(115 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 System is an operator-controlled flexible endoscope that provides the benefits of both a rigid endoscope and a computer assisted controller. The Flex System allows for the endoscope to be introduced via an operator-controlled user interface, providing visualization and surgical site access to structures within the oropharynx, and larynx. Like some other video endoscopes, visualization is provided by a digital camera incorporated in the distal end of the endoscope. The Flex System's endoscope also provides two accessory channels for use of varied flexible instruments.
The Medrobotics Flex System acceptance criteria and performance are as follows:
1. Table of Acceptance Criteria & Reported Device Performance:
| Acceptance Criteria (Study Type) | Target Performance | Reported Device Performance |
|---|---|---|
| Clinical Study: Five-Point Visualization & Access Procedure | ||
| Visualization Achieved - Palatine tonsil area | >90% | 100% (45/45 subjects) |
| Access Gained - Palatine tonsil area | >90% | 98% (44/45 subjects) |
| Visualization Achieved - Base of tongue area | >90% | 100% (45/45 subjects) |
| Access Gained - Base of tongue area | >90% | 98% (44/45 subjects) |
| Visualization Achieved - Epiglottis | >90% | 100% (45/45 subjects) |
| Access Gained - Epiglottis | >90% | 98% (44/45 subjects) |
| Visualization Achieved - Posterior pharyngeal wall | >90% | 100% (45/45 subjects) |
| Access Gained - Posterior pharyngeal wall | >90% | 98% (44/45 subjects) |
| Visualization Achieved - False vocal cords | >90% | 93% (42/45 subjects) |
| Access Gained - False vocal cords | >90% | 91% (41/45 subjects) |
| Clinical Study: Surgical Procedures | ||
| Surgical procedures successfully completed with surgical site access and visualization provided by Flex System | Not explicitly defined as a numerical percentage, but generally implied to be high for effectiveness. | 89% of 46 surgical procedures were successfully completed. |
| Bench Testing | Met performance specifications | Met performance specifications (Various tests listed) |
| Transportation Testing | Withstand anticipated shipping conditions | Withstood anticipated shipping conditions |
| Usability/Human Factors Testing | Meets intended user requirements and facilitates safe and effective user interactions with little chance of committing dangerous user errors | Meets intended user requirements and facilitates safe and effective user interactions with little chance of committing dangerous user errors |
| Animal Testing (Abrasion and blunt force trauma) | No increased level of abrasion and/or blunt force trauma compared to intubation control | No increased level of abrasion and/or blunt force trauma compared to intubation control |
| Electrical Safety | Compliance with UL 60601-1, CSA C22.2#601.1, ANSI/AAMI ES60601-1:2005, CAN/CSA-C22.2 No. 60601-1, IEC 60601-1-6, IEC 62366, IEC 60601-1-4 | Compliant |
| Electromagnetic Compatibility Testing | Compliance with EN 60601-1-2:2007/AC:2010, IEC 60601-1-2 Ed. 3.0 | Compliant |
| Biocompatibility (Flex Scope patient-contacting materials) | Pass Cytotoxicity, ISO Systemic Toxicity in Mice, ISO Intracutaneous Study, ISO Maximization Sensitization Study, ISO Oral Mucosal Irritation Test | Passed all studies |
| Sterilization (Flex Scope) | Sterility assurance level (SAL) of 10-6 | Validated to SAL of 10-6 |
| Packaging and Shelf Life (Flex Scope) | Packaging system stable over labeled shelf life | Validated |
| Cleaning and Sterilization of Reusable System Components (Flex Instrument Support) | Compliance with ANSI/AAMI ST79, AAMI TIR12, AAMI TIR30, ANSI/AAMI/ISO 17665-1 | Validated |
| Cleaning and Disinfection (Flex Base, Flex Cart, Stand, Flex Console, Monitor) | Compliance with AAMI TIR12, AAMI TIR30 | Validated |
| Software | Verified and Validated according to FDA guidance for "moderate level of concern" software | Verified and Validated |
2. Sample size used for the test set and the data provenance:
- Clinical Study: 45 subjects.
- Data Provenance: European post-market clinical follow-up study (prospective, originating from Europe).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") used to establish the ground truth for the clinical study. It mentions that "investigator visualized and accessed" the anatomical locations, implying the assessment was made by the medical professionals conducting the study.
4. Adjudication method for the test set:
- The document does not specify an adjudication method like 2+1 or 3+1 for the clinical study results. The reported percentages (e.g., "45 (100%)" or "44 (98%)") suggest direct observation and recording by the study investigators.
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 MRMC comparative effectiveness study was done to compare human readers with and without AI assistance described in this document. The Flex System is a robot-assisted visualization and surgical access device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The Flex System is an "operator-controlled flexible endoscope" and "robot-assisted visualization and surgical site access" device, explicitly designed for human-in-the-loop operation. Therefore, a standalone algorithm-only performance study would not be applicable or conducted for this type of device.
7. The type of ground truth used:
- Clinical Study: The ground truth was based on direct observation and assessment by the study investigators (medical professionals) during the "Five-Point Visualization & Access Procedure" and "Surgical Procedures." This is best described as expert consensus/direct observation by medical professionals.
- Bench, Animal, Electrical Safety, EMC, Biocompatibility, Sterilization, Packaging, Cleaning, Software Testing: Ground truth established through compliance with recognized standards, specifications, and validated test methodologies.
8. The sample size for the training set:
- The document does not provide details about a "training set" in the context of machine learning, as the device primarily involves robotic assistance and control rather than a learning algorithm. The software was verified and validated, but no specific training set size is mentioned.
9. How the ground truth for the training set was established:
- This question is not applicable as there is no mention or indication of a machine learning "training set" or corresponding ground truth establishment process for the Flex System in the provided text. The software validation refers to standard engineering verification and validation processes against requirements and specifications.
§ 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.