for image interpretation or diagnosis. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, standalone performance testing (in the sense of an AI algorithm performing a diagnostic task independently) was not done. The primary function of this device is to assist a human surgeon in performing a procedure.
7. The Type of Ground Truth Used
- For biocompatibility: Compliance with ISO 10993 standards and a rationale for not testing for specific components.
- For sterilization: Validation to a Sterility Assurance Level (SAL) of 10-6 and compliance with relevant ISO/AAMI standards.
- For electrical safety and EMC: Compliance with IEC standards.
- For usability: Safe and effective user interaction as observed and assessed by human factors experts (not detailed).
- For functional and performance testing: Meeting internal design specifications and comparing favorably to the predicate device.
- No clinical ground truth (e.g., pathology, outcomes data) was used in the context of diagnostic accuracy, as this is not a diagnostic device.
8. The Sample Size for the Training Set
- Not applicable. This document describes a robotic surgical system, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for the system refers to its design and engineering iterations, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for an AI model in this context.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.